Responding to children and adolescents who have been sexually abused: WHO clinical guidelines: web annex 6b: psychosocial and mental health interventions – children and caregivers: GRADE tables

1 | P a g e RESPONDING TO CHILDREN AND ADOLESCENTS WHO HAVE BEEN SEXUALLY ABUSED WHO CLINICAL GUIDELINES Web Annex 6b: Psychosocial and mental health interventions – children and caregivers: GRADE tables *Full guide: https://apps.who.int/iris/bitstream/handle/10665/259270/9789241550147-eng.pdf 2 | P a g e WHO/RHR/17.31 © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial- ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tables: psychosocial and mental health interventions for children and caregivers Recommendation 12 Question – Do psychosocial support interventions (I) involving children/adolescents who are likely to have been sexually abused and their nonoffending parents/caregivers (P), as compared to no or any other intervention (C), improve psychological well-being of parents/caregivers (e.g. stress, stigmatizing behaviours, healthy parent–child interactions, uptake of services) and/or mental health of children (O)? Table 1. Participant and study characteristics Study Intervention (n at baseline) Comparison (n at baseline) Intervention provider Participant mean age in years (range) Participant gender Country (income level, World Bank) Danielson et al. (1) RRFT (n = 15) Treatment as usual (n = 15) Clinical psychology graduate students completing predoctoral internships 14.8 (13–17) 88% adolescent girls 12% adolescent boys United States of America (high) Deblinger et al. (2), Mannarino et al. (3) TF-CBT with trauma narrative (8 weeks) (n = 52) TF-CBT with trauma narrative (16 weeks) (n = 52) TF-CBT, no trauma narrative (8 weeks) (n = 52) TF-CBT, no trauma narrative (16 weeks) (n = 54) Therapists with graduate degrees in psychology, clinical social work, or a related field and at least 3 years of clinical experience 7.6 (4–11) 62% girls 38% boys United States of America (high) Cohen et al. (4), Deblinger et al. (5) TF-CBT (n = 114) Child-centred therapy for treating PTSD (n = 115) Therapists with diverse their professional training (i.e. psychologists and social workers) 10.76 (8–14) 79% girls 21% boys United States of America (high) Deblinger et al. (6) Group-based CBT (n = 23) Supportive group therapy (n = 23) Not stated 8.52 (3–11) 61% girls 39% boys United States of America (high) King et al. (7) Child-alone CBT with a trauma focus (n = 12) Family CBT with a trauma focus (n = 12) Wait-list control (n = 12) Registered psychologists 11.4 (5–17) 69% girls 31% boys Australia (high) Cohen et al. (8), Cohen et al. (9), Cohen et al. (10) TF-CBT (n = 30) Nondirective supportive therapy (n = 19) Master’s level therapists from a clinical social work program 11.1 (7–15) 60% girls 31% boys United States of America (high) Celano et al. (11) CBT with a trauma focus (Recovering Treatment as usual (n = 17) Psychiatrists, psychologists, social workers, nurses and 10.5 (8–13) 100% girls United States of America 4 | P a g e from Abuse Program (RAP)) (n = 15) trainees in psychiatry and psychology (n = 18) (high) Cohen et al. (12), Cohen et al. (13), Cohen et al. (14), Cohen et al. (15) TF-CBT (n = 39) Non-directive supportive counselling (n = 28) Master’s-level clinicians with several years of clinical experience working with sexually abused children 4.68 (2.11–7.1) 58% girls 42% boys United States of America (high) Deblinger et al. (16), Deblinger et al. (17) TF-CBT (n = 25) Mother-only TF-CBT (n = 25) Mother-and-child TF- CBT (n = 25) Community control (standard of care) (n = 25) Mental health therapists trained in experimental CBT 9.84 (7–13) 83% girls 17% boys United States of America (high) Hyde et al. (18) Family/Network meetings Family/Network meetings with the addition of group work Not stated Not stated (4–16) 85% girls 15% boys United Kingdom (high) Notes. RRFT = Risk Reduction through Family Therapy; CBT = cognitive behavioural therapy; TF-CBT = trauma-focused CBT; PTSD = post-traumatic stress disorder; RAP = Recovering from Abuse Program. 5 | P a g e Table 2. Risk-of-bias assessment for the included studies Notes. Risk of bias: low (L), unclear (U) or high (H). Study Seque nce gener ation Allocati on conceal ment Blinding of participants /providers Blinding of outcome assessment Incomplet e outcome data Selective reporting Other bias Overall rating Cohen et al. (4) U U H L U L L L U Cohen et al. (10) L U U L U H L L U Hyde et al. (18) L L H H U L H U King et al. (7) U U U U H L L U Cohen, 1996 (12) L U U U H L L U Deblinger et al. (6) L U U U U L L U Danielson et al. (1) L U U U L L H U Celano et al. (11) U U U L U U L L U Deblinger et al. (2) U U H L H L H L U Deblinger et al. (17) U U U U H H L U 6 | P a g e Table 3.1. GRADE evidence profile: RRFT compared to treatment as usual for child sexual maltreatment Patient or population – Child sexual maltreatment Intervention – RRFT Comparison – Treatment as usual Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with treatment as usual1 Risk with RRFT Immediate post-treatment Change in PTSD (child report) (mixed gender) The mean change in PTSD (child report) was -12.7 The mean change in PTSD (child report) in the intervention group was 9.4 lower (17.39 lower to 1.41 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the adolescent-reported version of the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (UCLA-PTSDRI), 22 items; range 0–88; score ≥ 38 indicates PTSD. Calculated important difference2 shows a large3 effect (SMD = -0.82). Change in PTSD (parent report) (mixed gender) The mean change in PTSD (parent report) was -5.8 The mean change in PTSD (parent report) in the intervention group was 21.1 lower (28.09 lower to 14.11 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the parent-reported version of UCLA-PTSDRI. Calculated important difference shows a large effect (SMD = -2.10). 1 The units in all the GRADE evidence profiles depend on the scale used to measure the outcomes and hence vary across different outcomes. See the last column in each table, on comments, which specifies how outcomes were assessed. 2 This refers to the size of the intervention effect in each study. Where the size of intervention effect is expressed as standardized mean difference (SMD) – it is using a summary statistic because the studies included use a variety of measures or scales to measure the same outcome. SMD therefore expresses the size of the intervention effect in each study relative to the variability observed in that study – i.e. difference in means. 3 According to Cohen’s rule of thumb, where an SMD value under 0.2 indicates no effect; a value of 0.2–0.49 indicates a small effect; a value of 0.5–0.79 indicates a medium effect; and a value of ≥ 0.8, a large effect. Hence an SMD of -1.70 is indicated as having a large effect. 7 | P a g e Patient or population – Child sexual maltreatment Intervention – RRFT Comparison – Treatment as usual Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with treatment as usual1 Risk with RRFT Change in depression (mixed gender) The mean change in depression was -5.3 The mean change in depression in the intervention group was 8.3 lower (14.06 lower to 2.54 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0–2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. Calculated important difference shows a large effect (SMD = -1.00). Change in internalizing symptoms (mixed gender) The mean change in internalizing symptoms was -6.2 The mean change in internalizing symptoms in the intervention group was 8.2 lower (13.26 lower to 3.14 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the adolescent version of the Behavior Assessment System for Children (BASC-2-Int); 150 total items. T scores range from 0 to 100; scores of 60–69 indicate “at risk” and of ≥ 70, clinical diagnosis. Calculated important difference shows a large effect (SMD = -1.13). Change in externalizing symptoms (mixed gender) The mean change in externalizing symptoms was -6.1 The mean change in externalizing symptoms in the intervention group was 3.9 lower (11.5 lower to 3.7 higher) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWc,d Assessed using the adolescent version of the Behavior Assessment System for Children (BASC-2-Ext); 150 total items. T scores range from 0 to 100; scores of 60–69 indicate “at risk” and of ≥70, clinical diagnosis. Calculated important difference shows a small effect (SMD = -0.36). Follow-up at 6 months 8 | P a g e Patient or population – Child sexual maltreatment Intervention – RRFT Comparison – Treatment as usual Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with treatment as usual1 Risk with RRFT Change in PTSD (child report) (mixed gender) Follow-up: mean 6 months The mean change in PTSD (child report) was -11.8 The mean change in PTSD (child report) in the intervention group was 7.8 lower (15.88 lower to 0.28 higher) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWc,d Assessed using the adolescent-reported version of UCLA-PTSDRI. Calculated important difference shows a medium effect (SMD = -0.67). Change in PTSD (parent report) (mixed gender) Follow-up: mean 6 months The mean change in PTSD (parent report) was -6.7 The mean change in PTSD (parent report) in the intervention group was 15.6 lower (23.19 lower to 8.01 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the parent-reported version of UCLA-PTSDRI. Calculated important difference shows a large effect (SMD = -1.43). Change in depression (mixed gender) Follow-up: mean 6 months The mean change in depression was -7.6 The mean change in depression in the intervention group was 8.2 lower (12.83 lower to 3.57 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using CDI27-item . Calculated important difference shows a large effect (SMD = -1.23). Change in internalizing symptoms (mixed gender) Follow-up: mean 6 months The mean change in internalizing symptoms was -5.2 The mean change in internalizing symptoms in the intervention group was 8.7 lower (16.69 lower to 0.71 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the adolescent version of BASC- 2-Int. Calculated important difference shows a medium effect (SMD = -0.76). 9 | P a g e Patient or population – Child sexual maltreatment Intervention – RRFT Comparison – Treatment as usual Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with treatment as usual1 Risk with RRFT Change in externalizing symptoms (mixed gender) Follow-up: mean 6 months The mean change in externalizing symptoms was -4.5 The mean change in externalizing symptoms in the intervention group was 10.2 lower (16.43 lower to 3.97 lower) –– 30 (1 RCT) a ⨁◯◯◯ VERY LOWb Assessed using the adolescent version of BASC- 2-Ext. Calculated important difference shows a large effect (SMD = -1.14). *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect a Danielson et al (1). b Downgraded to very low due to serious concerns about the risk of bias, a sample size < 300 and imprecise effect sizes – see Table 4.1 below. c Downgraded due to serious concerns about the risk of bias – see Table 4.1 below. d Downgraded because of a sample size < 300 and an imprecise effect estimate – see Table 4.1 below. 10 | P a g e Table 4.1. Quality assessment: RRFT compared to treatment as usual for child sexual maltreatment Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations RRFT Treatment as usual Relative (95% CI) Absolute (95% CI) Change in PTSD (child report) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 9.4 lower (17.39 lower to 1.41 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (parent report) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 21.1 lower (28.09 lower to 14.11 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in depression 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 8.3 lower (14.06 lower to 2.54 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in internalizing symptoms 11 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations RRFT Treatment as usual Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 8.2 lower (13.26 lower to 3.14 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 15 15 –– MD 3.9 lower (11.5 lower to 3.7 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (child report) (follow-up: mean 6 months) 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 15 15 –– MD 7.8 lower (15.88 lower to 0.28 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (parent report) (follow-up: mean 6 months) 12 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations RRFT Treatment as usual Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 15.6 lower (23.19 lower to 8.01 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in depression (follow-up: mean 6 months) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 8.2 lower (12.83 lower to 3.57 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in internalizing symptoms (follow-up: mean 6 months) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 8.7 lower (16.69 lower to 0.71 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms (follow-up: mean 6 months) 13 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations RRFT Treatment as usual Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 15 15 –– MD 10.2 lower (16.43 lower to 3.97 lower) ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval; MD: Mean differencea Danielson et al (1). b Serious concerns about the risk of bias and a sample size < 300. c Serious concerns about the risk of bias. d The sample size is < 300 and the effect estimate is imprecise. 14 | P a g e Fig. 1.1. Forest plot: RRFT compared to treatment as usual (TAU) for child sexual maltreatment (immediate post- treatment, child-plus-parent focus) 15 | P a g e Fig. 1.2. Forest plot: RRFT compared to TAU for child sexual maltreatment (follow-up at 6 months, child-plus- parent focus) 16 | P a g e Table 3.2. GRADE evidence profile: CBT with a trauma focus compared to wait-list control for child sexual maltreatment (child-plus-parent focus) Patient or population – Child sexual maltreatment Intervention – CBT with trauma focus Comparison – Wait-list control Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with wait-list control Risk with CBT with a trauma focus Immediate post-treatment Change in PTSD (mixed gender) The mean change in PTSD was -1.47 The mean change in PTSD in the intervention group was 5.61 lower (8.12 lower to 3.1 lower) –– 24 (1 RCT)a ⨁◯◯◯ VERY LOWb Assessed using the 24-item Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) PTSD section of the Anxiety Disorders Interview Schedule (ADIS). The total possible range for the ADIS is 0–28, where a score of ≥ 7 indicates PTSD. Calculated important difference shows a large effect (SMD = -1.73). Change in depression (mixed gender) The mean change in depression was -1.83 The mean change in depression in the intervention group was 4.33 lower (9.82 lower to 1.16 higher) –– 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0–2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. Calculated important difference shows a medium effect (SMD = -0.61). Change in anxiety (mixed gender) The mean change in anxiety was -1.59 The mean change in anxiety in the intervention group was 4.16 lower (14 lower to 5.68 higher) –– 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using the Revised Children’s Manifest Anxiety Scale (R-CMAS), a 37-item instrument (items scored yes or no) with 28 items assessing anxiety (range 0–56) and ≥ 38 indicates anxiety. Calculated important difference shows a small effect (SMD = -0.33). 17 | P a g e Patient or population – Child sexual maltreatment Intervention – CBT with trauma focus Comparison – Wait-list control Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with wait-list control Risk with CBT with a trauma focus Change in internalizing symptoms (mixed gender) The mean change in internalizing symptoms was -5.65 The mean change in internalizing symptoms in the intervention group was 3.94 lower (10.73 lower to 2.85 higher) –– 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using the Children’s Behavior Checklist (CBCL-Int). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and scores > 63 are in the clinical range. Calculated important difference shows a small effect (SMD = -0.45). Change in externalizing symptoms (mixed gender) The mean change in externalizing symptoms was -5.85 The mean change in externalizing symptoms in the intervention group was 4.68 lower (12.96 lower to 3.6 higher) – 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using the Children’s Behavior Checklist (CBCL-Ext). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and scores > 63 are in the clinical range. Calculated important difference shows a small effect (SMD = -0.44). Follow-up at 6 months Change in PTSD (mixed gender) Follow-up: mean 3 months The mean change in PTSD was -1.91 The mean change in PTSD in the intervention group was 4.42 lower (6.97 lower to 1.87 lower) – 24 (1 RCT)a ⨁◯◯◯ VERY LOWb Assessed using the DSM-IV PTSD section of ADIS. Calculated important difference shows a large effect (SMD = -1.34). Change in depression (mixed gender) Follow-up: mean 3 months The mean change in depression was -3.50 The mean change in depression in the intervention group was 2.66 lower (8.37 lower to 3.05 higher) – 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using CDI. Calculated important difference shows a small effect (SMD = -0.36). 18 | P a g e Patient or population – Child sexual maltreatment Intervention – CBT with trauma focus Comparison – Wait-list control Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with wait-list control Risk with CBT with a trauma focus Change in anxiety (mixed gender) Follow-up: mean 3 months The mean change in anxiety was -1.59 The mean change in anxiety in the intervention group was 8 lower (16.27 lower to 0.27 higher) – 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using R-CMAS. Calculated important difference shows a medium effect (SMD = -0.75). Change in internalizing symptoms (mixed gender) Follow-up: mean 3 months The mean change in internalizing symptoms was 0 The mean change in internalizing symptoms in the intervention group was 7.44 lower (16.16 lower to 1.28 higher) – 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using CBCL-Int. Calculated important difference shows a medium effect (SMD = -0.66). Change in externalizing symptoms (mixed gender) Follow-up: mean 3 months The mean change in externalizing symptoms was 0.86 The mean change in externalizing symptoms in the intervention group was 8.76 lower (19.39 lower to 1.87 higher) – 24 (1 RCT)a ⨁◯◯◯ VERY LOWc,d Assessed using CBCL-Ext. Calculated important difference shows a medium effect (SMD = -0.64). *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference 19 | P a g e Patient or population – Child sexual maltreatment Intervention – CBT with trauma focus Comparison – Wait-list control Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with wait-list control Risk with CBT with a trauma focus GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect a King et al. (7). b Downgraded to very low because of serious concerns about the risk of bias and a sample size < 300 – see Table 4.2 below. c Downgraded to very low due to serious concerns about the risk of bias – see Table 4.2 below d Downgraded to very low as the sample size is < 300 and the effect estimate is imprecise – see Table 4.2 below. 20 | P a g e Table 4.2. Quality assessment: TF-CBT compared to wait-list control for child sexual maltreatment (child-plus-parent focus) Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations CBT with trauma focus Wait-list control Relative (95% CI) Absolute (95% CI) Change in PTSD 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 12 12 – MD 5.61 lower (8.12 lower to 3.1 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in depression 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 4.33 lower (9.82 lower to 1.16 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in anxiety 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 4.16 lower (14 lower to 5.68 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in internalizing symptoms 21 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations CBT with trauma focus Wait-list control Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 3.94 lower (10.73 lower to 2.85 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 4.68 lower (12.96 lower to 3.6 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (follow-up: mean 3 months) 1a Randomized trials Seriousb Not serious Not serious Very seriousb None 12 12 – MD 4.42 lower (6.97 lower to 1.87 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in depression (follow-up: mean 3 months) 22 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations CBT with trauma focus Wait-list control Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 2.66 lower (8.37 lower to 3.05 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in anxiety (follow-up: mean 3 months) 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 8 lower (16.27 lower to 0.27 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in internalizing symptoms (follow-up: mean 3 months) 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 7.44 lower (16.16 lower to 1.28 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms (follow-up: mean 3 months) 23 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations CBT with trauma focus Wait-list control Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousc Not serious Not serious Very seriousd None 12 12 – MD 8.76 lower (19.39 lower to 1.87 higher) ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval; MD: Mean difference a King et al. (7). b Serious concerns about the risk of bias and sample size <300. c Serious concerns about the risk of bias. d The sample size is < 300 and the effect estimate is imprecise. 24 | P a g e Fig. 2.1. Forest plot: CBT with trauma focus compared to wait-list control for child sexual maltreatment (immediate post-treatment, child-plus-parent focus) 25 | P a g e Fig. 2.2. Forest plot: CBT with trauma focus compared to wait-list control for child sexual maltreatment (at 3- month follow-up, child-plus-parent focus) 26 | P a g e Table 3.3. GRADE evidence profile: 8-session TF-CBT with trauma narrative compared to 8-session TF-CBT without trauma narrative for child sexual maltreatment Patient or population – Child sexual maltreatment Intervention – 8-session TF-CBT with trauma narrative Comparison – 8-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 8-session TF-CBT without trauma narrative Risk with 8-session TF-CBT with trauma narrative Immediate post-treatment PTSD (re-experiencing) (mixed gender) The mean PTSD (re- experiencing) was 1.79a The mean PTSD (re- experiencing) in the intervention group was 0.07 higher (0.53 lower to 0.67 higher) – 79 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the re-experiencing subscale of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS- E). Possible range not provided. Calculated important difference shows no effect (SMD = 0.05). PTSD (avoidance) (mixed gender) The mean PTSD (avoidance) was 1.8a The mean PTSD (avoidance) in the intervention group was 0.12 lower (0.66 lower to 0.42 higher) – 79 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the avoidance subscale of K- SADS-E. Calculated important difference shows no effect (SMD = -0.10). PTSD (hypervigilance) (mixed gender) The mean PTSD (hypervigilance) was 1.37a The mean PTSD (hypervigilance) in the intervention group was 0.1 lower (0.65 lower to 0.45 higher) – 79 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the hypervigilance subscale of K- SADS-E. Calculated important difference shows no effect (SMD = -0.08). 27 | P a g e Patient or population – Child sexual maltreatment Intervention – 8-session TF-CBT with trauma narrative Comparison – 8-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 8-session TF-CBT without trauma narrative Risk with 8-session TF-CBT with trauma narrative Depression (mixed gender) The mean depression was 6.5a The mean depression in the intervention group was 0.21 lower (3.22 lower to 2.8 higher) – 54 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0–2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. Calculated important difference shows no effect (SMD = -0.04). Anxiety (mixed gender) The mean anxiety was 48.75a The mean anxiety in the intervention group was 11.52 lower (20.49 lower to 2.55 lower) – 54 (1 RCT)c ⨁◯◯◯ VERY LOWf Assessed using the Multi-dimensional Anxiety Scale (MASC), a 39-item scale (range: 0–117). T scores > 70 indicate clinical diagnosis. Calculated important difference shows a medium effect (SMD = -0.68). Internalizing symptoms (mixed gender) The mean internalizing symptoms was 7.15a The mean internalizing symptoms in the intervention group was 0.72 lower (3.49 lower to 2.05 higher) – 78 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Children’s Behavior Checklist (CBCL-Int). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and scores > 63, in the clinical range. Calculated important difference shows no effect (SMD = - 0.11). Externalizing symptoms (mixed gender) The mean externalizing symptoms was 8.59a The mean externalizing symptoms in the intervention group was 1.16 higher (1.6 lower to 3.92 higher) – 78 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Children’s Behavior Checklist (CBCL-Ext). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and scores > 63, in the clinical range. Calculated important difference shows no effect (SMD = 0.18). Follow-up at 6 months 28 | P a g e Patient or population – Child sexual maltreatment Intervention – 8-session TF-CBT with trauma narrative Comparison – 8-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 8-session TF-CBT without trauma narrative Risk with 8-session TF-CBT with trauma narrative PTSD (re-experiencing) (mixed gender) Follow-up: mean 6 months The mean PTSD (re- experiencing) was 1.37 a The mean PTSD (re- experiencing) in the intervention group was 0.07 higher (0.64 lower to 0.78 higher) – 79 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using the re-experiencing subscale of K-SADS-E. Calculated important difference shows no effect (SMD = 0.04). PTSD (avoidance) (mixed gender) Follow-up: mean 6 months The mean PTSD (avoidance) was 1.68a The mean PTSD (avoidance) in the intervention group was 0.75 lower (1.42 lower to 0.08 lower) – 79 (1 RCT)g ⨁◯◯◯ VERY LOWf Assessed using the avoidance subscale of K- SADS-E. Calculated important difference shows a medium effect (SMD = -0.49). PTSD (hypervigilance) (mixed gender) Follow-up: mean 6 months The mean PTSD (hypervigilance) was 1.35a The mean PTSD (hypervigilance) in the intervention group was 0.15 lower (0.84 lower to 0.54 higher) – 79 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using the hypervigilance subscale of K- SADS-E. Calculated important difference shows no effect (SMD = -0.09). Depression (mixed gender) Follow-up: mean 6 months The mean depression was 3.78a The mean depression in the intervention group was 1.87 higher (1.72 lower to 5.46 higher) – 54 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using CDI. Calculated important difference shows a small effect (SMD = 0.27). Anxiety (mixed gender) Follow-up: mean 6 months The mean anxiety was 45.89a The mean anxiety in the intervention group was 11.65 lower (22.09 lower to 1.21 lower) – 54 (1 RCT)g ⨁◯◯◯ VERY LOWf Assessed using MASC. Calculated important difference shows a medium effect (SMD = -0.59). 29 | P a g e Patient or population – Child sexual maltreatment Intervention – 8-session TF-CBT with trauma narrative Comparison – 8-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 8-session TF-CBT without trauma narrative Risk with 8-session TF-CBT with trauma narrative Internalizing symptoms (mixed gender) Follow-up: mean 6 months The mean internalizing symptoms was 6.32a The mean internalizing symptoms in the intervention group was 0.85 higher (2.32 lower to 4.02 higher) – 78 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Int. Calculated important difference shows no effect (SMD = 0.12). Externalizing symptoms (mixed gender) Follow-up: mean 6 months The mean externalizing symptoms was 8.41a The mean externalizing symptoms in the intervention group was 1.72 higher (1.61 lower to 5.05 higher) – 78 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Ext. Calculated important difference shows a small effect (SMD = 0.23). Follow-up at 12 months PTSD (re-experiencing) (mixed gender) Follow-up: mean 12 months The mean PTSD (re- experiencing) was 1.03a The mean PTSD (re- experiencing) in the intervention group was 0.22 higher (0.47 lower to 0.91 higher) – 79 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using the re-experiencing subscale of K-SADS-E. Calculated important difference shows no effect (SMD = 0.14). PTSD (avoidance) (mixed gender) Follow-up: mean 12 months The mean PTSD (avoidance) was 1.36a The mean PTSD (avoidance) in the intervention group was 0.52 lower (1.17 lower to 0.13 higher) – 79 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using the avoidance subscale of K- SADS-E. Calculated important difference shows a small effect (SMD = -0.35). 30 | P a g e Patient or population – Child sexual maltreatment Intervention – 8-session TF-CBT with trauma narrative Comparison – 8-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 8-session TF-CBT without trauma narrative Risk with 8-session TF-CBT with trauma narrative PTSD (hypervigilance) (mixed gender) Follow-up: mean 12 months The mean PTSD (hypervigilance) was 0.9a The mean PTSD (hypervigilance) in the intervention group was 0.16 higher (0.53 lower to 0.85 higher) – 79 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using the hypervigilance subscale of K- SADS-E. Calculated important difference shows no effect (SMD = 0.10). Depression (mixed gender) Follow-up: mean 12 months The mean depression was 4.12a The mean depression in the intervention group was 0.37 higher (3.14 lower to 3.88 higher) – 54 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using CDI. Calculated important difference shows no effect (SMD = 0.06). Anxiety (mixed gender) Follow-up: mean 12 months The mean anxiety was 34.74a The mean anxiety in the intervention group was 2.78 lower (12.88 lower to 7.32 higher) – 54 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using MASC. Calculated important difference shows no effect (SMD = -0.15). Internalizing symptoms (mixed gender) Follow-up: mean 12 months The mean internalizing symptoms was 5.63a The mean internalizing symptoms in the intervention group was 1.1 higher (2.02 lower to 4.22 higher) – 78 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Int. Calculated important difference shows no effect (SMD = 0.15). 31 | P a g e Patient or population – Child sexual maltreatment Intervention – 8-session TF-CBT with trauma narrative Comparison – 8-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 8-session TF-CBT without trauma narrative Risk with 8-session TF-CBT with trauma narrative Externalizing symptoms (mixed gender) Follow-up: mean 12 months The mean externalizing symptoms was 6.4a The mean externalizing symptoms in the intervention group was 3.13 higher (0.01 higher to 6.25 higher)g – 78 (1 RCT)g ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Ext. Calculated important difference shows a small effect (SMD = 0.44). *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect a Data at end-point / follow-up only. c Deblinger et al. (2). d Downgraded to very low because of serious concerns about the risk of bias – see Table 4.3 below. e Downgraded to very low because the sample size is < 300 and the effect estimate is imprecise. f Downgraded to very low because of serious concerns about the risk of bias and a sample size < 300 – see Table 4.3 below g Mannarino et al (3). 32 | P a g e Table 4.3. Quality assessment: 8-session TF-CBT with trauma narrative compared to 8-session TF-CBT without trauma narrative for child sexual maltreatment Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) PTSD (re-experiencing) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40d – MD 0.07 higher (0.53 lower to 0.67 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (avoidance) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40d – MD 0.12 lower (0.66 lower to 0.42 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (hypervigilance) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40d – MD 0.1 lower (0.65 lower to 0.45 higher)e ⨁◯◯◯ VERY LOW CRITICAL 33 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) Depression 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 26 28d – MD 0.21 lower (3.22 lower to 2.8 higher)e ⨁◯◯◯ VERY LOW CRITICAL Anxiety 1a Randomized trials Seriousf Not serious Not serious Very seriousf None 26 28d – MD 11.52 lower (20.49 lower to 2.55 lower)e ⨁◯◯◯ VERY LOW CRITICAL Internalizing symptoms 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 38 40d – MD 0.72 lower (3.49 lower to 2.05 higher)e ⨁◯◯◯ VERY LOW CRITICAL Externalizing symptoms 34 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 38 40d – MD 1.16 higher (1.6 lower to 3.92 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (re-experiencing) (follow-up: mean 6 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40d – MD 0.07 higher (0.64 lower to 0.78 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (avoidance) (follow-up: mean 6 months) 1g Randomized trials Seriousf Not serious Not serious Very seriousf None 39 40d – MD 0.75 lower (1.42 lower to 0.08 lower)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (hypervigilance) (follow-up: mean 6 months) 35 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40d – MD 0.15 lower (0.84 lower to 0.54 higher)e ⨁◯◯◯ VERY LOW CRITICAL Depression (follow-up: mean 6 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 26 28d – MD 1.87 higher (1.72 lower to 5.46 higher)e ⨁◯◯◯ VERY LOW CRITICAL Anxiety (follow-up: mean 6 months) 1g Randomized trials Seriousf Not serious Not serious Very seriousf None 26 28d – MD 11.65 lower (22.09 lower to 1.21 lower)e ⨁◯◯◯ VERY LOW CRITICAL Internalizing symptoms (follow-up: mean 6 months) 36 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 38 40 d – MD 0.85 higher (2.32 lower to 4.02 higher)e ⨁◯◯◯ VERY LOW CRITICAL Externalizing symptoms (follow-up: mean 6 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 38 40d – MD 1.72 higher (1.61 lower to 5.05 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (re-experiencing) (follow-up: mean 12 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40 d – MD 0.22 higher (0.47 lower to 0.91 higher) e ⨁◯◯◯ VERY LOW CRITICAL PTSD (avoidance) (follow-up: mean 12 months) 37 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40 d – MD 0.52 lower (1.17 lower to 0.13 higher) e ⨁◯◯◯ VERY LOW CRITICAL PTSD (hypervigilance) (follow-up: mean 12 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 39 40 d – MD 0.16 higher (0.53 lower to 0.85 higher) e ⨁◯◯◯ VERY LOW CRITICAL Depression (follow-up: mean 12 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 26 28 d – MD 0.37 higher (3.14 lower to 3.88 higher) e ⨁◯◯◯ VERY LOW CRITICAL Anxiety (follow-up: mean 12 months) 38 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 8-session TF-CBT with trauma narrative 8-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 26 28 d – MD 2.78 lower (12.88 lower to 7.32 higher) e ⨁◯◯◯ VERY LOW CRITICAL Internalizing symptoms (follow-up: mean 12 months) 1g Randomized trials Seriousb Not serious Not serious Very seriousc None 38 40 d – MD 1.1 higher (2.02 lower to 4.22 higher) e ⨁◯◯◯ VERY LOW CRITICAL Externalizing symptoms (follow-up: mean 12 months) 1 Randomized trials Seriousb Not serious Not serious Very seriousc None 38 g 40 d – MD 3.13 higher (0.01 higher to 6.25 higher) e ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval; MD: Mean difference a Deblinger et al (2). b Serious concerns about the risk of bias. c Sample size < 300 and imprecise effect estimate. d Data at end-point/follow-up only. e Effect estimate based on differences in end-point/follow-up data. No baseline data available. 39 | P a g e f Serious concerns about the risk of bias and sample size < 300. g Mannarino et al (3). 40 | P a g e Fig. 3.1. Forest plot: 8-session TF-CBT with trauma narrative compared to 8-session TF-CBT without trauma narrative for child sexual maltreatment (immediate post-treatment, child-plus-parent focus) 41 | P a g e Fig. 3.2. Forest plot: 8-session TF-CBT with trauma narrative compared to 8-session TF-CBT without trauma narrative for child sexual maltreatment (follow-up at 6 months, child-plus-parent focus) 42 | P a g e Fig. 3.3. Forest plot: 8-session TF-CBT with trauma narrative compared to 8-session TF-CBT without trauma narrative for child sexual maltreatment (follow-up at 12 month, child-plus-parent focus) 43 | P a g e Table 3.4. GRADE evidence profile: 16-session TF-CBT with trauma narrative compared to 16-session TF-CBT without trauma narrative for child sexual maltreatment Patient or population – Child sexual maltreatment Intervention – 16-session TF-CBT with trauma narrative Comparison – 16-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 16- session TF-CBT without trauma narrative Risk with 16- session TF-CBT with trauma narrative Immediate post-treatment PTSD (re-experiencing) (mixed gender) The mean PTSD (re- experiencing) was 1.03a The mean PTSD (re- experiencing) in the intervention group was 0.42 higher (0.18 lower to 1.02 higher) – 79 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the re-experiencing subscale of the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS- E). Possible range not provided. Calculated important difference shows a small effect (SMD = 0.31). PTSD (avoidance) (mixed gender) The mean PTSD (avoidance) was 1.05 a The mean PTSD (avoidance) in the intervention group was 0.31 higher (0.23 lower to 0.85 higher) – 79 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the avoidance subscale of K- SADS-E). Possible range not provided. Calculated important difference shows a small effect (SMD = 0.25). PTSD (hypervigilance) (mixed gender) The mean PTSD (hypervigilance) was 0.83a The mean PTSD (hypervigilance) in the intervention group was 0.53 higher (0.02 lower to 1.08 higher) – 79 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the hypervigilance subscale of K- SADS-E). Possible range not provided. Calculated important difference shows a small effect (SMD = 0.42). 44 | P a g e Patient or population – Child sexual maltreatment Intervention – 16-session TF-CBT with trauma narrative Comparison – 16-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 16- session TF-CBT without trauma narrative Risk with 16- session TF-CBT with trauma narrative Depression (mixed gender) The mean depression was 6.19a The mean depression in the intervention group was 1.54 lower (4.42 lower to 1.34 higher) – 58 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0–2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. Calculated important difference shows a small effect (SMD = -0.27). Anxiety (mixed gender) The mean anxiety was 36.58a The mean anxiety in the intervention group was 5.42 higher (3.12 lower to 13.96 higher) – 57 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Multi-dimensional Anxiety Scale (MASC), a 39-item scale (range: 0–117). T scores > 70 indicate clinical diagnosis. Calculated important difference shows a small effect (SMD = 0.33). Internalizing symptoms (mixed gender) The mean internalizing symptoms was 3.99a The mean internalizing symptoms in the intervention group was 2.75 higher (0.01 lower to 5.51 higher) – 78 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Children’s Behavior Checklist (CBCL-Int). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and scores > 63 in the clinical range. Calculated important difference shows a small effect (SMD = 0.44). Externalizing symptoms (mixed gender) The mean externalizing symptoms was 6.05a The mean externalizing symptoms in the intervention group was 4.31 higher (1.52 higher to 7.1 higher) – 78 (1 RCT)c ⨁◯◯◯ VERY LOWd,e Assessed using the Children’s Behavior Checklist (CBCL-Ext). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and scores > 63 in the clinical range. Calculated important difference shows a medium effect (SMD = 0.68). Follow-up at 6 months 45 | P a g e Patient or population – Child sexual maltreatment Intervention – 16-session TF-CBT with trauma narrative Comparison – 16-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 16- session TF-CBT without trauma narrative Risk with 16- session TF-CBT with trauma narrative PTSD (re-experiencing) (mixed gender) Follow-up: mean 6 months The mean PTSD (re- experiencing) was 0.92 a The mean PTSD (re- experiencing) in the intervention group was 0.7 higher (0.01 higher to 1.39 higher) – 79 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using the re-experiencing subscale of K-SADS-E). Possible range not provided. Calculated important difference shows a small effect (SMD = 0.44). PTSD (avoidance) (mixed gender) Follow-up: mean 6 months The mean PTSD (avoidance) was 1.00a The mean PTSD (avoidance) in the intervention group was 0.36 higher (0.28 lower to 1 higher) – 79 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using the avoidance subscale of K- SADS-E. Calculated important difference shows a small effect (SMD = 0.25). PTSD (hypervigilance) (mixed gender) Follow-up: mean 6 months The mean PTSD (hypervigilance) was 0.8a The mean PTSD (hypervigilance) in the intervention group was 0.42 higher (0.25 lower to 1.09 higher) – 79 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using the hypervigilance subscale of K- SADS-E. Calculated important difference shows a small effect (SMD = 0.28). Depression (mixed gender) Follow-up: mean 6 months The mean depression was 3.32a The mean depression in the intervention group was 0.71 higher (2.26 lower to 3.68 higher) – 58 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using CDI. Calculated important difference shows no effect (SMD = 0.12). Anxiety (mixed gender) Follow-up: mean 6 months The mean anxiety was 37.64a The mean anxiety in the intervention group was 5.2 higher (3.46 lower to 13.86 higher) – 57 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using MASC. Calculated important difference shows a small effect (SMD = 0.31). 46 | P a g e Patient or population – Child sexual maltreatment Intervention – 16-session TF-CBT with trauma narrative Comparison – 16-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 16- session TF-CBT without trauma narrative Risk with 16- session TF-CBT with trauma narrative Internalizing symptoms (mixed gender) Follow-up: mean 6 months The mean internalizing symptoms was 5.99a The mean internalizing symptoms in the intervention group was 1.7 higher (1.37 lower to 4.77 higher) – 78 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Int. Calculated important difference shows a small effect (SMD = 0.24). Externalizing symptoms (mixed gender) Follow-up: mean 6 months The mean externalizing symptoms was 7.66a The mean externalizing symptoms in the intervention group was 2.68 higher (0.5 lower to 5.86 higher) – 78 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Ext. Calculated important difference shows a small effect (SMD = 0.37). Follow-up at 12 months PTSD (re-experiencing) (mixed gender) Follow-up: mean 12 months The mean PTSD (re- experiencing) was 0.71a The mean PTSD (re- experiencing) in the intervention group was 0.75 higher (0.04 higher to 1.46 higher) – 79 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using the re-experiencing subscale of K-SADS-E. Calculated important difference shows a small effect (SMD = 0.34). PTSD (avoidance) (mixed gender) Follow-up: mean 12 months The mean PTSD (avoidance) was 0.74a The mean PTSD (avoidance) in the intervention group was 0.64 higher (0.03 lower to 1.31 higher) – 79 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using the avoidance subscale of K- SADS-E. Calculated important difference shows a small effect (SMD = 0.42). 47 | P a g e Patient or population – Child sexual maltreatment Intervention – 16-session TF-CBT with trauma narrative Comparison – 16-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 16- session TF-CBT without trauma narrative Risk with 16- session TF-CBT with trauma narrative PTSD (hypervigilance) (mixed gender) Follow-up: mean 12 months The mean PTSD (hypervigilance) was 0.6a The mean PTSD (hypervigilance) in the intervention group was 0.96 higher (0.27 higher to 1.65 higher) – 79 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using the hypervigilance subscale of K- SADS-E. Calculated important difference shows a medium effect (SMD = 0.61). Depression (mixed gender) Follow-up: mean 12 months The mean depression was 4.61a The mean depression in the intervention group was 0.29 higher (2.86 lower to 3.44 higher) – 58 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using CDI. Calculated important difference shows no effect (SMD = 0.05). Anxiety (mixed gender) Follow-up: mean 12 months The mean anxiety was 35.8a The mean anxiety in the intervention group was 2.01 higher (6.96 lower to 10.98 higher) – 57 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using MASC. Calculated important difference shows a no effect (SMD = 0.11). Internalizing symptoms (mixed gender) Follow-up: mean 12 months The mean internalizing symptoms was 5.25a The mean internalizing symptoms in the intervention group was 2.36 higher (0.84 lower to 5.56 higher) – 78 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Int. Calculated important difference shows a small effect (SMD = 0.32). 48 | P a g e Patient or population – Child sexual maltreatment Intervention – 16-session TF-CBT with trauma narrative Comparison – 16-session TF-CBT without trauma narrative Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with 16- session TF-CBT without trauma narrative Risk with 16- session TF-CBT with trauma narrative Externalizing symptoms (mixed gender) Follow-up: mean 12 months The mean externalizing symptoms was 8.06a The mean externalizing symptoms in the intervention group was 2.28 higher (0.92 lower to 5.48 higher) – 78 (1 RCT)f ⨁◯◯◯ VERY LOWd,e Assessed using CBCL-Ext. Calculated important difference shows a small effect (SMD = 0.31). *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect a Data at end-point/follow-up only. c Deblinger et al (2). d Downgraded to very low because of serious concerns about the risk of bias – see Table 4.4 below. e Downgraded to very low because the sample size is < 300 and the effect estimate is imprecise – see Table 4.4 below. f Mannarino et al (3). 49 | P a g e Table 4.4. Quality assessment: 16-session TF-CBT with trauma narrative compared to 16-session TF-CBT without trauma narrative for child sexual maltreatment Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) PTSD (re-experiencing) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.42 higher (0.18 lower to 1.02 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (avoidance) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.31 higher (0.23 lower to 0.85 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (hypervigilance) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.53 higher (0.02 lower to 1.08 higher)e ⨁◯◯◯ VERY LOW CRITICAL 50 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) Depression 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 29 29d – MD 1.54 lower (4.42 lower to 1.34 higher)e ⨁◯◯◯ VERY LOW CRITICAL Anxiety 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 29 28d – MD 5.42 higher (3.12 lower to 13.96 higher)e ⨁◯◯◯ VERY LOW CRITICAL Internalizing symptoms 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 43 35d – MD 2.75 higher (0.01 lower to 5.51 higher)e ⨁◯◯◯ VERY LOW CRITICAL Externalizing symptoms 51 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 43 35d – MD 4.31 higher (1.52 higher to 7.1 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (re-experiencing) (follow-up: mean 6 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.7 higher (0.01 higher to 1.39 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (avoidance) (follow-up: mean 6 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.36 higher (0.28 lower to 1 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (hypervigilance) (follow-up: mean 6 months) 52 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.42 higher (0.25 lower to 1.09 higher)e ⨁◯◯◯ VERY LOW CRITICAL Depression (follow-up: mean 6 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 29 29d – MD 0.71 higher (2.26 lower to 3.68 higher)e ⨁◯◯◯ VERY LOW CRITICAL Anxiety (follo- up: mean 6 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 29 28d – MD 5.2 higher (3.46 lower to 13.86 higher)e ⨁◯◯◯ VERY LOW CRITICAL Internalizing symptoms (follow-up: mean 6 months) 53 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 43 35d – MD 1.7 higher (1.37 lower to 4.77 higher)e ⨁◯◯◯ VERY LOW CRITICAL Externalizing symptoms (follow-up: mean 6 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 43 35 d – MD 2.68 higher (0.5 lower to 5.86 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (re-experiencing) (follow-up: mean 12 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.75 higher (0.04 higher to 1.46 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (avoidance) (follow-up: mean 12 months) 54 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.64 higher (0.03 lower to 1.31 higher)e ⨁◯◯◯ VERY LOW CRITICAL PTSD (hypervigilance) (follow-up: mean 12 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 44 35d – MD 0.96 higher (0.27 higher to 1.65 higher)e ⨁◯◯◯ VERY LOW CRITICAL Depression (follow-up: mean 12 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 29 29d – MD 0.29 higher (2.86 lower to 3.44 higher)e ⨁◯◯◯ VERY LOW CRITICAL Anxiety (follow-up: mean 12 months) 55 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations 16-session TF-CBT with trauma narrative 16-session TF-CBT without trauma narrative Relative (95% CI) Absolute (95% CI) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 29 28d – MD 2.01 higher (6.96 lower to 10.98 higher)e ⨁◯◯◯ VERY LOW CRITICAL Internalizing symptoms (follow-up: mean 12 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 43 35d – MD 2.36 higher (0.84 lower to 5.56 higher)e ⨁◯◯◯ VERY LOW CRITICAL Externalizing symptoms (follow-up: mean 12 months) 1f Randomized trials Seriousb Not serious Not serious Very seriousc None 43 35d – MD 2.28 higher (0.92 lower to 5.48 higher)e ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval; MD: Mean difference a Deblinger et al (2). b Serious concerns about the risk of bias. c Sample size < 300 and imprecise effect estimate. d Data at end-point/follow-up only. e Effect estimate based on differences in end-point/follow-up data. No baseline data available. 56 | P a g e f Mannarino et al (3). 57 | P a g e Fig. 4.1. Forest plot: 16-session TF-CBT with trauma narrative compared to 16-session TF-CBT without trauma narrative for child sexual maltreatment (immediate post-treatment, child-plus-parent focus) 58 | P a g e Fig. 4.2. Forest plot: 16-session TF-CBT with trauma narrative compared to 16-session TF-CBT without trauma narrative for child sexual maltreatment (follow-up at 6 months, child-plus-parent focus) 59 | P a g e Fig. 4.3. Forest plot: 16-session TF-CBT with trauma narrative compared to 16-session TF-CBT without trauma narrative for child sexual maltreatment (follow-up at 12 months, child-plus-parent focus) 60 | P a g e Table 3.5. GRADE evidence profile: TF-CBT compared to non-CBT interventions for child sexual maltreatment (child-plus-parent focus) Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Immediate post-treatment Change in PTSD (mixed gender) – The standardized mean change in PTSD in the intervention group was 0.7 SD lower (1.24 lower to 0.16 lower) – 295 (3 RCTs)a ⨁⨁◯◯ LOWb Assessed with Schedule for Affective Disorders and Schizophrenia for Children (K-SADS-E; range NR) in 2 studies and the Trauma Symptom Checklist for Children (TSC-C), 10 items, range 0–30) in 1 study. Change in PTSD (female only) The mean change in PTSD was -4.4 The mean change in PTSD in the intervention group was 2.4 lower (6.74 lower to 1.94 higher) – 32 (1 RCT)c ⨁◯◯◯ VERY LOWd Assessed using the Children’s Impact of Traumatic Events Scale - Revised (CITES-R), with 26 items for PTSD (range 0–52). Calculated important difference shows a small effect (SMD = -0.38). Change in depression (mixed gender) The mean change in depression ranged from -0.14 to -3.32 The mean change in depression in the intervention group was 3.08 lower (5.81 lower to 0.34 lower) – 299 (3 RCTs)e ⨁⨁◯◯ LOWb Assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0–2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. Calculated important difference shows a medium effect (SMD = -0.54). 61 | P a g e Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Change in state anxiety (mixed gender) The mean change in state anxiety ranged from -1.59 to -3.72 The mean change in state anxiety in the intervention group was 1.81 lower (3.61 lower to 0.02 lower) – 309 (3 RCTs)f ⨁⨁◯◯ LOWb Assessed using the State scale (A-State) of the State/Trait Anxiety Inventory for Children (STAIC), a 20-item self-report scale used to assess situationally specific anxiety. Calculated important difference shows a small effect (SMD = -0.32). Change in trait anxiety (mixed gender) The mean change in trait anxiety ranged from -0.65 to -5.41 The mean change in trait anxiety in the intervention group was 1.59 lower (2.83 lower to 0.34 lower) – 309 (3 RCTs)f ⨁⨁◯◯ LOWb Assessed using the Trait scale (A-Trait) of the State/Trait Anxiety Inventory for Children (STAIC), a 20-item self-report inventory (range 0– 40. There are no published cutoffs for this score. Calculated important difference shows a small effect (SMD = -0.29). Change in internalizing symptoms (mixed gender) – The standardized mean change in internalizing symptoms in the intervention group was 0.53 SD lower (1.10 lower to 0.04 higher) – 371 (4 RCTs)g ⨁⨁◯◯ LOWb Assessed using the Children’s Behavior Checklist (CBCL-Int). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and ≥ 63 in the clinical range. Change in internalizing symptoms (female only) The mean change in internalizing symptoms was -10.4 The mean change in internalizing symptoms in the intervention group was 7.4 higher (1.72 higher to 13.08 higher) – 30 (1 RCT)c ⨁◯◯◯ VERY LOWd Assessed using CBCL-Int. Calculated important difference shows a large effect (SMD = 0.91). 62 | P a g e Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Change in externalizing symptoms (mixed gender) – The standardized mean change in externalizing symptoms in the intervention group was 0.34 SD lower (0.65 lower to 0.03 lower) – 358 (4 RCTs)h ⨁⨁◯◯ LOWb Assessed using the Children’s Behavior Checklist (CBCL-Ext). T scores (range 0–100) < 60 are considered normal range; 60–63 as borderline, and ≥ 63 in the clinical range. Change in externalizing symptoms (Female only) The mean change in externalizing symptoms was -7.60 The mean change in externalizing symptoms in the intervention group was 3.7 higher (1.26 lower to 8.66 higher) – 30 (1 RCT)c ⨁◯◯◯ VERY LOWd Assessed using CBCL-Ext. Calculated important difference shows a medium effect (SMD = 0.51). Follow-up at 6 months Change in PTSD (mixed gender) Follow-up: mean 6 months – The standardized mean change in PTSD in the intervention group was 0.65 SD lower (0.97 lower to 0.33 lower) – 262 (3 RCTs)a ⨁⨁◯◯ LOWb Assessed using K-SADS-Erange NR) in 2 studies and TSC-C in 1 study. 63 | P a g e Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Change in depression (mixed gender) Follow-up: mean 6 months The mean change in depression ranged from -0.67 to -6.34 The mean change in depression in the intervention group was 0.48 lower (2.47 lower to 1.52 higher) – 267 (3 RCTs)a ⨁◯◯◯ VERY LOWi Assessed using CDI). Calculated important difference shows no effect (SMD = -0.09). Change in state anxiety (mixed gender) Follow-up: mean 6 months The mean change in state anxiety ranged from -1.72 to -5.34 The mean change in state anxiety in the intervention group was 1.91 lower (5.45 lower to 1.64 higher) – 233 (2 RCTs)j ⨁◯◯◯ VERY LOWi Assessed using A-State of STAIC. Calculated important difference shows a small effect (SMD = -0.30). Change in trait anxiety (mixed gender) Follow-up: mean 6 months The mean change in trait anxiety ranged from -1.22 to -7.68 The mean change in trait anxiety in the intervention group was 1.51 lower (4.96 lower to 1.94 higher) – 232 (2 RCTs)j ⨁◯◯◯ VERY LOWi Assessed using A-Trait of STAIC. There are no published cutoffs for this score. Calculated important difference shows a small effect (SMD = -0.24). Change in internalizing symptoms (mixed gender) Follow-up: mean 6 months – The standardized mean change in internalizing symptoms in the intervention group was 0.12 SD lower (0.69 lower to 0.46 higher) – 291 (3 RCTs)k ⨁◯◯◯ VERY LOWi,l Assessed using CBCL-Int. 64 | P a g e Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Change in externalizing symptoms (mixed gender) Follow-up: mean 6 months – The standardized mean change in externalizing symptoms in the intervention group was 0.15 SD lower (0.48 lower to 0.18 higher) – 321 (4 RCTs)m ⨁⨁◯◯ LOWb,n Assessed using CBCL-Ext. Follow-up at 12 months Change in PTSD (mixed gender) Follow-up: mean 12 months – The standardized mean change in PTSD in the intervention group was 0.6 SD lower (1.09 lower to 0.11 lower) – 268 (3 RCTs)a ⨁⨁◯◯ LOWb,n Assessed using K-SADS-E in 2 studies and TSC- C in 1 study. Change in depression (mixed gender) Follow-up: mean 12 months The mean change in depression ranged from -1.53 to -6.86 The mean change in depression in the intervention group was 0.17 lower (2.16 lower to 1.82 higher) – 271 (3 RCTs)a ⨁◯◯◯ VERY LOWi Assessed using CDI. Calculated important difference shows no effect (SMD = -0.03). Change in state anxiety (mixed gender) Follow-up: mean 12 months The mean change in state anxiety ranged from -2.07 to -4.93 The mean change in state anxiety in the intervention group was 1.03 lower (3.28 lower to 1.23 higher) – 237 (2 RCTs)j ⨁◯◯◯ VERY LOWi Assessed using A-State of STAIC. Calculated important difference shows no effect (SMD = - 0.17). 65 | P a g e Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Change in trait anxiety (mixed gender) Follow-up: mean 12 months The mean change in trait anxiety ranged from -1.84 to -8.36 The mean change in trait anxiety in the intervention group was 1.46 lower (4.09 lower to 1.18 higher) – 237 (2 RCTs)j ⨁◯◯◯ VERY LOWi Assessed using A-Trait of STAIC. Calculated important difference shows a small effect (SMD = -0.24). Change in internalizing symptoms (mixed gender) Follow-up: mean 12 months – The standardized mean change in internalizing symptoms in the intervention group was 0.25 SD lower (0.75 lower to 0.26 higher) – 295 (3 RCTs)k ⨁◯◯◯ VERY LOWi,l Assessed using CBCL-Int. Change in externalizing symptoms (mixed gender) Follow-up: mean 12 months – The standardized mean change in externalizing symptoms in the intervention group was 0.23 SD lower (0.82 lower to 0.36 higher) – 325 (4 RCTs)m ⨁◯◯◯ VERY LOWl,n,p Assessed using CBCL-Ext. Follow-up at 24 months 66 | P a g e Patient or population – Child sexual maltreatment Intervention – TF-CBT Comparison – Non-CBT interventions Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with non-CBT interventions Risk with TF-CBT Change in PTSD (mixed gender) Follow-up: mean 24 months The mean change in PTSD was -5.36 The mean change in PTSD in the intervention group was 2.58 lower (4.06 lower to 1.1 lower) – 33 (1 RCT)o ⨁◯◯◯ VERY LOWd Assessed using K-SADS-E. Calculated important difference shows a large effect (SMD = -1.17). Change in depression (mixed gender) Follow-up: mean 24 months The mean change in depression was -3.74 The mean change in depression in the intervention group was 1.57 lower (4.95 lower to 1.81 higher) – 34 (1 RCT)o ⨁◯◯◯ VERY LOWd Assessed using CDI. Calculated important difference shows a small effect (SMD = -0.30). Change in externalizing symptoms (mixed gender) Follow-up: mean 24 months The mean change in externalizing symptoms was 4.25 The mean change in externalizing symptoms in the intervention group was 7.41 lower (13.37 lower to 1.45 lower) – 30 (1 RCT)o ⨁◯◯◯ VERY LOWd Assessed using CBCL-Ext. Calculated important difference shows a large effect (SMD = -0.91) *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; SMD: Standardized mean difference; MD: Mean difference GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect a Cohen et al (10); Deblinger et al (17); Deblinger et al (5). b Downgraded to low because of serious risk of bias and indirectness – see Table 4.5. 67 | P a g e c Celano et al (11). d Downgraded to very low because of serious concerns about the risk of bias, a sample size < 300 and very serious imprecision in effect estimate – see Table 4.5. e Cohen et al (10); Deblinger et al (17); Deblinger et al (5). f Cohen et al (10); Deblinger et al (16); Deblinger et al (5). g Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (16); Deblinger et al (5). h Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (17); Deblinger et al (5). i Downgraded to very low because of the serious risk of bias, a sample size < 300 and very serious imprecision in effect estimate – see Table 4.5. j Cohen et al (10); Deblinger et al (5). k Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (5). l Downgraded because the statistical heterogeneity is high and the direction of effect is not consistent across studies. m Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (17); Deblinger et al (5). n Downgraded because of serious imprecision in effect estimate. o Deblinger et al (17). p Downgraded because of the serious risk of bias. 68 | P a g e Table 4.5. Quality assessment: TF-CBT compared to non-CBT interventions for child sexual maltreatment (child-plus-parent focus) Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) Change in PTSD (immediate post-treatment) 3a Randomized trials Seriousb Not serious Seriousc Not serious None 149 146 – SMD 0.7 SD lower (1.24 lower to 0.16 lower) ⨁⨁◯◯ LOW CRITICAL Change in PTSD (immediate post-treatment) (Celano et al. (11) cannot be pooled) 1d Randomized trials Seriouse Not serious Seriousc Very seriouse None 15 17 – MD 2.4 lower (6.74 lower to 1.94 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in depression (immediate post-treatment) 4a Randomized trials Seriousb Not serious Seriousc Not serious None 152 147 – MD 3.08 lower (5.81 lower to 0.34 lower) ⨁⨁◯◯ LOW CRITICAL Change in state anxiety (immediate post-treatment) 69 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 4f Randomized trials Seriousb Not serious Seriousc Not serious None 155 154 – MD 1.81 lower (3.61 lower to 0.02 lower) ⨁⨁◯◯ LOW CRITICAL Change in trait anxiety (immediate post-treatment) 4f Randomized trials Seriousb Not serious Seriousc Not serious None 155 154 – MD 1.59 lower (2.83 lower to 0.34 lower) ⨁⨁◯◯ LOW CRITICAL Change in internalizing symptoms (immediate post-treatment) 5g Randomized trials Seriousb Not serious Seriousc Not serious None 190 181 – SMD 0.53 SD lower (1.10 lower to 0.04 higher) ⨁⨁◯◯ LOW CRITICAL Change in internalizing symptoms (immediate post-treatment) (Celano et al. (11) cannot be pooled) 70 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 1d Randomized trials Seriousd Not serious Seriousc Very seriouse None 14 16 – MD 7.4 higher (1.72 higher to 13.08 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms (immediate post-treatment) 5h Randomized trials Seriousb Not serious Seriousc Not serious None 186 172 – SMD 0.34 SD lower (0.65 lower to 0.03 lower) ⨁⨁◯◯ LOW CRITICAL Change in externalizing symptoms (immediate post-treatment) (Celano et al. Study, Cannot be pooled) 1d Randomized trials Seriousb Not serious Seriousc Very seriousi None 14 16 – MD 3.7 higher (1.26 lower to 8.66 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (follow up: mean 6 months) 71 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 3a Randomized trials Seriouse Not serious Seriousc Seriouse None 138 124 – SMD 0.65 SD lower (0.97 lower to 0.33 lower) ⨁⨁◯◯ LOW CRITICAL Change in depression (follow up: mean 6 months) 3a Randomized trials Seriousb Not serious Seriousc Very seriousi None 140 127 – MD 0.48 lower (2.47 lower to 1.52 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in state anxiety (follow up: mean 6 months) 2j Randomized trials Seriousb Not serious Seriousc Very seriousi None 121 112 – MD 1.91 lower (5.45 lower to 1.64 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in trait anxiety (follow up: mean 6 months) 72 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 2j Randomized trials Seriousb Not serious Seriousc Very seriousi None 120 112 – MD 1.51 lower (4.96 lower to 1.94 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in internalizing symptoms (follow up: mean 6 months) 3k Randomized trials Seriousb Seriousl Seriousc Seriousi None 155 136 – SMD 0.12 SD lower (0.69 lower to 0.46 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms (follow up: mean 6 months) 4m Randomized trials Seriousb Not serious Serious Seriousn None 173 148 – SMD 0.15 SD lower (0.48 lower to 0.18 higher) ⨁⨁◯◯ LOW CRITICAL Change in PTSD (follow up: mean 12 months) 73 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 3a Randomized trials Seriouse Not serious Seriousc Seriouse None 140 128 – SMD 0.6 SD lower (1.09 lower to 0.11 lower) ⨁⨁◯◯ LOW CRITICAL Change in depression (follow up: mean 12 months) 3a Randomized trials Seriousb Not serious Seriousc Very seriousi None 142 129 – MD 0.17 lower (2.16 lower to 1.82 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in state anxiety (follow up: mean 12 months) 2j Randomized trials Seriousb Not serious Seriousc Very seriousi None 123 114 – MD 1.03 lower (3.28 lower to 1.23 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in trait anxiety (follow up: mean 12 months) 74 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 2j Randomized trials Seriousb Not serious Seriousc Very seriousi None 123 114 – MD 1.46 lower (4.09 lower to 1.18 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in internalizing symptoms (follow up: mean 12 months) 3k Randomized trials Seriousb Seriousl Seriousc Seriousi None 158 137 – SMD 0.25 SD lower (0.75 lower to 0.26 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms (follow up: mean 12 months) 4m Randomized trials Seriousb Seriousl Seriousc Seriousn None 176 149 – SMD 0.23 SD lower (0.82 lower to 0.36 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (follow up: mean 24 months) 75 | P a g e Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Trauma focused CBT non-CBT interventions Relative (95% CI) Absolute (95% CI) 1o Randomized trials Seriousd Not serious Seriousc Very seriouse None 19 14 – MD 2.58 lower (4.06 lower to 1.1 lower) ⨁◯◯◯ VERY LOW CRITICAL Change in depression (follow up: mean 24 months) 1o Randomized trials Seriousb Not serious Seriousc Very seriousi None 19 15 – MD 1.57 lower (4.95 lower to 1.81 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in externalizing symptoms (follow up: mean 24 months) 1o Randomized trials Seriouse Not serious Seriousc Very seriouse None 18 12 – MD 7.41 lower (13.37 lower to 1.45 lower) ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval; SMD: Standardised mean difference; MD: Mean difference a Cohen et al (10); Deblinger, Steer & Lippmann (17); Deblinger, Steer & Lippmann (5). b Serious concerns about the risk of bias. c The population is indirect. d Celano et al (11). e Serious concerns about the risk of bias and a sample size < 300. f Cohen et al (10); Deblinger et al (16); Deblinger et al (5). g Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (16); Deblinger et al (5 h Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (17); Deblinger et al (5). 76 | P a g e i The sample size is < 300 and the effect estimate is imprecise. j Cohen et al (10); Deblinger et al (5) k 1) Cohen et al. (14); 2) Cohen et al. (10); 3) Deblinger et al. (5) l The statistical heterogeneity is high and direction of effect is not consistent across studies. m Cohen & Mannarino (14); Cohen et al (10); Deblinger et al (5). n The effect estimate is imprecise. o Deblinger et al (17). 77 | P a g e Fig. 5.1. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (PTSD, mixed gender; child-plus-parent focus) Fig. 5.2. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (PTSD, female only; child-plus-parent focus) 78 | P a g e Fig. 5.3. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (depression, mixed gender; child-plus-parent focus) 79 | P a g e Fig. 5.4. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (state anxiety, mixed gender; child-plus-parent focus) 80 | P a g e Fig. 5.5. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (trait anxiety, mixed gender; child-plus-parent focus) 81 | P a g e Fig. 5.6. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (internalizing symptoms, mixed gender; child-plus-parent focus) Fig. 5.7 Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (internalizing symptoms, mixed gender; child-plus-parent focus) 82 | P a g e Fig. 5.8. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (externalizing symptoms, mixed gender; child-plus-parent focus) Fig. 5.9. Forest plot: TF-CBT compared to non-CBT interventions for child sexual maltreatment (externalizing symptoms-female only; child-plus-parent focus) 83 | P a g e Table 3.6. GRADE evidence profile: CBT intervention compared to supportive counselling for child sexual maltreatment Patient or population – Child sexual maltreatment Intervention – CBT intervention Comparison – Supportive counselling Setting – Any Outcomes Anticipated absolute effects (95% CI) Relative effect (95% CI) No. of participants (studies) Quality of the evidence (GRADE) Comments Risk with supportive counselling Risk with CBT intervention Immediate post-treatment Change in PTSD (mixed gender) The mean change in PTSD was -7.95 The mean change in PTSD in the intervention group was 0.09 higher (4.3 lower to 4.48 higher) – 44 (1 RCT)a ⨁◯◯◯ VERY LOWb,c Assessed using the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-E). Possible range not provided. Calculated important difference shows no effect (SMD = 0.01). Follow-up at 3 months Change in PTSD (mixed gender) Follow-up: mean 3 months The mean change in PTSD was -8.82 The mean change in PTSD in the intervention group was 2.15 higher (2.39 lower to 6.69 higher) – 44 (1 RCT)a ⨁◯◯◯ VERY LOWb,c Assessed using K-SADS-E. Calculated important difference shows no effect (SMD = 0.27). *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean difference GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect 84 | P a g e a Deblinger et al (6). b Downgraded because of serious concerns about the risk of bias. c Downgraded because the sample size is < 300 and the effect estimate is imprecise. 85 | P a g e Table 4.6. Quality assessment: CBT intervention compared to supportive counselling for child sexual maltreatment Quality assessment No. of patients Effect Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations CBT intervention Supportive counselling Relative (95% CI) Absolute (95% CI) Change in PTSD 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 22 22 – MD 0.09 higher (4.3 lower to 4.48 higher) ⨁◯◯◯ VERY LOW CRITICAL Change in PTSD (Follow-up: mean 3 months) 1a Randomized trials Seriousb Not serious Not serious Very seriousc None 22 22 – MD 2.15 higher (2.39 lower to 6.69 higher) ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval; MD: Mean difference a Deblinger et al (6). b Serious concerns about the risk of bias. c Sample size < 300 and imprecise effect estimate. 86 | P a g e Fig. 6.1. Forest plot: CBT intervention compared to supportive counselling for child sexual maltreatment (PTSD, child-plus-parent focus) 87 | P a g e Table 3.7. GRADE evidence profile: family/network meetings with work group compared to family/network meetings without work group for child sexual maltreatment Patient or population – Child sexual maltreatment Intervention – Family/Network meetings with work group Comparison – Family/Network meetings without work group Setting – Any Outcomes Impact No. of participants (studies) Quality of the evidence (GRADE) Change in depression (mixed gender, immediate post-treatment) There were no significant differences between treatment groups for the outcome of change in depression (p = 0.26, NS), which was assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0–2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. 28 (1 RCT)a ⨁◯◯◯ VERY LOWb,c *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect a Hyde et al (18). b Downgraded because of serious concerns about the risk of bias. c Downgraded because the sample size is < 300 and the effect estimate is imprecise. 88 | P a g e Table 4.7. Quality assessment: family/network meetings with work group compared to family/network meetings without work group for child sexual maltreatment Quality assessment Impact Quality Importance No. of studies Study design Risk of bias Inconsistency Indirectness Imprecision Other considerations Change in depression, immediate post-treatment 1a Randomized trials Seriousb Not serious Not serious Very seriousc None There were no significant differences between treatment groups for the outcome of change in depression (p=0.26, NS), which was assessed using the Children’s Depression Inventory (CDI), a 27-item scale (items scored on range 0– 2). The total possible range for this scale is 0–54, where ≥ 19 indicates severe depression. ⨁◯◯◯ VERY LOW CRITICAL CI: Confidence interval a Hyde et al (18). b Downgraded because of serious concerns about the risk of bias. c Downgraded because the sample size is < 300 and the effect estimate is imprecise. 89 | P a g e References 1. 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