Responding to children and adolescents who have been sexually abused: WHO clinical guidelines: web annex 6a: psychosocial and mental health interventions – children and caregivers: evidence-to-decision table

1 | P a g e RESPONDING TO CHILDREN AND ADOLESCENTS WHO HAVE BEEN SEXUALLY ABUSED WHO CLINICAL GUIDELINES* Web Annex 6a: Psychosocial and mental health interventions – children and caregivers: evidence-to-decision table *Full guide: https://apps.who.int/iris/bitstream/handle/10665/259270/9789241550147-eng.pdf 2 | P a g e WHO/RHR/17.30 © 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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Evidence-to-decision table: psychosocial and mental health interventions – 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/caregive (P), as compared to no or any other intervention (C), improve the 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)? Population – Children (0–18) exposed to any form of sexual abuse and their non-offending caregivers. Intervention – Any psychosocial interventions to help children exposed to sexual abuse and their non-offending caregivers. Comparison – Any psychosocial interventions or no intervention. Main outcomes – 1. externalizing symptoms and disorders, 2. internalizing symptoms and disorders, 3. anxiety, 4. depression, 5. post-traumatic stress disorder (PTSD), 6. school functioning, 7. subjective well-being, 8. healthy parent–child interaction. Setting – Any health care setting. Perspective – Global population, including low- and middle-income countries (LMICs) and high-income countries (HICs). Notes – The term “psychosocial” is defined as “of or relating to the interrelation of social factors and individual thought and behaviour” (1). In research literature it is used to refer to nonpharmacological interventions, such as psychoeducation, psychotherapy, counselling, and eye-movement desensitization and reprocessing (EMDR) therapy. The WHO Mental Health Gap Action Programme (mhGAP) further distinguishes “brief” psychosocial interventions from “advanced” psychosocial interventions. An advanced psychosocial intervention is “an intervention that takes more than a few hours of a health-care provider’s time to learn and typically more than a few hours to implement”; this includes several types of advanced psychosocial interventions, such as cognitive behavioural therapy (CBT), family counselling and therapy, and parent skills training (2). This review examined advanced psychosocial interventions that addressed children exposed to sexual abuse, with a focus on stress management, CBT (trauma- focused and other forms),1 EMDR and nonspecific supportive counselling. 1 See the glossary in the guidelines (3) for the definition. 4 | P a g e Table 1. Summary of assessments based on which decision was made Factors considered in formulating recommendation Judgement Research evidence Problem Is the problem a priority? ☐ No ☐ Probably no ☐ Probably yes ☒ Yes 1. Child and adolescent sexual abuse is a major global public health problem, with many short- and long-term health effects. The health problems correlated with child and adolescent sexual abuse vary from physical and psychological to behavioural and sexual problems, such as HIV and other sexually transmitted infections (STIs) , depression, anxiety, substance abuse, suicidal behaviour, and high-risk sexual behaviours (4,5). ☐ Varies ☐ Don’t know Values Is there important uncertainty about or variability in how much people value the main outcomes? ☐ Important uncertainty or variability ☐ Possibly important uncertainty or variability ☒ Probably no important uncertainty or variability ☐ No important uncertainty or variability 1. An online survey, conducted in June 2016, asking the GDG to rank mental health outcomes, yielded the following as critical (i.e. that received average rating score of 7–9): 1. externalizing symptoms and disorders (M = 8.08); 2. internalizing symptoms and disorders (M = 8.08); 3. anxiety (M = 8.08); 4. depression (M = 8.08); 5. PTSD (M = 7.33); 6. school functioning (M = 7.25); 7. subjective well-being (M = 7.25). Studies were not excluded by outcomes, however; data were extracted on these outcomes from the included articles (see references). 2. A review of the effectiveness, acceptability and cost–effectiveness of psychosocial interventions for maltreated children and adolescents, conducted by MacDonald et al. (6), also covered advisory sessions with young people (aged under 18, 16–24 and 15–19) and found that children and young people being helped:  to learn skills to handle life’s ups and downs;  to understand what being treated badly is, and to recognize when things are not OK;  to learn ways to keep themselves safe (e.g. knowing when to report something and to whom to report it);  to feel safe;  to bounce back if things in their lives go wrong. ☐ No known undesirable outcomes 5 | P a g e Factors considered in formulating recommendation Judgement Research evidence Desirable effects (Benefits) How substantial are the desirable anticipated effects? ☐ Trivial ☐ Small ☒ Moderate ☐ Large Summary of findings (for further information, see full report web annex 6, pp. and Grading of Recommendations, Assessment, Development and Evaluation (GRADE)tables) 1. 9 randomized controlled trials (RCTs – n = 827 participants) examined interventions primarily addressing CBT with a trauma focus (including 5 studies that used the Cohen et al 20012 branded TF-CBT package). Each of the following intervention types were addressed with one study each: Risk Reduction through Family Therapy (RRFT), CBT and family network meetings with and without group work (the latter is primarily psychoeducational in approach). 2. RRFT vs treatment as usual, for adolescent girls/boys (aged 13–17), there is very low certainty that RRFT may enable:  a large benefit to PTSD symptoms (child and parent reports), depression and internalizing symptoms, and a small benefit to externalizing symptoms at post-treatment;  large benefits in PSTD (parent report) and medium benefits to PTSD (child report), seen at 6-month follow-up, as well as large benefits to depression, and internalizing and externalizing symptoms. 3. CBT with a trauma focus vs. wait-list, for girls/boys (aged 5–17), there is very low certainty that CBT with a trauma focus may enable large benefits to PTSD symptoms, medium benefits to depression symptoms and small benefits to anxiety, and internalizing and externalizing symptoms at post-treatment. At 6-month follow-up, large benefits to PTSD symptoms, small benefits to depression symptoms, and medium benefits to anxiety, internalizing, and externalizing symptoms are seen. ☐ Varies ☐ Don't know Undesirable effects (Harms) How substantial are the undesirable anticipated effects? ☐ Large ☐ Moderate ☐ Small ☐ Trivial ☐ Varies ☒ Don't know 2 Cohen JA, Mannarino AP, Deblinger E. Child and parent trauma-focused cognitive behavioural therapy manual. Philadelphia: Drexel University, College of Medicine; 2001. 6 | P a g e Factors considered in formulating recommendation Judgement Research evidence Certainty of evidence What is the overall certainty of the evidence of effects? ☐ Very low ☒ Low ☐ Moderate ☐ High ☐ No included studies 4. TF-CBT with a trauma narrative (TN) vs TF-CBT with no narrative (NN), for girls/boys (aged 4–11) there is  very low certainty that eight sessions of TF-CBT with TN may show a medium benefit to anxiety symptoms at post-treatment and small benefits to avoidance PTSD symptoms at 12-month follow-up, although the control group (i.e. with NN) also shows small benefits to externalizing symptoms at 12- month follow-up;  low certainty that 16 sessions of TF-CBT with TN may have a small benefit to depression symptoms, although the control group (i.e. with NN) shows small benefits, some of which persist at 12-month follow-up, and a medium benefit to hypervigilance PTSD symptoms. 5. As to TF-CBT vs non-CBT therapy (5 studies, pooled results), the findings are the following.  For girls/boys (aged 7–15) we have low certainty that there are medium benefits to PTSD, depression, internalizing and externalizing symptoms at post-treatment, as well as small benefits to state and trait anxiety for the TF-CBT group at post-treatment. At 24-month follow-up, we have very low certainty that there may be large benefits to PTSD symptoms and externalizing symptoms, as well as small benefits to depression symptoms. Findings from four studies are therefore in favour of TF-CBT.  For girls (aged 8–13), we have very low certainty that, immediately post-treatment, the control group (vs TF-CBT) may show large reductions in internalizing symptoms and small reductions in PTSD symptoms. Thus, this study is not effective for TF-CBT. 6. As to CBT vs supportive counselling, for boys/girls (aged 3–11), we have very low certainty that supportive counselling (the control group) shows a small benefit to PTSD symptoms at 3-month follow-up. 7. Overall, there is:  low certainty that CBT-type therapies with a trauma focus, particularly TF-CBT, have medium-to-large benefits for PTSD in particular, as compared to non-CBT-type therapies due to (a) serious concerns about risk of bias and (b) indirectness of evidence;  very low certainty for other interventions (e.g. CBT, RRFT) due to (a) serious concerns about risk of bias, (b) small sample sizes and (c) imprecise effect sizes; and  no evidence for other outcomes identified by the GDG as important, such as subjective well-being, school functioning or healthy parent–child interactions. 8. No reports of adverse effects were found. 7 | P a g e Factors considered in formulating recommendation Judgement Research evidence Balance of effects Does the balance between desirable and undesirable effects favour the intervention or the comparison? ☐ Favours the comparison ☐ Probably favours the comparison ☐ Does not favour either the intervention or the comparison ☒ Probably favours the intervention ☐ Favours the intervention 1. The GDG agreed that the balance of benefits and harms probably favours CBT with trauma focus, particularly TF-CBT. 2. The pooled results from the 4 studies (item 5 above) show low certainty of evidence for PTSD outcomes because of concerns about (a) serious concerns about risk of bias and (b) indirectness of evidence. 3. There was low-to-very-low certainty and small-to-medium effect sizes for other outcomes (e.g. depression, internalizing and externalizing disorders). ☐ Varies ☐ Don't know Resources required How large are the resource requirements (costs)? ☒ Large costs ☐ Moderate costs ☐ Negligible costs and savings ☐ Moderate savings ☐ Large savings The GDG did not agree with the initial rating of the resources required as moderate. Upon reviewing the evidence below, it agreed that the resources required for this intervention in LMICs are large and include the costs of supervising and mentoring trained providers. Thus, the GDG revised the initial assessment from moderate to “Large costs” based on the following considerations. 1. One cost–utility analysis, conducted from the Australian mental health care system for children exposed to sexual abuse, finds that, based on 2010–2011 Australian dollars for a 12-month 8 | P a g e Factors considered in formulating recommendation Judgement Research evidence ☐ Varies ☐ Don't know period, the total cost for non-directive counselling is $A 20 740 and for TF-CBT, $A 20 511 (7).  When adjusting for incremental cost per quality-adjusted life-year (QALY), the cost for non- directive counselling for a 12-month period was $A 34 567 and for TF-CBT, $A 22 790. 2. Additional 2006 data from the United Kingdom suggested the cost of CBT for adults is “no more than £750” (8) (no details offered about how this number was derived). 3. In LMICs, training local lay personnel to carry out psychosocial interventions may keep these interventions at a relatively low cost (9). Regular and reliable training and supervision to work through problems and to avoid burnout, however, would be an ongoing cost (10). 4. In LMICs, costs to families of transport to the place where the intervention is delivered may be prohibitive (11). 5. In LMICs, costs to families to take time away from work to attend intervention may also be prohibitive (11). Certainty of evidence of required resources What is the certainty of the evidence of resource requirements (costs)? ☒ Very low ☐ Low ☐ Moderate ☐ High ☐ No studies included 9 | P a g e Factors considered in formulating recommendation Judgement Research evidence Cost– effectiveness Does the cost- effectiveness of the intervention favour the intervention or the comparison? ☐ Favours the comparison ☐ Probably favours the comparison ☐ Does not favour either the intervention or the comparison ☒ Probably favours the intervention ☐ Favours the intervention 1. For the Australian cost–utility analysis mentioned above, a modelling analysis with a 31-year time horizon (assuming everything proceeds normally) determined that the incremental cost per QALY gained (when compared to no treatment) was $A 2 081.57 for non-directive counselling, $A 1 650.16 for TF-CBT only, and $A 1 706.61 for TF-CBT plus sertraline (7). 2. A United Kingdom cost–effectiveness analysis of CBT for children exposed to sexual abuse combined intervention costs with their standardized mean difference (SMD) calculations for PTSD and anxiety, and Child Depression Index (CDI) scores reported in five studies (6).  For PTSD and anxiety, the authors found that CBT was more cost-effective than the control at post-treatment. At 12-month follow-up, however, these effects no longer favoured CBT, but equally favoured the control and intervention groups.  For CDI scores, the authors found that cost–effectiveness favoured CBT at post-treatment, but not at 12 months, when it equally favoured the control and intervention groups). 3. Overall, both the Australian and the United Kingdom studies suggest that psychotherapeutic interventions may be cost effective, but specific interventions – such as TF-CBT – may not be more cost effective than other forms of psychotherapeutic interventions after 12 months. ☐ Varies ☐ No studies included Equity What would be the impact on health equity? ☐ Reduced ☒ Probably reduced ☐ Probably no impact ☐ Probably increased ☐ Increased 1. No research evidence was found about the impact on equity of recommending psychosocial interventions related to child sexual abuse . Nevertheless, in the 2013 WHO guidelines for responding to intimate partner violence and sexual violence against women(12), remark, in relation to the recommendation on psychotherapeutic interventions for children exposed to intimate-partner violence, indicate that the cost of intensive interventions and the lack of professionals trained to provide this type of intervention make it challenging to implement in 10 | P a g e Factors considered in formulating recommendation Judgement Research evidence ☐ Varies ☐ Don't know resource-poor settings. 2. Intensive psychosocial interventions may make implementation challenging in rural and remote communities in HICs, which may disproportionately affect certain communities, such as Indigenous communities. 3. Thus, psychosocial interventions may reduce equity:  for those residing in LMICs and rural parts of HICs where skilled personnel are not available to conduct treatment;  when specific psychosocial interventions are not yet widely available (e.g. CBT with trauma focus is only now being tested in some LMICs and may not be available in some rural and remote parts of HICs);  when psychosocial interventions are cost prohibitive (e.g. skilled personnel deliver the interventions and children and their families must bear the costs);  when psychosocial interventions are not available locally and the children/families must travel to access them. 4. Psychosocial interventions may contribute to the realization of human rights when they are provided in a culturally appropriate, accessible and sustainable manner. Acceptability Is the intervention acceptable to key stakeholders? ☐ No ☐ Probably no ☒ Probably yes ☐ Yes 1. Very little research has been conducted about the acceptability of psychosocial interventions has been carried out in LMICs, and it has tended to focus on adult patients. 2. A study on acceptability of TF-CBT for children in Zambia (13) suggests that: “talk therapy” may be relatively new and therefore unacceptable to families in some contexts. Findings suggested that:  efforts would need to be made to explain the benefits of these interventions in an acceptable way, as receiving services for mental health may be stigmatized;  families may not want information about sex to be communicated with children, so efforts to do so would need to be done gradually with permission of caregivers;  certain parenting techniques used in psychosocial interventions in the global north, such as time outs, may not be acceptable elsewhere. 3. A systematic review by Macdonald et al. (6) found that, in the United Kingdom, psychosocial interventions may be acceptable to local health care providers and lay personnel, if they are involved in both: 11 | P a g e Factors considered in formulating recommendation Judgement Research evidence ☐ Varies ☐ Don't know  the selection of appropriate interventions; and  the modification of these interventions so they are culturally appropriate (see feasibility section) (14,15).  however, young people may avoid services due to not wanting to be seen as having a mental health concern.(5)  Young people value choice on when to start and stop the treatment. They want to take part in the decision-making about whether to receive treatment. They also want a chance to meet the professional delivering treatment, in a setting of their choice; they value confidentiality and trust in the therapeutic relationship (6). 4. Other research suggests that young people may initially resist revisiting their trauma experiences (in trauma-focused therapies that include a TN), but some research suggests that they overcome this resistance in the course of the intervention (16). 5. Overall, this suggests that, for professionals and lay personnel, psychosocial interventions may be acceptable to providers if the professionals are involved in both the selection of appropriate interventions and their modification for cultural appropriateness. Feasibility Is the intervention feasible to implement? ☐ No ☐ Probably no ☒ Probably yes ☐ Yes 1. Research (11,17) suggests that major barriers to implementation of psychosocial interventions in LMICs include:  lacked of skilled personnel to carry them out;  lack of cultural acceptability of some of their components;  costs for families to receive intervention (e.g. time away from work, and the financial costs of traveling to an appointment). 2. Nevertheless, these barriers can be addressed through, for example:  training lay personnel to carry out evidence-based psychosocial interventions may be a feasible solution to lack of skilled personnel (14,15);  modifying existing evidence-based, psychosocial interventions so they are culturally acceptable (11);  reducing psychological jargon and delivering interventions in a way that includes considerations of families’ belief systems and context. ☐ Varies ☐ Don't know 12 | P a g e Recommendation 12 Table 2. Conclusions of the Guidelines Development Group Conclusions Content Type of recommendation Strong recommendation against the intervention ○ Conditional recommendation against the intervention ○ Conditional recommendation for either the intervention or the comparison ○ Conditional recommendation for the intervention ○X Strong recommendation for the intervention ○ Recommendation R 12: When safe and appropriate to involve at least one non-offending caregiver, cognitive behavioural therapy (CBT) with a trauma focus should be considered for children and adolescents who have been sexually abused and are experiencing symptoms of PTSD and their non- offending caregiver(s) (conditional/strong recommendation, low quality). Justification In formulating this recommendation, the GDG considered the following factors. 1. The evidence indicates that CBT with a trauma focus such as TF-CBT showed medium-to-large benefits over non-CBT-type therapies for PTSD. The GDG also considered that evidence showed small-to-medium benefits for other symptoms (e.g. depression, anxiety, internalizing and externalizing symptoms). The balance favoured recommending CBT with a trauma focus that involved the nonoffending caregiver for treatment of PTSD. 2. The evidence had low certainty because of serious concerns about the risk of bias and the indirectness of the evidence. 3. The evidence of the large costs of implementing the intervention, the limited cost–effectiveness for CBT with trauma focus in particular and the barriers to implementation (e.g. lack of specialized personnel; the effort needed to train, mentor and supervise lay personnel; the costs to caregivers of transport, loss of wages and time required for frequent visits) in LMICs makes it challenging for CBT with trauma focus to be applicable everywhere. Thus, the strength of the recommendation is rated as conditional. 4. Limited evidence from the United Kingdom suggests that the intervention may be acceptable to health care providers although young people receiving it may be concerned with stigma. Other qualitative evidence from Zambia also suggests that stigma may affect the acceptability of the interventions. For example, caregivers in different cultural contexts may be reluctant for their children to be given information about sex and to change culturally accepted parenting skills. 13 | P a g e Subgroup considerations 1. Age related considerations – the intervention will need to be adapted with diverse approaches to the different levels of maturity and cognitive development of children and adolescents. 2. In some settings girls may be more frequently victimized than boys, although this varies (18,19). On the other hand, boys are less likely than girls to seek services, and may face additional barriers related to stereotypes and lack of acceptance that boys can be abused, or fear of having their masculinity questioned. 3. Some evidence suggests that the mental health impacts may be more severe for those children who were exposed to sexual abuse earlier (20,21). 4. Mental health outcomes for non-offending caregivers will also need attention. Implementation considerations 1. The safety of the child or adolescent who has been sexually abused is paramount. Those providing psychological interventions should be aware of the potential risks for children or adolescents. Concern for the safety and well-being of the child should guide the involvement of caregivers, so the recommendation focuses on non-offending caregivers. Health-care providers should assess the safety implications of the treatment/care they provide and take action to minimize the risk of harm. 2. The minimum requirement for delivering psychological interventions, particularly CBT with trauma focus, include the need for thorough training and ongoing supportive supervision of personnel, particularly for nonspecialized providers. 3. Children should have an assessment by someone who is qualified to determine whether they have PTSD or symptoms of it. 4. CBT with a trauma focus can be offered to both those diagnosed with PTSD and those who have symptoms. 5. Where a trained provider is not available, children should be referred to one after the assessment. 6. Stress management may also be beneficial for children and adolescents with PTSD. 7. Given varying levels of cognitive development and maturity of children and adolescents, diverse approaches and adaptation to meet the needs of different age groups will be required. 8. Mental health outcomes for nonoffending caregivers will also need attention. 9. As to equity and human-rights considerations, access to psychological interventions may be challenging in LMICs and rural areas of HICs, where the availability of skilled health care providers or trained specialist, and physical access to facilities are limited, where costs are prohibitive, and for families who may have to take time off from work to attend or take their children to sessions. Access may similarly be limited for indigenous groups, children or adolescents with disabilities and other minority groups. References 1. Oxford English dictionary. Oxford: Oxford University Press; 2001. 2. mhGAP intervention guide for mental, neurological and substance use disorders in non-specialized health settings. Geneva: World Health Organization; 2010 (http://www.who.int/mental_health/publications/mhGAP_intervention_guide/en). 3. Responding to children and adolescents who have been sexually abused. WHO clinical guidelines. 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