Outcomes and moderators of a preventive school‐based mental health intervention for children affected by war in Sri Lanka: a cluster randomized trial

The civil war in Sri Lanka, which ended in 2009 when government security forces claimed victory over the Liberation Tigers of Tamil Eelam, has had an extensive impact on the mental health of the population 1,2. A number of epidemiological studies have documented the high prevalence of mental disorders among children in Sri Lanka. Two studies in the northeast of the country found prevalence rates of 25% and 30% for post-traumatic stress disorder (PTSD) and 20% for major depression 3,4. In addition, researchers have observed increased psychological distress among the general population and detrimental impacts of the long-term conflict on social structures, including family and community functioning in the north and east of Sri Lanka 5,6. Despite this evidence of augmented mental health and psychosocial problems, resources for mental health in Sri Lanka remain scarce and centralized, as is common in low- and middle-income countries (LMIC) 7. Given this existing gap in health services, there is a need for easily accessible interventions that can rapidly be disseminated to larger groups of children. To this end, school-based interventions implemented by trained non-specialized staff have often been advocated 8,9,10. A recent paper reviewed the evidence base of mental health and psychosocial support interventions for children in humanitarian settings 11. It reported two separate meta-analyses, focused on the most commonly used outcomes measured across studies: PTSD and internalizing symptoms. The first meta-analysis focused on four randomized controlled studies evaluating outcomes of school-based interventions for war-affected children and adolescents in Bosnia and Herzegovina 12, Indonesia 13,14, Nepal 15, and the Palestinian Territories 16, as well as a school-based intervention for children affected by the 2004 Tsunami in Sri Lanka 17. This meta-analysis did not find an overall effect for PTSD symptoms, and very high statistical heterogeneity of intervention effects on PTSD across studies. The second meta-analysis, including the studies in the first meta-analysis, as well as interpersonal group psychotherapy and creative play with adolescents affected by armed conflict in northern Uganda 18, and a group psychosocial intervention with mothers of young children affected by armed conflict in Bosnia Herzegovina 19, did show significant intervention benefits for internalizing symptoms. Given the high prevalence of mental health problems in settings of armed conflict and the increasing popularity of interventions for war-affected children in LMIC, more rigorous studies are clearly needed to assess outcomes of interventions. This study aimed to evaluate the outcomes of a school-based secondary prevention intervention for children affected by ongoing war in northern Sri Lanka. We hypothesized that the intervention would lead to improved child mental health. In addition, we were interested in moderators and mediators of the intervention. Since school-based interventions for war-affected children have sorted diverse effects, examining moderators presents an important strategy to identify for whom and under what conditions intervention is most effective. Study of mediators is aimed at identifying why and how interventions have effects 20,21. Gender and age have previously been shown to moderate effects of school-based interventions for children affected by armed conflict. In Indonesia, intervention was effective for PTSD and function impairment only for girls, whereas it was effective with regard to maintaining hope for both boys and girls 13,14. In Nepal, no main effects were found, but intervention effects were found for boys on general psychological difficulties and aggression and for girls on pro-social behavior. In addition, an age effect was observed, such that older children in the intervention condition showed larger improvements with respect to feelings of hope. Age and gender effects were also identified in the Palestinian Territories, where a school-based intervention showed treatment effects on diverse emotional and behavioral outcomes with school-aged children, particularly boys. For older children, intervention effects were only observed with adolescent girls 16. Furthermore, the importance of past exposure to violence in relation to current experience of war-related stressors for mental health has been debated, but not assessed in evaluation studies among children 22,23,24. Several studies have shown that current experience of war-related “daily stressors” (e.g., lack of access to basic needs, domestic and neighborhood violence, substance use) partly mediated the association between exposure to violence events (witnessing/experiencing murders, bomb blasts, sexual violence, getting caught in crossfires, etc.) and PTSD symptomatology 25,26. Given this mediating role identified in cross-sectional surveys, we expected that intervention would be less effective in reducing psychological complaints for those experiencing continuing high levels of war-related daily stressors (i.e., a moderating relationship in this evaluation study). Finally, we were interested in coping behavior as a potential mediator of intervention effects. Previous research with war-affected children has generally confirmed a relation between coping behavior and psychological symptoms, although it is not clear which specific coping styles (e.g., emotion-focused vs. problem-focused) are most protective in such settings 27. The evaluated intervention (described below) specifically aimed to enhance coping behavior. We expected that the intervention would increase the number of coping methods used by children, as well as their satisfaction with these coping methods, and that these increases would in turn be associated with decreases in psychological symptoms. We collected data in the Tellippalai and Uduvil divisions of the Jaffna district in northern Sri Lanka, between September 2007 and March 2008. In August 2006, a peace agreement that had been observed since 2002 was abandoned, followed by closure of the only land road into the Jaffna peninsula. The subsequent period was characterized by rationed food and other essential supplies, curfews, road blocks, disappearances, extrajudicial killings, and skirmishes between the army and Liberation Tigers. Based on experiences in previous periods of intensified armed conflict in the region, we expected that safety of participants and staff, and continuation of schooling, could be guaranteed in this specific area. We implemented a cluster randomized trial rather than an individually randomized trial to avoid contamination of the intervention within schools. We used a two-step randomization procedure. First, within district divisions, we randomly allocated each division to either the intervention or waitlist control condition (see Figure 1). Second, we randomly selected schools for inclusion in the study. All schools on the government-provided list were eligible. Participant flow diagram In randomly selected schools, we screened children in grades 4 through 7 (ages 9–12) for meeting inclusion criteria using the Child Psychosocial Distress Screener (CPDS), a screening instrument with established cross-cultural construct validity that was developed for use with children affected by armed conflict 28,29. In accordance with the secondary prevention aims of the intervention (i.e., targeting symptoms of psychological distress and common mental disorders, and strengthening protective factors), this 7-item screening procedure assesses, with both children and teachers: a) the existence of risk factors (i.e., reporting exposure to war-related events, distress during such exposure, current psychological symptoms, and affected school functioning); b) the absence of protective factors (i.e., reporting a lack of social support and coping capacity). No children were excluded after meeting inclusion criteria, and a small group of children reporting severe mental problems during screening were provided individual supportive counseling in addition to being enrolled in the study (n=19, 4.8%). We based our selection of 12 schools per study condition on an a priori power calculation. We calculated effect sizes of 1.10 for PTSD and 0.78 for depressive symptoms in earlier intervention outcome studies which applied the same instruments 30,31. To detect changes with the same effect sizes, with β equal to .02 (2-sided) and α equal to .95, we calculated that we needed a minimum of 18 and 35 children (for PTSD and depressive symptoms respectively) per study condition. To account for intracluster correlation, we multiplied 35 by 1 + (m−1)ρ, with m=30 (average cluster size), ρ =0.1 (intracluster correlation), and a power of 95%, resulting in an appropriate sample size of 137. To compensate attrition, we aimed at oversampling to reach approximately 180 children per study condition. We estimated that at least one group of 15 children per school would meet inclusion criteria after screening, and therefore decided to sample 12 schools per study condition. The mental health intervention consisted of 15 sessions over 5 weeks of a school-based group intervention implemented by locally identified non-specialized personnel trained and supervised in implementing the intervention for one year prior to the study. Interventionists had at least a high school diploma and were selected for their affinity and capacity to work with children as demonstrated in role-plays and interviews. The manualized intervention consists of cognitive behavioral techniques (psychoeducation, strengthening coping, and guided exposure to past traumatic events through drawing) and creative expressive elements (cooperative games, structured movement, music, drama, and dance) with groups of around 15 children, aimed at decreasing symptoms of common mental disorders and strengthening protective factors 32. The intervention follows a specific structure within and between sessions, with the following foci: information, safety, and control in week 1 (sessions 1–3); stabilization, awareness and self-esteem in week 2 (sessions 4–6); the trauma narrative in week 3 (sessions 7–9); resource identification and coping skills in week 4 (sessions 10–12); and reconnection with the social context and future planning in week 5 (sessions 13–15). Each session is divided into four parts, starting and ending with structured movement, songs and dance with the use of a “parachute” (i.e., large circular colored fabric). The second part is based on a “central activity” focused on the main theme of that week (e.g., a drama exercise to identify social supports in the environment, or drawing of traumatic events), and the third part is a cooperative game (i.e., a game in which all children have to participate in order to promote group cohesion). The intervention was part of a larger public mental health program for children affected by war, including primary and tertiary prevention approaches. All standardized outcome measures were selected based on a preliminary qualitative study, which encompassed 18 key informant interviews, 20 focus group discussions, and 23 semi-structured individual interviews with children and family members identified as having mental health complaints 33. Qualitative data collection was also applied to construct new measures. Standardized rating scales were translated to Tamil using a translation monitoring form, which provides a structured method to prepare instruments for transcultural research 34. PTSD symptoms were assessed with the Child PTSD Symptom Scale (CPSS), a 17-item scale which measures symptoms of PTSD according to the DSM-IV with a 4-point response scale (range 0–51) 35. Internal reliability (Cronbach alpha) in our sample was .84. Depressive symptoms were examined with the 18-item Depression Self-Rating Scale (DSRS), which employs a 3-point response scale (range 0–36) 36. Internal reliability in our sample was .65. We assessed anxiety symptoms with the 5-item version of the Screen for Anxiety Related Emotional Disorders (SCARED-5; 3-point response scale, range 0–10) 37. Internal reliability in our sample was .52. As a broad mental health outcome measure, we used the 25-item Strengths and Difficulties Questionnaire self-report version, which was available in Tamil and was validated in the Jaffna district 38. As suggested by the developers, the four subscales that refer to psychological difficulties were summed into an overall total difficulties score (range 0–40, internal reliability .78), and a fifth 5-item subscale assessed pro-social behavior (range 0–10, internal reliability .60). Using the qualitative interviews of the preliminary study, we listed and categorized all psychological complaints reported by participants, and identified two groups of symptoms not well covered by standardized rating scales: supernatural complaints (being affected by evil spirits, witchcraft or demons) and war-related conduct problems (use of violence as a way to solve conflicts, imitating soldiers/rebels). Selecting the most commonly mentioned complaints, we constructed 6-item and 8-item scales, both with a 4-point answering format (range 0–18 and 0–24, internal reliability .58 and .61, respectively). We also constructed a scale to assess function impairment 39. Following brief participant observation, collection of diaries, and focus groups with children, ten activities were selected that represented children's daily lives with respect to individual (e.g., hygiene, sleep), family (e.g., chores), peer (e.g., play), school (e.g., participation, homework), community (e.g., helping elders), and religious (e.g., worship at home) activities. Children were asked if they felt impaired in these activities on a 4-point answering format (range 0–30, internal reliability .80). Gender and age (in years) were assessed as part of the demographics section of the questionnaire. Exposure to violence and daily stressors were assessed with a locally constructed rating scale. After free listing major war-related adversities with 20 local humanitarian staff, we selected the most mentioned war-related events that children could be exposed to. This resulted in a dichotomous (yes/no) rating scale with 10 items reflecting past war exposure (range 0–10, e.g., seeing bomb blasts, witnessing murders, experiencing or witnessing torture, sexual violence) and 11 items assessing exposure to current war-related daily stressors (range 0–11, e.g., basic needs not being met, domestic violence, alcohol abuse, separation from family members, displacement). Coping repertoire and satisfaction were assessed with the child-rated Kidcope (Younger Version for ages 7–2) 40. The Kidcope contains 15 questions concerning 10 coping strategies, which were assessed in relation to an imagined school problem (working hard but receiving bad grades) by asking which coping strategies were used and how children their satisfaction with coping methods on a 3-point scale not at a a range coping repertoire internal reliability All instruments were by a group of not in in a at schools. were trained in a period in rating were not which schools intervention. starting research we our with the local schools, and in community All children and provided after being the and of research activities. was by the and the Jaffna district To assess of study and mental health at were by with or for and sample for measures. changes on outcome measures were examined through in a were used to the intervention main effect and to moderating effects for main effects All controlled for at the school was in two In a first we using and 18 weeks as and estimated the effect of intervention on changes over In the second we moderators and their main effects to potential in intervention effects. only two participants had data on outcome measures at the third to at 18 we a the two participants with We of size), exposure to violence, ongoing war-related and on outcome and found no significant between study conditions 1). The sample consisted of more boys than girls, was of and children were between and 12 Children were exposed to an of two of war-related The most common seeing witnessing the of family members and being in In addition, children reported an of four of ongoing daily most having been being affected by having meeting basic needs and in the neighborhood of outcome measures from to First, we assessed changes (i.e., not for as an of changes on outcome measures showed larger for boys in the intervention condition on anxiety and function impairment sizes to For girls, we found an such that girls in the waitlist condition showed larger improvements in PTSD symptoms than girls in the intervention condition size Second, to assess of changes on outcome measures and the of moderating we for of within schools. We examined if the study condition and if past exposure to violence and current experience of war-related stressors the effects of intervention over No significant between study condition and for our outcomes were found, the of study conditions at did not between study conditions for our primary outcome measures we did find for a secondary outcome in the intervention condition showed more in conduct problems over than participants in the waitlist condition was also a significant of study condition and age for conduct problems, such that children showed more than older children in the intervention condition In addition, we found a number of intervention effects for specific Gender PTSD and anxiety symptoms such that boys in the intervention condition showed more over than boys in the waitlist control condition. a significant with age was identified for pro-social behavior in age were associated with intervention in other the intervention was effective in increasing pro-social behavior only for children. We examined past violence exposure and current experience of war-related daily stressors as moderators of the previous showed significant on depressive symptoms, supernatural complaints, and general psychological symptoms, we did not this group of outcome measures in these We identified an important moderating role in experience of current war-related daily This experience treatment effects, such that children in the intervention condition with levels of such stressors showed larger improvements on PTSD anxiety and function impairment than children in the waitlist condition. of the were for all from to on the Finally, we examined coping behavior as a mediator of intervention effects. of both changes and to show between study conditions with regard to of coping repertoire and coping Since a significant relation between intervention and a mediator is a for a mediating role this condition was not we did not the potential role of coping behavior. This evaluation of a secondary intervention with children in Sri Lanka to the evidence for mental health and psychosocial support interventions in affected by armed conflict. to earlier school-based interventions for war-affected children, intervention effects were We found a main effect on a locally constructed scale for conduct problems, with intervention benefits for children. conduct problems, including for a to use violence as a to solve of to an important of war-related psychological complaints as by children, and in our qualitative study. Furthermore, intervention effects were identified for children experiencing levels of current war-related daily stressors function boys and anxiety and children we identified an effect of intervention for girls on PTSD symptoms. we these in more we to a number of of the applied study First, although we did not study condition to and we selected research to intervention we were not to control of study condition by children in the study. Second, although we did a locally validated Strengths and Difficulties our primary outcome measures for and anxiety have local internal reliability of of the measures was less than for anxiety Despite these this study to the a rigorous intervention outcome study to the in a trial intervention effects were the that girls in the waitlist condition showed improvements over on PTSD symptoms than girls in the intervention condition is an important outcome of this study. As a of this we to the in the moderating effects of gender and current experience of war-related daily between study condition and changes on PTSD and It is that the experience of current war-related daily stressors was for boys and girls, and that these are the effects of intervention. In addition, it is that specific of the of the intervention (e.g., strengthening specific coping methods or social support to effects for boys and would be with of previous psychological interventions with war-affected children and in which effects are often observed In the of this it be important to with separate gender the of what be appropriate interventions to the mental health impacts of war on children. the one based on the lack of identified main intervention effects on primary outcomes in this study, it be that interventions rather than school-based interventions would be a more appropriate of intervention. For studies in countries have found support for cognitive behavioral and and we would for the importance of primary and secondary prevention interventions with children affected by armed conflict for two First, these interventions have benefits on outcomes which are important less of war on the mental health of children 33. For this study showed improvements on conduct problems, pro-social and function and earlier studies showed benefits on social and general psychological difficulties Second, although observed effects of such interventions have been in effect size to individual interventions and be to specific population such interventions the potential to reach larger population groups with resources and in more accessible and therefore have effects on the of at large as interventions our clearly to the need for more to identify the specific of risk and protective factors for children affected by armed conflict in order to research was a key in a recent to research for mental health and psychosocial support in humanitarian settings This study the of the current in for and of mental health interventions in It is not to that when interventions from to community and from being implemented by to by intervention effects be more by factors (e.g., exposure to violence, social This study that it be for of mental health interventions to not only if interventions are effective but also how they be in order to interventions to context and population It has previously been that the of mental health in the role of the in be that of a public health the to mental health and increase of This and other studies show that in to this to trained health to promote mental health (e.g., increase coping, social and distress and In settings with ongoing need to be of moderators of and treatment of PTSD symptoms specifically a more or a treatment (e.g., an individual or We would to for this study. The had no role in and conduct of the and of the and or of the