Psychosocial interventions for children exposed to traumatic events in low- and middle-income countries: Study protocol of an individual patient data meta-analysis

Background: The burden of mental health and psychosocial problems in children exposed to traumatic events in humanitarian settings in low- and middle-income countries is substantial. An increasing number of randomized studies has shown promising effects of psychosocial interventions, but this evidence has shown complexity with regard to setting, conflict-phase, gender, and age. These complex findings raise the need of a detailed evaluation of the specific factors which influence size and direction of intervention effects. Individual patient data meta-analysis is a specific type of meta-analysis that allows the collection of exact information at an individual patient level, and to examine whether intervention and socio-demographic characteristics, trauma-related variables, environmental conditions, and social support may act as moderators and mediators of intervention effect. The aim of the present study is to carry out an individual patient data meta-analysis using data from all available randomized controlled trials (either published or unpublished) comparing psychosocial intervention with waiting list or no intervention arms in children exposed to traumatic events living in low- and middle-income countries. Methods/Design: All randomized trials comparing selective preventive psychosocial intervention versus waiting list or no treatment conditions in children (0-18 years) living in low- and middle-income countries will be included. Studies will be identified in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. There will be no restrictions on publication type, status, language, or date of publication. The primary outcome measures will be psychological symptoms (post-traumatic stress disorder, anxiety, depression). Secondary outcomes will be positive mental health outcomes (coping methods, social support, self-esteem), and function impairment. Discussion: We are expecting that some variables, like socio-demographic characteristics, trauma-related variables, environmental conditions, and social support will act as moderators/mediators of intervention effect. The investigation of the role of these factors on the intervention effects will help in the appropriate selection, development, implementation, and dissemination of evidence-based programs in low- and middle-income countries. Trial registration: This protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO) (registration number: CRD42013006960).