Community Research and Development Information Service - CORDIS


Evidence on the effectiveness of psychosocial support interventions in children exposed to traumatic events in humanitarian settings in low- and middle-income countries (HS-LMIC) is complex, as randomized studies have shown inconsistent results. The objective of the present study was to carry out an individual participant data meta-analysis using data from all available randomized controlled trials (RCTs) (either published or unpublished) comparing psychosocial interventions with waiting list or no intervention arms in children exposed to traumatic events living in low- and middle-income countries. A comprehensive analysis had the objective of understanding the mechanisms of action of psychosocial interventions, including why some children benefit from specific interventions more than others.
We performed a systematic review of randomized trials (published and unpublished) evaluating psychosocial interventions in children exposed to traumatic events in HS-LMIC. Each step of the systematic review was conducted according to the Cochrane methodology: search strategy, records screening, identification of eligible studies/excluded studies with reasons/awaiting assessment studies, data extraction form preparation, data extraction and double check, database preparation. We conducted an individual participant data (IPD) meta-analysis from 3,143 children recruited in 11 randomized controlled trials (RCT) of focused psychosocial support interventions versus waiting list. Dr. Purgato was able to collect 100% of the patients included in the 11 studies. We identified a beneficial effect of focused psychosocial support interventions on primary outcome Post Traumatic Stress Disorder symptoms (Standardised Mean Difference [SMD] -0.33 95% Confidence Interval [CI] -0.52 to -0.14), that was maintained at follow-up (SMD -0.21 95% CI -0.42 to -0.01). We also identified benefits for functional impairment (SMD -0.29 95% CI -0.43 to -0.15) and for outcomes related to strengths: coping (SMD -0.22 95% CI -0.43 to -0.02), hope (SMD -0.29 95% CI -0.48 to -0.09), and social support (SMD -0.27 95% CI -0.52 to -0.02). In addition, IPD meta-analyses considered the role of specific variables in influencing the interventions’ effect. When analyzing the role of age, gender, displacement status, region, and household size we found a stronger improvement in PTSD symptoms in children aged 15 to 18 years (SMD -0.43, 95% CI -0.63 to -0.23), in non-displaced children (SMD -0.40, 95% CI -0.52 to -0.27), and in children living in smaller households (<6 members) (SMD -0.27, 95% CI -0.42 to -0.11).
The full systematic review and IPD meta-analysis has recently been published in the Lancet Global Health, an international high impact factor peer-reviewed scientific journal. The main publication of results has been preceded by: the development of a detailed research protocol containing information on the rationale for the study, details on the methodology for data aggregation and analyses (with a specific focus on meta-analyses for aggregated and individual data); clear hypotheses definition with research questions; preparatory work on the public approach to mental health, distinguishing preventative, treatment, and promotive interventions in the field of global mental health.
Both the protocol and the preparatory work have been published in international peer-reviewed journals and in the international prospective register of systematic reviews PROSPERO (ID: CRD42013006960).
Dr. Purgato was able to develop an international network of researchers: all authors of the included primary studies were contacted and invited to be part of the individual participant data meta-analysis team. Authors were provided with a clear summary of the project, objectives and scientific and clinical rationale. All authors agreed to take part in the project and shared individual participant datasets.
After collecting individual participant datasets from included studies, Dr. Purgato created a new Excel database (to be subsequently exported in STATA and Review Manager) as a merge of all collected datasets. She performed a data quality check in interaction with authors of original studies when necessary. Moreover, she checked for data consistency by comparing individual participant datasets with published reports. The Item Response Theory (IRT) approach was applied for items harmonization across studies for all the outcomes (both primary and secondary outcomes). The IRT approach enables questionnaire items to be weighted differently in deriving the factor; questions more strongly correlated with other questions within and across the datasets are given greater weight. Additionally, the model defines appropriate locations, or thresholds, for individual question responses on the latent variable metric based on the sample probability of the symptom or behavior being endorsed. The methodology of each included study was evaluated according to the Cochrane Risk of Bias tool, using the software Review Manager (version 5.3).
Statistical analyses were performed both on aggregated and individual data on primary and secondary outcomes. IPD meta-analyses allowed exploring the role of specific variables (i.e., gender, age, displacement status, household size) on the interventions’ effectiveness.
The IPD meta-analysis was conducted by performing both a pooled analysis, which combined all the IPD across studies in a single model for each outcome as if they belonged to a single trial (“mega-trial” approach) and a coordinated analysis approach, in which studies were analyzed separately. Data were analyzed using the software STATA and Review Manager.
Dr. Purgato developed GRADE evidence-based profiles on the treatment of children exposed to traumatic events in HS-LMIC, in accordance to the methodology recommended by the GRADE international working group. Dr. Purgato created a registry containing all RCTs on the effectiveness of psychosocial interventions for children exposed to traumatic events in HS-LMIC. This register has been created by recording studies identified through the search strategy of the systematic review, crossed with search strategies performed by Cochrane for systematic reviews on similar topics/interventions. The registry will be kept regularly updated by adding newly conducted RCTs.
One of the main strengths of CHILD TRAUMA IN LMIC is the analysis of outcomes focused on resilience, that is a priority for humanitarian practitioners working with children, but is often ignored in evaluation studies. Our approach to mental health goes beyond the sole consideration of symptoms of mental disorders, giving the right emphasis on strengths in terms of coping strategies, social support, and hope. This innovative, public health perspective avoids the medicalization of mental conditions, stressing the importance of child resources, contextual and social factors. The scientific knowledge produced will facilitate a better matching of intervention with individual and contextual factors in the field of global mental health, with enormous impact on clinical practice and policies (considering also socio-economic factors). In addition, the project’s results are expected to significantly impact the development of clinical guidelines for the prevention and treatment of mental health conditions in children living in low- and middle-income countries. For these reasons, results of CHILD TRAUMA IN LMIC are important not only for clinicians, but also for general practitioners in HS, and for policy makers involved in the development of evidence-based guidelines and priority setting.

Contact details:
Webpage of the project (hosted by the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona):

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