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Life sciences · Interventional Study
ClinicalTrials.gov · November 4, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT03978533). This is a study registration, not published results. Lead sponsor: University of Illinois Chicago. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 215 participants (ACTUAL). Conditions: Depression, Anxiety, PTSD, Family Dynamics. Interventions: BEHAVIORAL: Family Support Group. Primary outcome measures: PTSD Checklist for DSM-5 (Adult Participants) , baseline, immediate post, three months post; General Health Questionnaire (GHQ-12) , baseline, immediate post, three months post; Child and Adolescent Trauma Screen (CATS) (for Adolescent Participants) , baseline, immediate post, 3 month post. Brief summary: The rapidly growing scale of humanitarian crises requires new response capabilities geared towards addressing populations with prolonged high vulnerability to mental health consequences and little to no access to mental health, health, and social resources. This R21 develops and pilot tests a novel model for helping urban refugee families in LMICs with little to no access to evidence-based mental health services, by delivering a transdiagnostic family intervention for common mental disorders in health sector and non-health sector settings. The project is located in Istanbul, Turkey. Aim 1 forms a Family Support Design Team (FSDT) to adopt the PM+ and CAFES manuals into a family support (FS) intervention for use with refugee families by lay providers in community sites and nurses in clinical sites using a four-session multiple family group format. Aim 2 pilots FS with families in community and clinical sites, and then through observations and qualitative interviews, assesses FS's feasibility, fidelity, the impact of context and local capacity, the experiences of intervention delivery, and practitioner and organizational perspectives on scale up. Aim 3 conducts pre, immediate post, and 3-month post assessments of the refugee families who received FS through all the sites, to demonstrate the kind of pre-post changes that have been reported for comparable interventions and to determine key parameters of interest with sufficient accuracy and precision. This exploratory investigation, conducted with the support and advice of the World Health Organization, will strengthen the research capabilities of the academic and community partners in Istanbul and will develop new evidence-based mental health services for refugees in Turkey and other LMICs, as well as for refugees and migrants in low resource communities in the United States.