nctId: NCT06261463 id: 2023-0326 id: K01MH128524-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/K01MH128524-01A1 briefTitle: Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-07 date: 2024-02-15 date: 2024-02-15 name: University of Illinois at Chicago class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions. conditions: Depression conditions: Anxiety conditions: PTSD conditions: Family Dynamics conditions: Social Functioning studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators will conduct a randomized controlled trial with Syrian refugee families (n=74). Half of the families will be randomized to receive CAFES2 and half will be randomized to the enhanced control condition where they will receive ongoing access to services through partner organizations and healthy lifestyle materials. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized. whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: CAFES2 measure: Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory) measure: Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory) measure: Changes in youth depression and anxiety via the Hospital Anxiety and Depression Scale (HADS, youth, exploratory) measure: Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory) measure: Changes in social support via the Medical Outcomes Study Social Support Survey measure: Changes in social interaction via the Duke Social Support Index, social interaction subscale measure: Changes in parenting via the Alabama Parenting Questionnaire (adult and youth) measure: Changes in family communication via the Family Problem Solving Communication Scale measure: Changes in acceptability of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure measure: Changes in feasibility of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure sex: ALL minimumAge: 12 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT hasResults: False