protocolSection identificationModule nctId: NCT06261463, orgStudyIdInfo id: 2023-0326, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule 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., conditionsModule conditions: Depression, conditions: Anxiety, conditions: PTSD, conditions: Family Dynamics, conditions: Social Functioning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo 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, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: CAFES2, outcomesModule primaryOutcomes measure: Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory), primaryOutcomes measure: Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory), primaryOutcomes measure: Changes in youth depression and anxiety via the Hospital Anxiety and Depression Scale (HADS, youth, exploratory), primaryOutcomes measure: Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory), secondaryOutcomes measure: Changes in social support via the Medical Outcomes Study Social Support Survey, secondaryOutcomes measure: Changes in social interaction via the Duke Social Support Index, social interaction subscale, secondaryOutcomes measure: Changes in parenting via the Alabama Parenting Questionnaire (adult and youth), secondaryOutcomes measure: Changes in family communication via the Family Problem Solving Communication Scale, otherOutcomes measure: Changes in acceptability of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure, otherOutcomes measure: Changes in feasibility of the intervention via the Johns Hopkins University Dissemination and Implementation Science Measure, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False