Recruiting

Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families

ClinicalTrials.gov IDNCT06261463

PhaseNA

Enrollment74

SponsorUniversity of Illinois at Chicago

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Anxiety, PTSD, Family Dynamics, Social Functioning, Family Support, Family Relations

About this study

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.

Interventions

Behavioral: CAFES2 — The adapted CAFES2 model includes an initial home visit and six multiple family group sessions delivered by peer providers. Families include at least one caregiver and one youth 12 years or older. Key model components include: 1) interfamilial discussion of stressors affecting families and family relationships, 2) psychoeducation on the effects of war and forced displacement on individuals, families and social relationships; 3) emotion regulation and self management strategies; 4) identification and activation of family and social strengths, 5) discussion of family identity and hopes for the future in resettlement and 5) discussion of social and community resources to support health and wellbeing. Each group session incorporates didactic components, family and small group discussion, skill building and separate breakout groups for adolescents and adults.

Primary outcomes

Changes in feasibility of the intervention via the Feasibility of Intervention Measure (immediate post-intervention)
Changes in acceptability of the intervention via the Acceptability of Intervention Mesure (immediate post-intervention.)
Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory) (baseline, immediate post-intervention and 6-week follow up)
Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory) (baseline, immediate post-intervention and 6-week follow up)
Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory) (baseline, immediate post-intervention and 6-week follow up)
Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory) (baseline, immediate post-intervention and 6-week follow up)
Changes in post-migration stress in youth and adults via the Refugee Post-Migration Stress Scale (baseline, immediate post-intervention and 6-week follow up)

Eligibility information

To participate in the study, the families must meet the following criteria: 1. Country of origin: Iraq, Syria, Lebanon, Jordan, Palestine or Yemen 2. refugee family living in Chicago \< three years 3. Contains at least one adult caregiver (18-55) and at least one of their children (age 12 and older) living in one household 4. One family member with \> 3 on the GHQ-12 5. able to give written informed consent. Exclusion criteria for refugee families: 1. Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen 2. men and women who do not have least one child aged 12 years and older living in one household 3. arrived in the U.S as a refugee greater than 3 years ago 4. persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention 5. persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).

Study locations

University of Illinios Chicago, Chicago, Illinois 60612 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.