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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06261463
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • CAFES2 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CAFES2 family and social strengthening intervention
    Families randomized into CAFES2 receive a home visit and participate in six multiple family group sessions in addition to any outside services or programs they are participating in.
  • No Intervention: Enhanced Control
    Families randomized to the enhanced control arm will not receive the CAFES2 intervention Instead, they will continue with their usual care, and also receive healthy lifestyle materials.

Primary Outcome Measure

Changes in feasibility of the intervention via the Feasibility of Intervention Measure [ Time Frame: immediate post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinios ChicagoChicagoIllinois60612
Mary Bunn, PhD

Find similar trials in Chicago, IL

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Illinios Chicago· Chicago, IL

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