RecruitingNot Applicable

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

United States74 participantsStarted 2024-05-31

Plain-language summary

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.

Who can participate

Age range12 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen
✕. men and women who do not have least one child aged 12 years and older living in one household
✕. arrived in the U.S as a refugee greater than 3 years ago
✕. persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention
✕. persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).

What they're measuring

Changes in feasibility of the intervention via the Feasibility of Intervention Measure

Timeframe: immediate post-intervention

Changes in acceptability of the intervention via the Acceptability of Intervention Mesure

Timeframe: immediate post-intervention.

Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)

Timeframe: baseline, immediate post-intervention and 6-week follow up

Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory)

Timeframe: baseline, immediate post-intervention and 6-week follow up

Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)

Timeframe: 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)

Timeframe: 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

Timeframe: baseline, immediate post-intervention and 6-week follow up

Trial details

NCT IDNCT06261463

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Mary Bunn, PhD

(312) 355-2136 mbunn@uic.edu

View on ClinicalTrials.gov More Depression trials

Plain-language summary

Who can participate

Age range12 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen
✕. men and women who do not have least one child aged 12 years and older living in one household
✕. arrived in the U.S as a refugee greater than 3 years ago
✕. persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention
✕. persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).