NCT06261463 Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families
| NCT ID | NCT06261463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2024-05-31 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2024-05-31 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Mary Bunn, PhD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT06261463 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 55 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06261463 currently recruiting?
Yes, NCT06261463 is actively recruiting participants. Contact the research team at mbunn@uic.edu for enrollment information.
Where is the NCT06261463 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06261463 clinical trial?
NCT06261463 is sponsored by University of Illinois at Chicago. The principal investigator is Mary Bunn, PhD at University of Illinois at Chicago. The trial plans to enroll 74 participants.
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