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

Recruiting · NCT06261463 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago

View the official record on ClinicalTrials.gov →

Depression Anxiety

Interventions studied

CAFES2

What this trial is about

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 take part

Age range

12 Years to 55 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

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).

Where it is running

2 locations listed across 1 US state.

University of Illinios Chicago - Chicago, Illinois, United States
University of Illinios Chicago - Chicago, Illinois, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →