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

Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CAFES2, a peer-led group program where refugee families build family and social support. It looks at whether the program is practical to run, whether families find it helpful, and whether it may improve mental health. It is for refugee families from six Middle Eastern countries who have lived in Chicago for less than three years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your family is from Iraq, Syria, Lebanon, Jordan, Palestine, or Yemen.
  • Your refugee family has lived in Chicago for less than three years.
  • At least one adult caregiver, age 18–55, lives with at least one of their children age 12 or older.
  • At least one family member scores above 3 on the GHQ-12, a mental health questionnaire.
  • You can give written consent to join the study.

Who can't join

  • Your family is not from Iraq, Syria, Jordan, Lebanon, Palestine, or Yemen.
  • You do not live with at least one child age 12 or older.
  • You arrived in the United States as a refugee more than three years ago.
  • You have a developmental disability that would keep you from taking part in the program.
  • You have a severe mental health problem, such as risk of suicide or a disorder that affects your sense of reality.
  • You have active substance use.
  • Your family is in a current crisis, such as violence at home or ongoing divorce proceedings.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

IL