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Behavioral Intervention
Peer-led Support Program for Refugee Families
N/A
Recruiting
Led By Mary Bunn, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Youth: between ages of 12 and 17 years old
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention and 6-week follow up
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess a program called Coffee and Family Education and Support, Version 2 (CAFES2) that aims to help refugee families with mental health support. The study will look at how well
Who is the study for?
This trial is for resettled refugee families with at least one school-aged child (12-17 years old) living with them. Participants should be between 18-45 years old and have arrived in the U.S. as refugees. At least one family member must show moderate emotional distress to qualify.
What is being tested?
CAFES2, a peer-led group intervention aimed at strengthening family and social dynamics among refugee families, is being tested for its feasibility, acceptability, and preliminary effectiveness using a pilot randomized hybrid design.
What are the potential side effects?
Since CAFES2 is a psychosocial intervention rather than a medical treatment, it may not have typical 'side effects,' but participants could experience discomfort or emotional distress when discussing sensitive topics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 17 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediate post-intervention and 6-week follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediate post-intervention and 6-week follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory)
Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)
Changes in acceptability of the intervention via the Acceptability of Intervention Mesure
+4 moreSecondary study objectives
Changes in family support via the Multidimensional Scale of Perceived Social Support (MSPSS, Family Support Sub-scale)
Changes in social interaction via the Duke Social Support Index, social interaction subscale
Changes in social support via the Medical Outcomes Study (MOS) Social Support Survey
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CAFES2 family and social strengthening interventionExperimental Treatment1 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.
Group II: Enhanced ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,913 Previous Clinical Trials
2,738,461 Total Patients Enrolled
University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,569,080 Total Patients Enrolled
Mary Bunn, PhDPrincipal InvestigatorUniversity of Illinois Chicago
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