Clinical trial NCT06261463: Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families
Official title: Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
PTSD
Family Dynamics
Social Functioning
Family Support
Family Relations
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-02-15
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a randomized controlled trial with refugee families from Arabic-speaking refugee families from the Middle East (n=74). Half of the participants will be randomized to receive CAFES2 and half will be randomized to the enhanced control condition where they will receive ongoing access to services through partner organizations and healthy lifestyle materials.
Primary purpose: PREVENTION

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.

Detailed description: In partnership with refugee service organizations in Chicago, the investigator explored the problems, strengths, and help-seeking preferences of refugee families. Qualitative findings indicated ongoing problems coping with stress, trauma and loss, strain and tension in family relationships and limited social support networks. Participants identified a need for family-focused, group-based services led by individuals with similar life experiences. Based on these findings, the investigators identified an evidence-based multiple-family group model, Coffee and Family Education and Support (CAFES) as a foundational model that could be adapted to meet the needs of refugee families. Drawing on this formative work and strong community partnerships, further research is needed to adapt CAFES to a new population, to reflect multi-level needs of families and for use by refugee peer facilitators in community-based organizations. Research is also needed to assess feasibility, acceptability and fidelity of model implementation, attentive to barriers and facilitators specific to peer-led mental health services and community settings.

The investigators will use a hybrid type 1 randomized pilot trial design to achieve the following specific research aims:

Aim 1: To adapt the multiple family CAFES model for delivery by peers in community organizations using an implementation science adaptation framework and participatory human-centered design methods to develop an intervention that addresses the complex needs of refugee families.

Aim 2: To pilot the adapted CAFES2 model with refugee families from Arabic-speaking countries in the Middle East to examine feasibility, acceptability and provider fidelity when implemented by refugee peers in two community-based organizations in Chicago. (n=74, 37 intervention, 37 control) Aim 3: To explore the impact of the adapted CAFES2 model compared to enhanced control on outcomes of adult and child mental health and family and community support and explore variables expected to mediate the intervention's impact.

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).

Primary outcomes:
measure: Changes in feasibility of the intervention via the Feasibility of Intervention Measure
timeFrame: immediate post-intervention
measure: Changes in acceptability of the intervention via the Acceptability of Intervention Mesure
timeFrame: immediate post-intervention.
measure: Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory)
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: 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
measure: 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
Secondary outcomes:
measure: Changes in social support via the Medical Outcomes Study (MOS) Social Support Survey
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: Changes in social interaction via the Duke Social Support Index, social interaction subscale
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: Changes in family support via the Multidimensional Scale of Perceived Social Support (MSPSS, Family Support Sub-scale)
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: Quality of the parent-child relationship via the Dimensions of Parenting Scale (sub-scale, warmth and responsiveness of parent-child relationship)
timeFrame: baseline, immediate post-intervention and 6-week follow up
measure: Degree of family strengths and difficulties via the SCORE-15 (family strengths, family difficulties sub-scales
timeFrame: baseline, immediate post-intervention and 6-week follow up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinios Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Mary Bunn, PhD
role: PRINCIPAL_INVESTIGATOR
References: