Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261463
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-02-08
Brief Title:
Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n74 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 interventions impact
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 n74 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 interventions impact
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01MH128524-01A1 | NIH | None | httpsreporternihgovquickSearchK01MH128524-01A1 |