DepressionNCT06261463
Hybrid Type 1 Randomized Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families
A study testing CAFES2 in people with Depression and Anxiety, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Depression, Anxiety, PTSD
- What is being tested?
- CAFES2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen
- men and women who do not have least one child aged 12 years and older living in one household
- arrived in the U.S as a refugee greater than 3 years ago
- persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention
- persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinios Chicago
Chicago, Illinois, 60612
Mary Bunn, PhD
About this study
Official title: Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees
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.
Read the 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.
- Conditions
- Depression, Anxiety, PTSD, Family Dynamics, Social Functioning, Family Support
- Being tested
- CAFES2
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAFES2Behavioural
Also called Coffee and Family Education and Support, Version 2
The adapted CAFES2 model includes an initial home visit and six multiple family group sessions delivered by peer providers. Families include at least one caregiver and one youth 12 years or older. Key model components include: 1) interfamilial discussion of stressors affecting families and family relationships, 2) psychoeducation on the effects of war and forced displacement on individuals, families and social relationships; 3) emotion regulation and self management strategies; 4) identification and activation of family and social strengths, 5) discussion of family identity and hopes for the future in resettlement and 5) discussion of social and community resources to support health and wellbeing. Each group session incorporates didactic components, family and small group discussion, skill building and separate breakout groups for adolescents and adults.
| Study group | Role | What they receive |
|---|---|---|
| CAFES2 family and social strengthening intervention | Experimental | 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. Receives: Behavioral: CAFES2 |
| Enhanced Control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in feasibility of the intervention via the Feasibility of Intervention Measure
This 4-item measure assesses the degree to which a given intervention is viewed as feasible for a given population and setting. Higher scores are associated with greater degrees of perceived feasibility.
Measured: immediate post-intervention
Changes in acceptability of the intervention via the Acceptability of Intervention Mesure
4-item measure assess the degree to which the intervention is viewed as agreeable or satisfactory, with higher scores indicating greater acceptability
Measured: immediate post-intervention.
Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)
PTSD Checklist utilizes a 5-point likert scale (0-4) to assess post traumatic stress symptoms. Higher scores indicate increasing levels of PTSD.
Measured: baseline, immediate post-intervention and 6-week follow up
Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory)
HSCL measures symptoms of anxiety and depression in adults using a 4-point likert scale (1-4) with high scores indicating higher levels of anxiety and depression symptoms.
Measured: baseline, immediate post-intervention and 6-week follow up
Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)
This scale measures symptoms of anxiety and depression in youth using a 3-point likert scale (0-3). Total scores are associated with mild, moderate or severe anxiety or depression.
Measured: baseline, immediate post-intervention and 6-week follow up
Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory)
CRIES is a measures to assess PTSD symptoms in children and youth. Higher total scores indicate higher PTSD symptoms.
Measured: baseline, immediate post-intervention and 6-week follow up
Changes in post-migration stress in youth and adults via the Refugee Post-Migration Stress Scale
The post-migration stressors scale assess stress in youth and adults. Higher total scores indicate higher levels of stress.
Measured: baseline, immediate post-intervention and 6-week follow up
Secondary outcomes (5)
Changes in social support via the Medical Outcomes Study (MOS) Social Support Survey
This measure assesses diverse forms of social support using a 5-point likert scale. Higher overall scores indicate greater degree of available support.
Measured: baseline, immediate post-intervention and 6-week follow up
Changes in social interaction via the Duke Social Support Index, social interaction subscale
The Duke Social Support Index, Social Interaction Subscale assesses diverse types of daily social interactions. Higher scores indicate greater degrees of social interaction.
Measured: baseline, immediate post-intervention and 6-week follow up
Changes in family support via the Multidimensional Scale of Perceived Social Support (MSPSS, Family Support Sub-scale)
Likert scale (1-7) that assesses degree of family support. Higher scores indicate greater degress of family support.
Measured: baseline, immediate post-intervention and 6-week follow up
Quality of the parent-child relationship via the Dimensions of Parenting Scale (sub-scale, warmth and responsiveness of parent-child relationship)
The Dimensions of Parenting, Warmth and responsiveness sub-scale assess the nature and quality of the parent-child relationship using a 3-point likert scale (1-3). Higher scores indicate greater degree of parent-child warmth and responsiveness.
Measured: baseline, immediate post-intervention and 6-week follow up
Degree of family strengths and difficulties via the SCORE-15 (family strengths, family difficulties sub-scales
A 15-item scale assess family communication, strengths and difficulties with lower scores indicating higher levels of family strengths and higher scores more family difficulties
Measured: baseline, immediate post-intervention and 6-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start31 May 2024
- Primary completionAug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mary Bunn, University of Illinois Chicago
- Investigators
- Mary Bunn, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261463
- Sponsor's protocol ID
- 2023-0326
- Other IDs
- K01MH128524-01A1
- Status last verified
- Sep 2025
- First submitted
- 8 Feb 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees
- ClinicalTrials.gov ID
- NCT06261463
- Acronym / sponsor ID
- 2023-0326
- Conditions
- Depression, Anxiety, PTSD, Family Dynamics, Social Functioning, Family Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 31 May 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAFES2 family and social strengthening intervention | Experimental | Behavioral: CAFES2Families 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. |
| Enhanced Control | No 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. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Not from one of the following Arabic-speaking countries in the Middle East: Iraq, Syria, Jordan, Lebanon, Palestine, Yemen
- men and women who do not have least one child aged 12 years and older living in one household
- arrived in the U.S as a refugee greater than 3 years ago
- persons with developmental disabilities which would preclude their participation in the adapted CAFES intervention
- persons with severe mental health (e.g., suicidality psychotic disorder), active substance use or current in family crisis (e.g., domestic violence, divorce proceedings).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAFES2Also: Coffee and Family Education and Support, Version 2The adapted CAFES2 model includes an initial home visit and six multiple family group sessions delivered by peer providers. Families include at least one caregiver and one youth 12 years or older. Key model components include: 1) interfamilial discussion of stressors affecting families and family relationships, 2) psychoeducation on the effects of war and forced displacement on individuals, families and social relationships; 3) emotion regulation and self management strategies; 4) identification and activation of family and social strengths, 5) discussion of family identity and hopes for the future in resettlement and 5) discussion of social and community resources to support health and wellbeing. Each group session incorporates didactic components, family and small group discussion, skill building and separate breakout groups for adolescents and adults. | Behavioural | CAFES2 family and social strengthening intervention |
Primary outcome
Changes in feasibility of the intervention via the Feasibility of Intervention Measure
Time frame: immediate post-intervention
This 4-item measure assesses the degree to which a given intervention is viewed as feasible for a given population and setting. Higher scores are associated with greater degrees of perceived feasibility.
Changes in acceptability of the intervention via the Acceptability of Intervention Mesure
Time frame: immediate post-intervention.
4-item measure assess the degree to which the intervention is viewed as agreeable or satisfactory, with higher scores indicating greater acceptability
Changes in PTSD symptoms via the PTSD Checklist (adult, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
PTSD Checklist utilizes a 5-point likert scale (0-4) to assess post traumatic stress symptoms. Higher scores indicate increasing levels of PTSD.
Changes in adult depression and anxiety via the Hopkins Symptom Checklist (HSCL, adult, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
HSCL measures symptoms of anxiety and depression in adults using a 4-point likert scale (1-4) with high scores indicating higher levels of anxiety and depression symptoms.
Changes in youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
This scale measures symptoms of anxiety and depression in youth using a 3-point likert scale (0-3). Total scores are associated with mild, moderate or severe anxiety or depression.
Changes in PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory)
Time frame: baseline, immediate post-intervention and 6-week follow up
CRIES is a measures to assess PTSD symptoms in children and youth. Higher total scores indicate higher PTSD symptoms.
Changes in post-migration stress in youth and adults via the Refugee Post-Migration Stress Scale
Time frame: baseline, immediate post-intervention and 6-week follow up
The post-migration stressors scale assess stress in youth and adults. Higher total scores indicate higher levels of stress.
5 secondary outcomes
Changes in social support via the Medical Outcomes Study (MOS) Social Support Survey
Time frame: baseline, immediate post-intervention and 6-week follow up
Changes in social interaction via the Duke Social Support Index, social interaction subscale
Time frame: baseline, immediate post-intervention and 6-week follow up
Changes in family support via the Multidimensional Scale of Perceived Social Support (MSPSS, Family Support Sub-scale)
Time frame: baseline, immediate post-intervention and 6-week follow up
Quality of the parent-child relationship via the Dimensions of Parenting Scale (sub-scale, warmth and responsiveness of parent-child relationship)
Time frame: baseline, immediate post-intervention and 6-week follow up
Degree of family strengths and difficulties via the SCORE-15 (family strengths, family difficulties sub-scales
Time frame: baseline, immediate post-intervention and 6-week follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Bunn, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAFES2 in people with Depression and Anxiety, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Bunn, PhD ((312) 355-2136, mbunn@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in feasibility of the intervention via the Feasibility of Intervention Measure (time frame: immediate post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.