Depression Clinical Trial
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.
Status | Recruiting |
Enrollment | 74 |
Est. completion date | September 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 55 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinios Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | immediate post-intervention | |
Primary | 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 | immediate post-intervention. | |
Primary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Primary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Primary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Primary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Primary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Secondary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Secondary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Secondary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Secondary | 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. | baseline, immediate post-intervention and 6-week follow up | |
Secondary | 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 | baseline, immediate post-intervention and 6-week follow up |
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