Leveraging Implementation Science and Design Methods to Sustain Community-based Mental Health Services for Refugees
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changes in feasibility of the intervention via the Feasibility of Intervention Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized.
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in feasibility of the intervention via the Feasibility of Intervention Measure
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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 PTSD in children and youth via the Child Revised Impacted of Events Scale (CRIES, youth, exploratory)
时间窗: 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 youth depression and anxiety via the Arab Mental Health Scale (youth, exploratory)
时间窗: 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 post-migration stress in youth and adults via the Refugee Post-Migration Stress Scale
时间窗: 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.
次要结局
- Changes in social interaction via the Duke Social Support Index, social interaction subscale(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)(baseline, immediate post-intervention and 6-week follow up)
- Changes in social support via the Medical Outcomes Study (MOS) Social Support Survey(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)(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(baseline, immediate post-intervention and 6-week follow up)
研究者
Mary Bunn
Assistant Professor
University of Illinois at Chicago