Integrating Psychosocial Support Into Protection and Community Programs for Women in Ecuador and Panama
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 3
- 主要终点
- Attrition - proportion of enrolled individuals who drop out of the study
研究概览
简要总结
The purpose of the current protocol is to describe a cluster randomized feasibility trial examining the integration of a scalable stress management intervention into Entre Nosotras ('among/between us'), a community-based psychosocial intervention for migrant and host community women in Ecuador and Panamá.
Specifically the study aims to:
- Explore the relevance, acceptability, and feasibility of integrating a stress management intervention into community-based participatory women's group
- Examine the feasibility of conducting a fully-powered cluster randomized controlled trial evaluating the effectiveness and implementation of integrating a stress management intervention into a community-based participatory women's group as compared to community-based participatory women's groups alone.
详细描述
The proposed research directly targets two public health areas with major gaps in evidence in the field of humanitarian settings: (1) protection and safety, and (2) mental health and psychosocial wellbeing.
This research will be conducted in three sites in Ecuador and Panama. Latin America has recently experienced increasing levels of forced migration due to political conflict, community violence, and other factors. Panamá and Ecuador host refugees, asylum seekers, and migrants from a range of Central and South American countries (e.g., Colombia, Nicaragua, Venezuela). Migrants in these contexts face mental health and psychosocial problems, threats to their safety, and disrupted social support systems. Gaps in psychosocial services to address these problems despite their high prevalence persist in both countries and have been exacerbated due to the COVID-19 pandemic.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult (18+ years) women residing in the study community who speak and understand Spanish
- •Displaced or host community members
排除标准
- •Severe psychological distress (Kessler-6 >=13)
- •Moderate or high risk of suicide
- •Cognitive impairment
结局指标
主要结局
Attrition - proportion of enrolled individuals who drop out of the study
时间窗: Up to 10 weeks
The proportion of enrolled individuals who drop out of the study will be used to indicate the feasibility of a fully-powered definitive trial.
Proportion of eligible and enrolled women who engage in sessions and/or complete all five group sessions.
时间窗: Up to 5 weeks
This is to measure the acceptability of the intervention. Safety, an indicator of acceptability, will also be assessed by adverse events reported during study period. Qualitative interviews with participants and facilitators will inquire about acceptability and will be integrated with quantitative estimates of intervention engagement and completion.
Proportion of women screened who are eligible to participate
时间窗: Baseline
This is to measure relevance of the intervention in the source population. Appropriateness of the intervention to population needs will be measured using quantitative indicators and qualitative reports from participants and facilitators during the process evaluation.
Intervention Usability Scale Score
时间窗: 5 weeks
Usability will be measured using the 10-item Intervention Usability Scale, which will be completed by facilitators after the final session of the intervention. Scores are scaled to range from 0-100 with scores exceeding 68 considered to indicate usable interventions.
Number of baseline imbalances between study conditions
时间窗: Baseline
The number of socio-demographic or study outcome imbalances between the intervention and comparison condition will be used to determine the feasibility of a fully-powered definitive trial and the success of the randomization process.
Recruitment rate
时间窗: Study period
The number of individuals enrolled per month will be used to determine the feasibility of a fully-powered definitive trial.
Contamination - proportion of sessions that did not include coping skills intervention components
时间窗: Up to 5 weeks
The proportion of experimental sessions that did not include coping skills intervention components and the proportion of control sessions that did include coping skills intervention components from the Doing What Matters in Times of Stress intervention.
Fidelity checklist score
时间窗: Up to 5 weeks
Average level of compliance with the intervention activities as intended within the manual. Assessed using a fidelity checklist with average item scores ranging from 0 = not implemented to 2 = implemented well. Scores between 0 and 2 indicate that the activities were partially implemented and/or could be improved.
Facilitator competence score
时间窗: Up to 5 weeks
This is to measure the feasibility of the intervention. Facilitator competencies assessed using items from ENACT along qualitative interviews with facilitators will be assessed together. For the quantitative items, we selected six domains that are each scored on a scale from 1=needs improvement to 3=done well.
次要结局
- Kessler 6 scale score(Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks))
- Oslo Social Support Scale Score(Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks))
- Brief COPE scale score(Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks))
- Personal Wellbeing Index(Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks))
- WHODAS Score(Baseline, Post-Intervention (approximately 5 Weeks), 5 Weeks Post-Intervention (approximately 10 Weeks))