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临床试验/NCT03796065
NCT03796065已完成不适用

Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial

Boston College4 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2018年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
354
试验地点
4
主要终点
Change in family conflict via the Intergenerational Conflict Index

研究概览

简要总结

The proposed study will employ a cross-cultural Community Based Participatory Research (CBPR) approach to build from prior needs assessments and mixed-methods research to evaluate the effectiveness of the Family Strengthening Intervention for Refugees (FSI-R), a preventative family home-based visiting intervention intended to mitigate mental health disparities among refugee children and families using a hybrid implementation-effectiveness design. Results of the investigator's trial will expand the evidence-base on community-based interventions for refugees and has the potential to be replicated to reduce mental health disparities affecting diverse groups of refugee children and families.

详细描述

Using a CBPR approach, a family based prevention model, the Family Strengthening Intervention for Refugees (FSI-R) was adapted from a tested model used in Africa and designed for delivery by refugee community health workers with through a process involving stakeholder consultation and local refugee Community Advisory Board input. Pilot data on the FSI-R demonstrates strong feasibility and acceptability, but further data are needed on effectiveness as well as barriers and facilitators to implementation by community health workers embedded in refugee-serving social services agencies. Specific aims are to (1) examine the impact of a family-based preventive intervention on outcomes of parent-child relationships, family functioning, and child mental health using a Hybrid Type 2 Effectiveness-Implementation Design (families with children aged 7-17 in a two-arm randomized controlled trial); (2) identify barriers and facilitators to implementation of the FSI-R by community health workers by conducting a process evaluation concurrent with the delivery of the intervention; and (3) strengthen the science of community engagement to address health disparities by fortifying CBPR-based pathways of change via collaborative partnerships between refugee communities, service providers, and academic stakeholders.

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 (Care Provider)

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
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • not meeting the above inclusion criteria
  • families in the midst of a crisis (e.g. active suicide attempts)

结局指标

主要结局

Change in family conflict via the Intergenerational Conflict Index

时间窗: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)

Utilizes a 5-point Likert scale (1-5) to assess intergenerational congruence across several domains of the parent-child relationship. Higher scores denote greater intergenerational congruence.

Change in conflict via the Family Conflict Scale

时间窗: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)

The Family Conflict Scale utilizes a 7-point Likert Scale (0-6) to assess family conflict within the past month. Higher scores reflect greater family conflict.

Change in communication via the Revised Parent- Adolescent Communication Form

时间窗: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)

Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children.

Change in parenting via the Alabama Parenting Questionnaire

时间窗: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)

Likert scale (1-5) that includes 5 sub-domains. Each sub-domain results in a summed score that relates to 5 domains of parenting: involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment.

次要结局

  • Change in youth externalizing behaviors via the African Youth Psychosocial Assessment(T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2))
  • Change in youth depression via the Center for Epidemiologic Studies-Depression scale(T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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