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Clinical Trials/NCT03796065
NCT03796065
Completed
Not Applicable

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

Boston College2 sites in 1 country354 target enrollmentAugust 27, 2018
ConditionsFamily Research

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Family Research
Sponsor
Boston College
Enrollment
354
Locations
2
Primary Endpoint
Change in family conflict via the Intergenerational Conflict Index
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 27, 2018
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in family conflict via the Intergenerational Conflict Index

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (2)

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