- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03796065
Addressing Mental Health Disparities in Refugee Children
February 6, 2023 updated by: Boston College
Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
354
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maine
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Lewiston, Maine, United States, 04240
- Maine Immigrant and Refugee Services
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Massachusetts
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Springfield, Massachusetts, United States, 01108
- Jewish Family Service
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for families:
- being a resettled refugee family
- having one or more school-aged children living in the home (aged 7-17)
Inclusion Criteria for parents/caregivers:
- be aged 18 or older
- cares for and lives in the same household of the children at least 50% of the time
- is the child'd legal guardian
Exclusion Criteria:
- not meeting the above inclusion criteria
- families in the midst of a crisis (e.g. active suicide attempts)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FSI-R Treatment
Families randomized into the FSI-R Treatment arm will receive the 10-module Family Strengthening Intervention in addition to any outside services or programs they are participating in.
|
The FSI-R involves a series of separate and joint meetings with parents and children to discuss challenges the family has faced and the strengths that helped them make it through past challenging times.
Additional psychoeducation on mental health and promoting resilience along with coaching to enhance parenting skills is provided throughout and may be tailored to family needs.
The FSI-R provides a shared space for refugee families both to recognize their strengths and to problem-solve in a more collective way on family challenges and shared hopes for the future.
The FSI-R is delivered in the home, by a trained interventionist, over the course of 10-modules.
Other Names:
|
NO_INTERVENTION: FSI-R Control
Families randomized into the FSI-R Control arm will not receive the FSI-R treatment.
Instead, they will continue with their usual care, referred to as Treatment as Usual (TAU).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
|
T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
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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.
|
T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
|
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)
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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.
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T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
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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)
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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.
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T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in youth externalizing behaviors via the African Youth Psychosocial Assessment
Time Frame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
|
This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems.
|
T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
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Change in youth depression via the Center for Epidemiologic Studies-Depression scale
Time Frame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
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This measures utilizes a 4-point Likert scale (0-3) to assess depression in youth with higher scores indicated increasing levels of depression.
The time frame referenced is "during the past week".
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T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 27, 2018
Primary Completion (ACTUAL)
June 30, 2022
Study Completion (ACTUAL)
June 30, 2022
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 7, 2019
First Posted (ACTUAL)
January 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18.251.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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