Clinical trial NCT03796065: Addressing Mental Health Disparities in Refugee Children
Official title: Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Research
Keywords: refugees
parental self-efficacy
family communication
family connectedness
refugee youth
youth functioning
integration
Lead sponsor: Boston College
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 354
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will conduct a Randomized Controlled Trial among Somali Bantu and Bhutanese families (N=300; 150 per group). Half of the families will be randomized to receive the FSI-R and half will be randomized to the control condition where the participants will receive Treatment as Usual (TAU).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in conflict via the Family Conflict Scale
timeFrame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
measure: Change in communication via the Revised Parent- Adolescent Communication Form
timeFrame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
measure: Change in family conflict via the Intergenerational Conflict Index
timeFrame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
measure: Change in parenting via the Alabama Parenting Questionnaire
timeFrame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Secondary outcomes:
measure: Change in youth externalizing behaviors via the African Youth Psychosocial Assessment
timeFrame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
measure: Change in youth depression via the Center for Epidemiologic Studies-Depression scale
timeFrame: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Maine Immigrant and Refugee Services
state: Maine
city: Springfield
country: United States
facility: Jewish Family Service
state: Massachusetts
Study officials:
affiliation: Boston College
name: Theresa Betancourt, ScD
role: PRINCIPAL_INVESTIGATOR
References: