NCT02562794

Brief Summary

This study will use CBPR mixed methods (qualitative and quantitative data collection) to conduct needs assessments and design and evaluate a core family-based intervention. Project activities will emphasize capacity building in two refugee communities resettled in Greater Boston-the Somali Bantu and the Bhutanese-actively engaging refugee community members, community advisory boards, services providers, and other stakeholders. Specific Aims are to: (1) deepen partnerships with the Somali Bantu and Bhutanese communities through co-leadership, capacity-building, and knowledge sharing; (2) collect and apply qualitative data to (a) prepare a needs assessment of mental health in children and adolescents, barriers to care, and services preferences with each target refugee group; (b) develop mental health/psychosocial assessments for refugee caregivers and children; (c) adapt the core components of a family-based strengthening intervention for use with refugees; and (3) conduct an 80-family pilot study to examine acceptability and sustainability of the intervention. Key outcomes will be reduced mental health symptoms among children and adolescents and improvement in caregiver-child relationships.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

July 22, 2015

Last Update Submit

July 9, 2019

Conditions

Keywords

refugee

Outcome Measures

Primary Outcomes (1)

  • Change in depressive symptoms among children and adolescents

    Depressive symptoms will be measured with an adapted version of the Center for Epidemiologic Study-Depression) CES-D scale

    Depressive symptoms will be measured at three time points - at baseline prior to intervention, immediately post-intervention (an average of 16 weeks after baseline), and 6 months after the completion of the intervention

Secondary Outcomes (3)

  • Change in anxiety symptoms among children and adolescents

    Anxiety symptoms will be measured at three time points - at baseline prior to intervention, immediately post intervention (an average of 16 weeks after baseline), and six months after the completion of the intervention

  • Change in externalizing/behavioral problems among children and adolescents

    Externalizing symptoms will be measured at three time points - at baseline prior to intervention, immediately post-intervention (an average of 16 weeks after the baseline), and 6 months after the completion of the intervention

  • Change in parent-child relationships

    Quality of parent-child relationships will be measured at three time points - at baseline prior to intervention, immediately post-intervention (an average of 16 weeks after the baseline), and 6 months after the completion of the intervention.

Study Arms (2)

Intervention

EXPERIMENTAL

Family Strengthening Intervention-Refugees. A total of 20 Somali Bantu and 20 Bhutanese refugee families will participate in a Family Strengthening Intervention adapted for use with refugees.

Behavioral: Family Strengthening Intervention-Refugees

Control

NO INTERVENTION

A total of 20 Somali Bantu and 20 Bhutanese refugee families will receive services as usual.

Interventions

This study aims to design a preventive intervention for at-risk refugee children and families. The intervention is focused on strengthening core family resources and promoting resilience and healthy parent-child interactions.

Intervention

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Refugee families must have a school-aged child (aged 5-17), and caregivers must be at least 18 years of age and live in the same household as the child.

You may not qualify if:

  • Untreated mental illness or active family crisis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chelsea Collaborative

Chelsea, Massachusetts, 02150, United States

Location

Jewish Family Service

Springfield, Massachusetts, 01108, United States

Location

Related Publications (1)

  • Betancourt TS, Frounfelker R, Mishra T, Hussein A & Falzarano R. American Journal of Public Health. Published on-line ahead of print April 23, 2015; e1-8. doi:10.2105/AJPH.2014.302504

    BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Theresa Betancourt, ScD

    Boston College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Salem Professor in Global Practice

Study Record Dates

First Submitted

July 22, 2015

First Posted

September 29, 2015

Study Start

August 1, 2016

Primary Completion

February 1, 2019

Study Completion

April 1, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations