Family ResearchNCT03796065
Addressing Mental Health Disparities in Refugee Children
A study testing FSI-R Treatment in people with Family Research, run by Boston College at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Family Research
- What is being tested?
- FSI-R Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- being a resettled refugee family
- having one or more school-aged children living in the home (aged 7-17)
- 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
Who cannot join
- not meeting the above inclusion criteria
- families in the midst of a crisis (e.g. active suicide attempts)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maine Immigrant and Refugee Services
Lewiston, Maine, 04240
Jewish Family Service
Springfield, Massachusetts, 01108
About this study
Official title: 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.
Read the 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.
- Conditions
- Family Research
- Being tested
- FSI-R Treatment
- Keywords
- refugees, parental self-efficacy, family communication, family connectedness, refugee youth, youth functioning, integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSI-R TreatmentBehavioural
Also called Family Strengthening Intervention for Refugees
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.
| Study group | Role | What they receive |
|---|---|---|
| FSI-R Treatment | Experimental | 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. Receives: Behavioral: FSI-R Treatment |
| FSI-R Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in conflict via the Family Conflict Scale
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.
Measured: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Change in communication via the Revised Parent- Adolescent Communication Form
Utilizes a 5-point Likert scale (1-5) to assess parent-child communication. Greater scores indicate higher communication between parents and their children.
Measured: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Change in family conflict via the Intergenerational Conflict Index
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.
Measured: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Change in parenting via the Alabama Parenting Questionnaire
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.
Measured: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Secondary outcomes (2)
Change in youth externalizing behaviors via the African Youth Psychosocial Assessment
This assessment utilizes a 4-point Likert scale (1-4) to assess for externalizing problems in youth with greater scores reflecting greater conduct problems.
Measured: 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
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".
Measured: T1 (Baseline), T2 (approximately 24-months post-baseline), T3 (6-months follow-up from T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start27 Aug 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa Betancourt, ScD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796065
- Sponsor's protocol ID
- 18.251.01
- Status last verified
- Feb 2023
- First submitted
- 3 Jan 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jung E, Black C, Placencio-Castro M, Chamlagai L, Osman R, Hoffman M, Beardslee W, Betancourt TS. Delivering a family-based child mental health promotion program among two resettled refugee communities during the COVID-19 pandemic: Lessons learned in a hybrid type II implementation-effectiveness randomized controlled trial. Am J Community Psychol. 2026 Mar;77(1-2):231-247. doi: 10.1002/ajcp.70021. Epub 2025 Oct 5.
PubMed 41046558
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial
- ClinicalTrials.gov ID
- NCT03796065
- Acronym / sponsor ID
- 18.251.01
- Conditions
- Family Research
- Keywords
- refugees, parental self-efficacy, family communication, family connectedness, refugee youth, youth functioning, integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| FSI-R Treatment | Experimental | Behavioral: FSI-R TreatmentFamilies 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. |
| FSI-R Control | No intervention | –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). |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- being a resettled refugee family
- having one or more school-aged children living in the home (aged 7-17)
- 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
Key exclusion criteria (2 listed)
- not meeting the above inclusion criteria
- families in the midst of a crisis (e.g. active suicide attempts)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSI-R TreatmentAlso: Family Strengthening Intervention for RefugeesThe 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. | Behavioural | FSI-R Treatment |
Primary outcome
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 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 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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 41046558Jung E, Black C, Placencio-Castro M, Chamlagai L, Osman R, Hoffman M, Beardslee W, Betancourt TS. Delivering a family-based child mental health promotion program among two resettled refugee communities during the COVID-19 pandemic: Lessons learned in a hybrid type II implementation-effectiveness randomized controlled trial. Am J Community Psychol. 2026 Mar;77(1-2):231-247. doi: 10.1002/ajcp.70021. Epub 2025 Oct 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Betancourt, ScD principal investigator
Boston College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSI-R Treatment in people with Family Research, run by Boston College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.