Child/Adolescent ProblemsNCT02562794
Addressing Mental Health Disparities in Refugee Children: A Community-based Participatory Research (CBPR) Collaboration
A study testing Family Strengthening Intervention-Refugees in people with Child/Adolescent Problems and Mental Disorders, run by Boston College at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child/Adolescent Problems, Mental Disorders
- What is being tested?
- Family Strengthening Intervention-Refugees
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to Apr 2019
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Untreated mental illness or active family crisis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chelsea Collaborative
Chelsea, Massachusetts, 02150
Jewish Family Service
Springfield, Massachusetts, 01108
About this study
Official title: Addressing Mental Health Disparities in Refugee Children: A CBPR Collaboration
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.
Read the detailed description
The proposed mixed methods study will apply CBPR methods in an innovative, cross-cultural project to assess mental health problems in children and community strengths in two refugee communities-the Somali Bantu and the Bhutanese-and to design and pilot test a family-based intervention for refugees in their native languages (Somali Bantu Maay Maay and the Nepali language used by Bhutanese refugees). We will use qualitative research methods developed in preliminary research with the Somali Bantu to identify local conceptualizations of mental health problems, resilience, attitudes about healing and help-seeking, and preferences for mental health services among resettled Bhutanese. The CBPR team will collaborate on mental health needs assessments for both communities, with attention paid to shared experiences and strengths.
Findings on risk and protective factors influencing child mental health will inform development of a preventive intervention. Community Advisory Boards (CABs) will actively participate in the review and selection of intervention components. Based on preliminary research with the Somali Bantu community, we anticipate that a family-based intervention model will respond well to community requests for parenting support and psychoeducation about trauma and effects in families. An intervention positively oriented towards existing sources of family resilience and self-efficacy has great potential for improving access to and engagement in mental health care and other social services, and for increasing both formal and non-formal supports-all essential for reducing mental health disparities.
In this manner, community and university partners will collaborate to achieve four Specific Aims:
Aim 1: Strengthen existing relationships and decision-making partnerships with the Somali Bantu and Bhutanese refugee communities in Greater Boston through community based participatory research in partnership with the Shanbaro Community Association and Chelsea Collaborative in Chelsea, Massachusetts.
Aim 2: Collect and analyze qualitative data on local conceptualizations of mental health problems and resilience in school-age children (ages 5-17) as well as help seeking and services preferences among Somali Bantu and Bhutanese refugee families; use findings to inform intervention targets and critical components of a family-based preventive intervention, the Family Strengthening Intervention (FSI) for refugees.
Aim 3: Use qualitative findings to prepare (a) a needs assessment of mental health in school-age children, community strengths, barriers to care, and services preferences with each target refugee group; (b) a preliminary battery of mental health/psychosocial measures for use in mental health assessment of children and caregivers; and (c) a draft set of intervention, recruitment, and training materials.
Aim 4: Use CBPR approaches to recruit and enroll 80 families in a feasibility study, with half randomized to care as usual and half to the FSI delivered by trained community interventionists; conduct longitudinal assessments at baseline, post-intervention, and 6 months. Hypothesis 4.1: Participation in the refugee FSI will be associated with improved communication and connectedness within families, increased mental health services access, and increased knowledge among caregivers and children on the consequences of trauma in refugee families. Hypothesis 4.2: Participation in the refugee FSI will be associated with increased application of healthy parenting skills, parental self-efficacy, parental supervision of children, improved functioning and reduced symptoms of internalizing and externalizing in school-age refugee children.
- Conditions
- Child/Adolescent Problems, Mental Disorders
- Being tested
- Family Strengthening Intervention-Refugees
- Keywords
- refugee
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Strengthening Intervention-RefugeesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Strengthening Intervention-Refugees |
| Control | No intervention | A total of 20 Somali Bantu and 20 Bhutanese refugee families will receive services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 with an adapted version of the CES-D
Measured: 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 with the (Youth Self-Report) YSR externalizing sub scale
Measured: 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
Parent-child relationships will be measured with an adapted version of the Alabama parenting scale
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startAug 2016
- Primary completionFeb 2019
- Study completionApr 2019
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 Child/Adolescent ProblemsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Theresa Betancourt, Boston College
- Investigators
- Theresa Betancourt, ScD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562794
- Sponsor's protocol ID
- 15860
- Other IDs
- R24MD008057
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2015
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Betancourt TS, Frounfelker R, Mishra T, Hussein A, Falzarano R. Addressing health disparities in the mental health of refugee children and adolescents through community-based participatory research: a study in 2 communities. Am J Public Health. 2015 Jul;105 Suppl 3(Suppl 3):S475-82. doi: 10.2105/AJPH.2014.302504. Epub 2015 Apr 23.
PubMed 25905818
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Mental Health Disparities in Refugee Children: A CBPR Collaboration
- ClinicalTrials.gov ID
- NCT02562794
- Acronym / sponsor ID
- 15860
- Conditions
- Child/Adolescent Problems, Mental Disorders
- Keywords
- refugee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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.
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.
Detailed description
The proposed mixed methods study will apply CBPR methods in an innovative, cross-cultural project to assess mental health problems in children and community strengths in two refugee communities-the Somali Bantu and the Bhutanese-and to design and pilot test a family-based intervention for refugees in their native languages (Somali Bantu Maay Maay and the Nepali language used by Bhutanese refugees). We will use qualitative research methods developed in preliminary research with the Somali Bantu to identify local conceptualizations of mental health problems, resilience, attitudes about healing and help-seeking, and preferences for mental health services among resettled Bhutanese. The CBPR team will collaborate on mental health needs assessments for both communities, with attention paid to shared experiences and strengths.
Findings on risk and protective factors influencing child mental health will inform development of a preventive intervention. Community Advisory Boards (CABs) will actively participate in the review and selection of intervention components. Based on preliminary research with the Somali Bantu community, we anticipate that a family-based intervention model will respond well to community requests for parenting support and psychoeducation about trauma and effects in families. An intervention positively oriented towards existing sources of family resilience and self-efficacy has great potential for improving access to and engagement in mental health care and other social services, and for increasing both formal and non-formal supports-all essential for reducing mental health disparities.
In this manner, community and university partners will collaborate to achieve four Specific Aims:
Aim 1: Strengthen existing relationships and decision-making partnerships with the Somali Bantu and Bhutanese refugee communities in Greater Boston through community based participatory research in partnership with the Shanbaro Community Association and Chelsea Collaborative in Chelsea, Massachusetts.
Aim 2: Collect and analyze qualitative data on local conceptualizations of mental health problems and resilience in school-age children (ages 5-17) as well as help seeking and services preferences among Somali Bantu and Bhutanese refugee families; use findings to inform intervention targets and critical components of a family-based preventive intervention, the Family Strengthening Intervention (FSI) for refugees.
Aim 3: Use qualitative findings to prepare (a) a needs assessment of mental health in school-age children, community strengths, barriers to care, and services preferences with each target refugee group; (b) a preliminary battery of mental health/psychosocial measures for use in mental health assessment of children and caregivers; and (c) a draft set of intervention, recruitment, and training materials.
Aim 4: Use CBPR approaches to recruit and enroll 80 families in a feasibility study, with half randomized to care as usual and half to the FSI delivered by trained community interventionists; conduct longitudinal assessments at baseline, post-intervention, and 6 months. Hypothesis 4.1: Participation in the refugee FSI will be associated with improved communication and connectedness within families, increased mental health services access, and increased knowledge among caregivers and children on the consequences of trauma in refugee families. Hypothesis 4.2: Participation in the refugee FSI will be associated with increased application of healthy parenting skills, parental self-efficacy, parental supervision of children, improved functioning and reduced symptoms of internalizing and externalizing in school-age refugee children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Family Strengthening Intervention-RefugeesFamily 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. |
| Control | No intervention | –A total of 20 Somali Bantu and 20 Bhutanese refugee families will receive services as usual. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Untreated mental illness or active family crisis
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 |
|---|---|---|
| Family Strengthening Intervention-RefugeesThis 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. | Behavioural | Intervention |
Primary outcome
Change in depressive symptoms among children and adolescents
Time frame: 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
Depressive symptoms will be measured with an adapted version of the Center for Epidemiologic Study-Depression) CES-D scale
3 secondary outcomes
Change in anxiety symptoms among children and adolescents
Time frame: 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
Time frame: 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
Time frame: 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.
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 10 Jul 2019.
- Background: PubMed 25905818Betancourt TS, Frounfelker R, Mishra T, Hussein A, Falzarano R. Addressing health disparities in the mental health of refugee children and adolescents through community-based participatory research: a study in 2 communities. Am J Public Health. 2015 Jul;105 Suppl 3(Suppl 3):S475-82. doi: 10.2105/AJPH.2014.302504. Epub 2015 Apr 23.
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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 Family Strengthening Intervention-Refugees in people with Child/Adolescent Problems and Mental Disorders, 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 1 inclusion and 1 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 10 Jul 2019. 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 depressive symptoms among children and adolescents (time frame: 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). 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 NCT02562794, 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 10 Jul 2019.