Addressing Mental Health Disparities in Refugee Children
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|ClinicalTrials.gov Identifier: NCT03796065|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Family Research||Behavioral: FSI-R Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1630 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Masking:||Single (Care Provider)|
|Masking Description:||The Research Assistants (RAs) who will collect both qualitative and quantitative data will be blind to the condition in which study participants are randomized.|
|Official Title:||Addressing Mental Health Disparities in Refugee Children Through Family and Community-based Prevention: A CBPR Collaboration and Hybrid Implementation Effectiveness Trial|
|Actual Study Start Date :||August 27, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 1, 2021|
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.
Behavioral: FSI-R Treatment
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 Name: Family Strengthening Intervention for Refugees
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).
- 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.
- 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.
- 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) ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796065
|Contact: Jordan Farrar, PhDfirstname.lastname@example.org|
|Contact: Jenna Berent, MPHemail@example.com|
|United States, Maine|
|Maine Immigrant and Refugee Services||Recruiting|
|Lewiston, Maine, United States, 04240|
|Contact: Rilwan Osman, MSW 207-753-2700 ext 101 firstname.lastname@example.org|
|United States, Massachusetts|
|Jewish Family Service||Recruiting|
|Springfield, Massachusetts, United States, 01108|
|Contact: Saad Abdulijabbar, MEd 413-737-2601 email@example.com|
|Principal Investigator:||Theresa Betancourt, ScD||Boston College|