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FMBI With War-affected Families

Primary Purpose

Family Mindfulness-based Intervention in War-affected Families, Intergenerational Trauma, War-Related Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Learning to BREATHE
After Deployment Adaptive Parenting Tools (ADAPT)
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Family Mindfulness-based Intervention in War-affected Families

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult inclusion criteria:

    • Above the age of 18
    • Karen refugees resettled to the United States greater than one year prior to enrollment
    • Caregiving responsibility for at least one child between the ages of 11 and 18
    • Reported primary or secondary torture or war trauma exposure, based on assessments conducted during UMN IRB STUDY00000729
    • Participation in UMN IRB STUDY00000729 and having agreed to be contacted for future research
  • Youth inclusion criteria:

    • Ages 11 to 18
    • Living in the home with the primary caregivers
    • Considered a dependent of the primary caregivers (still in high school or transitioning from school to workforce, not married and/or raising their own children - will take individual youth circumstances into consideration individually to make a determination of dependence)

Exclusion Criteria:

  • Self-reported or study team observed severe or unstable mental or physical illness such as acute psychosis, presence or risk of safety concerns, and/or a physical disability or illness, which prevents the potential participant from engaging in the study activities. Youth will be excluded if screening is positive for PTSD. Caregivers will not be excluded if mental health screening is positive for PTSD/severe depression.
  • Nonbiological caregiving relationships with child
  • If one member of the family declines to participate in the initial enrollment, the family will be excluded. If the randomly selected index youth declines to participate, we will open enrollment to other youth in the family that meet the inclusion criteria.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1 Youth Focus Group

Phase 2 Youth

Phase 2 Caregivers/Adults

Phase 1 Community Leadership Board (CLB)

Arm Description

Intervention adaptation and Community Health Worker Interventionist (CHWI) training through the delivery of the intervention to an adolescent focus group. CHWI from WellShare International will lead the recruitment of adolescent youth from the existing cohort of families and up to two Zoom focus groups will be held.

One randomly selected index youth per participating Karen family. Community health worker interventionists (CHWI) will deliver 7 weeks of home-based intervention with optional post-intervention focus groups to examine the feasibility of the community-based participatory research approach and intervention delivery by CHWIs.

Maternal and paternal caregivers (if present) of participating Karen family. Community health worker interventionists (CHWI) will deliver 7 weeks of home-based intervention with optional post-intervention focus groups to examine the feasibility of the community-based participatory research approach and intervention delivery by CHWIs.

Intervention adaptation and community health worker interventionist (CHWI) training through the delivery of the intervention to Community Leadership Board (CLB) members. The CLB will be made up of 4-7 Karen professionals representing prominent local organizations supporting Karen refugees in resettlement. Representatives will have lived cultural and historical expertise as well as professional expertise supporting the resettled community from mental health and social services perspectives. The expertise of the board ensures culturally centered preparations for intervention dissemination. The CLB will take an active role in the adaptation of the intervention.

Outcomes

Primary Outcome Measures

Rate of Study Completion
Outcome will be reported as the percent of participants who complete all study activities.
Participant Satisfaction
Participants satisfaction will be measured using questionnaire. Participants will rate satisfaction on a scale from 0 to 10 with higher scores representing higher satisfaction with study intervention.
Recruitment Target Rate
Outcome will be reported as the percent of participant families who complete FMBI sessions and structured assessments within 3 months of enrollment.
Safety of Intervention
Outcome will be reported as the number of adverse events reported by participants.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
February 20, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05241314
Brief Title
FMBI With War-affected Families
Official Title
Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study has two central research questions: 1) Is implementing a family mindfulness-based intervention with war-affected immigrant families through community based participatory research methods feasible?; and 2) Does the intervention demonstrate preliminary improvements in the social and behavioral health of war-affected caregivers and youth by addressing patterns of behavior that potentiate intergenerational trauma? The objective in the proposed study is to use Community Based Participatory Research strategies to test the feasibility and acceptability of a mindfulness-based intervention for Karen refugee families living post-resettlement in the United States. A key focus in this phase of the pilot will be intervention adaptation and establishing fidelity monitoring and quality improvement procedures through which the PI and community health worker interventionists are trained and evaluated in the delivery of the intervention.
Detailed Description
Intergenerational trauma is a major public health problem impacting war-affected families. The investigators' specific research contribution will test the feasibility of a 7-week family mindfulness-based intervention addressing key mechanisms central to the health of war-affected families. The significance of this contribution is tied to the conceptual understanding that caregivers uniquely influence the ways in which their children process trauma, experience stressful events, and thrive socially, behaviorally and physically. The responses of youth, in turn, affect the well-being of their parents. Left unaddressed, intergenerational trauma will continue to negatively impact the health and life course of immigrant youth and families. Collectively, this contributes to: higher burden of unaddressed mental and physical health disturbances in caregivers and youth; disruptions in family systems and community structures that negatively impact educational achievement and other indicators of youth adjustment; and increased exposure to familial and community violence. If a mindfulness-based intervention delivered directly to war-affected families in their homes can demonstrate improvements in the behavioral and social health effects of war trauma experienced by caregivers and their youth, then this study has the potential to offer a novel, effective approach to disrupting the generational impacts of war on war-affected families. The study will engage mothers, fathers, and youth to address intergenerational trauma fully. The investigators will establish plans for collaborative dissemination with WellShare International in phase I of the Clinical Translational Research Service pilot award, including academic dissemination (presentation and publication) as well as dissemination of results among key stakeholders and community members.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Mindfulness-based Intervention in War-affected Families, Intergenerational Trauma, War-Related Trauma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Youth Focus Group
Arm Type
Experimental
Arm Description
Intervention adaptation and Community Health Worker Interventionist (CHWI) training through the delivery of the intervention to an adolescent focus group. CHWI from WellShare International will lead the recruitment of adolescent youth from the existing cohort of families and up to two Zoom focus groups will be held.
Arm Title
Phase 2 Youth
Arm Type
Experimental
Arm Description
One randomly selected index youth per participating Karen family. Community health worker interventionists (CHWI) will deliver 7 weeks of home-based intervention with optional post-intervention focus groups to examine the feasibility of the community-based participatory research approach and intervention delivery by CHWIs.
Arm Title
Phase 2 Caregivers/Adults
Arm Type
Experimental
Arm Description
Maternal and paternal caregivers (if present) of participating Karen family. Community health worker interventionists (CHWI) will deliver 7 weeks of home-based intervention with optional post-intervention focus groups to examine the feasibility of the community-based participatory research approach and intervention delivery by CHWIs.
Arm Title
Phase 1 Community Leadership Board (CLB)
Arm Type
Experimental
Arm Description
Intervention adaptation and community health worker interventionist (CHWI) training through the delivery of the intervention to Community Leadership Board (CLB) members. The CLB will be made up of 4-7 Karen professionals representing prominent local organizations supporting Karen refugees in resettlement. Representatives will have lived cultural and historical expertise as well as professional expertise supporting the resettled community from mental health and social services perspectives. The expertise of the board ensures culturally centered preparations for intervention dissemination. The CLB will take an active role in the adaptation of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Learning to BREATHE
Intervention Description
A 6 session group-based intervention targeting adolescent mindfulness. The adapted and merged intervention will be delivered to individual families (home-based) in twice-weekly sessions over a 7-week period by two community health worker interventionists.
Intervention Type
Behavioral
Intervention Name(s)
After Deployment Adaptive Parenting Tools (ADAPT)
Intervention Description
A 14 session group-based mindful parenting intervention originally developed to increase emotion regulation among military caregivers with young children and improve youth adjustment. The adapted and merged intervention will be delivered to individual families (home-based) in twice-weekly sessions over a 7-week period by two community health worker interventionists.
Primary Outcome Measure Information:
Title
Rate of Study Completion
Description
Outcome will be reported as the percent of participants who complete all study activities.
Time Frame
3 months
Title
Participant Satisfaction
Description
Participants satisfaction will be measured using questionnaire. Participants will rate satisfaction on a scale from 0 to 10 with higher scores representing higher satisfaction with study intervention.
Time Frame
3 months
Title
Recruitment Target Rate
Description
Outcome will be reported as the percent of participant families who complete FMBI sessions and structured assessments within 3 months of enrollment.
Time Frame
3 months
Title
Safety of Intervention
Description
Outcome will be reported as the number of adverse events reported by participants.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult inclusion criteria: Above the age of 18 Karen refugees resettled to the United States greater than one year prior to enrollment Caregiving responsibility for at least one child between the ages of 11 and 18 Reported primary or secondary torture or war trauma exposure, based on assessments conducted during UMN IRB STUDY00000729 Participation in UMN IRB STUDY00000729 and having agreed to be contacted for future research Youth inclusion criteria: Ages 11 to 18 Living in the home with the primary caregivers Considered a dependent of the primary caregivers (still in high school or transitioning from school to workforce, not married and/or raising their own children - will take individual youth circumstances into consideration individually to make a determination of dependence) Exclusion Criteria: Self-reported or study team observed severe or unstable mental or physical illness such as acute psychosis, presence or risk of safety concerns, and/or a physical disability or illness, which prevents the potential participant from engaging in the study activities. Youth will be excluded if screening is positive for PTSD. Caregivers will not be excluded if mental health screening is positive for PTSD/severe depression. Nonbiological caregiving relationships with child If one member of the family declines to participate in the initial enrollment, the family will be excluded. If the randomly selected index youth declines to participate, we will open enrollment to other youth in the family that meet the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Hoffman, PHD, MPH, MSN, RN
Organizational Affiliation
University of Minnesota School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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FMBI With War-affected Families

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