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FMBI With War-affected Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05241314
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE February 4, 2022
First Posted Date  ICMJE February 15, 2022
Last Update Posted Date February 15, 2022
Actual Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2022)
  • Rate of Study Completion [ Time Frame: 3 months ]
    Outcome will be reported as the percent of participants who complete all study activities.
  • Participant Satisfaction [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    Outcome will be reported as the number of adverse events reported by participants.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FMBI With War-affected Families
Official Title  ICMJE Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Family Mindfulness-based Intervention in War-affected Families
  • Intergenerational Trauma
  • War-Related Trauma
Intervention  ICMJE
  • Behavioral: Learning to BREATHE
    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.
  • Behavioral: After Deployment Adaptive Parenting Tools (ADAPT)
    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.
Study Arms  ICMJE
  • Experimental: Phase 1 Youth Focus Group
    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.
    Intervention: Behavioral: Learning to BREATHE
  • Experimental: Phase 2 Youth
    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.
    Intervention: Behavioral: Learning to BREATHE
  • Experimental: Phase 2 Caregivers/Adults
    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: Behavioral: After Deployment Adaptive Parenting Tools (ADAPT)
  • Experimental: Phase 1 Community Leadership Board (CLB)
    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: Behavioral: After Deployment Adaptive Parenting Tools (ADAPT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2022)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sarah Hoffman, PHD, MPH, MSN, RN (512) 470-7128 hoff0742@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05241314
Other Study ID Numbers  ICMJE STUDY00011195
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sarah Hoffman, PHD, MPH, MSN, RN University of Minnesota School of Nursing
PRS Account University of Minnesota
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP