FMBI With War-affected Families

• ClinicalTrials.gov Identifier: NCT05241314
• Recruitment Status: Recruiting
• First Posted: February 15, 2022
• Last Update Posted: February 15, 2022
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

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.

Condition or disease	Intervention/treatment	Phase
Family Mindfulness-based Intervention in War-affected Families; Intergenerational Trauma; War-Related Trauma	Behavioral: Learning to BREATHE; Behavioral: After Deployment Adaptive Parenting Tools (ADAPT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention
• Actual Study Start Date: January 1, 2022
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. Rate of Study Completion [ Time Frame: 3 months ]
   Outcome will be reported as the percent of participants who complete all study activities.
2. 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.
3. 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.
4. Safety of Intervention [ Time Frame: 3 months ]
   Outcome will be reported as the number of adverse events reported by participants.

Eligibility Criteria

• Ages Eligible for Study: 11 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Sarah Hoffman, PHD, MPH, MSN, RN; (512) 470-7128; hoff0742@umn.edu

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Sarah Hoffman, PhD 612-625-0606 hoff0742@umn.edu

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Sarah Hoffman, PHD, MPH, MSN, RN; University of Minnesota School of Nursing

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05241314
• Other Study ID Numbers: STUDY00011195
• First Posted: February 15, 2022
• Last Update Posted: February 15, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Wounds and Injuries; War-Related Injuries; Historical Trauma; Psychological Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders