FMBI With War-affected Families

War-Related Trauma Clinical Trial

Official title:

Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241314
• Other study ID #: STUDY00011195
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intergenerational Trauma
• War-Related Injuries
• War-Related Trauma
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Study Completion	Outcome will be reported as the percent of participants who complete all study activities.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	Safety of Intervention	Outcome will be reported as the number of adverse events reported by participants.	3 months