N/A N=25 Health Services Research

FMBI With War-affected Families

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

Bottom Line

View on ClinicalTrials.gov: NCT05241314 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Youth Adjustment — -2.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Learning to BREATHE (Behavioral); After Deployment Adaptive Parenting Tools (ADAPT) (Behavioral)
Age: Pediatric, Adult, Older Adult · 11+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Youth Adjustment	-2.3	—
PRIMARY Mindfulness	-0.08; 0.06	—
PRIMARY Youth Trauma History, PTSD Screening	0.6	—
PRIMARY Emotion Regulation	0.062; 0.137	—
PRIMARY Parent Mental Health Distress	0.44	—
SECONDARY Physical Health Status	0.047; 0.013	—
SECONDARY Family Functioning	0.002; 0.003	—
SECONDARY Emotion Regulation	0.062; 0.137	—
SECONDARY Mindfulness	-0.08; 0.06	—
SECONDARY Physical Symptom Burden	7; -3.5	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05241314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.