FMBI With War-affected Families

NCT05241314 | Completed Results

• 1 other identifier: STUDY00011195
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Youth Adjustment

  Strengths and Difficulties Questionnaire (SDQ I/S). A 25-item youth behavioral screening questionnaire, Total difficulties score: generated by summing scores from all the scales except prosocial scale, Range 0-40. Higher score, higher adjustment challenges

  3 months

• Mindfulness

  Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). A 12-item assessment of mindfulness as a single construct. Items 2, 6, and 7 reverse-scored. After reversals, sum values for items 1-12. Sum of all values reflect greater mindful qualities. The range of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is 12-48. It is a 12-item scale where each item is rated on a 1-4 Likert scale, with higher scores indicating greater mindfulness.

  3 months

• Youth Trauma History, PTSD Screening

  UCLA Brief Screen for Child/Adolescent Trauma and PTSD (UCLA-B). A 11-item (+2 open ended) evaluation of trauma history and PTSD symptoms for identifying at-risk cases. A cutoff score of 35 is highly sensitive and specific for detecting a diagnosis of PTSD. Higher score, higher burden of PTSD symptoms UCLA brief trauma screen: This was a screening tool used to establish the eligibility of youth participants. This was not included in the analysis. Each item on the scale is rated on a 0-4 scale, with higher scores signifying greater symptom severity, range 0-44. The FACES instrument is not scored based on a range, as described.

  3 months

• Emotion Regulation

  Emotion Regulation Skills Questionnaire (ERSQ). A 27-item assessment of emotion regulation skills described in the ART model. Calculated mean of all questions. Higher score indicates better Emotion Regulation. The Emotion Regulation Skills Questionnaire (ERSQ) is a 27 item scale that uses a 5-point Likert scale for each item, 0 (not at all) to 4 (almost always), with a total score range of 0-108.

  3 months

• Parent Mental Health Distress

  Karen Mental Health Screener - Brief (KMHS-B). 5-item measure developed to screen for mental distress associated with MDD and PTSD. Possible score ranges for five items 0-15. For clinical use, clinical cut score of 4. Higher score, higher burden of PTSD symptoms. Used cut score to refer

  3 months

Secondary Outcomes (5)

• Physical Health Status

  3 months

• Family Functioning

  3 months

• Emotion Regulation

  3 months

• Mindfulness

  3 months

• Physical Symptom Burden

  3 months

Study Arms (2)

Phase 2 Youth

EXPERIMENTAL

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

Phase 2 Caregivers/Adults

EXPERIMENTAL

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)

Interventions

Learning to BREATHE BEHAVIORAL

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.

Phase 2 Youth

After Deployment Adaptive Parenting Tools (ADAPT) BEHAVIORAL

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.

Phase 2 Caregivers/Adults

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Historical Trauma; War-Related Injuries

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sarah Hoffman
• Organization: University of Minnesota

hoff0742@umn.edu

612-625-0606

Study Officials

• Sarah Hoffman, PHD, MPH, MSN, RN

  University of Minnesota School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)