FMBI With War-affected Families

Not Applicable

Completed

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

Interventions: Behavioral: After Deployment Adaptive Parenting Tools (ADAPT)
Behavioral: Learning to BREATHE

Registration Number: NCT05241314

Lead Sponsor: University of Minnesota

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2 Caregivers/Adults	After Deployment Adaptive Parenting Tools (ADAPT)	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.
Phase 1 Youth Focus Group	Learning to BREATHE	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.
Phase 2 Youth	Learning to BREATHE	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.
Phase 1 Community Leadership Board (CLB)	After Deployment Adaptive Parenting Tools (ADAPT)	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.

Primary Outcome Measures

Name	Time	Method
Youth Adjustment	3 months	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
Mindfulness	3 months	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.
Youth Trauma History, PTSD Screening	3 months	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.
Emotion Regulation	3 months	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.
Parent Mental Health Distress	3 months	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

Secondary Outcome Measures

Name	Time	Method
Physical Health Status	3 months	Cohen-Hoberman Inventory of Physical Symptoms (CHIPS). A 33-item assessment of perceived burden from physical symptoms. Total score generated by summing items. Range 0-132. Higher score, higher burden of physical symptoms
Family Functioning	3 months	Family Adaptability and Cohesion Scale IV (FACES). A 42-item assessment of cohesion and flexibility. Dividing the average of the balanced scales (Cohesion and Flexibility) by the average of the unbalanced scales (Rigid, Enmeshed, Chaotic and Rigid). The higher the ratio score the more balanced the family system. 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.
Emotion Regulation	3 months	Emotion Regulation Skills Questionnaire (ERSQ). A 27-item assessment of emotion regulation skills described in the ART model. ESRQ - 27 items, each scored 0-4, range 0-108, higher scores mean higher emotion regulation. Total scores used, no subscales. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) has a range of scores from 12 to 48, each of the 12 items is rated on a 4-point Likert scale (from "Rarely/Not at all" to "Almost Always") with higher scores indicating greater mindfulness.
Physical Symptom Burden	3 months	Cohen-Hoberman Inventory of Physical Symptoms (CHIPS). A 33-item assessment of perceived burden from physical symptoms. Total score generated by summing items. Range 0-132. Higher score, higher burden of physical symptoms
Mindfulness	3 months	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. ESRQ - 27 items, each scored 0-4, range 0-108, higher scores mean higher emotion regulation. Total scores used, no subscales. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) has a range of scores from 12 to 48, each of the 12 items is rated on a 4-point Likert scale (from "Rarely/Not at all" to "Almost Always") with higher scores indicating greater mindfulness.