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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Health Status | 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 | 3 months |
| Family Functioning |
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Inclusion Criteria:
Adult inclusion criteria:
Youth inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Hoffman, PHD, MPH, MSN, RN | University of Minnesota School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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Phase 1 described in the IRB protocol was for intervention adaptation only and not human subjects research. We did not record individual outcomes or baseline information but used the information to inform implementation in phase 2. This record is for phase 2 part of the study and not phase 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiver | Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT |
| FG001 | Youth | Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiver | Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT |
| BG001 | Youth | Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This outcome measure only pertains to the youth group | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caregiver | Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hoffman | University of Minnesota | 612-625-0606 | hoff0742@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Dec 21, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2022 | Dec 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000080037 | Historical Trauma |
| D000067398 | War-Related Injuries |
| ID | Term |
|---|---|
| D000067073 | Psychological Trauma |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
| 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 |
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. |
| 3 months |
| Emotion Regulation | 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. | 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. 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. | 3 months |
| Physical Symptom Burden | 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 | 3 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | 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. | This outcome measure only pertains to the youth group | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
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| Primary | 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. | This outcome measure only pertains to the youth group | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
| Primary | 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. | This outcome measure only pertains to the youth group | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| Primary | 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 | Measure only pertains to the caregiver group | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| Secondary | Physical Health Status | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| Secondary | Family Functioning | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
|
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| Secondary | Emotion Regulation | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| Secondary | 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. 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| Secondary | Physical Symptom Burden | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Youth | Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE | 0 | 11 | 0 | 11 | 0 | 11 |
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| D014947 | Wounds and Injuries |