Family Mindfulness-based Intervention in War-affected FamiliesNCT05241314
FMBI With War-affected Families
A study testing Learning to BREATHE and After Deployment Adaptive Parenting Tools (ADAPT) in people with Family Mindfulness-based Intervention in War-affected Families and Intergenerational Trauma, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Family Mindfulness-based Intervention in War-affected Families, Intergenerational Trauma, War-Related Trauma
- What is being tested?
- Learning to BREATHE and After Deployment Adaptive Parenting Tools (ADAPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention
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.
Read the 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.
- Conditions
- Family Mindfulness-based Intervention in War-affected Families, Intergenerational Trauma, War-Related Trauma
- Being tested
- Learning to BREATHE, After Deployment Adaptive Parenting Tools (ADAPT)
- Medical subject headings
- Historical Trauma, War-Related Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning to BREATHEBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: After Deployment Adaptive Parenting Tools (ADAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Secondary outcomes (5)
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
Measured: 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Family Mindfulness-based Intervention in War-affected FamiliesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Hoffman, PHD, MPH, MSN, RN, Principal investigator, University of Minnesota School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241314
- Sponsor's protocol ID
- STUDY00011195
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2022
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intergenerational Trauma in War-affected Families: Promoting Adolescent Adjustment Through a Family Mindfulness-based Intervention
- ClinicalTrials.gov ID
- NCT05241314
- Acronym / sponsor ID
- STUDY00011195
- Conditions
- Family Mindfulness-based Intervention in War-affected Families, Intergenerational Trauma, War-Related Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 2 Youth | Experimental | Behavioral: Learning to BREATHEOne 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 2 Caregivers/Adults | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adult inclusion criteria:
- Youth inclusion criteria:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Learning to BREATHEA 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. | Behavioural | Phase 2 Youth |
| 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. | Behavioural | Phase 2 Caregivers/Adults |
Primary outcome
Youth Adjustment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
5 secondary outcomes
Physical Health Status
Time frame: 3 months
Family Functioning
Time frame: 3 months
Emotion Regulation
Time frame: 3 months
Mindfulness
Time frame: 3 months
Physical Symptom Burden
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Hoffman, PHD, MPH, MSN, RN principal investigator
University of Minnesota School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning to BREATHE and After Deployment Adaptive Parenting Tools (ADAPT) in people with Family Mindfulness-based Intervention in War-affected Families and Intergenerational Trauma, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Adjustment (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.