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Learning to BREATHE for Family Mindfulness-based Intervention

N/A
Waitlist Available
Led By Sarah Hoffman, PHD, MPH, MSN, RN
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Above the age of 18
Karen refugees resettled to the United States greater than one year prior to enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is testing a mindfulness-based intervention for Karen refugee families in the United States to see if it is feasible and improves social and behavioral health.

Eligible Conditions
  • Family Mindfulness-based Intervention
  • Intergenerational Trauma
  • Post-Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant Satisfaction
Rate of Study Completion
Recruitment Target Rate
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 YouthExperimental Treatment1 Intervention
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.
Group II: Phase 2 Caregivers/AdultsExperimental Treatment1 Intervention
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.
Group III: Phase 1 Youth Focus GroupExperimental Treatment1 Intervention
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.
Group IV: Phase 1 Community Leadership Board (CLB)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Learning to BREATHE
2022
N/A
~30
After Deployment Adaptive Parenting Tools (ADAPT)
2022
N/A
~30

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,367 Previous Clinical Trials
1,587,486 Total Patients Enrolled
Sarah Hoffman, PHD, MPH, MSN, RNPrincipal InvestigatorUniversity of Minnesota School of Nursing

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of participants in this medical trial?

"Affirmative. Clinicaltrials.gov states that this experiment, initially made available on January 1st 2022, is presently seeking participants. Approximately 60 patients must be sourced from one clinical center."

Answered by AI

Is there a capacity for additional participants to join this study?

"Per the details present on clinicaltrials.gov, this medical trial is in progress and actively searching for participants. It was initially declared on January 1st 2022 with the latest update occurring on February 4th 2022."

Answered by AI
~7 spots leftby Mar 2025