Va Meh Du: A Sports-based Mental Health Promotion Intervention for Karenni Refugees

June 4, 2025 updated by: University of North Carolina, Greensboro

Continuing and Expanding Va Meh Du, A Mental Health Promotion Program for Karenni Refugee Children and Emerging Adults

The goal of this clinical trial is to learn if a soccer program focused on mental health positively impacts mental health in Karenni refugee young boys and men. The main questions it aims to answer are:

Does mental health education provided during a sports program improve mental health coping for Karenni refugee young boys and men? Does participation in a sports-program improve social connection for Karenni refugee young boys and men?

Researchers will compare those receiving mental health education to a comparison group to see if mental health education improves mental health coping skills.

Participants will:

Participate weekly soccer practices for 6 months Receive mental health education or comparison activities Answer questions about their health, such as their coping skills, social connection, and physical activity

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Recruiting
        • Bamboo Roots

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • For child/minor participants: 8-16 years old, self-identifies as Karenni, self-identifies as a boy, speaks English, currently lives in Piedmont Triad area of NC, has parental consent, assents to participate
  • For adult participants--18 years of age, self-identifies as Karenni, self-identifies as a man, speaks English and Karenni, currently lives in Piedmont Triad area of NC, consents to participate, anticipates missing no more than 2 practices

Exclusion Criteria:

  • [for adult participants only]: Criminal record indicating potential harm to children (i.e., convicted of a violent or sexual crime, registration in the Sex Offender Registry, Responsible Individual List, or Child Maltreatment Registry) or are expected to miss more than 2 practices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mental Health Education
Behavioral: Va Meh Du (Mental Health Education)
Participants randomized to Va Meh Du (mental health education) will receive 20-30 minutes of mental health education each week for roughly 5 weeks. Mental health education will be evidence-based, using sports psychology practices, and culturally targeted toward Karenni refugees.
Active Comparator: Comparison
Participants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks.
Behavioral: Active Compartor
Participants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping Skills
Time Frame: From enrollment to end of intervention at 6 months
Change in engagement coping skills will be measured using Coping Strategies Inventory-Short Form for adult participants and KIDCOPE for minor participants
From enrollment to end of intervention at 6 months
Social Connectedness
Time Frame: From enrollment to end of intervention at 6 months
Change in social connectedness will be measured using Social Connectedness Revised Scale for adult participants and NIH Toolbox Pediatric social relationship scales (Friendship and Loneliness) for minor participants
From enrollment to end of intervention at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Well being
Time Frame: From enrollment to end of intervention at 6 months
Change in psychological well-being will be measured using the Flourishing Scale and WHO-5 for adult and minor participants
From enrollment to end of intervention at 6 months
Physical Activity
Time Frame: From enrollment to end of intervention at 6 months
Change in physical activity will be measured via the self-report questions: "In the past 3 months, how physically active have you been?" and "In the past 6 months, how physically active have you been?" Participants will answer using a 5-point Likert Scale from 1 (Very often) to 5 (Never).
From enrollment to end of intervention at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Greensboro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UNCGreensboro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 12 months

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in IRB-approved research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact adsucaldito@uncg.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Physical Activity

Clinical Trials on Va Meh Du (Mental Health Education)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe