Coping SkillsNCT06921499
Va Meh Du: A Sports-based Mental Health Promotion Intervention for Karenni Refugees
A study testing Va Meh Du (Mental Health Education) and Active Compartor in people with Coping Skills and Social Connectedness, run by University of North Carolina, Greensboro at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coping Skills, Social Connectedness, Psychological Well Being
- What is being tested?
- Va Meh Du (Mental Health Education) and Active Compartor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- [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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bamboo Roots
Winston-Salem, North Carolina, 27104
About this study
Official title: 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?
Read more
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
- Being tested
- Va Meh Du (Mental Health Education), Active Compartor
- Keywords
- mental health education, sports-based mental health, mental health intervention, refugee health
- Medical subject headings
- Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Va Meh Du (Mental Health Education)Behavioural
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 CompartorBehavioural
Participants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Education | Experimental | Not described Receives: Behavioral: Va Meh Du (Mental Health Education) |
| Comparison | Active comparator | Participants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks. Receives: Behavioral: Active Compartor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping Skills
Change in engagement coping skills will be measured using Coping Strategies Inventory-Short Form for adult participants and KIDCOPE for minor participants
Measured: From enrollment to end of intervention at 6 months
Social Connectedness
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
Measured: From enrollment to end of intervention at 6 months
Secondary outcomes (2)
Psychological Well being
Change in psychological well-being will be measured using the Flourishing Scale and WHO-5 for adult and minor participants
Measured: From enrollment to end of intervention at 6 months
Physical Activity
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).
Measured: From enrollment to end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start17 May 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coping SkillsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921499
- Sponsor's protocol ID
- UNCGreensboro
- Status last verified
- Jun 2025
- First submitted
- 2 Apr 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuing and Expanding Va Meh Du, A Mental Health Promotion Program for Karenni Refugee Children and Emerging Adults
- ClinicalTrials.gov ID
- NCT06921499
- Acronym / sponsor ID
- UNCGreensboro
- Keywords
- mental health education, sports-based mental health, mental health intervention, refugee health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Study start
- 17 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Health Education | Experimental | Behavioral: Va Meh Du (Mental Health Education) |
| Comparison | Active comparator | Behavioral: Active CompartorParticipants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks. |
Who may qualify
- Ages
- 8 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- [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
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 |
|---|---|---|
| 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. | Behavioural | Mental Health Education |
| Active CompartorParticipants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks. | Behavioural | Comparison |
Primary outcome
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
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
2 secondary outcomes
Psychological Well being
Time frame: From enrollment to end of intervention at 6 months
Physical Activity
Time frame: From enrollment to end of intervention at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Va Meh Du (Mental Health Education) and Active Compartor in people with Coping Skills and Social Connectedness, run by University of North Carolina, Greensboro 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana D Sucaldito (336-334-3240, adsucaldito@uncg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping Skills (time frame: From enrollment to end of intervention at 6 months). The study lists 2 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 8 Jun 2025.