NCT06921499

Brief 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 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
May 2025Dec 2027

First Submitted

Initial submission to the registry

April 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

April 2, 2025

Last Update Submit

June 4, 2025

Conditions

Keywords

mental health educationsports-based mental healthmental health interventionrefugee health

Outcome Measures

Primary Outcomes (2)

  • Coping Skills

    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

    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 Outcomes (2)

  • Psychological Well being

    From enrollment to end of intervention at 6 months

  • Physical Activity

    From enrollment to end of intervention at 6 months

Study Arms (2)

Mental Health Education

EXPERIMENTAL
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.

Behavioral: Active Compartor

Interventions

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.

Mental Health Education

Participants randomized to comparison will receive 20-30 minutes of team-building activities each week for roughly 5 weeks.

Comparison

Eligibility Criteria

Age8 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \[for adult participants only\]: 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bamboo Roots

Winston-Salem, North Carolina, 27104, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Ana D Sucaldito

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2025

First Posted

April 10, 2025

Study Start

May 17, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
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
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

Locations