Va Meh Du Intervention

December 3, 2024 updated by: Wake Forest University Health Sciences

Va Meh Du: An Intervention to Promote Mental Wellness Among Karenni Young Adults and Children

This study is a conceptually integrated community-based participatory research study that includes the design and evaluation of an intervention to promote mental wellness and physical activity for Karenni children and young adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a non-randomized equivalent design of an implementation and evaluation of an intervention to promote mental health and wellness among Karenni young adults and children by engaging in evidence-based mental health practices, relationship-building and physical activity through the team sport of soccer.

Study Type

Interventional

Enrollment (Actual)

16

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 Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Self-identifies as Karenni
  • Speaks English or Karenni
  • Currently lives in Forsyth County
  • Male gender
  • Consents to participate

Exclusion Criteria:

  • None

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community-based Participatory Research
Coaching a six-month soccer program with the Va Meh Du intervention
Behavioral: Community-based participatory research intervention
Two training sessions (roughly two hours each) to train them in the intervention structure and curriculum
No Intervention: Standard Soccer Coaching
Standard six month soccer program without the Va Meh Du Intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological well-being
Time Frame: Month 6
Flourishing Scale (FS-8). FS-8 is an eight-item validated survey measuring psychological well-being by addressing different aspects of positive mental health (e.g. I lead a purposeful and meaningful life). Participants indicate their disagreement or agreement with each statement on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Scores range from 8 to 56, with higher scores indicating better levels of psychological well-being.
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coach retention rate
Time Frame: Month 6
count and percentage for coach retention
Month 6
Player retention rate
Time Frame: Month 6
count and percentage for player retention
Month 6
Coach completion rate
Time Frame: Month 6
count and percentage for coach participants, including participation in coach training and in soccer practice sessions
Month 6
Player completion rate
Time Frame: Month 6
player count and percentage for player participants, including participation in in soccer practice sessions
Month 6

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Stephanie Daniel, PhD, Wake Forest University Health Sciences
  • Principal Investigator: Ana Sucaldito, PhD, MPH, University of North Carolina

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)

June 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00111733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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