Va Meh Du Intervention

NCT06394193 | Completed

• 1 other identifier: IRB00111733
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Wellness

Keywords

physical activity; Karenni; community support

Outcome Measures

Primary Outcomes (1)

• Psychological well-being

  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 Outcomes (4)

• Coach retention rate

  Month 6

• Player retention rate

  Month 6

• Coach completion rate

  Month 6

• Player completion rate

  Month 6

Study Arms (2)

Community-based Participatory Research

EXPERIMENTAL

Coaching a six-month soccer program with the Va Meh Du intervention

Behavioral: Community-based participatory research intervention

Standard Soccer Coaching

NO INTERVENTION

Standard six month soccer program without the Va Meh Du Intervention.

Interventions

Community-based participatory research intervention BEHAVIORAL

Two training sessions (roughly two hours each) to train them in the intervention structure and curriculum

Community-based Participatory Research

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men/male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Stephanie Daniel, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Ana Sucaldito, PhD, MPH

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The 20 anticipated coach participants, 10 will be assigned to the intervention and 10 will be assigned to the comparison group; assignment will occur based on availability.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: June 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)