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NCT06394193 Clinical Trial

Va Meh Du Intervention

Mental Health Wellness Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06394193
Other study ID # IRB00111733
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2024

Study information
Verified date April 2024
Source Wake Forest University Health Sciences
Contact Lisa L. Lewis
Phone 336.713.5074
Email lisa.lynn.lewis@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Self-identifies as Karenni - Speaks English or Karenni - Currently lives in Forsyth County - Consents to participate Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Community-based participatory research intervention
Two training sessions (roughly two hours each) to train them in the intervention structure and curriculum

Locations
Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Coach retention rate count and percentage for coach retention Month 6
Secondary Player retention rate count and percentage for player retention Month 6
Secondary Coach completion rate count and percentage for coach participants, including participation in coach training and in soccer practice sessions Month 6
Secondary Player completion rate player count and percentage for player participants, including participation in in soccer practice sessions Month 6
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