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Va Meh Du Intervention

NCT ID: NCT06394193

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Health Wellness

Keywords

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physical activity Karenni community support

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Community-based Participatory Research

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

Group Type EXPERIMENTAL

Community-based participatory research intervention

Intervention Type BEHAVIORAL

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

Standard Soccer Coaching

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Community-based participatory research intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Daniel, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Ana Sucaldito, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00111733

Identifier Type: -

Identifier Source: org_study_id