Mental Health WellnessNCT06394193
Va Meh Du Intervention
A study testing Community-based participatory research intervention in people with Mental Health Wellness, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- Community-based participatory research intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identifies as Karenni
- Speaks English or Karenni
- Currently lives in Forsyth County
- Male gender
- Consents to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Wellness
- Being tested
- Community-based participatory research intervention
- Keywords
- physical activity, Karenni, community support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based participatory research interventionBehavioural
Two training sessions (roughly two hours each) to train them in the intervention structure and curriculum
| Study group | Role | What they receive |
|---|---|---|
| Community-based Participatory Research | Experimental | Coaching a six-month soccer program with the Va Meh Du intervention Receives: Behavioral: Community-based participatory research intervention |
| Standard Soccer Coaching | No intervention | Standard six month soccer program without the Va Meh Du Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (4)
Coach retention rate
count and percentage for coach retention
Measured: Month 6
Player retention rate
count and percentage for player retention
Measured: Month 6
Coach completion rate
count and percentage for coach participants, including participation in coach training and in soccer practice sessions
Measured: Month 6
Player completion rate
player count and percentage for player participants, including participation in in soccer practice sessions
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Jun 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Daniel, PhD, Principal investigator, Wake Forest University Health SciencesAna Sucaldito, PhD, MPH, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394193
- Sponsor's protocol ID
- IRB00111733
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Va Meh Du: An Intervention to Promote Mental Wellness Among Karenni Young Adults and Children
- ClinicalTrials.gov ID
- NCT06394193
- Acronym / sponsor ID
- IRB00111733
- Conditions
- Mental Health Wellness
- Keywords
- physical activity, Karenni, community support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Community-based Participatory Research | Experimental | Behavioral: Community-based participatory research interventionCoaching a six-month soccer program with the Va Meh Du intervention |
| Standard Soccer Coaching | No intervention | –Standard six month soccer program without the Va Meh Du Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identifies as Karenni
- Speaks English or Karenni
- Currently lives in Forsyth County
- Male gender
- Consents to participate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based participatory research interventionTwo training sessions (roughly two hours each) to train them in the intervention structure and curriculum | Behavioural | Community-based Participatory Research |
Primary outcome
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.
4 secondary outcomes
Coach retention rate
Time frame: Month 6
Player retention rate
Time frame: Month 6
Coach completion rate
Time frame: Month 6
Player completion rate
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Mental Health Wellness
Not yet recruiting
Integrated Psychoeducation Program for Internalized Stigma in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Daniel, PhD principal investigator
Wake Forest University Health Sciences
Ana Sucaldito, PhD, MPH principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based participatory research intervention in people with Mental Health Wellness, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological well-being (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.