- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05858593
Positive Youth Development in the Metaverse
Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings. It will also empower youth to engage with the afterschool program at their own pace by providing a safe space to learn and practice their socioemotional skills. Implemented at scale, these benefits of a VR-integrated afterschool program will be able to address the issues of health inequity head on by expanding access to high quality afterschool content without incurring high operating costs. The results from this pilot study will provide a critical foundation to apply for an extramurally funded clinical trial to demonstrate the efficacy of a VR-integrated afterschool program on youth mental wellbeing.
Aim 1: Determine feasibility of a VR-integrated afterschool program where youth can access the VR content on their own at home.
Aim 2: Test the hypothesis that complementing the in-person afterschool program with VR will increase a) engagement and b) socioemotional competencies in youth.
Aim 3: Test the hypothesis that youth will demonstrate better mental wellbeing when the in-person afterschool program is complemented with VR.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sun Joo Ahn, PhD
- Phone Number: 706-542-4791
- Email: sjahn@uga.edu
Study Contact Backup
- Name: Kyle Johnsen, PhD
- Phone Number: 706-583-8166
- Email: kjohnsen@uga.edu
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30606
- Recruiting
- Athens Chess & Community
-
Contact:
- Lemuel LaRoche
- Phone Number: 706-546-5910
- Email: director@chessandcommunity.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children enrolled in the Chess & Community program
- Between the ages of 9-17
- The parent/primary caregiver of these children
Exclusion Criteria:
- Children who are unable to wear a VR headset will not be recruited
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
In the treatment group, the child will receive the VR-based curriculum in addition to receiving the devices to use for 8 weeks.
|
Rather than rely on mere exposure to devices, participants in the treatment group will receive a curriculum that integrates the devices into traditional content delivered through the after school program.
|
Active Comparator: Control
In the control group, the child will still receive the devices to use for 8 weeks, but will not have the VR-based curriculum.
|
Children will be able to use the same devices but will not have access to a curriculum that integrates the devices with traditional content delivered through the after school program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-regulation
Time Frame: One-time assessment post-treatment (at 8 weeks)
|
Early Adolescent Temperament Questionnaire-Revised ( 1-Almost always untrue, 2-Usually untrue, 3-Sometimes true, sometimes untrue, 4-Usually true, 5-Almost always true)
|
One-time assessment post-treatment (at 8 weeks)
|
Mental well-being
Time Frame: One-time assessment post-treatment (at 8 weeks)
|
Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2)
|
One-time assessment post-treatment (at 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement
Time Frame: 8 weeks
|
Number of hours of programming delivered for both in-person and VR
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00006669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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