- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05858593
Positive Youth Development in the Metaverse
April 17, 2026 updated by: Sun Joo (Grace) Ahn, PHD, University of Georgia
Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30606
- Athens Chess & Community
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children enrolled in the Chess & Community program
- Between the ages of 9-17
Exclusion Criteria:
- Children who are unable to wear a VR headset will not be recruited
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
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.
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 |
|---|---|---|
|
Usability of VR System and Curriculum Content
Time Frame: One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.
|
Based on the validated System Usability Scale (SUS), we created open ended questionnaires and scale items that inquired about user attitude and usability of the system.
For scale items reported, all items were measured through a 5-point Likert scale, 1 = Strongly Disagree, 5 = Strongly Agree.
Five of the items were adapted from the original scale to assess the usability of the system, with five other items being converted to an open-ended item for a mixed-methods approach and richer contextual information from participants regarding usability issues.
|
One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.
|
|
Attrition Rate Post Assent to the VR Treatment
Time Frame: One-time assessment post-treatment, following 4 weeks of exposure to treatment
|
Fraction of the children lost to follow up post assent to the intended treatment via the VR system
|
One-time assessment post-treatment, following 4 weeks of exposure to treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step Count
Time Frame: To match the time frame of data collection between step count and heart rate, both measures were taken during a 2 hour observation window on the last day of the 4-week intervention.
|
Step count based on smart watch measurements.
Average steps were calculated from data collected during the 2-hour observation period.
Target variance metrics were decomposing the overall (SD), between (B-SD), and within child (W-SD) standard deviations to inform power computations for a large-scale behavioral trial.
Step count analysis also indicated that while step counts may be similar in child cohorts/classrooms/after-school programs, there is substantial variability within-child that would indicate response heterogeneity to future behavioral activity interventions with children of this age group.
Observation period was a 2 hour window post intervention.
|
To match the time frame of data collection between step count and heart rate, both measures were taken during a 2 hour observation window on the last day of the 4-week intervention.
|
|
Heart Rate
Time Frame: To match the time frame of data collection between step count and heart rate, both measures were taken during a 2 hour observation window on the last day of the 4-week intervention.
|
Heart rate (pulse) data from smart watch measurements.
Target variance metrics were decomposing the overall (SD), between (B-SD), and within child (W-SD) standard deviations to inform power computations for a large-scale behavioral trial.
|
To match the time frame of data collection between step count and heart rate, both measures were taken during a 2 hour observation window on the last day of the 4-week intervention.
|
|
Engagement
Time Frame: 4 week observation period
|
Achieving 240 minutes total exposure VR wear time over four 60-minute sessions.
|
4 week observation period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2023
Primary Completion (Actual)
July 30, 2024
Study Completion (Actual)
July 30, 2024
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
May 4, 2023
First Posted (Actual)
May 15, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
February 1, 2026
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)?
YES
IPD Plan Description
De-identified data used in published analyses will be made available upon request to other researchers with a verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications.
Intellectual property rights to all software applications and hardware products will be maintained by the University of Georgia.
IPD Sharing Access Criteria
Verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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