HealthyNCT05858593

Positive Youth Development in the Metaverse

A study testing Virtual reality curriculum and No Virtual reality curriculum in people with Healthy and Healthy Lifestyle, run by University of Georgia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Healthy Lifestyle, Childhood ALL
What is being tested?: Virtual reality curriculum and No Virtual reality curriculum
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 16 Sep 2023to 30 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 9 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children enrolled in the Chess \& Community program
Between the ages of 9-17

Who cannot join

Children who are unable to wear a VR headset will not be recruited

Trial locations and contacts

1 site in 1 country.

United States1 site

Athens Chess & Community
Athens, Georgia, 30606

Other trials in United States

About this study

Official title: Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth

Read the 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.

Conditions: Healthy, Healthy Lifestyle, Childhood ALL, Behavior, Child
Being tested: Virtual reality curriculum, No Virtual reality curriculum
Keywords: virtual reality, positive youth development, afterschool program
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Child Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual reality curriculumBehavioural
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.
No Virtual reality curriculumBehavioural
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.

Study groups in NCT05858593
Study group	Role	What they receive
Treatment	Experimental	In the treatment group, the child will receive the VR-based curriculum during the afterschool program. Receives: Behavioral: Virtual reality curriculum; Behavioral: No Virtual reality curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

Usability of VR System and Curriculum Content
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.
Measured: One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.
Attrition Rate Post Assent to the VR Treatment
Fraction of the children lost to follow up post assent to the intended treatment via the VR system
Measured: One-time assessment post-treatment, following 4 weeks of exposure to treatment

Secondary outcomes (3)

Step Count
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.
Measured: 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
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.
Measured: 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
Achieving 240 minutes total exposure VR wear time over four 60-minute sessions.
Measured: 4 week observation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 202330 Jul 2024

First posted15 May 2023
Study start16 Sep 2023
Primary completion30 Jul 2024
Study completion30 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05858593
Sponsor's protocol ID: 00006669
Status last verified: Feb 2026
First submitted: 19 Apr 2023
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth
ClinicalTrials.gov ID: NCT05858593
Acronym / sponsor ID: 00006669
Conditions: Healthy, Healthy Lifestyle, Childhood ALL, Behavior, Child
Keywords: virtual reality, positive youth development, afterschool program
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: University of GeorgiaUniversity, hospital or other
Study start: 16 Sep 2023 (actual)
Primary completion: 30 Jul 2024 (actual)
Study completion: 30 Jul 2024 (actual)
First posted: 15 May 2023 (actual)
Results: Posted 21 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Behavioral: Virtual reality curriculum, Behavioral: No Virtual reality curriculumIn the treatment group, the child will receive the VR-based curriculum during the afterschool program.

Who may qualify

Ages: 9 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Children enrolled in the Chess \& Community program
Between the ages of 9-17

Key exclusion criteria (1 listed)

Children who are unable to wear a VR headset will not be recruited

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
Virtual reality curriculumRather 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.	Behavioural	Treatment
No Virtual reality curriculumChildren 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.	Behavioural	Treatment

Primary outcome

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.
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

3 secondary outcomes

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.
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.
Engagement
Time frame: 4 week observation period

Results and safety

Results posted to the registry on 21 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	32	32

Primary outcome: Usability of VR System and Curriculum Content

Time frame: One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.. Mean (Standard Deviation). Unit: Units on an ordinal scale

Measure	Treatment n = 21
System adherence (I was able to follow instructions to use the system)	3.83 (.76)
System preference (I like to use the system)	4.21 (.78)
System enjoyment (I thought the system was fun to use)	3.8 (.64)
System enjoyment (I thought the VR was exciting)	4.33 (.74)
Technical problems (Did you experience any technical problems with the system? 1=no, 2 = yes)	1.55 (.43)

Population analysed: Detailed open ended responses to the usability questions were obtained from diary measures and reported as a supplementary document in the Study Documents section. Although all participants wore wearables to track their movement and engagement with the VR system, 21 participants out of 32 participants completed the self-reported survey portion of the study.

Primary outcome: Attrition Rate Post Assent to the VR Treatment

Time frame: One-time assessment post-treatment, following 4 weeks of exposure to treatment. Count of participants. Unit: Participants

Measure	Treatment n = 32
Value	0

Population analysed: Children in an afterschool program were assented to use the VR system without involvement from the research team throughout the 4 week process.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored based on the study protocol during the 4 week intervention period, from enrollment to the end of the intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): Based on the discussions and conversations with the community partner who participated in the clinical trial, initial plans for the feasibility study were changed due to shifts in their programmatic priorities and personnel changes. As a result, the duration of the intervention was reduced from 8 weeks to 4 weeks and the intended sample size changed from 100 to 32 children. This was due to the substantial reduction of the afterschool program size following budgetary changes in the program.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality curriculum and No Virtual reality curriculum in people with Healthy and Healthy Lifestyle, run by University of Georgia 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 2 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 21 Apr 2026. 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?

Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Usability of VR System and Curriculum Content (time frame: One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05858593.

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 21 Apr 2026.