An interventional study of Virtual reality curriculum and No Virtual reality curriculum in Healthy, Healthy Lifestyle and Childhood ALL, sponsored by University of Georgia. Completed at 1 site in United States. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University of Georgia · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
Behavioral: Virtual reality curriculum · Behavioral: No Virtual reality curriculum
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.
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.
Time frame: 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
Time frame: One-time assessment post-treatment, following 4 weeks of exposure to treatment
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.
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
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.
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
Achieving 240 minutes total exposure VR wear time over four 60-minute sessions.
Time frame: 4 week observation period
Participants were recruited in two waves, beginning September of 2023 and ending July of 2024.
| Milestone | Treatment |
|---|---|
| Started | 32 |
| Completed | 32 |
| Not completed | 0 |
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.
| Units on an ordinal scale | Treatment |
|---|---|
| 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 |
Fraction of the children lost to follow up post assent to the intended treatment via the VR system
| Participants | Treatment |
|---|---|
| Attrition Rate Post Assent to the VR Treatment | 0 |
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.
| Steps per minute | Treatment |
|---|---|
| Between Subjects Analysis | 87.6 ± 136.2 |
| Within Subjects Analysis | 87.6 ± 518.7 |
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.
| Beats per minute | Treatment |
|---|---|
| Between Subjects Analysis | 110.5 ± 21.2 |
| Within Subjects Analysis | 110.5 ± 28.1 |
Achieving 240 minutes total exposure VR wear time over four 60-minute sessions.
| Participants | Treatment |
|---|---|
| Engagement | 32 |
Collected over Adverse events were monitored based on the study protocol during the 4 week intervention period, from enrollment to the end of the intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
The study required participants to engage with the VR playground at least once a week for 4 weeks and use the smartwatch to track physical activity. Participants were required to wear their smartwatch during waking hours. We recruited and enrolled 32 adolescents (age range 9-17 years old, Mage = 12.46, SDage = 1.40).
| Age, Continuous(Years) | Treatment |
|---|---|
| Mean | 12.46 ± 1.40 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 5 |
| Male | 25 |
| Race/Ethnicity, Customized(Participants) | Treatment |
|---|---|
| Black or African American | 23 |
| White | 1 |
| More than one race | 3 |
| Unknown | 5 |
| Number of Participants with Prior Exposure to VR(Participants) | Treatment |
|---|---|
| Count of participants | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Analytic code
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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