Trial Outcomes & Findings for Positive Youth Development in the Metaverse (NCT NCT05858593)
NCT ID: NCT05858593
Last Updated: 2026-04-21
Results Overview
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.
COMPLETED
NA
32 participants
One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.
2026-04-21
Participant Flow
Participants were recruited in two waves, beginning September of 2023 and ending July of 2024.
This was a single arm study and all participants were assigned to the same intervention/treatment.
Participant milestones
| Measure |
Treatment
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 of the participants sex is unknown
Baseline characteristics by cohort
| Measure |
Treatment
n=32 Participants
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Age, Continuous
|
12.46 Years
STANDARD_DEVIATION 1.40 • n=32 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=30 Participants • 2 of the participants sex is unknown
|
|
Sex: Female, Male
Male
|
25 Participants
n=30 Participants • 2 of the participants sex is unknown
|
|
Race/Ethnicity, Customized
Black or African American
|
23 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=32 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=32 Participants
|
|
Number of Participants with Prior Exposure to VR
|
0 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system.Population: 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.
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.
Outcome measures
| Measure |
Treatment
n=21 Participants
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Usability of VR System and Curriculum Content
System enjoyment (I thought the system was fun to use)
|
3.8 Units on an ordinal scale
Standard Deviation .64
|
|
Usability of VR System and Curriculum Content
System enjoyment (I thought the VR was exciting)
|
4.33 Units on an ordinal scale
Standard Deviation .74
|
|
Usability of VR System and Curriculum Content
Technical problems (Did you experience any technical problems with the system? 1=no, 2 = yes)
|
1.55 Units on an ordinal scale
Standard Deviation .43
|
|
Usability of VR System and Curriculum Content
System preference (I like to use the system)
|
4.21 Units on an ordinal scale
Standard Deviation .78
|
|
Usability of VR System and Curriculum Content
System adherence (I was able to follow instructions to use the system)
|
3.83 Units on an ordinal scale
Standard Deviation .76
|
PRIMARY outcome
Timeframe: One-time assessment post-treatment, following 4 weeks of exposure to treatmentPopulation: Children in an afterschool program were assented to use the VR system without involvement from the research team throughout the 4 week process.
Fraction of the children lost to follow up post assent to the intended treatment via the VR system
Outcome measures
| Measure |
Treatment
n=32 Participants
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Attrition Rate Post Assent to the VR Treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.Population: Step count was assessed from participants who wore their smart watch for at least one session of the VR experience during the 4 week intervention. Although all 32 participants wore a tracking monitor, data from 25 participants who had the full range of step count data during the 2 hour observation period were used. Seven participants were dropped due to incomplete data collection (e.g., left early).
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.
Outcome measures
| Measure |
Treatment
n=25 Participants
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Step Count
Between Subjects Analysis
|
87.6 Steps per minute
Standard Deviation 136.2
|
|
Step Count
Within Subjects Analysis
|
87.6 Steps per minute
Standard Deviation 518.7
|
SECONDARY outcome
Timeframe: 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.Population: Heart rate was assessed from children who wore their pulse monitor throughout the 2-hour observation period. Due to incorrect wear and technical issues, particularly when young participants had small wrists, the sensor data was usable for 9 of the 32 participants.
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.
Outcome measures
| Measure |
Treatment
n=9 Participants
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Heart Rate
Between Subjects Analysis
|
110.5 Beats per minute
Standard Deviation 21.2
|
|
Heart Rate
Within Subjects Analysis
|
110.5 Beats per minute
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: 4 week observation periodPopulation: All participants were subject to one hour per week of VR exposure across a 4 week program (240 minutes).
Achieving 240 minutes total exposure VR wear time over four 60-minute sessions.
Outcome measures
| Measure |
Treatment
n=32 Participants
In the treatment group, the child will receive the VR-based curriculum during the afterschool program.
|
|---|---|
|
Engagement
|
32 Participants
|
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place