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Completed

NCT Number: NCT05858593

Positive Youth Development in the Metaverse

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.

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Key information

Conditions

Healthy Behavior Behavior, Child Child Behavior Childhood ALL Healthy Lifestyle Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athens Chess & Community

Athens, Georgia, 30606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality curriculum

Behavioral

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 curriculum

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Engagement

    Time frame: 4 week observation period

    Achieving 240 minutes total exposure VR wear time over four 60-minute sessions.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 15, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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