NCT05858593

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 16, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

April 19, 2023

Results QC Date

January 22, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

virtual realitypositive youth developmentafterschool program

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    One-time assessment post-treatment, following 4 weeks of exposure to treatment

Secondary Outcomes (3)

  • Step Count

    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

    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

    4 week observation period

Study Arms (1)

Treatment

EXPERIMENTAL

In the treatment group, the child will receive the VR-based curriculum during the afterschool program.

Behavioral: Virtual reality curriculumBehavioral: No Virtual reality curriculum

Interventions

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.

Treatment

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.

Treatment

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Athens Chess & Community

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaChild Behavior

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Sun Joo Ahn
Organization
University of Georgia

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants will be masked to which study condition they are assigned to.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 15, 2023

Study Start

September 16, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

April 21, 2026

Results First Posted

April 21, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
ANALYTIC CODE
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

Locations