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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05858593
Other study ID # 00006669
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date August 29, 2024

Study information

Verified date December 2023
Source University of Georgia
Contact Sun Joo Ahn, PhD
Phone 706-542-4791
Email sjahn@uga.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. Aim 1: Determine feasibility of a VR-integrated afterschool program where youth can access the VR content on their own at home. Aim 2: Test the hypothesis that complementing the in-person afterschool program with VR will increase a) engagement and b) socioemotional competencies in youth. Aim 3: Test the hypothesis that youth will demonstrate better mental wellbeing when the in-person afterschool program is complemented with VR.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 29, 2024
Est. primary completion date August 29, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years and older
Eligibility Inclusion Criteria: - Children enrolled in the Chess & Community program - Between the ages of 9-17 - The parent/primary caregiver of these children Exclusion Criteria: - Children who are unable to wear a VR headset will not be recruited

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
No Virtual reality curriculum
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.

Locations

Country Name City State
United States Athens Chess & Community Athens Georgia

Sponsors (1)

Lead Sponsor Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-regulation Early Adolescent Temperament Questionnaire-Revised ( 1-Almost always untrue, 2-Usually untrue, 3-Sometimes true, sometimes untrue, 4-Usually true, 5-Almost always true) One-time assessment post-treatment (at 8 weeks)
Primary Mental well-being Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2) One-time assessment post-treatment (at 8 weeks)
Secondary Engagement Number of hours of programming delivered for both in-person and VR 8 weeks
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