Positive Youth Development in the Metaverse

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05858593
• Other study ID #: 00006669
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Behavior, Child
• Childhood ALL
• Healthy
• Healthy Lifestyle
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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