Positive Youth Development in the Metaverse - a Pilot Study
Primary Purpose
Healthy, Healthy Lifestyle, Childhood ALL
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality curriculum
No Virtual reality curriculum
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring virtual reality, positive youth development, afterschool program
Eligibility Criteria
Inclusion Criteria: All children enrolled in the Chess & Community program, between the ages of 9-17, and theirparent/primary caregiver. Exclusion Criteria: Children who are unable to wear a VR headset will not be recruited.
Sites / Locations
- Athens Chess & Community
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
In the treatment group, the child will receive the VR-based curriculum in addition to receiving the devices to use for 8 weeks.
In the control group, the child will still receive the devices to use for 8 weeks, but will not have the VR-based curriculum.
Outcomes
Primary Outcome Measures
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)
Mental well-being
Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2)
Secondary Outcome Measures
Engagement
Number of hours of programming delivered for both in-person and VR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05858593
Brief Title
Positive Youth Development in the Metaverse - a Pilot Study
Official Title
Positive Youth Development in the Metaverse - Development of a Virtual Reality Afterschool Program for Middle Childhood Youth
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
August 29, 2024 (Anticipated)
Study Completion Date
August 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Healthy Lifestyle, Childhood ALL, Behavior, Child
Keywords
virtual reality, positive youth development, afterschool program
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be masked to which study condition they are assigned to.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
In the treatment group, the child will receive the VR-based curriculum in addition to receiving the devices to use for 8 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
In the control group, the child will still receive the devices to use for 8 weeks, but will not have the VR-based curriculum.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality curriculum
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No Virtual reality curriculum
Intervention Description
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 Outcome Measure Information:
Title
Self-regulation
Description
Early Adolescent Temperament Questionnaire-Revised ( 1-Almost always untrue, 2-Usually untrue, 3-Sometimes true, sometimes untrue, 4-Usually true, 5-Almost always true)
Time Frame
One-time assessment post-treatment (at 8 weeks)
Title
Mental well-being
Description
Strengths and Difficulties Questionnaire (Not true = 0, Somewhat true = 1, Certainly true = 2)
Time Frame
One-time assessment post-treatment (at 8 weeks)
Secondary Outcome Measure Information:
Title
Engagement
Description
Number of hours of programming delivered for both in-person and VR
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All children enrolled in the Chess & Community program, between the ages of 9-17, and theirparent/primary caregiver.
Exclusion Criteria:
Children who are unable to wear a VR headset will not be recruited.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Joo Ahn, PhD
Phone
706-542-4791
Email
sjahn@uga.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle Johnsen, PhD
Phone
706-583-8166
Email
kjohnsen@uga.edu
Facility Information:
Facility Name
Athens Chess & Community
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lemuel LaRoche
Phone
706-546-5910
Email
director@chessandcommunity.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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
Learn more about this trial
Positive Youth Development in the Metaverse - a Pilot Study
We'll reach out to this number within 24 hrs