Group-Based Online Virtual Reality Gaming to Improve Mental Health Among Children With Physical Disabilities

Phase 1

Completed

• Conditions: Disability Physical
• Interventions: Behavioral: Intervention

• Registration Number: NCT05259462
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

COVID-19 has had a negative impact on the mental health of many children with physical disabilities. This project aims to test the potential effects of an online multiplayer virtual reality group-based, active video game program on social isolation and depression and will include a total of 12 children with physical disabilities.

Detailed Description

This pilot feasibility study will investigate the potential effects of a revised multiplayer virtual reality exergaming program on depression, socialization, and loneliness among children with physical disabilities. This proposed study will use both quantitative and qualitative research methods, to gain a deep understanding of program benefits and implementation procedures that can be refined for a large clinical trial. The active video game program will last 1-month and include 2 supervised 1-hour sessions per week of group-based gaming. Game sessions will be supervised by 2 research staff who will act as gaming and mindfulness coaches. Outcomes will be measured by self-report questionnaires before and after the program. The program will be completed in two waves (6 people per wave). After the program, participants will undergo a one-on-one semi-structured interview, where they can describe their perceptions of the program.

Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-02-28
• Study Start: 2022-06-01
• Primary Completion: 2023-01-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Study Completion: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• self-reported mobility disability (e.g., use of a mobility device or presence of a mobility impairment)
• access to a Wi-Fi internet connection in the home
• a caregiver to support the child if <18 years of age
• a Facebook account to link to the virtual reality head-mounted display

Exclusion Criteria

• physically active (defined as >150 minutes/week of moderate-to-vigorous intensity exercise)
• cannot use the arms for exercise or operate the controller buttons using their fingers
• prone to seizures
• complete blindness or deafness
• unable to communicate verbally in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group-active virtual reality gaming	Intervention	Participants will undergo the intervention.

Primary Outcome Measures

Name	Time	Method
Changes in Social Isolation / Loneliness	Changes from baseline (week 0) to post-intervention (week 5)	Measured by the version 3 of the UCLA Loneliness Scale 20 items (UCLA-20).
Changes in Depression	Changes from baseline (week 0) to post-intervention (week 5)	Changes in self-reported feelings of depression measured by the Children's Depression Inventory 2 Short Form (CDI-S 2).

Secondary Outcome Measures

Name	Time	Method
Multiplayer feedback survey	Week 5	A questionnaire measuring multiplayer playtime (self-reported times played per week), friendship creation (yes/no), and friendship strength (assessed via Likert scale).
Participants Perceptions of Completing the Program	Week 5	Semi-structured interviews evaluating their perceptions of completing the program, with specific attention to providing more in-depth responses (i.e.,explanations) for each of the 8 outcomes.
Class attendance	Weeks 1 - 4	Percent of classes attended divided by the total
Exercise volume	Week 0 and Week 5	Self-reported minutes of exercise per week completed. Measured by the Godin Leisure-Time Exercise Questionnaire (GLTEQ).
Quality of social interactions	Week 5	A scale measure of how participants felt about the quality of social interactions they had during online virtual reality gameplay. The scale ranges from 1-5, where 5 indicates a very high quality of social interactions and a 1 indicates a very low quality of social interactions.
Perceived enjoyment of the group classes	Week 5	A scale measure of how enjoyable online group gameplay was. The scale ranges from 1-5, where 5 indicates a very high level of perceived enjoyment with the group classes and a 1 indicates a very low perceived enjoyment with the group classes.
Satisfaction with program delivery	Week 5	A scale measure of participants' satisfaction with how the classes were conducted. The scale ranges from 1-5, where 5 indicates a very high perceived satisfaction of the program delivery and a 1 indicates a very low perceived satisfaction with the program delivery.

Trial Locations

Locations (1)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States