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

Disability Physical Clinical Trial

Official title:

Improving Social Isolation and Loneliness Among Children With Physical Disabilities Through Group-Based Online Virtual Reality Gaming

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259462
• Other study ID #: CEDHARS6306
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical

Intervention

Behavioral:
• Intervention
Participants will utilize low-cost, consumer available head-mounted displays to meet with peers and coaches online. The program will last 4 weeks and include 2 x 1-hour sessions per week of supervised peer-to-peer gaming. The coaches will utilize behavioral change and mindfulness techniques to promote autonomy, competence, and relatedness through a respectful, cohesive, and positive atmosphere. These strategies will be framed by the Self-Determination Theory and learned from the National Center on Health, Physical Activity, and Disability (NCHPAD) mindfulness coaching workshops. Some of the mindfulness-based strategies will include guided breathing focused exercises, body scanning, meditation, and acceptance of social anxiety and shyness

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Depression	Changes in self-reported feelings of depression measured by the Children's Depression Inventory 2 Short Form (CDI-S 2).	Changes from baseline (week 0) to post-intervention (week 5)
Primary	Changes in Social Isolation / Loneliness	Measured by the version 3 of the UCLA Loneliness Scale 20 items (UCLA-20).	Changes from baseline (week 0) to post-intervention (week 5)
Secondary	Class attendance	Percent of classes attended divided by the total	Weeks 1 - 4
Secondary	Exercise volume	Self-reported minutes of exercise per week completed. Measured by the Godin Leisure-Time Exercise Questionnaire (GLTEQ).	Week 0 and Week 5
Secondary	Quality of social interactions	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.	Week 5
Secondary	Perceived enjoyment of the group classes	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.	Week 5
Secondary	Satisfaction with program delivery	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.	Week 5
Secondary	Multiplayer feedback survey	A questionnaire measuring multiplayer playtime (self-reported times played per week), friendship creation (yes/no), and friendship strength (assessed via Likert scale).	Week 5
Secondary	Participants Perceptions of Completing the Program	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.	Week 5