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Completed

NCT Number: NCT05259462

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

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.

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Key information

Conditions

Disability Physical

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Primary outcomes

  1. Changes in Depression

    Time frame: 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).

  2. Changes in Social Isolation / Loneliness

    Time frame: Changes from baseline (week 0) to post-intervention (week 5)

    Measured by the version 3 of the UCLA Loneliness Scale 20 items (UCLA-20).

Secondary outcomes

  1. Class attendance

    Time frame: Weeks 1 - 4

    Percent of classes attended divided by the total

  2. Exercise volume

    Time frame: Week 0 and Week 5

    Self-reported minutes of exercise per week completed. Measured by the Godin Leisure-Time Exercise Questionnaire (GLTEQ).

  3. Quality of social interactions

    Time frame: 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.

  4. Perceived enjoyment of the group classes

    Time frame: 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.

  5. Satisfaction with program delivery

    Time frame: 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.

  6. Multiplayer feedback survey

    Time frame: Week 5

    A questionnaire measuring multiplayer playtime (self-reported times played per week), friendship creation (yes/no), and friendship strength (assessed via Likert scale).

  7. Participants Perceptions of Completing the Program

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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