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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT05259462
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group pre-to-post design trial that will last 1-year and include 2 waves (n=6 per wave)Single group pre-to-post design trial that will last 1-year and include 2 waves (n=6 per wave)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Social Isolation and Loneliness Among Children With Physical Disabilities Through Group-Based Online Virtual Reality Gaming
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group-active virtual reality gaming

Participants will undergo the 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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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).

Secondary Outcome Measures

  1. Class attendance [Weeks 1 - 4]

    Percent of classes attended divided by the total

  2. Exercise volume [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Alabama Birmingham Alabama United States 35233

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Byron Lai, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05259462
Other Study ID Numbers:
  • CEDHARS6306
First Posted:
Feb 28, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Byron Lai, Assistant Professor, University of Alabama at Birmingham

Study Results

No Results Posted as of Jul 5, 2022