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

NCT05259462 | Completed Phase 1

• 1 other identifier: CEDHARS6306
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability Physical

Keywords

virtual reality

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (7)

• Class attendance

  Weeks 1 - 4

• Exercise volume

  Week 0 and Week 5

• Quality of social interactions

  Week 5

• Perceived enjoyment of the group classes

  Week 5

• Satisfaction with program delivery

  Week 5

Study Arms (1)

Group-active virtual reality gaming

EXPERIMENTAL

Participants will undergo the intervention.

Behavioral: Intervention

Interventions

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

Group-active virtual reality gaming

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

• Lai B, Young R, Craig M, Chaviano K, Swanson-Kimani E, Wozow C, Davis D, Rimmer JH. Improving Social Isolation and Loneliness Among Adolescents With Physical Disabilities Through Group-Based Virtual Reality Gaming: Feasibility Pre-Post Trial Study. JMIR Form Res. 2023 Dec 6;7:e47630. doi: 10.2196/47630.

  PMID: 38055309 DERIVED

• Lai B, Davis D, Young R, Swanson-Kimani E, Wozow C, Chaviano K, Rimmer JH. Group Telegaming Through Immersive Virtual Reality to Improve Mental Health Among Adolescents With Physical Disabilities: Pre- and Posttrial Protocol. JMIR Res Protoc. 2022 Oct 13;11(10):e42651. doi: 10.2196/42651.

  PMID: 36194864 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single group pre-to-post design trial that will last 1-year and include 2 waves (n=6 per wave)

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: June 1, 2022
• Primary Completion: January 4, 2023
• Study Completion: March 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)