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Clinical Trials/NCT05259462
NCT05259462
Completed
Phase 1

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

University of Alabama at Birmingham1 site in 1 country12 target enrollmentJune 1, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Disability Physical
Sponsor
University of Alabama at Birmingham
Enrollment
12
Locations
1
Primary Endpoint
Changes in Social Isolation / Loneliness
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
March 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Byron Lai

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Multiplayer feedback survey(Week 5)
  • Participants Perceptions of Completing the Program(Week 5)
  • 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 Sites (1)

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