Clinical trial NCT05259462: Group-Based Online Virtual Reality Gaming to Improve Mental Health Among Children With Physical Disabilities
Official title: Improving Social Isolation and Loneliness Among Children With Physical Disabilities Through Group-Based Online Virtual Reality Gaming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Disability Physical
Keywords: virtual reality
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre-to-post design trial that will last 1-year and include 2 waves (n=6 per wave)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Depression
timeFrame: Changes from baseline (week 0) to post-intervention (week 5)
measure: Changes in Social Isolation / Loneliness
timeFrame: Changes from baseline (week 0) to post-intervention (week 5)
Secondary outcomes:
measure: Class attendance
timeFrame: Weeks 1 - 4
measure: Exercise volume
timeFrame: Week 0 and Week 5
measure: Quality of social interactions
timeFrame: Week 5
measure: Perceived enjoyment of the group classes
timeFrame: Week 5
measure: Satisfaction with program delivery
timeFrame: Week 5
measure: Multiplayer feedback survey
timeFrame: Week 5
measure: Participants Perceptions of Completing the Program
timeFrame: Week 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
Study officials:
References:
citation: 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.