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Disability PhysicalPhase 1NCT05259462

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

A Phase 1 study testing Intervention in people with Disability Physical, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Disability Physical
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 1 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Intervention
Keywords
virtual reality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionBehavioural

    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

Study groups in NCT05259462
Study groupRoleWhat they receive
Group-active virtual reality gamingExperimentalParticipants will undergo the intervention.
Receives: Behavioral: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Depression

    Changes in self-reported feelings of depression measured by the Children's Depression Inventory 2 Short Form (CDI-S 2).

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

  2. Changes in Social Isolation / Loneliness

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

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

Secondary outcomes (7)

  1. Class attendance

    Percent of classes attended divided by the total

    Measured: Weeks 1 - 4

  2. Exercise volume

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

    Measured: Week 0 and Week 5

  3. Quality of social interactions

    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.

    Measured: Week 5

  4. Perceived enjoyment of the group classes

    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.

    Measured: Week 5

  5. Satisfaction with program delivery

    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.

    Measured: Week 5

  6. Multiplayer feedback survey

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

    Measured: Week 5

  7. Participants Perceptions of Completing the Program

    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.

    Measured: Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start1 Jun 2022
  3. Primary completion4 Jan 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single group pre-to-post design trial that will last 1-year and include 2 waves (n=6 per wave)
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05259462
Sponsor's protocol ID
CEDHARS6306
Status last verified
Feb 2023
First submitted
17 Feb 2022
Last updated
2 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38055309

  • 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.

    PubMed 36194864

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intervention in people with Disability Physical, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Depression (time frame: Changes from baseline (week 0) to post-intervention (week 5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259462, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.

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