Virtual Reality for Autism

(SoCaVR Trial)

Recruiting at 16 trial locations

Overseen By Liz Pascual

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Floreo, Inc.

Disqualifiers: Epilepsy, Migraine, Vertigo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children. The main question it aims to answer is: • Does the Floreo VR clinical product show clinical improvement in autism symptoms? Participants will engage the VR product for twice a week for twelve weeks. They will be randomized to either the Floreo Clinical Product or a VR Control group experience. Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Floreo VR for autism?

Research shows that virtual reality (VR) can be a safe and effective tool for teaching social skills to individuals with autism. Studies indicate that VR is motivating and feasible for use, helping users learn important life skills and improve social interactions. ^{1 2 3 4 5}

Is virtual reality safe for people with autism?

Research shows that virtual reality (VR) is generally safe for people with autism. Studies found no major negative effects, and most participants reported no discomfort or issues while using VR devices. ^{1 2 4 6 7}

How is the Floreo VR treatment different from other autism treatments?

Floreo VR is unique because it uses virtual reality to create interactive, three-dimensional simulations of real-world settings, helping individuals with autism develop social and interaction skills in a safe and controlled environment. This approach is different from traditional therapies as it provides an immersive experience that can be both engaging and effective for learning practical life skills. ^{1 2 4 5 8}

Research Team

Suzanne Goh, MD

Principal Investigator

Cortica

Eligibility Criteria

This trial is for children with autism, including those diagnosed with Autism Spectrum Disorder or Social Communication Disorder. They'll use VR technology twice a week for twelve weeks to see if it helps improve their social skills.

Inclusion Criteria

I can complete and pass a VR orientation test.

I go to the clinic at least twice a week for treatments.

My legal guardian can sign the consent for me and I understand what the study involves.

Exclusion Criteria

Participants are enrolled in another clinical study

Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.

I do not have any health issues like uncontrolled epilepsy, severe migraines, balance disorders, blindness, deafness, or eye movement problems that would stop me from safely participating in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the VR product twice a week for twelve weeks, randomized to either the Floreo Clinical Product or a VR Control group experience

12 weeks

24 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 16, 20, and 24 weeks

12 weeks

VR Control Crossover

Participants who opt in will run the 12 week Floreo VR program

12 weeks

Treatment Details

Interventions

• Floreo VR
• VR Control
• VR Control Crossover

Trial Overview The study tests the effectiveness of a Virtual Reality (VR) program called Floreo VR against a control VR experience. Children will be randomly placed in one of these two groups to compare skill and behavior development.

Participant Groups

Group I: VR Control Crossover Experimental Treatment 2 Interventions

For participants who opt in, they will run the 12 week Floreo VR program

Group II: Floreo VR Experimental Treatment 1 Intervention

Floreo VR is a 12 week program

Group III: VR Control Active Control 1 Intervention

VR Control is a 12 week program that matches the Floreo VR interactions

Floreo VR is already approved in United States, European Union for the following indications:

Approved in United States as Floreo VR for:

• Autism Spectrum Disorder (ASD) therapy
• Social skills training
• Communication skills training

Approved in European Union as Floreo VR for:

• Autism Spectrum Disorder (ASD) therapy
• Social skills training
• Communication skills training

Who Is Running the Clinical Trial?

Floreo, Inc.

Lead Sponsor

Trials

4

Recruited

290+

Findings from Research

The pilot study involving 12 school-aged children with autism demonstrated that Floreo's Joint Attention Module is safe and well-tolerated, with no serious side effects reported and high levels of enjoyment and perceived value from the VR experience.

Preliminary results indicated positive changes in joint attention skills, including increased interactions, eye contact, and initiation of interactions, suggesting that the VR platform may effectively support skill development in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study. Ravindran, V., Osgood, M., Sazawal, V., et al.[2023]

A study involving 60 verbally fluent adolescents and adults with autism spectrum disorder (ASD) found that immersive virtual reality (VR) is safe and feasible for training social skills, with participants engaging in up to three 45-minute sessions without significant side effects.

The VR training program was reported to be highly usable and enjoyable, suggesting it could be an effective tool for helping individuals with ASD learn to interact safely with police officers and develop other critical life skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of an Immersive Virtual Reality Intervention Program for Teaching Police Interaction Skills to Adolescents and Adults with Autism. McCleery, JP., Zitter, A., Solórzano, R., et al.[2021]

In a study involving 78 preschool children with autism spectrum disorder (ASD), the addition of virtual reality-incorporated cognitive behavioral therapy (VR-CBT) to a learning style profile (LSP) intervention significantly improved core symptoms of ASD, as measured by the Autism Behavior Checklist (ABC) and the Childhood Autism Rating Scale (CARS).

The VR-CBT intervention also led to notable improvements in behavioral performance on tasks requiring response inhibition and reduced hyperactivity-impulsivity symptoms in children with comorbid ADHD, indicating its potential as an effective adjunctive digital therapy for young children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial. Chu, L., Shen, L., Ma, C., et al.[2023]

In a study involving 29 participants with autism spectrum disorder (ASD), all were willing to wear the Oculus Rift™ head-mounted display (HMD), indicating a positive reception towards this virtual reality technology.

Participants reported high levels of enjoyment and immersion while using the HMD, suggesting that these devices could be beneficial tools for engaging individuals with ASD, regardless of their IQ levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: A Pilot Study of the Use of a Virtual Reality Headset in Autism Populations. Newbutt, N., Sung, C., Kuo, HJ., et al.[2019]

Virtual reality (VR) technology shows promise as an innovative tool for assessing and treating children with autism spectrum disorder (ASD), particularly in enhancing social communication skills such as emotion recognition and speech.

The review highlights the need for further development in VR applications for ASD, addressing current limitations and advocating for improvements in technology and theoretical models to better support children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Technology as an Educational and Intervention Tool for Children with Autism Spectrum Disorder: Current Perspectives and Future Directions. Zhang, M., Ding, H., Naumceska, M., et al.[2022]

In a study involving 18 children and adults with autism spectrum disorders (ASD), the Empowered Brain AR smartglasses were found to be safe, with 89% of users able to wear and use the device without reporting negative effects.

Caregivers also reported no negative effects, and the majority of users and caregivers expressed satisfaction with the design, indicating that AR technology could be a beneficial tool for social communication in individuals with ASD, although further research is needed on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Lack of Negative Effects of Wearable Augmented-Reality Social Communication Aid for Children and Adults with Autism. Sahin, NT., Keshav, NU., Salisbury, JP., et al.[2023]

Children with autism were able to wear a virtual reality (VR) helmet and successfully identify familiar objects and their qualities in their environment, indicating a positive acceptance of the technology.

The study suggests that VR could be a valuable tool for enhancing our understanding of autism and developing treatment strategies, although further research is needed to determine if these learning experiences can be applied in different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: two case studies using virtual reality as a learning tool for autistic children. Strickland, D., Marcus, LM., Mesibov, GB., et al.[2019]

The study involved six teenagers with Autistic Spectrum Disorders (ASDs) who used a Virtual Environment (VE) of a café, which led to significant improvements in their judgments and explanations about seating choices in both café and bus videos.

The findings suggest that Virtual Reality can be an effective tool for teaching social skills to individuals with ASDs, as improvements were noted based on the timing of the VE experience in relation to video assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using virtual environments for teaching social understanding to 6 adolescents with autistic spectrum disorders. Mitchell, P., Parsons, S., Leonard, A.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of an Immersive Virtual Reality Intervention Program for Teaching Police Interaction Skills to Adolescents and Adults with Autism. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Brief Report: A Pilot Study of the Use of a Virtual Reality Headset in Autism Populations. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Technology as an Educational and Intervention Tool for Children with Autism Spectrum Disorder: Current Perspectives and Future Directions. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Lack of Negative Effects of Wearable Augmented-Reality Social Communication Aid for Children and Adults with Autism. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Brief report: two case studies using virtual reality as a learning tool for autistic children. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Using virtual environments for teaching social understanding to 6 adolescents with autistic spectrum disorders. [2018]