What is the mechanism of action of this treatment?

Common treatments for Autism Spectrum Disorder (ASD) often focus on behavioral, educational, and therapeutic interventions designed to improve social skills, communication, and adaptive behaviors. Virtual Reality (360° Video) is an emerging treatment that provides an immersive and engaging experience, which can help distract and calm children with ASD. This matters for Autism patients because it can reduce pre-visit anxiety, making medical or dental visits less stressful and more manageable. The immersive nature of VR can also help children with ASD practice social scenarios in a controlled, safe environment, potentially improving their real-world interactions.

What side effects are associated with this type of intervention?

Common treatments for autism include behavioral therapies, medications, and alternative approaches like virtual reality (VR). Behavioral therapies generally have minimal side effects but can be time-intensive. Medications, such as antipsychotics and stimulants, can cause side effects like weight gain, drowsiness, and irritability. VR treatments, aimed at reducing anxiety and improving experiences, are generally well-tolerated with few reported side effects, though some children may experience mild discomfort or dizziness. Overall, VR is considered a safe and engaging tool for managing anxiety in children with autism.

What prior FDA approvals exist?

The provided context does not mention any specific FDA-approved treatments for autism spectrum disorder (ASD) that are similar to the virtual reality (360° video) approach being studied. However, it does highlight the potential of extended reality (XR) technologies in healthcare, as seen with the FDA-approved EndeavorRx for ADHD, which uses video game therapy to engage and treat children. While XR-assisted treatments for ASD are still in their infancy, they hold promise for reducing anxiety and improving the overall experience for children with ASD.

What other types of research exist?

Promising alternatives to Virtual Reality (360° Video) for autism patients include: 1) Augmented Reality (AR) applications, which overlay digital information onto the real world, providing interactive and engaging experiences. 2) Hypnotherapy, which has shown effectiveness in reducing anxiety and functional nausea in children. 3) Telehealth-based cognitive-behavioral therapy (CBT), which can be tailored to individual needs and delivered remotely. 4) Integrative therapies such as music therapy and hydrotherapy, which can enhance focus, attention, and physical well-being. These alternatives offer immersive and engaging experiences that can help distract and calm children with autism.

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Virtual Dental Office Experience for Autism Spectrum Disorder

N/A

Waitlist Available

Led By Azadeh Kushki, PhD

Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A community diagnosis of ASD

Aged 4-12

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a 360° VR video and a social story to help children with autism feel less anxious before dental visits. The VR video allows children to explore a virtual dentist's office, while the social story explains the visit in simple terms. Both methods aim to make the dental visit less stressful by familiarizing children with what to expect.

Who is the study for?

This trial is for children aged 4-12 with autism spectrum disorder who have a dental appointment at least 3 weeks away and are predicted to have difficulty sitting through it. It's their first time at Holland Bloorview Dental, and they must have an ASD diagnosis from the community.

What is being tested?

The study compares two methods to reduce pre-visit anxiety for dental appointments in children with ASD: one uses virtual reality (360° video) while the other uses a social story. The cost of both methods will also be compared.

What are the potential side effects?

Since this trial involves non-invasive interventions like watching videos or reading stories, there are no significant medical side effects expected. However, individual reactions to VR experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Autism Spectrum Disorder.

Select...

I am between the ages of 4 and 12.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dental visit "completeness"

Secondary study objectives

Pre-visit anxiety

Other study objectives

Cost comparison analysis

Heart rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Condition (360° Video)Experimental Treatment1 Intervention

The 360° video (experimental) group will be mailed a study tablet with the 360° video prior to the dental visit.

Group II: Control Condition (Social Story)Active Control1 Intervention

The treatment-as-usual (control) group will be mailed a study tablet with a social story prior to the dental visit.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) often focus on behavioral, educational, and therapeutic interventions designed to improve social skills, communication, and adaptive behaviors. Virtual Reality (360° Video) is an emerging treatment that provides an immersive and engaging experience, which can help distract and calm children with ASD. This matters for Autism patients because it can reduce pre-visit anxiety, making medical or dental visits less stressful and more manageable. The immersive nature of VR can also help children with ASD practice social scenarios in a controlled, safe environment, potentially improving their real-world interactions.

Using virtual reality to target positive autobiographical memory in individuals with moderate-to-moderately severe depressive symptoms: A single case experimental design.Adherence to home-based videogame treatment for amblyopia in children and adults.Virtual reality in psychiatric disorders: A systematic review of reviews.