Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)

Study Overview
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Brief Summary
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A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)

Detailed Description
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In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group. The Floreo VR Building Social Connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.

Official Title
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A Randomized Controlled Phase II Study to Assess the Efficacy of Floreo VR Building Social Connections vs. Active VR Exposure Control as Treatment for Social Skills in Autistic Children

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Floreo VR Building Social Connections
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization). Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate. A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised. Participants must receive ABA therapy at Cortica, with scheduled ABA sessions in clinic at least 3 times per week. Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff Exclusion Criteria: A history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (EEG) Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled History of balance disorder including vertigo, motion sensitivity, or balance disorder Primary sensory impairment (blindness, deafness) Motor disorder that would interfere with VR engagement

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The two parallel groups include an experimental group that will receive the Floreo VR Building Social Connections program and a control group that will receive non-interventional active VR programing.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Floreo VR Building Social Connections<br>Participants will receive Floreo VR Building Social Connections lessons approximately 3 times a week for no more than 15 minutes per session. | Device: Floreo VR Building Social Connections<br>* Floreo's VR platform consists of a VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) that are seamlessly linked in real time, allowing the therapist (or monitor) to set up lessons, change the interactive environment, and provide live verbal and VR-based guidance, feedback, and rewards to users. The lessons that will be implemented in this intervention are aimed at targeting social skills such as communication, joint attention, and social interactions.<br>|
| Sham Comparator: Sham<br>Participants will receive non-interventional active VR videos approximately 3 times a week for no more than 15 minutes per session. | Device: Sham<br>* This condition will contain the same VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) as the intervention condition, but instead of social skill lessons, only non-intervention, active VR videos such as underwater fish swimming will be shown.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autism Impact Measure (AIM) Assessment | The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms. The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). The items cover distinct sub-domains of ASD symptoms including Repetitive Behavior, Atypical Behavior, Social Reciprocity, and Peer Interaction. A composite score is also calculated. | The AIM takes approximately 30 minutes to complete. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CARS-2 | The CARS-2 is a 15-item rating scale used to identify children with autism and determine overall symptom severity. The scale is completed by a clinician familiar with the assessment of ASD after collecting information by direct interview and observation. The rater will also make use of supplemental collected using an unscored Parent/Caregiver Questionnaire. Only the CARS-2 Standard rating scale will be used for the purposes of this study. | The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD, Virtual Reality, VR, Social Communication, Applied Behavior Analysis Therapy