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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-06-29

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)

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Subjects and their parents/caregivers will be blinded to whether they are receiving Floreo VR therapy vs active VR exposure control. Research staff administering the therapy or control will not be blinded to the therapy; however, the clinicians doing pre/post assessments will be blinded.

Study Groups

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Floreo VR Building Social Connections

Participants will receive Floreo VR Building Social Connections lessons approximately 3 times a week for no more than 15 minutes per session.

Group Type EXPERIMENTAL

Floreo VR Building Social Connections

Intervention Type DEVICE

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.

Sham

Participants will receive non-interventional active VR videos approximately 3 times a week for no more than 15 minutes per session.

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

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.

Interventions

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Floreo VR Building Social Connections

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.

Intervention Type DEVICE

Sham

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.

Intervention Type DEVICE

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No