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

NCT05791071 | Completed Phase 2 FDA Device

• 1 other identifier: Floreo Cortica Protocol
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Autism Spectrum Disorder

Keywords

ASD; Virtual Reality; VR; Social Communication; Applied Behavior Analysis Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CARS-2

  The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected

Other Outcomes (3)

• AIM sub-domain scores

  The AIM takes approximately 30 minutes to complete.

• Vineland-3 Adaptive Behavior Composite and sub-domain scores

  The Vineland-3 Comprehensive Interview Form takes approximately 60-90 minutes to complete

• Adverse events related to VR use

  5-10 minutes as needed to fill out AE form

Study Arms (2)

Floreo VR Building Social Connections

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Device: Sham

Interventions

Floreo VR Building Social Connections 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.

Floreo VR Building Social Connections

Sham 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.

Sham

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Floreo, Inc.: lead
• Cortica: collaborator

Study Sites (1)

Cortica

Thousand Oaks, California, 91361, United States

Location

Related Publications (1)

• Kanne SM, Mazurek MO, Sikora D, Bellando J, Branum-Martin L, Handen B, Katz T, Freedman B, Powell MP, Warren Z. The Autism Impact Measure (AIM): initial development of a new tool for treatment outcome measurement. J Autism Dev Disord. 2014 Jan;44(1):168-79. doi: 10.1007/s10803-013-1862-3.

  PMID: 23748386 BACKGROUND

Related Links

• Floreo Website
• Cortica Website

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 30, 2023
• Study Start: February 15, 2023
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

US (1)