VR for Joint Attention Support in ASD

Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder

The overall objective of this study is to determine the effectiveness of the Floreo VR Joint Attention Module in improving social communication skills in children with ASD. An additional objective is ongoing investigation of the tolerability of the product and the extent of potential adverse effects of Floreo VR, if any.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Floreo Joint Attention Module; Behavioral: Regularly Scheduled Therapy

Detailed Description

The study will be a Phase II randomized controlled trial in which the Floreo VR Joint Attention Module is the intervention being evaluated. Floreo is a mobile application that offers a supervised virtual reality experience for individuals with ASD. The application provides a 3D immersive scene for Google Cardboard-compatible smartphones and a WiFi paired supervisory overview that can run on smartphones or tablets.

The therapeutic content will consist of a Learning Module focused on Joint Attention. This Joint Attention Learning Module will include separate Learning Cards (LCs) that address specific subskills necessary to develop appropriate joint attention. Each Learning Card will consist of a virtual reality environment in a safari-themed setting, complete with animals designed to draw the learner's attention when necessary.

The product will be implemented at The Children's SPOT by a therapist working with a client during the course of a therapy session.

The intervention arm participant would engage in one or two VR episodes during a scheduled session. Each episode would last no more than 5 minutes. If two episodes are done in a day, there is a mandatory break of at least 3 minutes in between them. The sessions would occur two days per week, with at least two days in between sessions to allow the eyes time to rest.

There are 15 total VR sessions in the protocol, and completion of all study sessions would take 8 weeks.

The control condition is treatment as usual, that is, regularly scheduled therapy.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Children's SPOT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented ASD diagnosis, between 7 and 17 years of age

Exclusion Criteria:

• History of seizures, migraines, vertigo, psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Intervention; Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week	Device: Floreo Joint Attention Module; Two sessions per week for eight weeks of the Floreo VR Joint Attention Module, delivered via a Google Cardboard compatible VR headset. Each session includes one or two 5-minute VR episodes and an intermission that is at least 3 minutes long
Active Comparator: Treatment as Usual; Regularly scheduled therapy	Behavioral: Regularly Scheduled Therapy; therapy as regularly scheduled at therapy center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Joint Attention Protocol score at 12 weeks	A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention	immediately before and 4 weeks after intervention or control period of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Joint Attention Assessment score at 12 weeks	an in-person, videotaped, play-based measure to rate frequency of joint attention skills in school-aged children. Instances of each joint attention behavior observed are summed to provide a total Joint Attention Assessment score, with higher numbers reflecting more frequent joint attention behaviors.	immediately before and 4 weeks after intervention or control period of the study
Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score	a parent-reported measure of adaptive skills, commonly used for assessment of individuals with developmental disabilities. The Vineland provides an Adaptive Behavior Composite (ABC) score, which can be compared to a normative mean score of 100 with a normative standard deviation of 15.	immediately before and 4 weeks after intervention or control period of the study

Collaborators and Investigators

• Sponsor: Floreo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: Floreo Salus Protocol 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No