VR for Joint Attention Support in ASD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Floreo Joint Attention Module
* Behavioral: Regularly Scheduled Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented ASD diagnosis, between 7 and 17 years of age Exclusion Criteria: History of seizures, migraines, vertigo, psychosis

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR Intervention<br>Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week | Device: Floreo Joint Attention Module<br>* 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<br>|
| Active Comparator: Treatment as Usual<br>Regularly scheduled therapy | Behavioral: Regularly Scheduled Therapy<br>* therapy as regularly scheduled at therapy center<br>|

What is the study measuring?
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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 |