VR for Joint Attention Support in ASD

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04016701
• Other study ID #: Floreo Salus Protocol 1
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 20, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: July 2019
• Source: Floreo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of seizures, migraines, vertigo, psychosis

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

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

Behavioral:
• Regularly Scheduled Therapy
therapy as regularly scheduled at therapy center

Locations

Country	Name	City	State
United States	Children's SPOT	Columbia	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Floreo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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