NCT04016701

VR for Joint Attention Support in ASD

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Floreo, Inc. · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-20
• Primary completion: 2019-07-16
• Completion: 2019-07-16
• First posted: 2019-07-11
• Last updated: 2019-07-17

Locations

1 site across 1 country: United States