VR for Joint Attention Support in ASD

Floreo

Status and phase: Withdrawn; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Regularly Scheduled Therapy; Device: Floreo Joint Attention Module

Study type: Interventional

Funder types: Industry

Identifiers

NCT04016701

Floreo Salus Protocol 1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• History of seizures, migraines, vertigo, psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

VR Intervention

Experimental group

Description:

Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week

Treatment:

Device: Floreo Joint Attention Module

Treatment as Usual

Active Comparator group

Description:

Regularly scheduled therapy

Treatment:

Behavioral: Regularly Scheduled Therapy