VR for Joint Attention Support in ASD

NCT04016701 | Withdrawn Phase 2

• 1 other identifier: Floreo Salus Protocol 1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline Joint Attention Assessment score at 12 weeks

  immediately before and 4 weeks after intervention or control period of the study

• Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score

  immediately before and 4 weeks after intervention or control period of the study

Study Arms (2)

VR Intervention

EXPERIMENTAL

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

Device: Floreo Joint Attention Module

Treatment as Usual

ACTIVE COMPARATOR

Regularly scheduled therapy

Behavioral: Regularly Scheduled Therapy

Interventions

Floreo Joint Attention Module DEVICE

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

VR Intervention

Regularly Scheduled Therapy BEHAVIORAL

therapy as regularly scheduled at therapy center

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• History of seizures, migraines, vertigo, psychosis

Sponsors & Collaborators

• Floreo, Inc.: lead

Study Sites (1)

Children's SPOT

Columbia, Maryland, 21045, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: July 20, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)