RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)

Floreo

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder; Social Communication

Treatments: Device: VR Control Crossover; Device: Floreo VR; Device: VR Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT06453629

FLO-CL-2023-001

Details and patient eligibility

About

The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children.

The main question it aims to answer is:

• Does the Floreo VR clinical product show clinical improvement in autism symptoms?

Participants will engage the VR product for twice a week for twelve weeks.

They will be randomized to either the Floreo Clinical Product or a VR Control group experience.

Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors.

Full description

The purpose of this study is to find out if Floreo's VR clinical program can help with autism symptoms such as social communication skills in autistic children. Recent advances in VR technology offers a new way to improve these types of skills in children with autism in an immersive and controlled environment.

Questionnaires answered by adult caregivers will be used to assess the child's behaviors during the time of treatment.

Clinician observations will also be conducted as a part of this study.

Enrollment: 100 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Five to eighteen years old (inclusive) at the time of consent
• Legal guardian is able and willing to properly sign and date informed consent indicating that they have been informed about the study and able to complete all visits [If age appropriate, an assent will also be administered to the participant to inform them of the study and give them an opportunity to proceed or decline]
• Verified diagnosis of ASD documented by a qualified clinician according to DSM-V criteria
• Receiving therapies at least two times per week in a clinic setting
• Participant is able to complete and pass the VR orientation screening

Exclusion criteria

• Significant medical condition(s) [examples listed below] or other circumstances which, in the opinion of the treating clinician, would preclude compliance with the protocol, adequate cooperation in the study, or may prevent the participant from safely participating in the study:
• Uncontrolled neurological conditions such as epilepsy, migraine
• Current disorders affecting balance, such as vertigo
• Primary sensory impairment such as blindness or deafness
• Eye movement impairment, such as strabismus
• Participants are enrolled in another clinical study
• Participants known to be pregnant
• Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 3 patient groups

Floreo VR

Experimental group

Description:

Floreo VR is a 12 week program

Treatment:

Device: Floreo VR

VR Control

Active Comparator group

Description:

VR Control is a 12 week program that matches the Floreo VR interactions

Treatment:

Device: VR Control

VR Control Crossover

Other group

Description:

For participants who opt in, they will run the 12 week Floreo VR program

Treatment:

Device: Floreo VR

Device: VR Control Crossover