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

Description

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.

Conditions

Autism Spectrum Disorder, Social Communication

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Study Overview

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Study Details

Study overview

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.

A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children with Autism Using VR Technology

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

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Carlsbad

Cortica- Carlsbad, Carlsbad, California, United States, 92008

Glendale

Cortica- Glendale, Glendale, California, United States, 91203

Irvine

Cortica- Irvine, Irvine, California, United States, 92705

Laguna Niguel

Cortica- Laguna Niguel, Laguna Niguel, California, United States, 92677

San Diego

Cortica- San Diego, San Diego, California, United States, 92121

San Rafael

Cortica- Marin, San Rafael, California, United States, 94903

Torrance

Cortica- Torrance, Torrance, California, United States, 90503

Westlake Village

Cortica- Westlake Village, Westlake Village, California, United States, 91361

Ridgefield

Cortica- Ridgefield, Ridgefield, Connecticut, United States, 06877

Trumbull

Cortica- Trumbull, Trumbull, Connecticut, United States, 06611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

5 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Floreo, Inc.,

Suzanne Goh, MD, PRINCIPAL_INVESTIGATOR, Cortica

Study Record Dates

2025-02-15