ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-05-31
Study Completion:2026-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06453629

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.

Ages Eligible for Study:5 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Five to eighteen years old (inclusive) at the time of consent
  2. * 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 \[If age appropriate, an assent will also be administered to the participant to inform them of the study and give them an opportunity to proceed or decline\]
  3. * Verified diagnosis of ASD documented by a qualified clinician according to DSM-V criteria
  4. * Receiving therapies at least two times per week in a clinic setting
  5. * Participant is able to complete and pass the VR orientation screening
  1. * 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:
  2. * Uncontrolled neurological conditions such as epilepsy, migraine
  3. * Current disorders affecting balance, such as vertigo
  4. * Primary sensory impairment such as blindness or deafness
  5. * Eye movement impairment, such as strabismus
  6. * Participants are enrolled in another clinical study
  7. * Participants known to be pregnant
  8. * Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.

Contacts and Locations

Principal Investigator

Suzanne Goh, MD
PRINCIPAL_INVESTIGATOR
Cortica

Study Locations (Sites)

Cortica- Carlsbad
Carlsbad, California, 92008
United States
Cortica- Glendale
Glendale, California, 91203
United States
Cortica- Irvine
Irvine, California, 92705
United States
Cortica- Laguna Niguel
Laguna Niguel, California, 92677
United States
Cortica- San Diego
San Diego, California, 92121
United States
Cortica- Marin
San Rafael, California, 94903
United States
Cortica- Torrance
Torrance, California, 90503
United States
Cortica- Westlake Village
Westlake Village, California, 91361
United States
Cortica- Ridgefield
Ridgefield, Connecticut, 06877
United States
Cortica- Trumbull
Trumbull, Connecticut, 06611
United States
Cortica- Naperville
Naperville, Illinois, 60564
United States
Cortica- Westchester
Westchester, Illinois, 60154
United States
Cortica- Burlington
Burlington, Massachusetts, 01830
United States
Cortica- Dedham
Dedham, Massachusetts, 20815
United States
Cortica- Shrewsbury
Shrewsbury, Massachusetts, 01545
United States
Cortica- Plano
Plano, Texas, 75093
United States
Cortica- The Woodlands
The Woodlands, Texas, 77381
United States

Collaborators and Investigators

Sponsor: Floreo, Inc.

  • Suzanne Goh, MD, PRINCIPAL_INVESTIGATOR, Cortica

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-31
Study Completion Date2026-03-15

Study Record Updates

Study Start Date2024-05-31
Study Completion Date2026-03-15

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Social Communication