Clinical trial NCT06453629: RCT to Evaluate Social Skills in Children with Autism Using VR Technology (SoCaVR)
Official title: A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children with Autism Using VR Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Social Communication
Keywords: Virtual Reality
Lead sponsor: Floreo, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Experimental: Floreo VR- 12 week with follow up Active Comparator: VR Control- 12 week with ability to crossover or follow up Other: VR Control Crossover- 12 week of Floreo VR
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Autism Impact Measure (AIM)
timeFrame: Baseline-12 weeks
Secondary outcomes:
measure: Assessment of Functional Living Skills (AFLS)
timeFrame: Baseline-12 weeks
measure: Child and Family Quality of Life (CFQL-2)
timeFrame: Baseline-12 weeks
measure: Assessment of Functional Living Skills (AFLS)
timeFrame: baseline, 16 weeks, 20 weeks, 24 weeks
measure: Total Autism Impact Measure (AIM) Score
timeFrame: baseline, 16 weeks, 20 weeks, 24 weeks
measure: Child and Family Quality of Life (CFQL-2)
timeFrame: baseline, 16, 20, and 24 weeks
Other outcomes:
measure: Childhood Autism Rating Scale (CARS-2)
timeFrame: baseline, 12 weeks, 24 weeks
measure: Floreo Skills Acquisition and Observations
timeFrame: baseline, 12 weeks, 24 weeks
measure: Rate of Skills Acquisition
timeFrame: baseline, 12 weeks, 24 weeks
measure: Subdomain 1 of the Autism Impact Measure in Repetitive Behaviors
timeFrame: baseline, 12 weeks, 24 weeks
measure: Subdomain 2 of the Autism Impact Measure in Communications
timeFrame: baseline, 12 weeks, 24 weeks
measure: Subdomain 3 of the Autism Impact Measure in Atypical Behavior
timeFrame: baseline, 12 weeks, 24 weeks
measure: Subdomain 4 of the Autism Impact Measure in Social Reciprocity
timeFrame: baseline, 12 weeks, 24 weeks
measure: Subdomain 5 of the Autism Impact Measure in Peer Interaction
timeFrame: baseline, 12 weeks, 24 weeks
measure: Subdomain 6 of the Autism Impact Measure in questions not related to other subdomains
timeFrame: baseline, 12 weeks, 24 weeks
Locations:
city: Carlsbad
country: United States
facility: Cortica- Carlsbad
state: California
city: Glendale
country: United States
facility: Cortica- Glendale
state: California
city: Irvine
country: United States
facility: Cortica- Irvine
state: California
city: Laguna Niguel
country: United States
facility: Cortica- Laguna Niguel
state: California
city: San Diego
country: United States
facility: Cortica- San Diego
state: California
city: San Rafael
country: United States
facility: Cortica- Marin
state: California
city: Torrance
country: United States
facility: Cortica- Torrance
state: California
city: Westlake Village
country: United States
facility: Cortica- Westlake Village
state: California
city: Ridgefield
country: United States
facility: Cortica- Ridgefield
state: Connecticut
city: Trumbull
country: United States
facility: Cortica- Trumbull
state: Connecticut
city: Naperville
country: United States
facility: Cortica- Naperville
state: Illinois
city: Westchester
country: United States
facility: Cortica- Westchester
state: Illinois
city: Burlington
country: United States
facility: Cortica- Burlington
state: Massachusetts
city: Dedham
country: United States
facility: Cortica- Dedham
state: Massachusetts
city: Shrewsbury
country: United States
facility: Cortica- Shrewsbury
state: Massachusetts
city: West Springfield
country: United States
facility: Cortica- West Springfield
state: Massachusetts
city: Plano
country: United States
facility: Cortica- Plano
state: Texas
city: The Woodlands
country: United States
facility: Cortica- The Woodlands
state: Texas
Study officials:
affiliation: Cortica
name: Suzanne Goh, MD
role: PRINCIPAL_INVESTIGATOR
References: