Autism Spectrum DisorderSoCaVRNCT06453629
RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)
A study testing Floreo VR in people with Autism Spectrum Disorder and Social Communication, run by Floreo, Inc. at 17 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder, Social Communication
- What is being tested?
- Floreo VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 17 sitesUnited States
- Study dates
- 31 May 2024to 3 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Cortica- Burlington
Burlington, Massachusetts, 01830
Cortica- Carlsbad
Carlsbad, California, 92008
Cortica- Dedham
Dedham, Massachusetts, 20815
Cortica- Glendale
Glendale, California, 91203
Cortica- Irvine
Irvine, California, 92705
Cortica- Laguna Niguel
Laguna Niguel, California, 92677
Cortica- Naperville
Naperville, Illinois, 60564
Cortica- Plano
Plano, Texas, 75093
Cortica- Ridgefield
Ridgefield, Connecticut, 06877
Cortica- San Diego
San Diego, California, 92121
Cortica- Marin
San Rafael, California, 94903
Cortica- Shrewsbury
Shrewsbury, Massachusetts, 01545
Cortica- The Woodlands
The Woodlands, Texas, 77381
Cortica- Torrance
Torrance, California, 90503
Cortica- Trumbull
Trumbull, Connecticut, 06611
Cortica- Westchester
Westchester, Illinois, 60154
Cortica- Westlake Village
Westlake Village, California, 91361
About this study
Official title: A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children With Autism Using VR Technology
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Social Communication
- Being tested
- Floreo VR, VR Control, VR Control Crossover
- Keywords
- Virtual Reality
- Medical subject headings
- Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floreo VRDevice
12 week VR program to help children with ASD to reduce the core symptoms of Autism
VR ControlDevice
12 week program administered in VR
VR Control CrossoverDevice
Also called Crossover group
If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program
| Study group | Role | What they receive |
|---|---|---|
| Floreo VR | Experimental | Floreo VR is a 12 week program Receives: Device: Floreo VR |
| VR Control | Active comparator | VR Control is a 12 week program that matches the Floreo VR interactions Receives: Device: VR Control |
| VR Control Crossover | Other | For participants who opt in, they will run the 12 week Floreo VR program Receives: Device: Floreo VR; Device: VR Control Crossover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Impact Measure (AIM)
The primary objective of this study is to determine if administration of the Floreo VR compared to VR Control results in clinically significant improvement in autism symptoms as measured by the Autism Impact Measure (AIM) in the study participant population.
Measured: Baseline-12 weeks
Secondary outcomes (5)
Assessment of Functional Living Skills (AFLS)
Change from baseline to 12 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)
Measured: Baseline-12 weeks
Child and Family Quality of Life (CFQL-2)
Change from baseline to 12 weeks in scores of the Child and Family Quality of Life (CFQL-2)
Measured: Baseline-12 weeks
Assessment of Functional Living Skills (AFLS)
Change from 16, 20, 24 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)
Measured: baseline, 16 weeks, 20 weeks, 24 weeks
Total Autism Impact Measure (AIM) Score
Responder rate at 16, 20, and 24 weeks for the Total AIM score
Measured: baseline, 16 weeks, 20 weeks, 24 weeks
Child and Family Quality of Life (CFQL-2)
Change from baseline to 24 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)
Measured: baseline, 16, 20, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start31 May 2024
- Primary completion30 Nov 2025
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Floreo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Goh, MD, Principal investigator, Cortica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453629
- Sponsor's protocol ID
- FLO-CL-2023-001
- Acronym
- SoCaVR
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plans to share
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children With Autism Using VR Technology
- ClinicalTrials.gov ID
- NCT06453629
- Acronym / sponsor ID
- SoCaVR / FLO-CL-2023-001
- Conditions
- Autism Spectrum Disorder, Social Communication
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Floreo, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Floreo VR | Experimental | Device: Floreo VRFloreo VR is a 12 week program |
| VR Control | Active comparator | Device: VR ControlVR Control is a 12 week program that matches the Floreo VR interactions |
| VR Control Crossover | Other | Device: Floreo VR, Device: VR Control CrossoverFor participants who opt in, they will run the 12 week Floreo VR program |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floreo VR12 week VR program to help children with ASD to reduce the core symptoms of Autism | Device | Floreo VR, VR Control Crossover |
| VR Control12 week program administered in VR | Device | VR Control |
| VR Control CrossoverAlso: Crossover groupIf opt in, this group will crossover at the end of 12 weeks to the Floreo VR program | Device | VR Control Crossover |
Primary outcome
Autism Impact Measure (AIM)
Time frame: Baseline-12 weeks
The primary objective of this study is to determine if administration of the Floreo VR compared to VR Control results in clinically significant improvement in autism symptoms as measured by the Autism Impact Measure (AIM) in the study participant population.
5 secondary outcomes
Assessment of Functional Living Skills (AFLS)
Time frame: Baseline-12 weeks
Child and Family Quality of Life (CFQL-2)
Time frame: Baseline-12 weeks
Assessment of Functional Living Skills (AFLS)
Time frame: baseline, 16 weeks, 20 weeks, 24 weeks
Total Autism Impact Measure (AIM) Score
Time frame: baseline, 16 weeks, 20 weeks, 24 weeks
Child and Family Quality of Life (CFQL-2)
Time frame: baseline, 16, 20, and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. No plans to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Goh, MD principal investigator
Cortica
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Floreo VR in people with Autism Spectrum Disorder and Social Communication, run by Floreo, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Impact Measure (AIM) (time frame: Baseline-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.