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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Floreo VR | Experimental | Floreo VR is a 12 week program |
|
| VR Control | Active Comparator | VR Control is a 12 week program that matches the Floreo VR interactions |
|
| VR Control Crossover | Other | For participants who opt in, they will run the 12 week Floreo VR program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Floreo VR | Device | 12 week VR program to help children with ASD to reduce the core symptoms of Autism |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline-12 weeks |
| Child and Family Quality of Life (CFQL-2) |
| Measure | Description | Time Frame |
|---|---|---|
| Childhood Autism Rating Scale (CARS-2) | Change from baseline,12, and 24 weeks in scores on the Childhood Autism Rating Scales-2 (CARS-2) | baseline, 12 weeks, 24 weeks |
| Floreo Skills Acquisition and Observations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Goh, MD | Cortica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cortica- Carlsbad | Carlsbad | California | 92008 | United States | ||
| Cortica- Glendale |
No plans to share
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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
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Participant and their adult caregiver will be blinded. The Outcomes Assessor (Clinician) with the adult caregiver will also be blinded.
| VR Control | Device | 12 week program administered in VR |
|
| VR Control Crossover | Device | If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program |
|
|
Change from baseline to 12 weeks in scores of the Child and Family Quality of Life (CFQL-2) |
| 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) | 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 | 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) | baseline, 16, 20, and 24 weeks |
Floreo specific skills scores
| baseline, 12 weeks, 24 weeks |
| Rate of Skills Acquisition | Social Skills goals | baseline, 12 weeks, 24 weeks |
| Subdomain 1 of the Autism Impact Measure in Repetitive Behaviors | Subdomain of the Autism Impact Measure in Repetitive Behaviors | baseline, 12 weeks, 24 weeks |
| Subdomain 2 of the Autism Impact Measure in Communications | Subdomain of the Autism Impact Measure in Communications | baseline, 12 weeks, 24 weeks |
| Subdomain 3 of the Autism Impact Measure in Atypical Behavior | Subdomain of the Autism Impact Measure in Atypical Behavior | baseline, 12 weeks, 24 weeks |
| Subdomain 4 of the Autism Impact Measure in Social Reciprocity | Subdomain of the Autism Impact Measure in Social Reciprocity | baseline, 12 weeks, 24 weeks |
| Subdomain 5 of the Autism Impact Measure in Peer Interaction | Subdomain of the Autism Impact Measure in Peer Interaction | baseline, 12 weeks, 24 weeks |
| Subdomain 6 of the Autism Impact Measure in questions not related to other subdomains | Subdomain of the Autism Impact Measure in questions not related to other subdomains | baseline, 12 weeks, 24 weeks |
| 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 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D003142 | Communication |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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