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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
12 week VR program to help children with ASD to reduce the core symptoms of Autism
12 week program administered in VR
If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program
Cortica- Carlsbad
Carlsbad, California, United States
Cortica- Glendale
Glendale, California, United States
Cortica- Irvine
Irvine, California, United States
Cortica- Laguna Niguel
Laguna Niguel, California, United States
Cortica- San Diego
San Diego, California, United States
Cortica- Marin
San Rafael, California, United States
Cortica- Torrance
Torrance, California, United States
Cortica- Westlake Village
Westlake Village, California, United States
Cortica- Ridgefield
Ridgefield, Connecticut, United States
Cortica- Trumbull
Trumbull, Connecticut, United States
...and 7 more locations
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.
Time frame: Baseline-12 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: baseline, 16, 20, and 24 weeks
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