We are currently enrolling children ages 31-84 months in a new study that will examine if an investigational medical device, the EarliPoint Evaluation for Autism Spectrum Disorder (ASD), can be used to diagnose autism. The device detects the presence and severity of autism and related developmental delays. The device tracks where children look as they watch videos on a screen, showing researchers how typically developing children and children with autism visually explore the world differently.
Study information
The EarliPoint™ Evaluation for Autism Spectrum Disorder (the device) tracks where children are looking as they watch videos on a screen, which shows us how typically developing children and children with autism visually explore the world differently. This study is looking at whether the device can give comparable results to current diagnostic tests performed by clinicians.
What will my family be asked to do?
To participate in the study, you will be asked to review an Informed Consent document which explains all the details of the study. If you agree to allow your child to participate, you will be asked to sign and return the consent document to the researchers. You and your child will be asked to attend one study visit. Your child will undergo testing by the EarliPoint device, and the researchers will observe and evaluate your child’s developmental status and conduct an expert clinician diagnosis for autism spectrum disorder and related developmental delays.
Eligibility requirements include:
- Individual is suspected of having ASD or are typically developing
- Individual is physically able to sit in a chair, highchair, or booster seat at a table and watch age-appropriate videos on a screen
- Individual has normal to corrected-to-normal vision and hearing
- Individual can understand instructions presented in English
How long will this take?
Your child will participate in one study visit. They will watch some social videos on the device and undergo assessments. This study uses gold-standard diagnostic assessments that can be lengthy. The entire visit can take around 4 hours.
Sponsored by EarliTec Diagnostics