SenseToKnow Autism Screening Device Validation Study
Launched by DUKE UNIVERSITY · May 12, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The SenseToKnow Autism Screening Device Validation Study is looking to see how well the SenseToKnow app can identify autism spectrum disorder (ASD) in children aged 16 to 36 months. This study is important because early detection of autism can help children get the support they need sooner. The study is currently recruiting participants, and both boys and girls are welcome to join. To be eligible, children must be patients at Duke Health and have a parent or guardian who speaks English or Spanish and can give permission for them to participate.
If your child qualifies and you decide to participate, you'll be asked to help your child watch videos on the app while sitting in your lap. The study aims to collect valuable information, so it's important that your child is able to stay engaged during this time. There are some reasons a child might not be eligible, such as having severe motor or sensory impairments that make it hard to complete the study or if they have certain medical conditions. Overall, this study aims to improve the way we screen for autism in young children, helping to ensure they receive timely and effective care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Duke Health pediatric patient at enrollment
- • 2. 16-\<37 months of age at enrollment
- • 3. Parent/legal guardian speaks English or Spanish
- • 4. Parent/legal guardian understands and voluntarily provides informed consent
- Exclusion Criteria:
- • 1. Severe motor impairment that precludes study measure completion
- • 2. Known genetic disorders
- • 3. Severe hearing or visual impairment as determined on physical examination according to parent report
- • 4. Acute illnesses likely to prevent successful or valid data collection
- • 5. Uncontrolled epilepsy or seizure disorder
- • 6. History or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator
- • 7. Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
- • 8. Receiving therapies that affect vision
- • 9. Parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos
- • 10. Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
- • 11. Participants who are otherwise judged as unable to comply with the protocol by the investigator
- • 12. Any other factor that the investigator feels would make the study measures invalid
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Patients applied
Trial Officials
Geraldine Dawson, PhD
Principal Investigator
Duke University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported