Actively Recruiting
SenseToKnow Autism Screening Device Validation Study
Led by Duke University · Updated on 2026-03-06
350
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the detection of autism spectrum disorder in children 16-36 months of age.
CONDITIONS
Official Title
SenseToKnow Autism Screening Device Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Duke Health pediatric patient at enrollment
- Age between 16 and less than 37 months at enrollment
- Parent or legal guardian speaks English or Spanish
- Parent or legal guardian understands and voluntarily provides informed consent
You will not qualify if you...
- Severe motor impairment that prevents completing study measures
- Known genetic disorders
- Severe hearing or visual impairment based on examination and parent report
- Acute illnesses likely to prevent valid data collection
- Uncontrolled epilepsy or seizure disorder
- Clinically significant medical disease or mental state that could affect the study or harm the child
- Acute worsening of chronic illnesses likely to prevent valid data collection
- Receiving therapies that affect vision
- Child unable or unwilling to sit in parent's lap to watch app videos as judged by parent or investigator
- Parent or child unwilling or unable to complete app use, surveys, or diagnostic assessment
- Participant judged unable to comply with the protocol by the investigator
- Any other factor the investigator believes would invalidate study measures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
G
Geraldine Dawson, PhD
CONTACT
C
Charlotte Stoute, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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