SenseToKnow Autism Screening Device Validation Study

Recruiting now

Conditions studied: Autism, Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT05874466

Run by

Duke University

People needed

350

Starts

2023-07-07

Expected to finish

2027-12-01

Last updated by the study team

2026-03-06

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Duke Health pediatric patient at enrollment
• 16-<37 months of age at enrollment
• Parent/legal guardian speaks English or Spanish
• Parent/legal guardian understands and voluntarily provides informed consent

You may not qualify if…

• Severe motor impairment that precludes study measure completion
• Known genetic disorders
• Severe hearing or visual impairment as determined on physical examination according to parent report
• Acute illnesses likely to prevent successful or valid data collection
• Uncontrolled epilepsy or seizure disorder
• 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
• Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
• Receiving therapies that affect vision
• 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
• Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
• Participants who are otherwise judged as unable to comply with the protocol by the investigator
• Any other factor that the investigator feels would make the study measures invalid

Where it is running

• Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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