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SenseToKnow Autism Screening Device Validation Study

RecruitingObservational studyHealthy volunteers welcome

SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development

Who can join

16 Months – 36 Months · All sexes · Healthy volunteers welcome

Full 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 the study

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.

Sponsor: Duke University · Participants: 350 · Started: Jul 7, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05874466

Locations in the U.S.

North CarolinaDuke University, Durham

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.