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
- Geraldine Dawson, PhD · Phone: 9196680070
- Charlotte Stoute, BA · Phone: 919-681-9730
Official record on ClinicalTrials.gov — NCT05874466
Locations in the U.S.
| North Carolina | Duke University, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.