Tests a screening device for autism in young children
Tests whether the SenseToKnow device can detect autism in children aged 16 to 36 months.
Plain-language title generated from the registry record
Registry title: SenseToKnow Autism Screening Device Validation Study
Key facts
- Where
- Durham, United StatesSee the site
Where in United States
- Duke UniversityDurham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT05874466
- Record updated
- 6 March 2026
- Original description
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.Read full original descriptionShow less
SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
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.
Inclusion: 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.
Exclusion: Receiving therapies that affect vision; 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; 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.