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SenseToKnow Autism Screening Device Validation Study

Duke University · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT05874466

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1–3 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
350
US sites recruiting
1
Study start
July 7, 2023
Record last updated
March 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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: Autism; Autism Spectrum Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

  • Duke University

    Durham, NC 27705

    Site contact: Geraldine Dawson, PhD · 919-668-0070

Study contacts (from the official record)

  • Geraldine Dawson, PhD · 9196680070 · geraldine.dawson@duke.edu
  • Charlotte Stoute, BA · 919-681-9730 · charlotte.stoute@duke.edu
All healthy volunteers studies in North Carolina →
SenseToKnow Autism Screening Device Validation Study (NCT05874466) | Bored Studies