SenseToKnow Autism Screening Device Validation Study

Recruiting Observational Study
Autism Autism Spectrum Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
16 Months – 36 Months
Sex
Any
Study type
Observational
Participants needed
350 (estimated)
Sponsor
Duke University · Other
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About This Trial

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.

Trial Locations
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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…
Contacts

Geraldine Dawson, PhD

9196680070

geraldine.dawson@duke.edu

CONTACT

Charlotte Stoute, BA

919-681-9730

charlotte.stoute@duke.edu

CONTACT