๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-04

SenseToKnow Autism Screening Device Validation Study (NCT05874466)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Duke University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Duke University โ€” Durham, North Carolina

Age range: 16 Months to 36 Months

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Duke University โ€” Durham, North Carolina

๐Ÿ“ž Contact the Study Coordinator

Phone: (919) 668-0070

Email: geraldine.dawson@duke.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Autism clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—