NCT05874466

SenseToKnow Autism Screening Device Validation Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 16 Months – 36 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow device for the classification of autism spectrum disorder when administered by parents in a sample of patients 16-36 months of age. The trial design is a non-interventional cross-sectional study comparing the SenseToKnow device classification of autism spectrum disorder ("autism") versus non-autism with the patient's diagnostic status based on expert clinical diagnosis in a population of pediatric patients.

Conditions

• Autism
• Autism Spectrum Disorder

Timeline

• Start date: 2023-07-07
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2023-05-25
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States