SenseToKnow Autism Screening Device Validation Study

Status Recruiting

Clinical Trial Summary

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.

Clinical Trial Description

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app 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 app 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05874466
Study type	Observational
Source	Duke University
Contact	Geraldine Dawson, PhD
Phone	9196680070
Email	geraldine.dawson@duke.edu
Status	Recruiting
Phase
Start date	July 7, 2023
Completion date	August 2028

View Details

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