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SenseToKnow Autism Screening Device Validation Study | Clinical Trials | Clareo Health

RECRUITING

SenseToKnow Autism Screening Device Validation Study

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

NCT05874466•Duke University

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.

Eligibility

Age

1 - 3 years

Sex

ALL

Healthy Volunteers

Yes

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 study measure completion
•2. Known genetic disorders
•3. Severe hearing or visual impairment as determined on physical examination according to parent report
•4. Acute illnesses likely to prevent successful or valid data collection
•5. Uncontrolled epilepsy or seizure disorder
•6. 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
•7. Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
•8. Receiving therapies that affect vision
•9. 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
•10. Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
+2 more criteria

Locations (1)

Duke University

Durham, North Carolina, United States

Key Dates

Start Date

July 7, 2023

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 6, 2026

Enrollment

350

ESTIMATED participants

Conditions

AutismAutism Spectrum Disorder

Contacts

Geraldine Dawson, PhD

CONTACT

9196680070 geraldine.dawson@duke.edu

Charlotte Stoute, BA

CONTACT

919-681-9730 charlotte.stoute@duke.edu

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

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Neurologic DisordersAutism+2 more

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Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SenseToKnow Autism Screening Device Validation Study

Inclusion Criteria

Exclusion Criteria

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs

Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

Behavior Analytic Support of Needle-related Hospital Visits for Autistic Patients

Oxytocin Effects on Bone in Children With Autism Spectrum Disorder