Recruiting

Autism Screening

Sponsor:

Duke University

Code:

NCT05874466

Conditions

Autism

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Autism

Autism Spectrum Disorder

Study ID

NCT05874466

Start date

Jul 7, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Accepted

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
11. Participants who are otherwise judged as unable to comply with the protocol by the investigator
12. Any other factor that the investigator feels would make the study measures invalid

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric patients, 16-36 months of age, recruited through pediatric medical clinics

Consecutive pediatric participants will be recruited and enrolled via >= 6 participating sites comprised of pediatric medical clinics (e.g., primary care and family medicine clinics) that are part of the broader Duke University Health System (DUHS) located in North Carolina. Enrollment will proceed until the targets of N = 150 participants diagnosed with autism spectrum disorder and N = 200 without autism are reached.

Primary outcome measure

  • Sensitivity of the SenseToKnow screening device based on a machine learning algorithm that combines SenseToKnow digital data with data from the SenseToKnow Caregiver survey for autism detection [ Time Frame: Will be calculated based on data from Baseline/Timepoint 1 ]
  • Specificity of the SenseToKnow screening device based on machine earning algorithm that combines SenseToKnow digital data with data from the SenseToKnow Caregiver survey for autism detection [ Time Frame: Will be calculated based on data from Baseline/Timepoint 1 ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Geraldine Dawson, PhD

919-668-0070

More Information

Sponsor

Duke University

Last update posted

Mar 6, 2026

Last verified

Feb, 2026

Keywords

  • Diagnosis
  • Digital device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-06.