SenseToKnow Autism Screening Device Validation Study

Last updated: May 21, 2024
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Autism Spectrum Disorder (Asd)

Asperger's Disorder

Treatment

N/A

Clinical Study ID

NCT05874466
Pro00111371
2P50HD093074
  • Ages 16-36
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 accordingto 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 statethat could confound the study or be detrimental to the subject as determined by theinvestigator

  7. Acute exacerbations of chronic illnesses likely to prevent successful or valid datacollection

  8. Receiving therapies that affect vision

  9. Parent/legal guardian and/or investigator believes that the child will beunable/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 tocomplete the app administration, surveys, or diagnostic assessment

  11. Participants who are otherwise judged as unable to comply with the protocol by theinvestigator

  12. Any other factor that the investigator feels would make the study measures invalid

Study Design

Total Participants: 350
Study Start date:
July 07, 2023
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • Duke University

    Durham, North Carolina 27705
    United States

    Active - Recruiting

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