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NCT05874466 | RECRUITING | Autism

SenseToKnow Autism Screening Device Validation Study
Sponsor:

Duke University

Brief 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.

Condition or disease

Autism

Autism Spectrum Disorder

Detailed 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 Type : OBSERVATIONAL
Estimated Enrollment : 350 participants
Official Title : SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
Actual Study Start Date : 2023-07-07
Estimated Primary Completion Date : 2028-08
Estimated Study Completion Date : 2028-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Months to 36 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
SenseToKnow Autism Screening Device Validation Study

Location Details

NCT05874466

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27705