SenseToKnow Autism Screening Device Validation Study

Description

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.

Conditions

Autism, Autism Spectrum Disorder

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Study Overview

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Study Details

Study overview

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.

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

SenseToKnow Autism Screening Device Validation Study

Condition
Autism
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University, Durham, North Carolina, United States, 27705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

16 Months to 36 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Geraldine Dawson, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2028-08