SenseToKnow Autism Screening Device Validation Study
Purpose
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
Eligibility
- Eligible Ages
- Between 16 Months and 36 Months
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Duke University
Durham, North Carolina 27705
Durham, North Carolina 27705
Contact:
Geraldine Dawson, PhD
919-668-0070
Geraldine Dawson, PhD
919-668-0070
More Details
- NCT ID
- NCT05874466
- Status
- Recruiting
- Sponsor
- Duke University
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.