SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
Duke University
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.
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.
Eligibility
- Age range
- 1–3 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Location
- Duke UniversityDurham, North Carolina