Validation of the SenseToKnow app for autism screening in young children
SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
This study is testing a new app called SenseToKnow to see if it can help parents identify autism in their toddlers aged 16 to 36 months compared to expert diagnoses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 16 Months to 36 Months |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05874466 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the SenseToKnow app in detecting autism spectrum disorder in children aged 16 to 36 months. Parents will use the app to classify their child's condition, which will then be compared to expert clinical diagnoses. The study is designed to assess the app's sensitivity and specificity in identifying autism versus non-autism cases. It is a non-interventional, cross-sectional study conducted at Duke University.
Who should consider this trial
Good fit: Ideal candidates are children aged 16 to 36 months who are patients at Duke Health and whose parents speak English or Spanish.
Not a fit: Patients with severe motor impairments, known genetic disorders, or significant sensory impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could provide a reliable and accessible tool for early autism detection in young children.
How similar studies have performed: Other studies have explored digital tools for autism screening, but the specific approach of this app is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Geraldine Dawson, PhD — Duke University
- Study coordinator: Geraldine Dawson, PhD
- Email: geraldine.dawson@duke.edu
- Phone: 9196680070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.