Validation of the SenseToKnow app for autism screening in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AdiaVita and glutathione for autism in kids and teens

  This study tests whether adding AdiaVita (cord-blood stem cells and exosomes) to glutathione helps improve ASD symptoms in children and other participants compared with glutathione alone.

  Recruiting at 2 sites Phase 1 Greater Atlanta Integrative Pediatrics · Roswell, Georgia and 1 other locations · NCT07622316

• Online test of BlinkLab Dx1 for autism in kids aged 2–11

  This study tests whether the BlinkLab Dx1 smartphone app can help identify autism in children aged 2 to 11 by comparing app-based measurements with prior clinical diagnoses.

  Recruiting Blinklab Limited · Princeton, New Jersey · NCT07590973

• Trauma‑Focused Cognitive Behavioral Therapy adapted for autistic children and teens (pilot implementation)

  This pilot will try TF‑CBT adapted for autistic children and teens with trauma-related symptoms to see if community mental health clinicians can deliver it and families find it acceptable.

  Recruiting Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT07420478

• CRUSH curriculum for romance and sexual health for autistic young adults

  This project will try the CRUSH program—a group course plus one-to-one coaching—to teach sexual health and dating skills to autistic adults ages 18 to 30.

  Recruiting Boston Children's Hospital · Brookline, Massachusetts · NCT07406100

• Static balance testing in children with autism using a virtual reality system

  This project tests whether a virtual reality rehabilitation system can measure static balance differences in children with autism aged 6–10.

  Recruiting Istituto per la Ricerca e l'Innovazione Biomedica · Messina · NCT07403396

• Do AdiaVita stem cells plus glutathione help kids with autism more than glutathione alone?

  This 12-month study tests whether adding AdiaVita stem cells and exosomes to glutathione helps children aged 3–12 with autism more than glutathione alone.

  Recruiting at 2 sites Phase 1 Adia Med of Winter Park LLC · Winter Park, Florida and 1 other locations · NCT07304440

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.