NCT05874466 · Duke University
SenseToKnow Autism Screening Device Validation Study
What this study is about
This is a pivotal, forward-looking, where neither patients nor doctors know which treatment is given, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Duke Health pediatric patient at enrollment
- 16-\<37 months of age at enrollment
- Parent/legal guardian speaks English or Spanish
- Parent/legal guardian understands and voluntarily provides informed consent
Exclusion criteria
- Severe motor impairment that precludes study measure completion
- Known genetic disorders
- Severe hearing or visual impairment as determined on physical examination according to parent report
- Acute illnesses likely to prevent successful or valid data collection
- Uncontrolled epilepsy or seizure disorder
- 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
- Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
- Receiving therapies that affect vision
- 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
- Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
- Participants who are otherwise judged as unable to comply with the protocol by the investigator
- Any other factor that the investigator feels would make the study measures invalid
Where
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2026 · Source of record for eligibility and locations