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New device could spot autism in toddlers earlier

NCT ID NCT05874466

Diagnosis Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called SenseToKnow that uses video and a caregiver survey to help detect autism in children aged 16 to 36 months. The goal is to see how accurate the device is compared to a doctor's diagnosis. About 350 children from Duke Health will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be patients 16-36 months of age recruited from \> 6 sites comprised of pediatric medical clinics that are part of the broader Duke University Health System in North Carolina.

Ages

16 to 36 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism Autism spectrum disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.