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AI-Powered tool could spot autism in toddlers earlier than ever

NCT ID NCT07006948

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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

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Status unknown
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First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study will test a machine-assisted system that uses five simple behavioral tasks—like responding to their name or pointing—to screen toddlers for autism. Researchers will enroll 1,000 children aged 1.5 to 2.5 years, including those with autism, developmental delays, language disorders, and typical development. The goal is to see if the system can accurately identify autism early, which could lead to faster support and better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
machine-assisted system with behavioral paradigms
What this could lead to
If successful, this could provide a faster, more objective tool for early autism screening in toddlers, helping families get support sooner.
What could go wrong
This is an early observational study, not a treatment trial. The system may not be accurate enough for widespread use, and results may vary across different regions.

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 1,000 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jun 2029

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

The diagnostic accuracy study will be performed in children with ASD, GDD, LD, and healthy, typically developing children aged between 1.5 to 2.5 years old.

Ages

18 to 30 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.

ASD group: Inclusion Criteria: 1. Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2; 2. Ages 1.5-2.5 years; 3. Parents/caregivers understand the content of the study and agree to participate in. GDD group: Inclusion Criteria: 1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g; 2. Clinically diagnosed with GDD (Global Developmental Delay) according to the DSM-V diagnostic criteria, with a Griffiths Development Scales-Chinese edition(GDS-C) assessment showing a Developmental Quotient (DQ) ≤75 in two or more domains; 3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) using M-CHAT-R/F. LD group: Inclusion Criteria: 1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000 g; 2. Clinically diagnosed with LD (Language Disorder) according to the DSM-V diagnostic criteria, with a Developmental Quotient (DQ) ≤75 in the language domain of the Griffiths Development Scales-Chinese edition(GDS-C) and DQ \>75 in all other domains; 3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) assessed by M-CHAT-R/F Exclusion Criteria for ASD, GDD, and LD groups: 1. Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases; 2. Children with brain injuries, specific chronic or congenital diseases. 3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g. TD group: Inclusion Criteria: 1. Healthy, typically developing toddlers aged 1.5-2.5 years ; 2. gestational age of 37-42 weeks, birth weight of 2500-4000 g; 3. Developmental Quotients(DQs) are greater than 75 in all domains of theGriffiths Development Scales-Chinese edition(GDS-C); 4. Screened negative by M-CHAT-R/F screening for autism spectrum disorder (ASD). Exclusion Criteria: Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 sites. 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

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610073, China

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102, China

  • Dehong People's Hospital

    Dehong, Yunnan, 678499, China

  • Hefei First People's Hospital

    Hefei, Anhui, 230061, China

  • Kunshan Maternal and Child Health Care Hospital

    Kunshan, Jiangsu, 215300, China

  • Liuzhou Maternity and child Healthcare Hospital

    Liuzhou, Guangxi, 545001, China

  • Ningbo Women and Children's Hospital

    Ningbo, Zhejiang, 315012, China

  • The Sixth Affiliated Hospital of Harbin Medical University

    Harbin, Helongjiang, 150023, China

  • Xi'an Children's Hospital

    Xi'an, Shaanxi, 710082, China

  • Xiamen Children's Hospital

    Xiamen, Fujian, 361004, China

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