AI-Powered tool could spot autism in toddlers earlier than ever
NCT ID NCT07006948
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
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 30 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610073, China
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
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Dehong People's Hospital
Dehong, Yunnan, 678499, China
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Hefei First People's Hospital
Hefei, Anhui, 230061, China
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Kunshan Maternal and Child Health Care Hospital
Kunshan, Jiangsu, 215300, China
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Liuzhou Maternity and child Healthcare Hospital
Liuzhou, Guangxi, 545001, China
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Ningbo Women and Children's Hospital
Ningbo, Zhejiang, 315012, China
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The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Helongjiang, 150023, China
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Xi'an Children's Hospital
Xi'an, Shaanxi, 710082, China
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Xiamen Children's Hospital
Xiamen, Fujian, 361004, China
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Other studies related to the condition(s) this trial covers.
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- Can an AI chatbot help autism caregivers find their way?
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- Can virtual reality boost thinking skills in kids with autism?