Tests a computer-assisted tool for spotting autism in young toddlers
Checks whether a machine-assisted system can identify autism in toddlers.
Plain-language title generated from the registry record
Registry title: Multicenter Validation Study on Autism Screening Using a Machine-assisted System
Key facts
- Where
- Chengdu, Dehong, Harbin, Hefei, Kunshan, Liuzhou, Ningbo, Shanghai, Xi'an, and Xiamen, ChinaSee the 10 sites
Where in China
- Chengdu Women's and Children's Central HospitalChengdu, ChinaNo longer taking part
- Dehong People's HospitalDehong, ChinaNo longer taking part
- The Sixth Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaNo longer taking part
- Hefei First People's HospitalHefei, ChinaNo longer taking part
- Kunshan Maternal and Child Health Care HospitalKunshan, ChinaNo longer taking part
- Liuzhou Maternity and child Healthcare HospitalLiuzhou, ChinaNo longer taking part
- Ningbo Women and Children's HospitalNingbo, ChinaNo longer taking part
- Children's Hospital Of Fudan UniversityShanghai, ChinaNo longer taking part
- Xi'an Children's HospitalXi'an, ChinaNo longer taking part
- Xiamen Children's HospitalXiamen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital of Fudan University
- Trial code
- NCT07006948
- Record updated
- 16 September 2025
- Original description
The goal of this observational study is to assess the effectiveness of a machine-assisted system for early screening of autism. The main questions it aims to answer are:Read full original descriptionShow less
Multicenter Validation Study on the Effectiveness of a Machine-Assisted System for Early Screening of Autism
The goal of this observational study is to assess the effectiveness of a machine-assisted system for early screening of autism. The main questions it aims to answer are:
* Does the machine-assisted system including 5 main behavioral paradigms identify toddlers with autism from those with other neurodevelopmental disorders and typical development? * Are there any differences in the early symptoms of autism among toddlers over the whole mainland China? Participants will receive some developmental and social communicational evaluations for clinical diagnoses. They will also receive the behavior evaluations of the machine-assisted system. The above evaluations will be performed just once.
Inclusion: Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2; Ages 1.5-2.5 years; Parents/caregivers understand the content of the study and agree to participate in; GDD group：; Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g; 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; Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) using M-CHAT-R/F; LD group：; Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000 g; 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; Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) assessed by M-CHAT-R/F; Healthy, typically developing toddlers aged 1.5-2.5 years ; gestational age of 37-42 weeks, birth weight of 2500-4000 g; Developmental Quotients(DQs) are greater than 75 in all domains of theGriffiths Development Scales-Chinese edition(GDS-C); Screened negative by M-CHAT-R/F screening for autism spectrum disorder (ASD).
Exclusion: Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases; Children with brain injuries, specific chronic or congenital diseases; Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded; The gestational age is less than 37 weeks, or the birth weight is lower than 2500g; TD group：.
ASD group：.