Multicenter Validation Study on Autism Screening Using a Machine-assisted System

Other illness

• 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.

Age

• The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
  • TD group：

• 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).

Criteria the registry did not label

• ASD group：