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

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new system that uses technology to help screen toddlers for autism. The main goal is to see if this machine-assisted system can accurately identify children with autism compared to those with other developmental disorders or those who are developing typically. The study will involve toddlers aged 1.5 to 2.5 years from across mainland China, who will undergo both social and developmental evaluations, as well as assessments using the machine system. This will all happen in one visit.

To participate, children must meet certain criteria. For the autism group, they need to have a diagnosis of autism that meets specific guidelines. Other groups include children with global developmental delay or language disorders, as well as typically developing toddlers. It’s important to note that children with certain genetic syndromes or serious health issues are not eligible for this study. Overall, this trial aims to improve early detection of autism, which can lead to better support and resources for affected children and their families.

Gender

ALL

Eligibility criteria

• • 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.