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

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.

NCT Number	NCT07006948
Lead Sponsor	Children's Hospital of Fudan University Collaborators: Harbin Institute of Technology, Shenzhen, Kunshan City Maternal and Child Health, Hefei First People's Hospital, Ningbo Women & Children's Hospital, Xiamen Children's Hospital, Chengdu Women's and Children's Central Hospital, Liuzhou Maternity and Child Healthcare Hospital, Xian Children's Hospital, Dehong People's Hospital, The Sixth Affiliated Hospital of Harbin Medical University
Conditions	Autism Spectrum Disorder, Early Developmental Impairment, Language Development Disorders
Enrollment	1,000 participants
Start Date	2025-09-15
Primary Completion	2028-06-15 (estimated)
Study Completion	2029-06-15 (estimated)
Updated on ClinicalTrials.gov	2025-09-16