NCT07006948

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

Multicenter Validation Study on the Effectiveness of a Machine-Assisted System for Early Screening of Autism

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Months – 30 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The current study is a diagnostic accuracy study. In total, 1000 Toddlers with autism spectrum disorder, global developmental delay, language disorder, and typical development (n=250 for each group) will be recruited in this study. The gold standard of the diagnosis of autism spectrum disorder will be the clinical diagnosis from developmental and behavioral pediatricians, and the diagnoses will be confirmed by Autism Diagnostic Observation Schedule-2nd edition and Griffiths Development Scales-Chinese edition(GDS-C). The diagnostic accuracy of the machine-assisted system for early screening of autism will be evaluated.

Conditions

• Autism Spectrum Disorder
• Early Developmental Impairment
• Language Development Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)	The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.
DIAGNOSTIC_TEST	Griffiths Developmental Scales, Chinese edition(GDS-C)	The toddlers diagnosed with ASD, GDD, LD, and typically developing will receive the GDS-C evaluation to confirm the diagnosis.

Timeline

• Start date: 2025-09-15
• Primary completion: 2028-06-15
• Completion: 2029-06-15
• First posted: 2025-06-05
• Last updated: 2025-09-16

Locations

10 sites across 1 country: China