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NCT07006948

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

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Months - 30 Months

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-09-15

Completion Date

2029-06-15

Last Updated

2025-09-16

Healthy Volunteers

Yes

Interventions

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.

Locations (10)

Hefei First People's Hospital

Hefei, Anhui, China

Xiamen Children's Hospital

Xiamen, Fujian, China

Liuzhou Maternity and child Healthcare Hospital

Liuchow, Guangxi, China

The Sixth Affiliated Hospital of Harbin Medical University

Harbin, Helongjiang, China

Kunshan Maternal and Child Health Care Hospital

Kunshan, Jiangsu, China

Xi'an Children's Hospital

Xi'an, Shaanxi, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Dehong People's Hospital

Dehong, Yunnan, China

Ningbo Women and Children's Hospital

Ningbo, Zhejiang, China