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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.
The toddlers diagnosed with ASD, GDD, LD, and typically developing will receive the GDS-C evaluation to confirm the diagnosis.
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
Total Score of 5 main social behaviors
The 5 main social behaviors include Response to name, Response to instructions, Joint attention, request by pointing, and free play. Scores of the 5 scenes range from 0 to 4, and the total score ranges from 0 to 16. Higher score indicates better social skills. Subjects' behaviors will be scored both by investigators and the machine-assisted system.
Time frame: The assessment will be performed during 1.5 to 2.5 years old.
Clinical diagnoses
The clinical diagnoses of autism spectrum disorder (ASD), global developmental delay (GDD), and language disorder (LD) will be made according to the standard of DSM-5. The diagnosis of ASD will be confirmed by The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F) and Autism Diagnostic Observation Schedule, the 2nd edition (ADOS-2). The diagnoses of GDD and LD will be confirmed by Griffiths Development Scales-Chinese edition (GDS-C). Subjects in TD group will also receive assessments of M-CHAT-R/F, (negative) and GDS-C (DQs\>75).
Time frame: The diagnoses will be made during 1.5 to 2.5 years old.
Scores of Autism Diagnostic Observation Schedule-2nd edition(ADOS-2)
The scores of social affect and restricted repetitive behaviors and the comparison score of ADOS-2 will be used for confirming the clinical diagnosis of autism spectrum disorder(ASD). The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.
Time frame: The assessment will be performed during 1.5 to 2.5 years old.
development quotient development quotient Development quotients (DQs) of Griffiths Developmental Scales-Chinese edition(GDS-C)
DQs of Griffiths Development Scales-Chinese edition(GDS-C) will be used for confirming the diagnoses of global developmental delay(GDD) and language disorder(LD), also be used to evaluate the development level of typically developing toddlers. The average scores of DQ in different domains are 100, and the standard deviations are 15. The DQ lower than 70(including 70) means lower than normal.
Time frame: The assessment will be performed during 1.5 to 2.5 years old.
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