An observational study in Autism Spectrum Disorder, Early Developmental Impairment and Language Development Disorders, sponsored by Children's Hospital of Fudan University. Not yet recruiting at 10 sites in China. Open to participants aged 18 Months to 30 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Children's Hospital of Fudan University · Observational
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:
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The diagnostic accuracy study will be performed in children with ASD, GDD, LD, and healthy, typically developing children aged between 1.5 to 2.5 years old.
ASD group：
Inclusion Criteria:
GDD group：
Inclusion Criteria:
LD group：
Inclusion Criteria:
Exclusion Criteria for ASD, GDD, and LD groups:
TD group：
Inclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes toddlers diagnosed with autism spectrum disorder aged between 1.5 to 2.5 years old.
Diagnostic Test: Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2) · Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C)
This group includes toddlers diagnosed with global development disorder aged between 1.5 to 2.5 years old.
Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C)
This group includes toddlers diagnosed with language disorder aged between 1.5 to 2.5 years old.
Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C)
This group includes typically developing toddlers aged between 1.5 to 2.5 years old.
Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C)
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Jun 2028, 33 months later.
Of 98 non-industry observational studies under Autism Spectrum Disorder, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 120. This study's planned 33 months is below that.
Counting every sponsor, half of 112 studies reached it within 40 months; a quarter within 26 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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