Multicenter Validation Study on Autism Screening Using a Machine-assisted System
NCT ID: NCT07006948
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2025-09-15
2029-06-15
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ASD group
This group includes toddlers diagnosed with autism spectrum disorder aged between 1.5 to 2.5 years old.
Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)
The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.
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.
GDD group
This group includes toddlers diagnosed with global development disorder aged between 1.5 to 2.5 years old.
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.
LD group
This group includes toddlers diagnosed with language disorder aged between 1.5 to 2.5 years old.
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.
TD group
This group includes typically developing toddlers aged between 1.5 to 2.5 years old.
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.
Interventions
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Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)
The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.
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.
Eligibility Criteria
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Inclusion Criteria
2. Ages 1.5-2.5 years;
3. Parents/caregivers understand the content of the study and agree to participate in.
GDD group：
1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g;
2. Clinically diagnosed with GDD (Global Developmental Delay) according to the DSM-V diagnostic criteria, with a Griffiths Development Scales-Chinese edition(GDS-C) assessment showing a Developmental Quotient (DQ) ≤75 in two or more domains;
3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) using M-CHAT-R/F.
LD group：
1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000 g;
2. Clinically diagnosed with LD (Language Disorder) according to the DSM-V diagnostic criteria, with a Developmental Quotient (DQ) ≤75 in the language domain of the Griffiths Development Scales-Chinese edition(GDS-C) and DQ \>75 in all other domains;
3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) assessed by M-CHAT-R/F
1. Healthy, typically developing toddlers aged 1.5-2.5 years ;
2. gestational age of 37-42 weeks, birth weight of 2500-4000 g;
3. Developmental Quotients(DQs) are greater than 75 in all domains of theGriffiths Development Scales-Chinese edition(GDS-C);
4. Screened negative by M-CHAT-R/F screening for autism spectrum disorder (ASD).
Exclusion Criteria
2. Children with brain injuries, specific chronic or congenital diseases.
3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
TD group：
Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.
18 Months
30 Months
ALL
Yes
Sponsors
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Harbin Institute of Technology, Shenzhen
UNKNOWN
Kunshan City Maternal and Child Health
OTHER
Hefei First People's Hospital
UNKNOWN
Ningbo Women & Children's Hospital
OTHER
Xiamen Children's Hospital
OTHER
Chengdu Women's and Children's Central Hospital
OTHER
Liuzhou Maternity and Child Healthcare Hospital
OTHER
Xian Children's Hospital
OTHER_GOV
Dehong People's Hospital
UNKNOWN
The Sixth Affiliated Hospital of Harbin Medical University
UNKNOWN
Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Xiu Xu
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
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Hefei First People's Hospital
Hefei, Anhui, China
Xiamen Children's Hospital
Xiamen, Fujian, China
Liuzhou Maternity and child Healthcare Hospital
Liuzhou, 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
Countries
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Central Contacts
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Facility Contacts
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Peiting Shen
Role: primary
Huiping Li
Role: primary
Aiwen Li
Role: primary
Lijie Wu
Role: primary
Qinyi Zhang
Role: primary
Chunyang Li
Role: primary
Lan Zhang
Role: primary
Xueyan Li
Role: primary
Lanqiu Lv
Role: primary
Other Identifiers
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AI multicenter
Identifier Type: -
Identifier Source: org_study_id
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