Multicenter Validation Study on Autism Screening Using a Machine-assisted System
1 other identifier
observational
1,000
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 5, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2029
September 16, 2025
September 1, 2025
2.8 years
May 28, 2025
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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).
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.
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.
The assessment will be performed during 1.5 to 2.5 years old.
Study Arms (4)
ASD group
This group includes toddlers diagnosed with autism spectrum disorder aged between 1.5 to 2.5 years old.
GDD group
This group includes toddlers diagnosed with global development disorder aged between 1.5 to 2.5 years old.
LD group
This group includes toddlers diagnosed with language disorder aged between 1.5 to 2.5 years old.
TD group
This group includes typically developing toddlers aged between 1.5 to 2.5 years old.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
- Ages 1.5-2.5 years;
- Parents/caregivers understand the content of the study and agree to participate in.
- GDD group：
- Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g;
- 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;
- Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) using M-CHAT-R/F.
- LD group：
- Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000 g;
- 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;
- Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) assessed by M-CHAT-R/F
You may not qualify if:
- Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
- Children with brain injuries, specific chronic or congenital diseases.
- The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
- TD group：
- Healthy, typically developing toddlers aged 1.5-2.5 years ;
- gestational age of 37-42 weeks, birth weight of 2500-4000 g;
- Developmental Quotients(DQs) are greater than 75 in all domains of theGriffiths Development Scales-Chinese edition(GDS-C);
- Screened negative by M-CHAT-R/F screening for autism spectrum disorder (ASD).
- Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Fudan Universitylead
- Harbin Institute of Technology, Shenzhencollaborator
- Kunshan City Maternal and Child Healthcollaborator
- Hefei First People's Hospitalcollaborator
- Ningbo Women & Children's Hospitalcollaborator
- Xiamen Children's Hospitalcollaborator
- Chengdu Women's and Children's Central Hospitalcollaborator
- Liuzhou Maternity and Child Healthcare Hospitalcollaborator
- Xian Children's Hospitalcollaborator
- Dehong People's Hospitalcollaborator
- The Sixth Affiliated Hospital of Harbin Medical Universitycollaborator
Study Sites (10)
Hefei First People's Hospital
Hefei, Anhui, 230061, China
Xiamen Children's Hospital
Xiamen, Fujian, 361004, China
Liuzhou Maternity and child Healthcare Hospital
Liuchow, Guangxi, 545001, China
The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Helongjiang, 150023, China
Kunshan Maternal and Child Health Care Hospital
Kunshan, Jiangsu, 215300, China
Xi'an Children's Hospital
Xi'an, Shaanxi, 710082, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610073, China
Dehong People's Hospital
Dehong, Yunnan, 678499, China
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, 315012, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiu Xu
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 5, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
June 15, 2028
Study Completion (Estimated)
June 15, 2029
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share