Autism Spectrum DisorderNCT07006948
Multicenter Validation Study on Autism Screening Using a Machine-assisted System
An observational study of Autism Spectrum Disorder and Early Developmental Impairment, run by Children's Hospital of Fudan University at 10 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Early Developmental Impairment, Language Development Disorders
- What is being tested?
- Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2) and Griffiths Developmental Scales, Chinese edition(GDS-C)
- How many people
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- 15 Sep 2025to 15 Jun 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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;
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- 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
- 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).
Who cannot join
- 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：
- Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610073
Lan Zhang
Dehong People's Hospital
Dehong, Yunnan, 678499
Xueyan Li
The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Helongjiang, 150023
Lijie Wu
Hefei First People's Hospital
Hefei, Anhui, 230061
Peiting Shen
Kunshan Maternal and Child Health Care Hospital
Kunshan, Jiangsu, 215300
Qinyi Zhang, 15950187911
Liuzhou Maternity and child Healthcare Hospital
Liuzhou, Guangxi, 545001
Aiwen Li
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, 315012
Lanqiu Lv
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Xi'an Children's Hospital
Xi'an, Shaanxi, 710082
Chunyang Li
Xiamen Children's Hospital
Xiamen, Fujian, 361004
Huiping Li
About this study
Official title: Multicenter Validation Study on the Effectiveness of a Machine-Assisted System for Early Screening of Autism
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.
Read the detailed description
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.
- Being tested
- Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2), Griffiths Developmental Scales, Chinese edition(GDS-C)
- Medical subject headings
- Autism Spectrum Disorder, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)Diagnostic test
The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.
Griffiths Developmental Scales, Chinese edition(GDS-C)Diagnostic test
The toddlers diagnosed with ASD, GDD, LD, and typically developing will receive the GDS-C evaluation to confirm the diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | This group includes toddlers diagnosed with autism spectrum disorder aged between 1.5 to 2.5 years old. Receives: Diagnostic Test: Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2); Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C) | |
| GDD group | This group includes toddlers diagnosed with global development disorder aged between 1.5 to 2.5 years old. Receives: Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C) | |
| LD group | This group includes toddlers diagnosed with language disorder aged between 1.5 to 2.5 years old. Receives: Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C) | |
| TD group | This group includes typically developing toddlers aged between 1.5 to 2.5 years old. Receives: Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: The assessment will be performed during 1.5 to 2.5 years old.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Harbin Institute of Technology, Shenzhen, Kunshan City Maternal and Child Health, Hefei First People's Hospital, Ningbo Women & Children's Hospital, Xiamen Children's Hospital, Chengdu Women's and Children's Central Hospital, Liuzhou Maternity and Child Healthcare Hospital, Xian Children's Hospital, Dehong People's Hospital, The Sixth Affiliated Hospital of Harbin Medical University
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006948
- Sponsor's protocol ID
- AI multicenter
- Status last verified
- Sep 2025
- First submitted
- 28 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation Study on the Effectiveness of a Machine-Assisted System for Early Screening of Autism
- ClinicalTrials.gov ID
- NCT07006948
- Acronym / sponsor ID
- AI multicenter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Harbin Institute of Technology, Shenzhen, Kunshan City Maternal and Child Health, Hefei First People's Hospital, Ningbo Women & Children's Hospital, Xiamen Children's Hospital, Chengdu Women's and Children's Central Hospital, Liuzhou Maternity and Child Healthcare Hospital, Xian Children's Hospital, Dehong People's Hospital, The Sixth Affiliated Hospital of Harbin Medical University
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | 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 autism spectrum disorder aged between 1.5 to 2.5 years old. |
| GDD group | – | 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. |
| LD group | – | 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. |
| TD group | – | Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C)This group includes typically developing toddlers aged between 1.5 to 2.5 years old. |
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (5 listed)
- 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：
- Children with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ASD group |
| 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. | Diagnostic test | ASD group, GDD group, LD group, TD group |
Primary outcome
Total Score of 5 main social behaviors
Time frame: The assessment will be performed during 1.5 to 2.5 years old.
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.
Clinical diagnoses
Time frame: The diagnoses will be made during 1.5 to 2.5 years old.
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).
Scores of Autism Diagnostic Observation Schedule-2nd edition(ADOS-2)
Time frame: The assessment will be performed during 1.5 to 2.5 years old.
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.
development quotient development quotient Development quotients (DQs) of Griffiths Developmental Scales-Chinese edition(GDS-C)
Time frame: The assessment will be performed during 1.5 to 2.5 years old.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiu Xu principal investigator
Children's Hospital of Fudan University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Early Developmental Impairment, run by Children's Hospital of Fudan University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingrui Zhou (13701989113, zbr1800@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score of 5 main social behaviors (time frame: The assessment will be performed during 1.5 to 2.5 years old.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.