Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harbin Institute of Technology, Shenzhen | UNKNOWN |
| Kunshan City Maternal and Child Health | OTHER |
| Hefei First People's Hospital | UNKNOWN |
| Ningbo Women & Children's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
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.
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bingrui Zhou | Contact | 13701989113 | zbr1800@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiu Xu | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei First People's Hospital | Hefei | Anhui | 230061 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| 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. |
|
| The assessment will be performed during 1.5 to 2.5 years old. |
| Xiamen Children's Hospital | Xiamen | Fujian | 361004 | China |
|
| Liuzhou Maternity and child Healthcare Hospital | Liuzhou | 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 |
|
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007805 | Language Development Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided