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National Study on Autism Spectrum Disorder in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02200679
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
National Health and Family Planning Commission, P.R.China
Information provided by (Responsible Party):
Yi Wang, Fudan University

Brief Summary:
The aims of the national population-based study on Autism Spectrum Disorder (ASD) include: (1) to understand the overall prevalence of ASD in children aged 6-12 years in 8 cities (n=120,000), (2) to explore environmental and genetic risk factors associated with ASD

Condition or disease
Autism Spectrum Disorders

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 143755 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Study on Approach and Standards for Diagnosis, Prevention and Control of Autism Spectrum Disorder in Children in China
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Autism Spectrum Disorders
Cases were children living in target communities who are identified as positive based on questionnaire screen and the following diagnosis with DSM-Ⅳ, ADOS and ADI-R



Primary Outcome Measures :
  1. prevalence of autism spectrum disorder [ Time Frame: 3-12 years ]
    The outcome of the study include ASD and its commorbidities. The disease occurs in children as early as 18 months old, however the confirmation of diagnosis usually is 3 or later. 6-12 years is time frame for confirmed diagnosis.


Secondary Outcome Measures :
  1. ASRS [ Time Frame: 6-18 years ]
    ASRS is a measure for screen ASD.

  2. ADI-R [ Time Frame: 4-18 yeas ]
    The ADI-R is a good diagnosis tool for children with ASD

  3. ADOS [ Time Frame: 14months-16 years ]
    The ADOS is a appropriate instrutment for ASD diagnosis.


Biospecimen Retention:   Samples With DNA
whole blood 2*5ml, (isolate Plasma, Serum and white cell) Hair, Urine(biosample will be collected only for Cases 1200 +Controls 1200)


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community-based populations aged 6-12 years old form 8 cities in China
Criteria

Inclusion Criteria:

  • All children aged 6-12 years old and have lived in the recruied community over 6 months.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200679


Locations
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China, Beijing
Capital Institute of Pediatrics
Beijing, Beijing, China
China, Chongqing
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing, China
China, Guangdong
The Third Affiliated Hosptial,Sun Yat-Sen University
Guangzhou, Guangdong, China
China, Heilongjiang
Harbin Medical University
Harbin, Heilongjiang, China
China, Hunan
Central South University
ChangSha, Hunan, China
China, Sichuan
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Sichuan University
Chengdu, Sichuan, China
China, Zhejiang
The 2nd Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Fudan University
National Health and Family Planning Commission, P.R.China
Investigators
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Principal Investigator: Yi Wang, PhD,MD Children's Hospital of Fudan University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi Wang, Vice Prsident Chlidren's Hospital of Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT02200679    
Other Study ID Numbers: 201302002
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Keywords provided by Yi Wang, Fudan University:
Autism spectrum disorders
Prevalence
Diagnosis
Screen
Risk Factor
SRS
ASRS
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders