NCT02200679

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143,755

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2.9 years

First QC Date

July 24, 2014

Last Update Submit

May 15, 2017

Conditions

Autism Spectrum Disorders

Keywords

Autism spectrum disordersPrevalenceDiagnosisScreenRisk FactorSRSASRS

Outcome Measures

Primary Outcomes (1)

  • prevalence of autism spectrum disorder

    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.

    3-12 years

Secondary Outcomes (3)

  • ASRS

    6-18 years

  • ADI-R

    4-18 yeas

  • ADOS

    14months-16 years

Study Arms (1)

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-â…£, ADOS and ADI-R

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community-based populations aged 6-12 years old form 8 cities in China

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Capital Institute of Pediatrics

Beijing, Beijing Municipality, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The Third Affiliated Hosptial,Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Harbin Medical University

Harbin, Heilongjiang, China

Location

Central South University

Changsha, Hunan, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Location

Sichuan University

Chengdu, Sichuan, China

Location

The 2nd Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Related Publications (2)

  • Yan W, Siegert RJ, Zhou H, Zou X, Wu L, Luo X, Li T, Huang Y, Guan H, Chen X, Mao M, Xia K, Zhang L, Li E, Li C, Zhang X, Zhou Y, Shih A, Fombonne E, Zheng Y, Han J, Sun Z, Jiang YH, Wang Y. Psychometric properties of the Chinese Parent Version of the Autism Spectrum Rating Scale: Rasch analysis. Autism. 2021 Oct;25(7):1872-1884. doi: 10.1177/13623613211004054. Epub 2021 Apr 12.

    PMID: 33845648DERIVED

  • Zhou H, Zhang L, Wu L, Zou X, Luo X, Xia K, Wang Y, Xu X, Ge X, Sun C, Deng H, Fombonne E, Jiang YH, Yan W, Wang Y. Validity and reliability analysis of the Chinese parent version of the Autism Spectrum Rating Scale (6-18 years). Psychiatry Res. 2015 Dec 15;230(2):255-61. doi: 10.1016/j.psychres.2015.09.003. Epub 2015 Sep 8.

    PMID: 26384573DERIVED

Related Links

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)

MeSH Terms

Conditions

Autism Spectrum DisorderDisease

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yi Wang, PhD,MD

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Prsident Chlidren's Hospital of Fudan University

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 25, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

CN(8)