Prevalence of Autism Spectrum Conditions in Mainland China

NCT ID: NCT02065193

Last Updated: 2014-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

280000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Brief Summary

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The China SCORE study is a prevalence study of Autism Spectrum Conditions (ASC) in 14 regions in mainland China. It will include the following steps:

1. Large population-based screening This study will be conducted in urban areas but not rural areas across mainland China. One city of each region will participate, and in total there will be 14 cities for screening. Within each city, a number of 40 to 60 ordinary primary schools will be randomly selected from the defined region. All the students who are in 1st to 4th grade will asked to participate in order to form a sample of approximately 20,000 students.

Screening questionnaires The screening pack includes the Chinese CAST, the AQ-Child, the AQ-Adult short version (10 items), and risk factors questionnaire. An information sheet and consent form will be included in the pack as well.
2. Further assessments We expect approximately 5% on the CAST will score positive in ordinary school population. Thus, for a 20,000 sample, we would expect 900 positives (90% response rate). All the screen-positives and a random selected 5% from borderline group will be invited for clinical assessment. The diagnosis of clinical assessment will be divided into three categories: definite ASC, suspected ASC, and non-ASC. Then all the children with clinical assessment results as definite ASC and suspected ASC and a randomly selected 10-20 non-ASC will be invited for research diagnostic assessment using the ADOS and ADI-R, as well as RPM as IQ test. After that, the consensus diagnosis between ADOS/ADI-R assessment and the clinical diagnosis will be the final diagnosis.
3. Case identification in special schools All the children in special schools or training institutes in study region will be asked to fill in the screening pack. The children who do not attend any ordinary or special schools will be identified according to their residential ID in the studied regions. All screen-positives in special education will be assessed using the ADOS and ADI-R. Then those who met the criteria of ASC on ADOS or/and ADI-R will be assessed by psychiatrists and the clinical diagnosis will be the final diagnosis.

If we combine the prevalence of ordinary schools and special schools together, we will get an estimate of the prevalence of ASC in school-population in China. If we combine all the cases identified from schools and from residential records, we will generate an estimate of the prevalence of ASC in the general population in mainland China.

Detailed Description

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Conditions

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Autism Spectrum Conditions/Disorders

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Beijing group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Guangdong group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Shenzhen group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Shanxi group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Liaoning group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Jilin group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Heilongjiang group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Jiangsu group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Zhejiang group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Fujian group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Henan group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Hubei group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Hunan group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

'Shanxi group

ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Interventions

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ADOS/ADI-R/Clinical assessment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All children who are in study region will be recruited for this study.
* All children aged 6-11 years old.

Exclusion Criteria

* Children who are not in the study region.
* Children who are not found from ordinary schools, private training centres, public special schools and community household with the help of local residence records will not be included for this study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Disabled Persons Federation

OTHER_GOV

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Sophia Xiang Sun

Cambridge-CUHK International Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carol Brayne, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Simon Baron-Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Carrie Allison, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Hong You, MD

Role: PRINCIPAL_INVESTIGATOR

China Disabled Persons Federation

Jibin Han, Master

Role: PRINCIPAL_INVESTIGATOR

China Disabled Persons Federation

Sian Griffiths, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Huso Yi, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Xiang Sun, PhD

Role: PRINCIPAL_INVESTIGATOR

Cambridge/CUHK

Fiona E Matthews, PhD

Role: PRINCIPAL_INVESTIGATOR

MRC Biostatistics Unit

Bonnie Auyeung, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

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Fujian CDPF

Fuzhou, Fujian, China

Site Status RECRUITING

Shenzhen CDPF

Shenzhen, Guangdong, China

Site Status RECRUITING

Heilongjiang CDPF

Jiamusi, Heilongjiang, China

Site Status RECRUITING

Luoyang CDPF

Luoyang, Henan, China

Site Status RECRUITING

Hengyang CDPF

Hengyang, Hunan, China

Site Status RECRUITING

Jilin Mingzhi Centre

Jilin, Jilin, China

Site Status COMPLETED

Liaoning CDPF

Benxi, Liaoning, China

Site Status RECRUITING

Shanxi CDPF

Changzhi, Shanxi, China

Site Status RECRUITING

Shanxi CDPF

Xian, Shanxi, China

Site Status RECRUITING

Beijing CDPF

Beijing, , China

Site Status RECRUITING

Guangdong CDPF

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Zhejiang CDPF

Hangzhou, , China

Site Status NOT_YET_RECRUITING

Hubei CDPF

Wuhan, , China

Site Status RECRUITING

Jiangsu CDPF

Yangzhou, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xiang Sun, PhD

Role: CONTACT

Xiang Sun

Role: CONTACT

Facility Contacts

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Qiulan Wu

Role: primary

Zhenzhong Mao

Role: primary

Wei Peng

Role: primary

Zhanwei Chen

Role: primary

Zhengrong Dai

Role: primary

Donghong Su

Role: primary

Jiaqiu Li

Role: primary

Xiaofei Gao

Role: primary

Yong Li

Role: primary

Jianrong Liu

Role: primary

Yuwen Hua

Role: primary

Qin Li

Role: primary

Yue Zhang

Role: primary

Other Identifiers

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China SCORE study

Identifier Type: -

Identifier Source: org_study_id

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