Prevalence of Autism Spectrum Conditions in Mainland China (China SCORE)

Social Communication Research and Epidemiological Study in China

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Conditions/Disorders
• Intervention / Treatment: Behavioral: ADOS/ADI-R/Clinical assessment

• Study Type: Observational
• Enrollment (Anticipated): 280000

Contacts and Locations

• Study Contact: Name: Xiang Sun, PhD; Email: xs227@medschl.cam.ac.uk
• Study Contact Backup: Name: Xiang Sun; Email: sophiasunx@hotmail.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing CDPF
  • Guangzhou, China
    • Not yet recruiting
    • Guangdong CDPF
    • Contact: Jianrong Liu
  • Hangzhou, China
    • Not yet recruiting
    • Zhejiang CDPF
    • Contact: Yuwen Hua
  • Wuhan, China
    • Recruiting
    • Hubei CDPF
    • Contact: Qin Li
  • Yangzhou, China
    • Not yet recruiting
    • Jiangsu CDPF
    • Contact: Yue Zhang
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian CDPF
      • Contact: Qiulan Wu
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen CDPF
      • Contact: Zhenzhong Mao
  • Heilongjiang
    • Jiamusi, Heilongjiang, China
      • Recruiting
      • Heilongjiang CDPF
      • Contact: Wei Peng
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • Luoyang CDPF
      • Contact: Zhanwei Chen
  • Hunan
    • Hengyang, Hunan, China
      • Recruiting
      • Hengyang CDPF
      • Contact: Zhengrong Dai
  • Jilin
    • Jilin, Jilin, China
      • Completed
      • Jilin Mingzhi Centre
  • Liaoning
    • Benxi, Liaoning, China
      • Recruiting
      • Liaoning CDPF
      • Contact: Donghong Su
  • Shanxi
    • Changzhi, Shanxi, China
      • Recruiting
      • Shanxi CDPF
      • Contact: Jiaqiu Li
    • Xian, Shanxi, China
      • Recruiting
      • Shanxi CDPF
      • Contact: Xiaofei Gao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population in each city is a defined region, usually a district or two districts. We focus on urban populations in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

14

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Beijing group	Behavioral: ADOS/ADI-R/Clinical assessment
Guangdong group	Behavioral: ADOS/ADI-R/Clinical assessment
Shenzhen group	Behavioral: ADOS/ADI-R/Clinical assessment
Shanxi group	Behavioral: ADOS/ADI-R/Clinical assessment
Liaoning group	Behavioral: ADOS/ADI-R/Clinical assessment
Jilin group	Behavioral: ADOS/ADI-R/Clinical assessment
Heilongjiang group	Behavioral: ADOS/ADI-R/Clinical assessment
Jiangsu group	Behavioral: ADOS/ADI-R/Clinical assessment
Zhejiang group	Behavioral: ADOS/ADI-R/Clinical assessment
Fujian group	Behavioral: ADOS/ADI-R/Clinical assessment
Henan group	Behavioral: ADOS/ADI-R/Clinical assessment
Hubei group	Behavioral: ADOS/ADI-R/Clinical assessment
Hunan group	Behavioral: ADOS/ADI-R/Clinical assessment
'Shanxi group	Behavioral: ADOS/ADI-R/Clinical assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Three-staged consensus diagnosis	The prevalence of Autism Spectrum Conditions will be measured using screening and diagnostic instruments including the Childhood Autism Spectrum Test , the Autism Diagnostic Observation Schedule, the Autism Diagnostic Interview-Revised, and Clinical diagnosis.	The assessments will be finished in one year.

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: Chinese University of Hong Kong; China Disabled Persons Federation
• Investigators: Principal Investigator: Carol Brayne, MD, University of Cambridge; Principal Investigator: Simon Baron-Cohen, PhD, University of Cambridge; Principal Investigator: Carrie Allison, PhD, University of Cambridge; Principal Investigator: Hong You, MD, China Disabled Persons Federation; Principal Investigator: Jibin Han, Master, China Disabled Persons Federation; Principal Investigator: Sian Griffiths, MD, Chinese University of Hong Kong; Principal Investigator: Huso Yi, PhD, Chinese University of Hong Kong; Principal Investigator: Xiang Sun, PhD, Cambridge/CUHK; Principal Investigator: Fiona E Matthews, PhD, MRC Biostatistics Unit; Principal Investigator: Bonnie Auyeung, PhD, University of Cambridge

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Estimate): February 17, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: China SCORE study