Autism Spectrum Conditions/DisordersChina SCORENCT02065193
Prevalence of Autism Spectrum Conditions in Mainland China
An observational study of Autism Spectrum Conditions/Disorders, run by University of Cambridge at 14 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Autism Spectrum Conditions/Disorders
- What is being tested?
- ADOS/ADI-R/Clinical assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280,000 participants
- Where
- 14 sitesChina
- Study dates
- Apr 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All children who are in study region will be recruited for this study.
- All children aged 6-11 years old.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
Xiang Sun, PhD contact
Xiang Sun contact
14 sites in 1 country
China14 sites, 13 recruiting
- Recruiting
Beijing CDPF
Beijing
Yong Li
- Recruiting
Liaoning CDPF
Benxi, Liaoning
Donghong Su
- Recruiting
Shanxi CDPF
Changzhi, Shanxi
Jiaqiu Li
- Recruiting
Fujian CDPF
Fuzhou, Fujian
Qiulan Wu
- Not yet recruiting
Guangdong CDPF
Guangzhou
Jianrong Liu
- Not yet recruiting
Zhejiang CDPF
Hangzhou
Yuwen Hua
- Recruiting
Hengyang CDPF
Hengyang, Hunan
Zhengrong Dai
- Recruiting
Heilongjiang CDPF
Jiamusi, Heilongjiang
Wei Peng
- Completed
Jilin Mingzhi Centre
Jilin City, Jilin
- Recruiting
Luoyang CDPF
Luoyang, Henan
Zhanwei Chen
- Recruiting
Shenzhen CDPF
Shenzhen, Guangdong
Zhenzhong Mao
- Recruiting
Hubei CDPF
Wuhan
Qin Li
- Recruiting
Shanxi CDPF
Xian, Shanxi
Xiaofei Gao
- Not yet recruiting
Jiangsu CDPF
Yangzhou
Yue Zhang
About this study
Official title: 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:
- 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.
- 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.
- 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.
- Conditions
- Autism Spectrum Conditions/Disorders
- Being tested
- ADOS/ADI-R/Clinical assessment
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADOS/ADI-R/Clinical assessmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Beijing group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Guangdong group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Shenzhen group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Shanxi group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Liaoning group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Jilin group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Heilongjiang group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Jiangsu group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Zhejiang group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Fujian group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Henan group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Hubei group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| Hunan group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment | |
| 'Shanxi group | Not described Receives: Behavioral: ADOS/ADI-R/Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The assessments will be finished in one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Conditions/DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 280,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- China Disabled Persons Federation, Chinese University of Hong Kong
- Responsible party
- Principal investigator, Sophia Xiang Sun, Chinese University of Hong Kong
- Investigators
- Carol Brayne, MD, Principal investigator, University of CambridgeSimon Baron-Cohen, PhD, Principal investigator, University of CambridgeCarrie Allison, PhD, Principal investigator, University of CambridgeHong You, MD, Principal investigator, China Disabled Persons FederationJibin Han, Master, Principal investigator, China Disabled Persons FederationSian Griffiths, MD, Principal investigator, Chinese University of Hong KongHuso Yi, PhD, Principal investigator, Chinese University of Hong KongXiang Sun, PhD, Principal investigator, Cambridge/CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065193
- Sponsor's protocol ID
- China SCORE study
- Acronym
- China SCORE
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Communication Research and Epidemiological Study in China
- ClinicalTrials.gov ID
- NCT02065193
- Acronym / sponsor ID
- China SCORE / China SCORE study
- Conditions
- Autism Spectrum Conditions/Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280,000 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- China Disabled Persons Federation, Chinese University of Hong Kong
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- All children who are in study region will be recruited for this study.
- All children aged 6-11 years old.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADOS/ADI-R/Clinical assessment | Behavioural | 'Shanxi group, Beijing group, Fujian group, Guangdong group, Heilongjiang group, Henan group, Hubei group, Hunan group, Jiangsu group, Jilin group, Liaoning group, Shanxi group, Shenzhen group, Zhejiang group |
Primary outcome
Three-staged consensus diagnosis
Time frame: The assessments will be finished in one year.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Sun, PhD contact
Xiang Sun contact
Carol Brayne, MD principal investigator
University of Cambridge
Simon Baron-Cohen, PhD principal investigator
University of Cambridge
Carrie Allison, PhD principal investigator
University of Cambridge
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Conditions/Disorders, run by University of Cambridge at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Sun, PhD (xs227@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-staged consensus diagnosis (time frame: The assessments will be finished in one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.