AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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

xs227@medschl.cam.ac.uk

Xiang Sun contact

sophiasunx@hotmail.com

14 sites in 1 country

China14 sites, 13 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

    Recruiting
  • Guangdong CDPF

    Guangzhou

    Jianrong Liu

    Not yet recruiting
  • Zhejiang CDPF

    Hangzhou

    Yuwen Hua

    Not yet recruiting
  • Hengyang CDPF

    Hengyang, Hunan

    Zhengrong Dai

    Recruiting
  • Heilongjiang CDPF

    Jiamusi, Heilongjiang

    Wei Peng

    Recruiting
  • Jilin Mingzhi Centre

    Jilin City, Jilin

    Completed
  • 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

    Recruiting
  • Jiangsu CDPF

    Yangzhou

    Yue Zhang

    Not yet recruiting

Other trials in China

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:

  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.

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 groups in NCT02065193
Study groupRoleWhat they receive
Beijing groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Guangdong groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Shenzhen groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Shanxi groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Liaoning groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Jilin groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Heilongjiang groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Jiangsu groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Zhejiang groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Fujian groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Henan groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Hubei groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
Hunan groupNot described
Receives: Behavioral: ADOS/ADI-R/Clinical assessment
'Shanxi groupNot 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.

  1. 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.

  1. First posted17 Feb 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionJan 2015 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in