Autism Spectrum Conditions/Disorders Clinical Trial
— China SCOREOfficial 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.
| Status | Recruiting |
| Enrollment | 280000 |
| Est. completion date | |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 11 Years |
| Eligibility |
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. |
Observational Model: Ecologic or Community, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing CDPF | Beijing | |
| China | Liaoning CDPF | Benxi | Liaoning |
| China | Shanxi CDPF | Changzhi | Shanxi |
| China | Fujian CDPF | Fuzhou | Fujian |
| China | Guangdong CDPF | Guangzhou | |
| China | Zhejiang CDPF | Hangzhou | |
| China | Hengyang CDPF | Hengyang | Hunan |
| China | Heilongjiang CDPF | Jiamusi | Heilongjiang |
| China | Jilin Mingzhi Centre | Jilin | Jilin |
| China | Luoyang CDPF | Luoyang | Henan |
| China | Shenzhen CDPF | Shenzhen | Guangdong |
| China | Hubei CDPF | Wuhan | |
| China | Shanxi CDPF | Xian | Shanxi |
| China | Jiangsu CDPF | Yangzhou |
| Lead Sponsor | Collaborator |
|---|---|
| University of Cambridge | China Disabled Persons Federation, Chinese University of Hong Kong |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |