Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT02065193
Status:
UNKNOWN
Last Update Posted:
2014-02-17
First Post:
2014-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Autism Spectrum Conditions in Mainland China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-14', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Three-staged consensus diagnosis', 'timeFrame': 'The assessments will be finished in one year.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Autism Spectrum Conditions/Disorders']}, 'descriptionModule': {'briefSummary': '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:\n\n1. 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.\n\n 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.\n2. 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.\n3. 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.\n\nIf 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population in each city is a defined region, usually a district or two districts. We focus on urban populations in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children who are in study region will be recruited for this study.\n* All children aged 6-11 years old.\n\nExclusion Criteria:\n\n* Children who are not in the study region.\n* 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.'}, 'identificationModule': {'nctId': 'NCT02065193', 'acronym': 'China SCORE', 'briefTitle': 'Prevalence of Autism Spectrum Conditions in Mainland China', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'Social Communication Research and Epidemiological Study in China', 'orgStudyIdInfo': {'id': 'China SCORE study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Beijing group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Guangdong group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Shenzhen group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Shanxi group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Liaoning group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Jilin group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Heilongjiang group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Jiangsu group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Zhejiang group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Fujian group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Henan group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Hubei group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': 'Hunan group', 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}, {'label': "'Shanxi group", 'interventionNames': ['Behavioral: ADOS/ADI-R/Clinical assessment']}], 'interventions': [{'name': 'ADOS/ADI-R/Clinical assessment', 'type': 'BEHAVIORAL', 'armGroupLabels': ["'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']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiulan Wu', 'role': 'CONTACT'}], 'facility': 'Fujian CDPF', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenzhong Mao', 'role': 'CONTACT'}], 'facility': 'Shenzhen CDPF', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Jiamusi', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Peng', 'role': 'CONTACT'}], 'facility': 'Heilongjiang CDPF', 'geoPoint': {'lat': 46.79711, 'lon': 130.31118}}, {'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhanwei Chen', 'role': 'CONTACT'}], 'facility': 'Luoyang CDPF', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Hengyang', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengrong Dai', 'role': 'CONTACT'}], 'facility': 'Hengyang CDPF', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}, {'city': 'Jilin', 'state': 'Jilin', 'status': 'COMPLETED', 'country': 'China', 'facility': 'Jilin Mingzhi Centre', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Benxi', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Donghong Su', 'role': 'CONTACT'}], 'facility': 'Liaoning CDPF', 'geoPoint': {'lat': 41.28861, 'lon': 123.765}}, {'city': 'Changzhi', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiaqiu Li', 'role': 'CONTACT'}], 'facility': 'Shanxi CDPF', 'geoPoint': {'lat': 36.18389, 'lon': 113.10528}}, {'city': 'Xian', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofei Gao', 'role': 'CONTACT'}], 'facility': 'Shanxi CDPF'}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Li', 'role': 'CONTACT'}], 'facility': 'Beijing CDPF', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianrong Liu', 'role': 'CONTACT'}], 'facility': 'Guangdong CDPF', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuwen Hua', 'role': 'CONTACT'}], 'facility': 'Zhejiang CDPF', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Li', 'role': 'CONTACT'}], 'facility': 'Hubei CDPF', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Yangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Zhang', 'role': 'CONTACT'}], 'facility': 'Jiangsu CDPF', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Xiang Sun, PhD', 'role': 'CONTACT', 'email': 'xs227@medschl.cam.ac.uk'}, {'name': 'Xiang Sun', 'role': 'CONTACT', 'email': 'sophiasunx@hotmail.com'}], 'overallOfficials': [{'name': 'Carol Brayne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'Simon Baron-Cohen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'Carrie Allison, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'Hong You, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Disabled Persons Federation'}, {'name': 'Jibin Han, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Disabled Persons Federation'}, {'name': 'Sian Griffiths, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}, {'name': 'Huso Yi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}, {'name': 'Xiang Sun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge/CUHK'}, {'name': 'Fiona E Matthews, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MRC Biostatistics Unit'}, {'name': 'Bonnie Auyeung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Disabled Persons Federation', 'class': 'OTHER_GOV'}, {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cambridge-CUHK International Fellow', 'investigatorFullName': 'Sophia Xiang Sun', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}