Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-03 @ 3:30 PM
Study NCT ID:
NCT04063202
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Predictive Index for Probable Depression Among Secondary School Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4799}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of probable depression', 'timeFrame': '12 months', 'description': 'To examine the incidence of probable depression from non-depression (CESD\\<16) at baseline to probable depression (CESD\\>=16) at month 12.'}, {'measure': 'Adolescent Depression Prediction Index (ADPI)', 'timeFrame': '12 months', 'description': 'To develop a new prediction index ADPI and test test its performance in predicting incidence of depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent', 'Depression', 'Stress', 'Resilience'], 'conditions': ['Depression', 'Stress', 'Youth']}, 'descriptionModule': {'briefSummary': 'The present study aims to develop a new predictive index to predict future depression of adolescents by using factors including individual, interpersonal and environmental. The index can be used to predict likelihood of students who are non-probable depression cases convert into probable depression cases. In addition, the investigators also test the factors of depression remission. It can hence be used in school setting to identify high-risk students, and provide them with secondary interventions that are designed by considering modifiable significant variables identified in this unique, large-scale, longitudinal study.', 'detailedDescription': 'A 12-month longitudinal study will be conducted in secondary school settings.\n\nThe investigators will investigate incidence of probable depression (i.e., from non-depression, CESD\\<16, at baseline to probable depression, CESDā„16, at month 12) and remission of probable depression.\n\nThe investigators will investigate factors that can prospectively predict new cases/remission of probable depression, including both well-documented risk/protective factors and some under-examined but potentially important local factors (e.g. school/academic stress, psychological resilience). The relative importance of the risk/protective factors at different socio-ecological levels will be compared and their combined effect will be identified.\n\nBased on the selected factors, the investigators will derive a new prediction index called the Adolescent Depression Prediction Index (ADPI) in a model building sample and test its performance in predicting incidence of depression in a validation sample among secondary school students in Hong Kong.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Out of the 18 districts in Hong Kong, nine randomly selected districts will select randomly two schools and while the rest nine will randomly select one school. Replacements of schools will be made upon refusals. Within the selected schools, all Secondary 1-4 students will be invited to join the study. Students will be asked to fill in baseline questionnaires in the absence of teachers in classroom settings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Secondary 1 (seventh year of formal education) to Secondary 4 Chinese students, who are studying local mainstream schools in Hong Kong.\n* Able to read Chinese and speak either Cantonese or Mandarin.\n\nExclusion Criteria:\n\n* Eligible students whose parents refuse to give consent to take part in the study.'}, 'identificationModule': {'nctId': 'NCT04063202', 'briefTitle': 'Development of a Predictive Index for Probable Depression Among Secondary School Students', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Longitudinal Study for Identifying Predictors of Incidence/Remission of Probable Depression and Developing a Predictive Index for Probable Depression Among Secondary School Students', 'orgStudyIdInfo': {'id': 'HMRF16171001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-cases', 'description': 'Secondary school students (seventh to tenth years of education) without probable depression at baseline interview.', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'The anonymous structured questionnaire will be self-administered by the participating students in the absence of their teachers in class-room settings.', 'armGroupLabels': ['Non-cases']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'role': 'CONTACT', 'phone': '2958 9694'}], 'facility': 'China Holiness Church Living Spirit College', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'role': 'CONTACT', 'phone': '2670 9229'}], 'facility': 'Christian Alliance SW Chan Memorial College (Christian Alliance SW Chan Memorial Secondary School)', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'role': 'CONTACT', 'phone': '2441 7100'}], 'facility': 'Ho Ngai College ( Sponsored By Sik Sik Yuen)', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'role': 'CONTACT', 'phone': '2337 9594'}], 'facility': 'Kit Sam Lam Bing Yim Secondary Schoo', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Xue Yang, PhD', 'role': 'CONTACT', 'email': 'sherryxueyang@cuhk.edu.hk', 'phone': '+852 2252 8740'}], 'overallOfficials': [{'name': 'Xue Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JC School of Public Health and Primary Care, Faculty of Medicine, CUHK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Dr. Xue YANG', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}