Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05435469
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2022-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Changes of Coping With Stressful Events Among Adolescents Under the COVID-19 Pandemic.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2022-06-25', 'studyFirstSubmitQcDate': '2022-06-25', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coping strategies used after the pandemic', 'timeFrame': 'Baseline', 'description': 'The Coping strategies used by the adolescents for the stressful life events after the COVID-19 pandemic will be measured by Coping Inventory For Stressful Situations with the 21-items.'}, {'measure': 'Coping strategies used before the pandemic', 'timeFrame': 'Baseline', 'description': 'The Coping strategies used by the adolescents for the stressful life events before the COVID-19 pandemic will be measured by Coping Inventory For Stressful Situations with the 21-items.'}, {'measure': 'Mental health', 'timeFrame': 'Baseline', 'description': 'The mental health level of the adolescents will be measured by brief-symptom-inventory with 53-items.'}, {'measure': 'Emotional Intelligence status', 'timeFrame': 'Baseline', 'description': 'The Emotional Intelligence status of the adolescents will be measured by Wong and Law EI Scale with 16-items.'}], 'secondaryOutcomes': [{'measure': 'Stressful Life Events after pandemic', 'timeFrame': 'Baseline', 'description': 'The Stressful Life Events experienced by the adolescents after the COVID-19 pandemic will be measured by Adolescent Self-Rating Life Events Check List with the 27-items.'}, {'measure': 'Stressful Life Events before pandemic', 'timeFrame': 'Baseline', 'description': 'The Stressful Life Events experienced by the adolescents before the COVID-19 pandemic will be measured by Adolescent Self-Rating Life Events Check List with the 27-items.'}, {'measure': 'Social support', 'timeFrame': 'Baseline', 'description': 'The social support that the adolescent could approach will be measured by Social Skills Rating System with the 10-items.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescent', 'pandemic', 'coping behavior', 'mental health', 'stressful life event'], 'conditions': ['Coping Behavior', 'Mental Health Issue']}, 'referencesModule': {'references': [{'pmid': '37528555', 'type': 'DERIVED', 'citation': 'Ding H, Xu Z, Hu W, Guo Y, Wang C, Li S, Hui Z, Wang J, Peng X, Xia W. Changes of stressful life events, coping strategies and mental health among youths in the pre- and post-coronavirus 2019 pandemic era: A cross-sectional study. Int J Soc Psychiatry. 2023 Dec;69(8):2018-2030. doi: 10.1177/00207640231188321. Epub 2023 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents.', 'detailedDescription': 'Under the special background of normalization of the epidemic situation, this paper describes and discusses the subjective feelings, changes in coping strategies, and causes of adolescent stressful life events, and puts forward a coping mechanism model of stressful adolescent events, which reflects the psychological changes of adolescent groups in the era of the epidemic situation and provides the basis for subsequent intervention measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 14-25\n* Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization.\n* Have the normal cognitive ability, expression ability, and social participation ability.\n\nExclusion Criteria:\n\n* Be diagnosed with psychological or mental illness.\n* Incapacitated or unable to provide informed consent.\n* Patients with severe diseases.'}, 'identificationModule': {'nctId': 'NCT05435469', 'briefTitle': 'The Changes of Coping With Stressful Events Among Adolescents Under the COVID-19 Pandemic.', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study on the Changes of Coping Strategies With Stressful Events and Mental Health Level Among Adolescents Before and After COVID-19 Pandemic.', 'orgStudyIdInfo': {'id': 'L2022SYSU-HL-044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaires assessed adolescents', 'description': '① Teenagers aged 14-25. ② Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization. ③ Have the normal cognitive ability, expression ability, and social participation ability.', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Participants will be asked to respond to the demographic information sheet, Adolescent Self-Rating Life Events Check List, Coping Inventory For Stressful Situations, Social Skills Rating System, brief-symptom-inventory, and Wong and Law EI Scale.', 'armGroupLabels': ['Questionnaires assessed adolescents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'XIAW', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Wei Xia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'After the publication of the study', 'ipdSharing': 'YES', 'description': 'The non-identified IPD will be shared after the outcomes have been published.', 'accessCriteria': 'Researchers should contact the PI for approval of the study protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei XIA, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wei XIA, PhD', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}