Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT04371250
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Resilience and Loneliness in Youth (18 - 25 Years Old) During the COVID-19 Pandemic Lock-down Measures.
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-rated measure of Resilience', 'timeFrame': 'Up to 1 week after the end of the lock-down measures', 'description': 'Measured with the Resilience Scale for Adults (RSA).'}, {'measure': 'Self-rated measure of Loneliness', 'timeFrame': 'Up to 1 week after the end of the lock-down measures', 'description': 'Measured with the UCLA (University of California, Los Angeles) Loneliness Scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mental Health', 'Emerging Adulthood'], 'conditions': ['Resilience, Psychological', 'Loneliness', 'Youth', 'Surveys and Questionnaires']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Boffo, M., Mannarini, S., & Munari, C. (2012). Exploratory Structure Equation Modeling of the UCLA Loneliness Scale: A contribution to the Italian adaptation. TPM: Testing, Psychometrics, Methodology in Applied Psychology, 19(4).'}, {'pmid': '27031088', 'type': 'BACKGROUND', 'citation': 'Bonfiglio NS, Renati R, Hjemdal O, Friborg O. The resilience scale for adults in italy: A validation study comparing clinical substance abusers with a nonclinical sample. Psychol Addict Behav. 2016 Jun;30(4):509-15. doi: 10.1037/adb0000176. Epub 2016 Mar 31.'}, {'type': 'BACKGROUND', 'citation': 'Friborg, O., Martinussen, M., & Rosenvinge, J. H. (2006). Likert-based vs. semantic differential-based scorings of positive psychological constructs: A psychometric comparison of two versions of a scale measuring resilience. Personality and Individual Differences, 40(5), 873-884. https://doi.org/10.1016/j.paid.2005.08.015'}, {'type': 'BACKGROUND', 'citation': "Grace, G. D. E., Joshi, P., Pelletier, R., & Laval, U. (1993). L'Echelle de solitude de l'Universite Laval ( ESUL ): validation canadienne-francaise du UCLA Loneliness Scale. (1959), 12-27."}, {'type': 'BACKGROUND', 'citation': 'Hjemdal, O., Friborg, O., Braun, S., Kempenaers, C., Linkowski, P., & Fossion, P. (2011). The resilience scale for adults: Construct validity and measurement in a Belgian sample. International Journal of Testing, 11(1), 53-70. https://doi.org/10.1080/15305058.2010.508570'}, {'pmid': '17551351', 'type': 'BACKGROUND', 'citation': 'Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.'}, {'pmid': '24277491', 'type': 'BACKGROUND', 'citation': 'Marcoen A, Goossens L, Caes P. Lonelines in pre-through late adolescence: Exploring the contributions of a multidimensional approach. J Youth Adolesc. 1987 Dec;16(6):561-77. doi: 10.1007/BF02138821.'}]}, 'descriptionModule': {'briefSummary': 'The outbreak linked to SARS-CoV-2 pandemic resulted in lock-down measures in almost all European countries.\n\nThis online survey assesses these measures implications on Mental Health in emerging adults.\n\nThe questionnaires evaluate two psychometric variables (Resilience and Loneliness) and Mental Health status (mental health professional help-seeking, use of psychotropic drugs, or possible diagnosis) before and during Lock-down Measures.\n\nAt least 600 healthy participants aged form 18 to 25 years old will be attended to fill the survey during the SARS-CoV2 Pandemic Lock-down Measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy youth living in a European Country where SARS-CoV2 Pandemic Lock-down Measures are underway.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* French-speaking or Italian-speaking\n* Subjects who accepted to participated to the online survey\n* Inhabitants of a European country where SARS-CoV2 Pandemic Lock-down Measures are underway\n* Survey filling date up to one week after the end of Lock-down Measures in the Country of residence\n\nExclusion Criteria:\n\n* Incomplete surveys'}, 'identificationModule': {'nctId': 'NCT04371250', 'briefTitle': 'Study of Resilience and Loneliness in Youth (18 - 25 Years Old) During the COVID-19 Pandemic Lock-down Measures.', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Mental Health Implications During and After the COVID-19 Pandemic Lock-down Measures in Youth (18 - 25 Years Old) in French-Speaking Belgium and Italy: Resilience and Loneliness Evaluation.', 'orgStudyIdInfo': {'id': 'SRB2020_158'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Youth', 'description': 'Assessed group', 'interventionNames': ['Other: Survey and Questionnaire']}], 'interventions': [{'name': 'Survey and Questionnaire', 'type': 'OTHER', 'description': 'Resilience and Loneliness questionnaires', 'armGroupLabels': ['Youth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}, {'name': 'King Baudouin Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}