Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT04406558
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2020-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], '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': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2020-05-24', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety score from the Generalized Anxiety Disorder 7 (GAD-7) questionnaire', 'timeFrame': 'At inclusion', 'description': 'Scale 0-21'}], 'secondaryOutcomes': [{'measure': 'Depression score from the Adolescent Depression Rating Scale (ADRS) questionnaire', 'timeFrame': 'At inclusion', 'description': 'Scale 0-60'}, {'measure': "Post traumatic score questionnaire: Children's Revised Impact of Events Scales -CRIES13", 'timeFrame': 'At inclusion', 'description': '8 items that are scored on a four-point scale and 3 sub scales: intrusion (4 items); avoidance (4 items) and arousal (5 items)'}, {'measure': 'Presence or absence of difficulty in falling asleep, sleeping', 'timeFrame': 'At inclusion', 'description': 'a question on the quality and quantity of sleep will be asked to the teenager on a questionnaire'}, {'measure': 'Presence or absence of feeding difficulty', 'timeFrame': 'At inclusion', 'description': 'a question on the presence or absence of feeding difficulty will be asked to the teenager on a questionnaire'}, {'measure': 'Presence or absence of difficulty performing physical activity', 'timeFrame': 'At inclusion', 'description': 'a question on the presence or absence of difficulty performing physical activity will be asked to the teenager on a questionnaire'}, {'measure': 'Presence or absence of toxic consomption (drug, acohol) during the lockdown', 'timeFrame': 'At inclusion', 'description': 'a question on the presence or absence of toxic consomption will be asked to the teenager on a questionnaire'}, {'measure': 'Mean duration time in front of screen (hours per day)', 'timeFrame': 'At inclusion'}, {'measure': 'Presence or absence of difficulties with social interactions', 'timeFrame': 'At inclusion', 'description': 'A question on the presence or absence of difficulties with social interactions will be asked to the teenager on a questionnaire'}, {'measure': 'Presence or absence of difficulties with familial interactions', 'timeFrame': 'At inclusion', 'description': 'Presence or absence of difficulties with familial interactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Adaptation', 'Psychology, Social']}, 'descriptionModule': {'briefSummary': 'The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be proposed to all the adolescents followed in the Centre hospitalier Intercommunal de Creteil for a chronic disease or not.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged 11 to 18 years old\n* Previous consultation in the Centre Hospitalier intercommunal de Creteil\n* Agree to participate\n\nExclusion Criteria:\n\n* Lack of computer equipment or internet connection'}, 'identificationModule': {'nctId': 'NCT04406558', 'acronym': 'COVADO', 'briefTitle': 'Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)', 'orgStudyIdInfo': {'id': 'COVADO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'otherNames': ['Interview'], 'description': 'An online questionnaire on the experience of the period of confinement and deconfinement will be sent to the cohort of adolescents followed at the CHI Creteil for a chronic disease or not. Forty adolescents will be randomly selected for a remote interview on the experience and memorization of the period of confinement and deconfinement.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Camille JUNG', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}