Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT05551234
Status:
UNKNOWN
Last Update Posted:
2022-09-22
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reciprocal Benefit by Intergenerational Meetings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For Senior : the 3-point loneliness scale;', 'timeFrame': 'At 8 months', 'description': 'The 3-point lonelisness scale evaluates loneless with 3 questions.'}, {'measure': 'For children : SDQ-fra', 'timeFrame': 'At 8 months', 'description': 'The SDQ is a behavioral screening questionnaire applicable to children aged 3 to 16 and comprising 25 questions divided into 5 domains (emotional symptoms, conduct problems, hyperactivity/inattention, relationship problems with other children, social behavior).'}], 'secondaryOutcomes': [{'measure': 'For Senior : the Nottingham Perceptual Health Indicator score (ISPN or NHP)', 'timeFrame': 'Before (Month 0), after the sessions (Month 7), one month after the end of the sessions (M8)', 'description': 'This is a self-questionnaire of 38 items covering 6 dimensions: pain, physical mobility, sleep, energy, emotional reaction, social isolation. We will focus on the average score (and not the classes/slices: low, medium, etc.).\n\nThis is a self-questionnaire of 38 items covering 6 dimensions: pain, physical mobility, sleep, energy, emotional reaction, social isolation. We will focus on the average score (and not the classes/slices: low, medium, etc.).'}, {'measure': 'Geriatric depression scale 15', 'timeFrame': 'Up to 8 months', 'description': 'The GDS is a 15-item scale used to screen for mood disorders.'}, {'measure': 'rosenberg self-esteem scale', 'timeFrame': 'Up to 8 months', 'description': 'This scale consists of 10 questions each evaluated by a 4-level Likert scale.'}, {'measure': 'satisfaction questionnaire', 'timeFrame': 'At 7 months', 'description': 'for children and their parents and teachers, for the senior'}, {'measure': 'semi-directive interiew', 'timeFrame': 'Up to 7 months', 'description': '"for children, for the senior, for entourage of senior and children interview defined especially for this study to evaluate social impact written transcription or oral records"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Isolation, Social']}, 'descriptionModule': {'briefSummary': 'The investigators want to set up an experiment that allows a reciprocal benefit to 2 fragile populations: isolated seniors and disadvantaged children. The main hypothesis is that regular exchanges between these two populations reduce the feeling of social isolation of seniors and improve the school behavior of childrens. Therefore the investigators propose the following study design. The seniors and childrens will meet once a week, for 7 months, in a defined location in the city of Vallauris, over a period of one and a half hours, outside school hours (4:30 p.m. to 6:00 p.m.) and school holidays. During the school holidays the group will meet 3 times for day-long activities in the presence of at least one of the parents and possibly brothers and sisters. At the end of the project, a convivial evening will be organized in the presence of the families. The group will meet in a room in the city center and in the presence of a facilitator so that an adult will never be alone with a child. The formed pair will follow a defined schedule where will alternate activities proposed by the senior, sessions proposed by the facilitator and convivial moments in the presence of families . During the sessions proposed by the senior, he will offered the child a leisure activity that he likes and masters (eg gardening, DIY, sewing, etc.). All the proposed activities will be validated upstream by the project managers. The sessions proposed by the facilitator (e.g. games, walks) could be done with the participation of an outside speaker (e.g. for writing a gazette). A new evaluation session will be offered to all participants at the end of the meeting period, then at the end of the project, 1 month after the end of the meeting period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'isolated seniors (from 65 years old) and disadvantaged children (from 5 years old)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for children :\n\n* Girls or boys from last year of kindergarten to last year of elementary school,\n* Educated in priority education network,\n* Having the cognitive and sensory-motor capacities to follow and interact during the workshops,\n\nExclusion Criteria for children :\n\n\\- subject does not speak French, does not read French,\n\nInclusion Criteria for seniors:\n\n* Men or women over the age of 65, - MMSE score greater than or equal to 24/30,\n* A score above 4 on the 3-point Loneliness Scale (Three-item Loneliness Scale),\n* Clean record.\n\nExclusion Criteria for Seniors:\n\n* subject does not speak French, does not read French,\n* subject with visual impairment,\n* subject under guardianship or curatorship,'}, 'identificationModule': {'nctId': 'NCT05551234', 'acronym': "Part'Ages", 'briefTitle': 'Reciprocal Benefit by Intergenerational Meetings', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Reciprocal Benefit by Intergenerational Meetings Between 2 Fragile Populations', 'orgStudyIdInfo': {'id': '22CMRR01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isolated senior', 'interventionNames': ['Other: Regular exchanges']}, {'label': 'Children', 'interventionNames': ['Other: Regular exchanges']}], 'interventions': [{'name': 'Regular exchanges', 'type': 'OTHER', 'description': 'The seniors and childrens will meet once a week, for 7 months, over a period of one and a half hours, outside school hours (4:30 p.m. to 6:00 p.m.) and school holidays.', 'armGroupLabels': ['Children', 'Isolated senior']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Julie BROUSSE', 'role': 'CONTACT', 'email': 'brousse.j@chu-nice.fr', 'phone': '+33492034775'}, {'name': 'Justine LEMAIRE', 'role': 'CONTACT', 'email': 'lemaire.j@chu-nice.fr', 'phone': '+33492034778'}], 'facility': 'Institut Claude Pompidou', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Julie BROUSSE', 'role': 'CONTACT', 'email': 'brousse.j@chu-nice.fr', 'phone': '+334.92.03.47.75'}, {'name': 'Justine LEMAIRE', 'role': 'CONTACT', 'email': 'lemaire.j@chu-nice.fr', 'phone': '+334.92.03.47.78'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD sharing is not planed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}