- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05551234
Reciprocal Benefit by Intergenerational Meetings (Part'Ages)
Reciprocal Benefit by Intergenerational Meetings Between 2 Fragile Populations
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Julie BROUSSE
- Phone Number: +334.92.03.47.75
- Email: brousse.j@chu-nice.fr
Study Contact Backup
- Name: Justine LEMAIRE
- Phone Number: +334.92.03.47.78
- Email: lemaire.j@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06100
- Institut Claude Pompidou
-
Contact:
- Julie BROUSSE
- Phone Number: +33492034775
- Email: brousse.j@chu-nice.fr
-
Contact:
- Justine LEMAIRE
- Phone Number: +33492034778
- Email: lemaire.j@chu-nice.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for children :
- Girls or boys from last year of kindergarten to last year of elementary school,
- Educated in priority education network,
- Having the cognitive and sensory-motor capacities to follow and interact during the workshops,
Exclusion Criteria for children :
- subject does not speak French, does not read French,
Inclusion Criteria for seniors:
- Men or women over the age of 65, - MMSE score greater than or equal to 24/30,
- A score above 4 on the 3-point Loneliness Scale (Three-item Loneliness Scale),
- Clean record.
Exclusion Criteria for Seniors:
- subject does not speak French, does not read French,
- subject with visual impairment,
- subject under guardianship or curatorship,
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children
|
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.
|
|
Isolated senior
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
For Senior : the 3-point loneliness scale;
Time Frame: At 8 months
|
The 3-point lonelisness scale evaluates loneless with 3 questions.
|
At 8 months
|
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For children : SDQ-fra
Time Frame: At 8 months
|
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).
|
At 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
For Senior : the Nottingham Perceptual Health Indicator score (ISPN or NHP)
Time Frame: Before (Month 0), after the sessions (Month 7), one month after the end of the sessions (M8)
|
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.). 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.). |
Before (Month 0), after the sessions (Month 7), one month after the end of the sessions (M8)
|
|
Geriatric depression scale 15
Time Frame: Up to 8 months
|
The GDS is a 15-item scale used to screen for mood disorders.
|
Up to 8 months
|
|
rosenberg self-esteem scale
Time Frame: Up to 8 months
|
This scale consists of 10 questions each evaluated by a 4-level Likert scale.
|
Up to 8 months
|
|
satisfaction questionnaire
Time Frame: At 7 months
|
for children and their parents and teachers, for the senior
|
At 7 months
|
|
semi-directive interiew
Time Frame: Up to 7 months
|
"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"
|
Up to 7 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22CMRR01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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