Reciprocal Benefit by Intergenerational Meetings (Part'Ages)

September 19, 2022 updated by: Centre Hospitalier Universitaire de Nice

Reciprocal Benefit by Intergenerational Meetings Between 2 Fragile Populations

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

isolated seniors (from 65 years old) and disadvantaged children (from 5 years old)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

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)?

No

IPD Plan Description

IPD sharing is not planed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Isolation, Social

Clinical Trials on Regular exchanges

Subscribe