NCT05551234

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

September 9, 2022

Last Update Submit

September 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • For Senior : the 3-point loneliness scale;

    The 3-point lonelisness scale evaluates loneless with 3 questions.

    At 8 months

  • For children : SDQ-fra

    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 Outcomes (5)

  • For Senior : the Nottingham Perceptual Health Indicator score (ISPN or NHP)

    Before (Month 0), after the sessions (Month 7), one month after the end of the sessions (M8)

  • Geriatric depression scale 15

    Up to 8 months

  • rosenberg self-esteem scale

    Up to 8 months

  • satisfaction questionnaire

    At 7 months

  • semi-directive interiew

    Up to 7 months

Study Arms (2)

Isolated senior

Other: Regular exchanges

Children

Other: Regular exchanges

Interventions

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.

ChildrenIsolated senior

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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,

You may not qualify if:

  • \- subject does not speak French, does not read French,
  • 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.
  • subject does not speak French, does not read French,
  • subject with visual impairment,
  • subject under guardianship or curatorship,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Claude Pompidou

Nice, 06100, France

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 22, 2022

Study Start

September 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

IPD sharing is not planed

Locations