An observational study in Isolation, Social, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's enrollment of 10 is below the median of 200 across 35 observational studies indexed under Social Isolation.
Browse Social Isolation studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
isolated seniors (from 65 years old) and disadvantaged children (from 5 years old)
Inclusion Criteria for children :
Exclusion Criteria for children :
- subject does not speak French, does not read French,
Inclusion Criteria for seniors:
Exclusion Criteria for Seniors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Regular exchanges
Other: Regular exchanges
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.
For Senior : the 3-point loneliness scale;
The 3-point lonelisness scale evaluates loneless with 3 questions.
Time frame: 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).
Time frame: At 8 months
For Senior : the Nottingham Perceptual Health Indicator score (ISPN or NHP)
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.).
Time frame: Before (Month 0), after the sessions (Month 7), one month after the end of the sessions (M8)
Geriatric depression scale 15
The GDS is a 15-item scale used to screen for mood disorders.
Time frame: Up to 8 months
rosenberg self-esteem scale
This scale consists of 10 questions each evaluated by a 4-level Likert scale.
Time frame: Up to 8 months
satisfaction questionnaire
for children and their parents and teachers, for the senior
Time frame: At 7 months
semi-directive interiew
"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"
Time frame: Up to 7 months
Plan to share: No — IPD sharing is not planed
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in May 2026, 44 months.
Of 17 observational studies under Social Isolation, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 44. This study's 44 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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