Isolation, SocialPart'AgesNCT05551234
Reciprocal Benefit by Intergenerational Meetings
An observational study of Isolation, Social, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Isolation, Social
- What is being tested?
- Regular exchanges
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 12 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: isolated seniors (from 65 years old) and disadvantaged children (from 5 years old)
Who may be able to join
- 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,
- 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.
Who cannot join
- subject does not speak French, does not read French,
- subject does not speak French, does not read French,
- subject with visual impairment,
- subject under guardianship or curatorship,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Isolation, Social
- Being tested
- Regular exchanges
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular exchangesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Isolated senior | Not described Receives: Other: Regular exchanges | |
| Children | Not described Receives: Other: Regular exchanges |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Senior : the 3-point loneliness scale;
The 3-point lonelisness scale evaluates loneless with 3 questions.
Measured: 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).
Measured: At 8 months
Secondary outcomes (5)
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.).
Measured: 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.
Measured: Up to 8 months
rosenberg self-esteem scale
This scale consists of 10 questions each evaluated by a 4-level Likert scale.
Measured: Up to 8 months
satisfaction questionnaire
for children and their parents and teachers, for the senior
Measured: 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"
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Sep 2022
- Primary completion19 May 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolation, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551234
- Sponsor's protocol ID
- 22CMRR01
- Acronym
- Part'Ages
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing is not planed
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reciprocal Benefit by Intergenerational Meetings Between 2 Fragile Populations
- ClinicalTrials.gov ID
- NCT05551234
- Acronym / sponsor ID
- Part'Ages / 22CMRR01
- Conditions
- Isolation, Social
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated senior | – | Other: Regular exchanges |
| Children | – | Other: Regular exchanges |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- isolated seniors (from 65 years old) and disadvantaged children (from 5 years old)
Key inclusion criteria (6 listed)
- 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,
- 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),
Key exclusion criteria (4 listed)
- subject does not speak French, does not read French,
- subject does not speak French, does not read French,
- subject with visual impairment,
- subject under guardianship or curatorship,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular exchangesThe 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. | Other | Children, Isolated senior |
Primary outcome
For Senior : the 3-point loneliness scale;
Time frame: At 8 months
The 3-point lonelisness scale evaluates loneless with 3 questions.
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).
5 secondary outcomes
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)
Geriatric depression scale 15
Time frame: Up to 8 months
rosenberg self-esteem scale
Time frame: Up to 8 months
satisfaction questionnaire
Time frame: At 7 months
semi-directive interiew
Time frame: Up to 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No. IPD sharing is not planed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolation, Social, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For Senior : the 3-point loneliness scale; (time frame: At 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.