- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07581171
Creating Encounters Between Generations - Together Instead of Alone (GemsE) (GemsE)
Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The GemsE project - Creating Encounters: Generations in Action - Together Instead of Alone is an interventional study evaluating intergenerational mentoring between seniors and CYP from families with parents who have mental illness. The aim is to build stable, voluntary relationships that reduce loneliness and improve the mental well-being and health-related quality of life of both groups.
As part of the study, approximately 40 seniors and 40 children or adolescents will be accompanied in sponsorships over a period of six months. The impact of the sponsorships will be measured using standardized, validated questionnaires on loneliness, psychosocial well-being, and health-related quality of life. The results should provide insights into how intergenerational sponsorships can be effectively designed and integrated into psychosocial care services.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Silke Wiegand-Grefe, Prof. Dr.
- Telefonnummer: +4940741053603
- E-post: swiegand-grefe@uke.de
Studer Kontakt Backup
- Navn: Jana Wiehe
- Telefonnummer: +4940741024155
- E-post: j.wiehe@uke.de
Studiesteder
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Hamburg, Tyskland, 20246
- Rekruttering
- University Medical Center Hamburg-Eppendorf
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Ta kontakt med:
- Silke Wiegand-Grefe, Prof. Dr.
- Telefonnummer: +4940741053603
- E-post: swiegand-grefe@uke.de
-
Ta kontakt med:
- Jana Wiehe
- Telefonnummer: 49040741024155
- E-post: j.wiehe@uke.de
-
Hovedetterforsker:
- Silke Wiegand-Grefe, Prof. Dr.
-
Underetterforsker:
- Theresa Paumen
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Underetterforsker:
- Jana Wiehe
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Older adults aged 60 years and older who are residents of Hamburg
- Children and adolescents aged 12 to 21 years with at least one parent with a mental illness and who are residents of Hamburg
- Sufficient German language proficiency
- Ability and willingness to provide informed consent to participate in the study
Exclusion Criteria:
- Children and adolescents with severe acute psychological symptoms requiring inpatient treatment, including acute suicidality, acute substance use, or acute psychotic symptoms
- Older adults with acute psychological crises or untreated severe mental illness preventing reliable participation
- Older adults with cognitive impairment or dementia preventing reliable participation in the intervention
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Establishing intergenerational tandems
The intervention focuses on establishing stable mentoring relationships between senior citizens and children or adolescents from families with parents who have mental health issues. The main objectives of this intervention are to build reliable relationships, reduce loneliness, and promote mental well-being and quality of life for both groups. This intervention is coordinated by the project team at GemsE - Creating encounters: Generations in Action - Together Instead of Alone -. |
The project Creating Encounters Between Generations - Together Instead of Alone (German acronym GemsE) aims to provide social support and integration for both groups by establishing tandems between lonely senior citizens and COPMI, and to scientifically evaluate the effectiveness of these tandems.
The tandems run for six months, with weekly meetings between senior and CYP.
The tandems consist of weekly individual meetings with joint activities such as playing games, learning, cooking, or going for walks.
Senior citizens and CYP engage in tandems built on trust, shared experiences, and cooperation, fostering connections that benefit both sides at eye level.
Project coordinators accompany the participants and support the process management.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Loneliness
Tidsramme: Change from baseline to 6 months.
|
The primary clinically relevant parameter of the study is the experience of loneliness among children, adolescents, and seniors, measured using the 6-item short version of the De Jong Gierveld Loneliness Scale.The response options are three-point (yes, more or less, no) from 0-6 with higher scores indicating greater loneliness.
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Change from baseline to 6 months.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mental well-being
Tidsramme: Change from baseline to 6 months.
|
The mental well-being of seniors and young adults is assessed using the SDQ 18+, while the SDQ 11-17 is used for self-assessment for adolescents.
Scores range from 0 to 40, with higher scores indicating greater psychological difficulties and poorer mental well-being.
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Change from baseline to 6 months.
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Health-Related Quality of Life in Adults
Tidsramme: Change from baseline to 6 months.
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Health-related quality of life in participants aged 18 years and older will be assessed using the SF-12.
Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
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Change from baseline to 6 months.
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Health-Related Quality of Life in Children and Adolescents
Tidsramme: Change from baseline to 6 months.
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Health-related quality of life in participants aged 12 to 17 years will be assessed using the KIDSCREEN-27 Questionnaire.
Scores range from 0 to 100, with higher scores indicating better quality of life.
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Change from baseline to 6 months.
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Health-Related Quality of Life in Adults (EQ-5D-5L)
Tidsramme: Change from baseline to 6 months
|
Health-related quality of life in participants aged 18 years and older will be assessed using the EQ-5D-5L.
The instrument assesses five health dimensions across 5 response levels, generating a 5-digit health profile in which lower levels indicate fewer health problems, as well as a visual analogue scale (VAS) score ranging from 0 to 100 and, where applicable, a utility index score typically ranging from below 0 to 1, with higher VAS and utility scores indicating better HRQoL.
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Change from baseline to 6 months
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Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)
Tidsramme: Change from baseline to 6 months
|
Health-related quality of life in participants from 12-17 years will be assessed using the EQ-5D-Y-5L.
The instrument assesses five health dimensions across 5 response levels, generating a 5-digit health profile in which lower levels indicate fewer health problems, as well as a visual analogue scale (VAS) score ranging from 0 to 100 and, where applicable, a utility index score typically ranging from below 0 to 1, with higher VAS and utility scores indicating better HRQoL.
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Change from baseline to 6 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Silke Wiegand-Grefe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-101662-BO-ff
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