- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07581171
Creating Encounters Between Generations - Together Instead of Alone (GemsE) (GemsE)
Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Loneliness
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mental well-being
Ramy czasowe: 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.
|
Change from baseline to 6 months.
|
|
Health-Related Quality of Life in Adults
Ramy czasowe: Change from baseline to 6 months.
|
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.
|
Change from baseline to 6 months.
|
|
Health-Related Quality of Life in Children and Adolescents
Ramy czasowe: Change from baseline to 6 months.
|
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.
|
Change from baseline to 6 months.
|
|
Health-Related Quality of Life in Adults (EQ-5D-5L)
Ramy czasowe: 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.
|
Change from baseline to 6 months
|
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Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)
Ramy czasowe: 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.
|
Change from baseline to 6 months
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-101662-BO-ff
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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