- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07581171
Creating Encounters Between Generations - Together Instead of Alone (GemsE) (GemsE)
Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: 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.
|
Change from baseline to 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental well-being
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
|
|
Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-101662-BO-ff
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Loneliness
-
Chinese University of Hong KongThe Salvation Army, Hong Kong and Macau CommandNot yet recruiting
-
Columbia UniversityNational Institute of Mental Health (NIMH)Recruiting
-
University of OregonNational Institute on Drug Abuse (NIDA); HopeLab FoundationCompleted
-
University Hospital, BonnThe German-Israeli Foundation for Scientific Research and Development; Prof...Unknown
-
Centre Hospitalier Universitaire de NiceCompleted
-
Education University of Hong KongRecruiting
-
Education University of Hong KongThe University of Hong KongRecruiting
-
University College, LondonUniversity of Manchester; National Academy for Social Prescribing; We Do WellbeingActive, not recruiting
-
University of RochesterNational Institute on Aging (NIA)Completed
Clinical Trials on Mechanisms and effectiveness of intergenerational tandems
-
University Hospital HeidelbergRecruiting
-
Hospices Civils de LyonCompletedDiabetic Foot InfectionFrance
-
Harvard UniversityNational Institute on Aging (NIA); Massachusetts Institute of Technology; Ludwig-Maximilians...CompletedCovid19 | Influenza, Human | Flu, HumanUnited States
-
Damascus UniversityCompleted
-
Cumhuriyet UniversityAksaray UniversityRecruitingSmoking | Health Risk Behaviors | Blind EyeTurkey
-
Mackay Memorial HospitalCompleted
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...CompletedHIVUnited States, Puerto Rico
-
Istanbul University - Cerrahpasa (IUC)Not yet recruitingQuality of Life | Hepatitis B, Chronic | Adherence, Medication
-
Yeditepe UniversityActive, not recruitingCartilage Damage | Osteoarthritis of Knee | Allograft | Osteochondral LesionTurkey
-
University of Beira InteriorCompletedThis Study Highlights Differences in Baropodometry Between GendersPortugal