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NCT Number: NCT07581171

Creating Encounters Between Generations - Together Instead of Alone (GemsE)

Elderly people and children and young people (CYP) and from families with mentally ill parents are particularly affected by loneliness. The GemsE project is investigating whether intergenerational mentoring between seniors and children or young people helps to reduce loneliness and improve the mental well-being and quality of life of both groups. The aim of the study is to scientifically record the effect of these sponsorships and to find out how such encounters can be successfully organized.

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Key information

Conditions

Loneliness Behavior Health-Related Quality of Life Mental Well-being Personal Satisfaction Psychological Well-Being

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanisms and effectiveness of intergenerational tandems

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Creating Encounters: Generations in Action - Together Instead of Alone (GemsE)

Acronym: GemsE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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