NCT07581171

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

March 24, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

elderly peoplechildren of parents with mental illnesslonelinesspsychosocial healthintergenerational tandems

Outcome Measures

Primary Outcomes (1)

  • Loneliness

    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 Outcomes (5)

  • Mental well-being

    Change from baseline to 6 months.

  • Health-Related Quality of Life in Adults

    Change from baseline to 6 months.

  • Health-Related Quality of Life in Children and Adolescents

    Change from baseline to 6 months.

  • Health-Related Quality of Life in Adults (EQ-5D-5L)

    Change from baseline to 6 months

  • Health-Related Quality of Life in Children and Adolescents (EQ-5D-Y-5L)

    Change from baseline to 6 months

Study Arms (1)

Establishing intergenerational tandems

EXPERIMENTAL

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 -.

Behavioral: Mechanisms and effectiveness of intergenerational tandems

Interventions

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.

Establishing intergenerational tandems

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 24, 2026

First Posted

May 12, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share