Clinical trial Recruiting at 4 sites Interventional Ages 8 and up

Mentalization-based prevention program to boost well-being for 8–11 year olds and families

Official title: Foster Long-term Well-being in Pre-adolescent Children and Their Families

Run by University Hospital Heidelberg · NCT07494929 · Data updated 2026-11-12

A multi-country program tests whether a family-focused, mentalization-based approach can improve well-being and mental health in primary-school children and their parents.

Quick facts

Study typeInterventional
Ages8 Years and up
SexAll
Enrollment15200 (estimated)
SponsorUniversity Hospital Heidelberg
Academic / other
Locations4 sites (Heidelberg and 3 other locations)
StatusRecruiting
StartedApril 14, 2026
Main results expectedMarch 2028
Study endsMarch 2028
Registry record updatedJuly 30, 2026
Trial IDNCT07494929 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are 8–11 year-old children in participating schools and their parents who are able to engage in the program.

Probably not a fit

Some families may not experience measurable benefits due to variability in engagement or resources.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The FLOW project implements a multi-level mentalization prevention program in four European countries (Germany, Lithuania, Spain, Switzerland) aimed at 8–11 year-old children and their families. It uses a universal school-based workshop for students and parents, with additional parent trainings or a parenting guidebook, while measuring outcomes over one year. The study employs a cross-cultural, partially randomized design across cohorts to compare universal and selective prevention approaches against an active control, with surveys of children, parents, and teachers. Primary outcomes focus on well-being and mental health, while secondary outcomes include help-seeking behavior and classroom climate. The project involves up to 5,000 children, 2,500 parents, and 200 teachers per country, led by Svenja Taubner and collaborators from multiple universities.

Why it matters

Potential benefit: If successful, the program could improve well-being and mental health for children and parents and provide a scalable prevention model.

How similar studies have gone: Prior research supports multi-level mentalization approaches for child and parent well-being, but this project extends to a cross-cultural, partially randomized design.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Children: Age range 8 to 11 year olds
* All participants: Sufficient language knowledge (self-reported)

Exclusion Criteria:

* Children: Missing consent forms from all guardians
* Datasets that indicate random answer patterns or non-engaged responding

Where it's running

  • Institut für Psychosoziale Prävention-Department für Psychosoziale Medizin, Prävention und Familiengesundheit-Universitätsklinikum Heidelberg
    Heidelberg, Germany
    Recruiting
  • Developmental Psychopathology Research Center-Institute of Psychology- Faculty of Philosophy-Vilnius university
    Vilnius, Lithuania
    Recruiting
  • Department of Education Sciences-Universidad de La Rioja
    Logroño, Spain
    Recruiting
  • Faculty of Psychology and Educational Sciences-University of Geneva
    Geneva, Switzerland
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.