A Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families

Recruiting now · Not applicable

Conditions studied: Mental Health, Well-being

In brief

The FLOW project involves the implementation and rigorous evaluation of an evidence-based, multi-level mentalization prevention program targeting social and psychological determinants of well-being in four European countries (Germany, Lithuania, Spain, and Switzerland). Prevention programs will be tailored to the needs of 8-10 year old children in elementary schools and their parents. All children will participate in a project day focused on mental health. Parents will either attend one of two parent trainings of varying lengths or receive a parenting guidebook. A total of 5,000 children, along with their teachers and parents, are included in the survey. To measure long-term effects, surveys are conducted over the course of a whole year. The project examines the following hypotheses: Primary hypotheses: A multilevel mentalization based prevention program will lead to significantly greater improvements in well-being and mental health among children and parents compared to control groups, as measured at the post-intervention assessment. Secondary hypotheses: 1. A universal prevention program on mental health enhances help-seeking behavior and reduces mental health stigma among children, parents and teachers at post and follow-up measurement. 2. A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement. 3. A multi-level mentalization based prevention program leads to greater improvements in well-being and mental health among children and parents than control groups, as measured at follow-up. 4. A multi-level mentalization based prevention program leads to greater improvements in parental efficacy and family adjustment in parents and reduces parental stress compared to control groups at post and follow-up measurement. 5. The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.

Key facts

Study ID

NCT07494929

Run by

Svenja Taubner

People needed

15200

Starts

2026-04-14

Expected to finish

2028-03-01

Last updated by the study team

2026-07-30

Who can join

Age: 8 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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