NCT07494929 A Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families
| NCT ID | NCT07494929 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Svenja Taubner |
| Condition | Mental Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 15,200 participants |
| Start Date | 2026-04-14 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15,200 participants in total. It began in 2026-04-14 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07494929 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, studying Mental Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07494929 currently recruiting?
Yes, NCT07494929 is actively recruiting participants. Contact the research team at svenja.taubner@med.uni-heidelberg.de for enrollment information.
Where is the NCT07494929 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Vilnius, Lithuania, Logroño, Spain, Geneva, Switzerland.
Who is sponsoring the NCT07494929 clinical trial?
NCT07494929 is sponsored by Svenja Taubner. The trial plans to enroll 15,200 participants.