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

NCT07494929 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15200

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Lighthouse Program

The Reflective Parenting Lighthouse Program (Byrne et al., 2019; Taubner et al., 2025) consists of 12 weekly group sessions targeting secure attachment parenting behaviors, reflective parenting and dysfunctional parental behavior related to parental mental health problems or trauma.

OTHER

Mentalization Based Skills Training

The Mentalization Based Skills Training (MBST-P) consists of 6 bi-weekly group sessions and trains essential parental skills on attentional control, emotion regulation and reflective functioning using role plays with the imagined child. The training is based on the EFST-P training (Dolhanty et al., 2022) and adapted by adding a mentalization component for the purpose of the FLOW-study.

OTHER

Lighthouse program parenting guidebook

Parenting guidebook on the lighthouse-parent training program (Taubner \& Byrne 2026; The Little Boat and its Lighthouse)

Sponsors & Collaborators

  • University of Geneva, Switzerland

    collaborator OTHER
  • University of La Rioja

    collaborator OTHER
  • Vilnius University

    collaborator OTHER
  • CHANSE (Collaboration of Humanities and Social Sciences in Europe)

    collaborator UNKNOWN
  • Student organization "Vitaphilie" (Medical Students' Association of the Heidelberg University)

    collaborator UNKNOWN
  • Svenja Taubner

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Germany
  • Lithuania
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494929 on ClinicalTrials.gov