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NOT YET RECRUITING
NCT07494929
NA

A Cross-Cultural Randomized Controlled Trial Using a Multi-Level Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families

Sponsor: Svenja Taubner

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15200

Start Date

2026-04

Completion Date

2028-03

Last Updated

2026-03-27

Healthy Volunteers

Yes

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)

Locations (4)

Institut für Psychosoziale Prävention-Department für Psychosoziale Medizin, Prävention und Familiengesundheit-Universitätsklinikum Heidelberg

Heidelberg, Germany

Developmental Psychopathology Research Center-Institute of Psychology- Faculty of Philosophy-Vilnius university

Vilnius, Lithuania

Department of Education Sciences-Universidad de La Rioja

Logroño, Spain

Faculty of Psychology and Educational Sciences-University of Geneva

Geneva, Switzerland