NCT07494929

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15,200 (estimated)
• Sponsor: Svenja Taubner · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

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.

Detailed description

FLOW will follow four different cohorts in Germany, Lithuania, Spain, and Switzerland using a cross-cultural prospective partially randomized controlled trial where stepwise prevention is offered to children, parents and teachers. In each country, up to 50 elementary school classes will be invited to participate in a universal prevention program with children at the age of minimum of 8 years and maximum of 10 years (50 teachers, 1.250 children and 2500 parents in each participating country; 200 teachers, 5.000 children and 10.000 parents in total). In the second step - the selective prevention - participating school classes will be randomized into one of two intervention groups or an active control group. The FLOW project seeks to answer the following questions: 1. Is a multi-level mentalization based prevention program consisting of a universal prevention workshop at schools for children and parents effective in fostering (a) well-being and (b) mental health? 2. Is a multi-level mentalization based prevention program for children and parents effective in changing effective parenting, help-seeking or classroom climate change? 3. What is the appropriate treatment with regard to family needs and resources to sustain well-being and mental health in children? Primary goals: 1. Promote well-being in parents and children. 2. Promote mental health in parents and children Secondary goals: 1\) Children: Improve help-seeking behaviour and positive mental health; Decrease mental health stigma. 2\) Parents: Improve help-seeking behavior, parental efficacy, child-parent interaction and positive mental health; Decrease parental stress and mental health stigma. 3\) Teachers: Improve perception of classroom climate and teaching self-efficacy; Decrease mental health stigma. 1. Universal prevention and initial data collection: At participating schools, all children will take part in a workshop based on the prevention program "Talking Mental Health". The program is tailored to 8- to 10-year-old children and uses child-friendly material to address small and big feelings, mental health and peer-related helping skills (listening and asking sensitive questions). This workshop will be delivered in four regular school lessons by the children's teachers, a school social worker or trained university students. At school, before the start of the workshop, data from participating children will be collected. This timepoint will be referred to as "baseline" or t0. School teachers take part in a mandatory training course on the universal program. Before training (t-1 or "enrolment") school teachers will also be asked to fill out questionnaires for data collection. All parents will receive information on help-seeking and how to address as well as recognize mental health difficulties within their children. Participating parents will be asked to fill out questionnaires for data collection at timepoint t-1 as well. 2. Randomization: In parallel to the universal prevention program, participating school classes will be randomized into either an active control group (33.33% of classes) or one of two intervention groups (33.33% in each group). The active control group (ACG), will receive a parenting guidebook on the lighthouse-parent training program. Parents from participating school classes are offered the opportunity to participate in the respective groups. Both intervention groups will consist of 8-12 participants and will be carried out over a timespan of three months. Intervention group 1 (IG1), using the Lighthouse Program, 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. Intervention group 2 (IG2), using 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 and adapted by adding a mentalization component for the purpose of the FLOW-study. Parents who do not want to take part in the intervention, will form a passive control group (PCG) and still take part in follow-up measures. 3. Post- and follow-up data collection: Data from children is collected at baseline (t0) after the selective prevention (t1) and after 6 months (FU1). Data from parents is collected before the universal prevention (t-1), after the selective prevention (t1) and after 6 months (FU1) as well as 12 months (FU2). Data from teachers is collected before the universal prevention (t-1) after the selective prevention (t1) and after 6 months (FU1). 4. User involvement, implementation and focus groups: After the post-assessment (t1), 3-4 focus groups will be conducted in each country from all participating groups (children, parents, teachers and stakeholders) to discuss program implementation, feasibility and satisfaction with content and format of the intervention as well as sustainability. The focus group format enables group discussion between the participants, stakeholders and researchers. Discussions will be audio-transcribed and analysed qualitatively using content analysis and Grounded Theory. Results will inform future dissemination and the open online resources.

Conditions

• Mental Health
• Prevention
• Mentalization
• Primary School
• Well-being

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

4 sites across 4 countries: Germany, Lithuania, Spain, Switzerland