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

NCT07494929 | Not Yet Recruiting

• 4 other identifiers: 539850647S-NORFACE-25-1PCI2025-163191FNS 10NR17_222938
• Study Type: interventional
• Target: 15,200
• Locations: 4 countries
• Sites: 4

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. 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. 2.A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement.
3. 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. 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. 5.The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.

Conditions

Mental Health; Well-being

Keywords

Randomized Control Trial; Parent trainings; Mentalization; Well-Being; Primary school; Mental Health; Prevention

Outcome Measures

Primary Outcomes (4)

• Children's well-being measured by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010)

  To assess children's well-being, the KIDSCREEN10 Index will be used both as a self-report completed by the children and as an external proxy report provided by their parents. Responses are recorded on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (very much/always). The ten items on mental health are summed up to yield a total score ranging from 10 to 50, where lower scores indicate poorer mental health and higher scores reflect better mental health.

  From enrollment/baseline (t-1; t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months) to follow-up 2 (FU2 after 12 months-only parent report)

• Children's mental health measured by the SDQ (Goodman, 1997)

  The Strengths and Difficulties Questionnaire (SDQ) will be used to assess mental health difficulties in children. The SDQ is completed as an external proxy report by parents and consists of 25 items, which are distributed across five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior. Items are rated on a 3-point Likert scale ranging from 0 (not true) to 2 (certainly true). For each subscale, items scores are summed to yield a total score. Additionally, a Total Difficulties Score is calculated by summing the scores of the first four subscales, whereas the Prosocial Behavior subscale is analyzed separately. Higher scores on the Total Difficulties Scale indicate increased behavioral and emotional challenges, whereas higher scores on the Prosocial Behavior subscale reflect stronger social competencies.

  From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months)

• Parental well-being measured by the EQ-5D-5L (EuroQol Group, 1990; Herdman et al., 2011)

  Well-being of parents will be measured using the European Quality of Life 5 Dimensions 5 Level Version. Parents assess their level of well-being across five dimensions: Mobility, Self-care, Usual activities, Pain/Discomfort, and Anxiety/Depression. Response options include: no, slightg, moderate, severe, extreme problems. Additionally, participants complete a scale on which they can rate their current health from 0-100, with 100 being the best possible health and 0 the worst possible health. Scores for the five-dimensional scale will be summed and treated separately to the health-scale score.

  From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months).

• Parental mental health measured by the DASS-21 (Lovibond & Lovibond, 1995)

  The Depression, Anxiety and Stress Scale-Short Version will be used to assess mental health in parents over the past seven days based on severity. The 21 items are divided into three 7-item subscales, each representing one of the emotional states. The items are rated on a 4-point Likert-type scale ranging from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). The severity score for each subscale is calculated by summing the valid item scores and multiplying the result by two.

  From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months)

Secondary Outcomes (12)

• Children's Positive Mental Health measured by the PMH-Kids (Lippert et al., 2024)

  From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

• Children's stigma towards mental health measured by the PMHSS (McKeague et al., 2015)

  From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

• Children's Help-seeking behavior measured by the AHSQ (Rickwood & Braithwaite, 1994)

  From baseline (t-1; t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

• Parental Positive Mental Health measured by the PMH (Lukat et al., 2016)

  From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months).

• Parental stigma towards mental health the PMHSS (McKeague et al., 2015)

  From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months).

Other Outcomes (13)

• Mediator-Children's bias in mentalization measured by the Biased Mentalization Task

  From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

• Mediator-Children's Emotion Regulation measured by the ERQ-CA (Gullone & Taffe, 2012)

  From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

• Mediator-Attention regulation (Smolker et al., 2022)

  From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

Study Arms (3)

Intervention Group 1-Lighthouse Program

EXPERIMENTAL

Other: Lighthouse Program

Intervention Group 2-Mentalization Based Skills Training for Parents

EXPERIMENTAL

Other: Mentalization Based Skills Training

Active control group

ACTIVE COMPARATOR

Other: Lighthouse program parenting guidebook

Interventions

Mentalization Based Skills Training OTHER

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.

Also known as: (MBST-P), short program

Intervention Group 2-Mentalization Based Skills Training for Parents

Lighthouse Program OTHER

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.

Also known as: Lighthouse parenting program, Long program

Intervention Group 1-Lighthouse Program

Lighthouse program parenting guidebook OTHER

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

Also known as: Parenting guide

Active control group

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Svenja Taubner: lead
• CHANSE (Collaboration of Humanities and Social Sciences in Europe): collaborator
• University of Geneva, Switzerland: collaborator
• University of La Rioja: collaborator
• Vilnius University: collaborator
• Student organization "Vitaphilie" (Medical Students' Association of the Heidelberg University): collaborator

Study Sites (4)

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

Heidelberg, 69115, Germany

Location

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

Vilnius, 01513, Lithuania

Location

Department of Education Sciences-Universidad de La Rioja

Logroño, 26004, Spain

Location

Faculty of Psychology and Educational Sciences-University of Geneva

Geneva, 1205, Switzerland

Location

Related Publications (5)

• Taubner, S. & Byrne, G. (2026). The Little Boat and Its Lighthouse: A Workbook for the FLOW Study in Eight Stories for Young and Old. Imagine Books.

  BACKGROUND

• Taubner, S., Georg, A., Volkert, J., Hauschild, S., Köllner, C., & Byrne, G. (2020). 12-week LIGHTHOUSE PROGRAMME. Mentalisation-based programme for parents. Manual of the Outpatient Clinic for Family Therapy at the Institute for Psychosocial Prevention adapted for FLOW. Institute for Psychosocial Prevention; Heidelberg University Hospital, Heidelberg University.

  BACKGROUND

• Schultze-Lutter F, Schimmelmann BG, Schmidt SJ. Resilience, risk, mental health and well-being: associations and conceptual differences. Eur Child Adolesc Psychiatry. 2016 May;25(5):459-66. doi: 10.1007/s00787-016-0851-4. No abstract available.

  PMID: 27105994 BACKGROUND

• Dolhanty, J., Hjemseth, V., Austbø, B., & Vassbø Hagen, A. H. (2022). Emotion Focused Skills Training for Parents. Empty Chair Publisher.

  BACKGROUND

• Byrne G, Sleed M, Midgley N, Fearon P, Mein C, Bateman A, Fonagy P. Lighthouse Parenting Programme: Description and pilot evaluation of mentalization-based treatment to address child maltreatment. Clin Child Psychol Psychiatry. 2019 Oct;24(4):680-693. doi: 10.1177/1359104518807741. Epub 2018 Nov 2.

  PMID: 30387373 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Svenja Taubner, Prof.Dr.

CONTACT

+49(0)6221564700; svenja.taubner@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Cross-cultural, prospective, randomized controlled trial with a parallel group design

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: IPD will only be shared upon request with researchers who need the data for their own scientific endeavours or to replicate our findings. The secure sync-and-share service "HeiBox" from the University of Heidelberg will be used to shared anonymised data sets for collaboration.

Locations

DE (1); LI (1); CH (1); ES (1)