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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorSvenja Taubner

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Children: Age range 8 to 11 year olds

All participants: Sufficient language knowledge (self-reported)

Disqualifiers

Children: Missing consent forms from all guardians

Datasets that indicate random answer patterns or non-engaged responding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lighthouse Program

    Other intervention

    The Reflective Parenting Lighthouse Program (Byrne et al., 2019; Taubner et al., 2025) consists of 10 weekly group sessions targeting secure attachment parenting behaviors, reflective parenting and dysfunctional parental behavior related to parental mental health problems or trauma.

  • Mentalization Based Skills Training

    Other intervention

    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.

  • Lighthouse program parenting guidebook

    Other intervention

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

Treatment groups

15,200 Participants
are divided into 3 treatment groups
Group A: Intervention Group 1-Lighthouse ProgramExperimental treatment 1 intervention
Group B: Intervention Group 2-Mentalization Based Skills Training for ParentsExperimental treatment 1 intervention
Group C: Active control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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)
2

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.

Time frame
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)
3

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.

Time frame
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).
4

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.

Time frame
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

1

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

The Positive Mental Health Scale for children and adolescents (PMH-Kids) measures positive mental health in children and adolescents between 6 and 18 years old. The scale consists of 9 self-reported items. The items are rated on a 4-point Likert-type scale ranging from 0 (do not agree) to 3 (totally agree). The total score ranges from 0 to 27 with higher scores representing a higher degree of positive mental health.

Time frame
From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
2

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

The Peer Mental Health Stigmatization Scale (PMHSS) will be used to assess stigmatizing attitudes towards children with mental health. The questionnaire comprises 11 items rated on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree).The total stigma score is calculated by summing responses across all items. The resulting scores range from 11 to 55, whereby a lower score indicates a higher level of stigmatization.

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

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

The Actual Help-Seeking Questionnaire will be used to assess actual help-seeking behavior. Children will be asked to tick resources from a provided checklist of 8 potential resources from whom they have sought help in the past six months because they experienced a mental health problem. In addition, they will have the option to add a person not listed, to indicate that they did not seek help from anyone, and to indicate that they did not have a mental health problem in the past six months.

Time frame
From baseline (t-1; t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
4

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

The Positive Mental Health Scale (PMH) will be used to assess positive mental health in parents. The scale consists of 9 self-reported items. The items are rated on a 4-point Likert-type scale ranging from 0 (Do not agree) to 3 (Totally agree). The total score ranges from 0 to 27 with higher scores representing a higher degree of positive mental health.

Time frame
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

1

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

Bias in mentalization, i.e. an overly negative, balanced or overly positive judgment of peer-interactions, will be assessed using an adapted version of the Biased Mentalization Task (Sharp et al., 2007). The adapted version was approved by the authors of the original publication. The Biased Mentalization Task measures biases in mentalizing through the use of 10 ambiguous peer-related social scenarios. The children can choose from three response options: One response option that contains an overly positive bias, one response option that contains an overly negative bias and a balanced response option. Each scenario will be displayed as a video. Frequency analyses and latent class analyses will be used to divide the children into the three bias types.

Time frame
From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
2

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

The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) will be used to assess the use of two emotion regulation strategies - cognitive reappraisal and expressive suppression. The scale consists of 10 items answered on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Subscale scores are calculated as the mean of the valid items.

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

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

The Emotional Word-Emotional Face Stroop (EWEFS) task assesses attentional processes in children by measuring cognitive control over emotionally distracting stimuli and concurrently indexing processing speed and attentional vigilance via performance on congruent trials. On each trial, participants classify the emotional valence of a centrally presented word (positive or negative) via button press while ignoring a task-irrelevant face displaying either congruent or incongruent emotion. The task comprises 96 trials split into two 48-trial blocks: a mostly congruent block (75% congruent, 25% incongruent) and an equal block (50 % congruent, 50 % incongruent). Reaction time (RT) and accuracy on congruent trials capture basic processing speed and attentional vigilance.

Time frame
From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
4

Mediator-Parental Mentalization measured by the PRFQ-A (Luyten et al., 2017)

The Parental Reflective Functioning Questionnaire Adolescent version (PRFQ-A) will be used to assess parental reflective functioning, i.e. a parent's capacity to understand and interpret both their own and their child's mental states. The PRFQ-A consists of 18 self-report items, divided into three subscales: Pre-Mentalizing Modes (PM), Certainty about Mental States (CMS), and Interest and Curiosity (IC). Items are rated on a 7-point Likert-scale ranging from 1= "Strongly disagree" to 7=" Strongly agree". Subscale scores are calculated as the mean of the respective items of each respective subscale. Higher scores on the PM subscale indicate greater difficulties in mentalizing, whereas higher scores on the CMS and IC subscales reflect greater certainty and curiosity about the child's mental states, respectively. It should be noted that a very high score on the CMS or IC subscale may indicate hyper/pseudo-mentalizing.

Time frame
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).

Sponsors and contacts

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Svenja Taubner

Lead sponsor

University Hospital Heidelberg

Sponsor institution

University of Geneva, Switzerland

Collaborator

University of La Rioja

Collaborator

Vilnius University

Collaborator

CHANSE (Collaboration of Humanities and Social Sciences in Europe)

Collaborator

Heidelberg University

Collaborator