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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Children's well-being measured by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010) — 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)
  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.
• Children's mental health measured by the SDQ (Goodman, 1997) — 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)
  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.
• Parental well-being measured by the EQ-5D-5L (EuroQol Group, 1990; Herdman et al., 2011) — 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).
  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.
• Parental mental health measured by the DASS-21 (Lovibond & Lovibond, 1995) — 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)
  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.

Trial sites (4)

Other trials for the same condition