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

April 21, 2026 updated by: Svenja Taubner

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

15200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Heidelberg, Germany, 69115
        • Institut für Psychosoziale Prävention-Department für Psychosoziale Medizin, Prävention und Familiengesundheit-Universitätsklinikum Heidelberg
        • Contact:
        • Contact:
      • Vilnius, Lithuania, 01513
        • Developmental Psychopathology Research Center-Institute of Psychology- Faculty of Philosophy-Vilnius university
        • Contact:
      • Logroño, Spain, 26004
        • Department of Education Sciences-Universidad de La Rioja
        • Contact:
      • Geneva, Switzerland, 1205
        • Faculty of Psychology and Educational Sciences-University of Geneva
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children: Age range 8 to 11 year olds
  • All participants: Sufficient language knowledge (self-reported)

Exclusion Criteria:

  • Children: Missing consent forms from all guardians
  • Datasets that indicate random answer patterns or non-engaged responding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active control group
Parenting guidebook on the lighthouse-parent training program (Taubner & Byrne 2026; The Little Boat and its Lighthouse)
Other Names:
  • Parenting guide
Experimental: Intervention Group 1-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 Names:
  • Lighthouse parenting program
  • Long program
Experimental: Intervention Group 2-Mentalization Based Skills Training for Parents
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 Names:
  • (MBST-P)
  • short program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's well-being measured by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010)
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)
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)
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)
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)
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).
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)
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Positive Mental Health measured by the PMH-Kids (Lippert et al., 2024)
Time Frame: From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
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.
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)
Time Frame: From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
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.
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)
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)
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.
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)
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).
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.
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)
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).
The Peer Mental Health Stigmatization Scale (PMHSS) (McKeague et al., 2015) 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.
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).
Parents' Help-Seeking Behavior by the GHSQ (Wilson et al., 2005) & AHSQ (Rickwood & Braithwaite, 1994)
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).
The General Help-Seeking Questionnaire will be administered to assess the intentional help-seeking. Parents rate 8 items using a 7-point Likert scale (Extremely unlikely-Extremely likely). The questionnaire lists 8 potential sources of help options and an open-ended response to specify other persons not listed. For scoring purposes, the sum is used to calculate an overall score between 8 and 56. Higher scores indicate greater help-seeking intentions. The Actual Help-Seeking Questionnaire will be used to assess actual help-seeking behavior. Parents 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 their child 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.
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 Stress measured by the PSS (Berry & Jones, 1995)
Time Frame: From enrollment (t-1) to post (after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months).
The Parental Stress Scale will be employed to assess parents' current levels of perceived stress in their caregiving role. The scale consists of 10 self-report items that are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated by summing all item responses, with higher scores indicating greater levels of parental stress.
From enrollment (t-1) to post (after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months).
Parental efficacy measured by the BPSES (Woolgar et al., 2023)
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).
The Brief Parental Self-Efficacy Scale will be used to assess parents' perceived self-efficacy in managing disruptive child behavior. This self-report questionnaire consists of five items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 5 to 25, with higher scores indicating greater parental self-efficacy.
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).
Parenting practices and parental adjustment measured by the PAFAS (Sanders et al., 2014)
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).
The Parenting and Family Adjustment Scales will be used to assess parenting practices and family adjustment. The PAFAS consists of 30 self-report items. It has two major subscales, the "Parenting practices" (18 items) subscale and the "Family adjustment" (12 items) subscale. The major subscales are further subdivided into minor subscales. All items are scored on a 4-point Likert scale ranging from 0 = "not at all (true)" to 3 = "very much (true)". The total score ranges from 0 to 90 and is calculated by summing the item responses. Higher overall scores indicate higher difficulty coping with the emotional demands of parenting, a strained child-parent relationship and greater use of coercive parenting techniques.
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).
Teacher efficacy measured by the TSES (Scherer et al., 2016)
Time Frame: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
The Teachers' Sense of Self-Efficacy Scale-Short Version (TSES) version will be used to assess teachers' beliefs in their ability to influence student engagement, implement effective instructional practices, and manage classroom environment. The scale consists of 12 items, measuring three dimensions of self-efficacy: classroom management, instruction, and student engagement. Items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (a lot). The overall self-efficacy score is calculated as the mean of the valid item responses.
From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
Perception of classroom climate measured by the TMCI-SF (Sink & Spencer, 2007)
Time Frame: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
The My Class Inventory - Short Form for Teachers (TMCI-SF) will be used to assess teachers' perceptions of classroom climate across five domains: Satisfaction, Friction, Competitiveness, Difficulty, and Peer Relations, as well as the perceived impact of the school counselor. The instrument consists of 24 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate more favorable perceptions in the domains of Satisfaction, Peer Relations, and School Counselor Impact, whereas lower scores are desirable in the domains of Friction, Competitiveness, and Difficulty. Total and subscale scores are computed by summing up the respective item responses.
From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
Teacher's stigma towards mental health measured by the PMHSS (McKeague et al., 2015)
Time Frame: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
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.
From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediator-Children's bias in mentalization measured by the Biased Mentalization Task
Time Frame: From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
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 will be used to divide the children into the three bias types.
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)
Time Frame: From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
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.
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)
Time Frame: From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
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.
From baseline (t0) to post ( t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
Mediator-Parental Emotion Regulation measured by the ERQ (Gross & John, 2003)
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).
The Emotion Regulation Questionnaire (ERQ) will be used to assess the use of two emotion regulation strategies - cognitive reappraisal and expressive suppression - in parents. The scale consists of 10 items answered on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Subscale scores are calculated as the mean of the valid items.
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).
Moderator-Parental adverse childhood experiences measured by the ACE-Q (Felitti et al., 1998)
Time Frame: At enrollment (t-1)
Parental adverse childhood experiences will be measured using the ACE-Q. The tool consists of a checklist of 10 adverse childhood experiences that cover neglect, emotional, physical, sexual abuse experienced as a child as well as drug problems, mental illness or incarceration of caregivers. Parents will be asked to answer the questions based on their own experiences up to the age of 18 years. Each checked item adds a score of 1. Vulnerability for a decrease in well-being correlates with higher ACE-Q scores, however a score above 4 is considered a particularly high risk.
At enrollment (t-1)
Moderator-Parental Personality Functioning measured by the LPFS-BF (Hutsebaut et al., 2016)
Time Frame: At enrollment (t-1)
The Levels of Personality Functioning Scale-Brief Form will be used to assess self-reported personality dysfunction based on the DSM-5 Alternative Model for Personality Disorders. The LPFS-BF consists of 12 items and is divided into two 6-item subscales: Self-Functioning and Interpersonal Functioning. Items are rated using a binary response format: 0 (No) or 1 (Yes). Scores are summed for each subscale and for the total scale, with higher scores indicating greater impairment in personality functioning.
At enrollment (t-1)
Moderator-Parental Social Support measured by the MSPSS (Zimet et al., 1988)
Time Frame: At enrollment (t-1)
The Multidimensional Scale of Perceived Social Support (MSPSS) will be used to assess self-reported social support in parents. The 12 items relate to support from family, friends and significant other and are rated on a 7-point Likert scale ranging from 1 (Very Strongly Disagree) to 7 (Very Strongly Agree). A total mean 1 to 2.9 is considered "low support".
At enrollment (t-1)
Moderator-Household income
Time Frame: At enrollment (t-1)

Parents will be asked how many members live in their household and what their monthly household income is after social transfers (net) (i.e., net of government benefits and taxes) in Euros.

To identify households at risk of poverty, this study will use the EU-SILC (European Union Statistics on Income and Living Conditions) definition of poverty risk, as applied within each respective country (Eurostat, 2022). The at-risk-of-poverty threshold is defined as 60% of the national median equivalized disposable income after social transfers, adjusted for household size and composition using the modified OECD equivalence scale.

At enrollment (t-1)
Moderator-Parental Level of education
Time Frame: At enrollment (t-1)
Parents will be asked to choose the most applicable of eight levels of education options ranging from "left school without degree" to "university degree". In addition, parents will have the option to add a level of education that was not listed or tick "other" as an option.
At enrollment (t-1)
Moderator-Migration background
Time Frame: At enrollment (t-1)
The official definition of the Federal Statistical Office of Germany will be used to collect data on participants' migration background. Children, parents and teachers will be asked three binary (yes/no) questions about their own place of birth as well as the place of birth of their parents. Additionally, parents attending without the other parent of the child will be asked to provide details about the other parent's place of birth.
At enrollment (t-1)
Covariate: General cognitive ability (IQ-proxy) measured by the Shortened Raven's Standard Progressive Matrices (Langener et al., 2022)
Time Frame: At baseline (t0)

Children's general cognitive ability will be assessed using the shortened 15-item version of the Raven's Standard Progressive Matrices (RSPM; Raven, 1989), adapted specifically for children and adolescents. The shortened RSPM strongly predicts the full 60-item RSPM scores (r = .89 for ages 9-12).

The test has one practice item where participants receive feedback. The 15 test items do not contain feedback.

Each participant's total score on the 15-item version is calculated by summing the number of correct answers, resulting in a raw score ranging from 0 to 15. This raw score serves as a proxy measure of general cognitive ability, however, it cannot be used for diagnostic purposes. Norm references do not exist but will be calculated within the FLOW-study.

At baseline (t0)
Covariate: Children's Social Desirability measured by the Social Desirability Short Scale (Miller et al., 2015)
Time Frame: At baseline (t0)
The Children's Social Desirability Short Scale (CSD-S) will be used to measure social desirability bias in children (Miller et al., 2015). The scale consists of 14 binary (yes/no) items. An example item is: "Do you always listen to your parents?". The total score ranges from 0 to 14, with higher scores indicating greater social desirability bias. The internal consistency of the instrument is good (Cronbach's α = .83).
At baseline (t0)
Mediator-Parental Mentalization measured by the PRFQ-A (Luyten et al., 2017)
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 539850647 (Other Grant/Funding Number: Deutsche Forschungsgemeinschaft)
  • S-NORFACE-25-1 (Other Grant/Funding Number: Research Council of Lithuania)
  • PCI2025-163191 (Other Grant/Funding Number: Ministerio de Ciencia, Innovación y Universidades del gobierno de España y la Agencia Estatal de Investigación)
  • FNS 10NR17_222938 (Other Grant/Funding Number: Swiss National Science Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised quantitative participant data will be shared upon request.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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