Mental HealthFLOWNCT07494929
A Mentalization Based Prevention Program to Foster Well-Being and Mental Health in Pre-Adolescent Children and Their Families
A study testing Lighthouse Program, Mentalization Based Skills Training and Lighthouse program parenting guidebook in people with Mental Health and Well-being, run by Svenja Taubner at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Well-being
- What is being tested?
- Lighthouse Program, Mentalization Based Skills Training and Lighthouse program parenting guidebook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,200 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 14 Apr 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children: Age range 8 to 11 year olds
- All participants: Sufficient language knowledge (self-reported)
Who cannot join
- Children: Missing consent forms from all guardians
- Datasets that indicate random answer patterns or non-engaged responding
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Germany1 site, 1 recruiting
- Recruiting
Institut für Psychosoziale Prävention-Department für Psychosoziale Medizin, Prävention und Familiengesundheit-Universitätsklinikum Heidelberg
Heidelberg, 69115
Svenja Taubner, Prof.Dr., +49(0)6221-564700, svenja.taubner@med.uni-heidelberg.de
Sophia Peter, Msc., +49 6221 56 37569, sophia.peter@med.uni-heidelberg.de
Lithuania1 site, 1 recruiting
- Recruiting
Developmental Psychopathology Research Center-Institute of Psychology- Faculty of Philosophy-Vilnius university
Vilnius, 01513
Rasa Barkauskienė, Prof.Dr., +370 5 266 7605, rasa.barkauskiene@fsf.vu.lt
Spain1 site, 1 recruiting
- Recruiting
Department of Education Sciences-Universidad de La Rioja
Logroño, 26004
Eduardo Fonseca Pedrero, Prof.Dr., eduardo.fonseca@unirioja.es
Switzerland1 site, 1 recruiting
- Recruiting
Faculty of Psychology and Educational Sciences-University of Geneva
Geneva, 1205
Martin Debbané, Prof.Dr., +22 3799418, Martin.Debbane@unige.ch
About this study
Official title: 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:
Read more
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:
- 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.
- A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement.
- 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.
- 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.
- The longer intervention group will yield greater improvements in outcome measures compared to the shorter intervention group.
Read the 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:
- 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?
- Is a multi-level mentalization based prevention program for children and parents effective in changing effective parenting, help-seeking or classroom climate change?
- What is the appropriate treatment with regard to family needs and resources to sustain well-being and mental health in children?
Primary goals:
- Promote well-being in parents and children.
- Promote mental health in parents and children
Secondary goals:
- Children: Improve help-seeking behaviour and positive mental health; Decrease mental health stigma.
- Parents: Improve help-seeking behavior, parental efficacy, child-parent interaction and positive mental health; Decrease parental stress and mental health stigma.
- Teachers: Improve perception of classroom climate and teaching self-efficacy; Decrease mental health stigma.
- 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.
- 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 10 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.
- 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).
- 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, Well-being
- Being tested
- Lighthouse Program, Mentalization Based Skills Training, Lighthouse program parenting guidebook
- Keywords
- Randomized Control Trial, Parent trainings, Mentalization, Well-Being, Primary school, Mental Health, Prevention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lighthouse ProgramOther
Also called Lighthouse parenting program, Long 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 TrainingOther
Also called (MBST-P), short program
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 guidebookOther
Also called Parenting guide
Parenting guidebook on the lighthouse-parent training program (Taubner \& Byrne 2026; The Little Boat and its Lighthouse)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1-Lighthouse Program | Experimental | Not described Receives: Other: Lighthouse Program |
| Intervention Group 2-Mentalization Based Skills Training for Parents | Experimental | Not described Receives: Other: Mentalization Based Skills Training |
| Active control group | Active comparator | Not described Receives: Other: Lighthouse program parenting guidebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (13)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
Children's mental health knowledge
Description: The Children's Mental Health knowledge questionnaire is a self-constructed questionnaire comprising 16 items. It will be used to assess the gain of knowledge on mental health and help-seeking related to the content taught in the universal prevention programm. stigmatizing attitudes towards children with mental health. The questionnaire comprises 17 items that can be answered with either "True", "False" or "I don't know". "I don't know"-type responses are coded as "False".
Measured: Time Frame: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start14 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cross-cultural, prospective, randomized controlled trial with a parallel group design
- Masking
- None (open label)
- Enrolment
- 15,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Svenja Taubner
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, University of La Rioja, Vilnius University, CHANSE (Collaboration of Humanities and Social Sciences in Europe), Heidelberg University
- Responsible party
- Sponsor-investigator, Svenja Taubner, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494929
- Sponsor's protocol ID
- 539850647
- Other IDs
- 539850647, S-NORFACE-25-1, PCI2025-163191, FNS 10NR17_222938
- Acronym
- FLOW
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised quantitative participant data will be shared upon request.
Publications
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.
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.
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.
PubMed 27105994Dolhanty, J., Hjemseth, V., Austbø, B., & Vassbø Hagen, A. H. (2022). Emotion Focused Skills Training for Parents. Empty Chair Publisher.
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.
PubMed 30387373
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foster Long-term Well-being in Pre-adolescent Children and Their Families
- ClinicalTrials.gov ID
- NCT07494929
- Acronym / sponsor ID
- FLOW / 539850647
- Conditions
- Mental Health, Well-being
- Keywords
- Randomized Control Trial, Parent trainings, Mentalization, Well-Being, Primary school, Mental Health, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15,200 participants (estimated)
- Lead sponsor
- Svenja TaubnerUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, University of La Rioja, Vilnius University, CHANSE (Collaboration of Humanities and Social Sciences in Europe), Heidelberg University
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- A universal prevention program on mental health improves classroom climate and increases teaching efficacy at post and follow-up measurement.
- 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.
- 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.
- 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:
- 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?
- Is a multi-level mentalization based prevention program for children and parents effective in changing effective parenting, help-seeking or classroom climate change?
- What is the appropriate treatment with regard to family needs and resources to sustain well-being and mental health in children?
Primary goals:
- Promote well-being in parents and children.
- Promote mental health in parents and children
Secondary goals:
- Children: Improve help-seeking behaviour and positive mental health; Decrease mental health stigma.
- Parents: Improve help-seeking behavior, parental efficacy, child-parent interaction and positive mental health; Decrease parental stress and mental health stigma.
- Teachers: Improve perception of classroom climate and teaching self-efficacy; Decrease mental health stigma.
- 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.
- 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 10 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.
- 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).
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cross-cultural, prospective, randomized controlled trial with a parallel group design
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Children: Age range 8 to 11 year olds
- All participants: Sufficient language knowledge (self-reported)
Key exclusion criteria (2 listed)
- Children: Missing consent forms from all guardians
- Datasets that indicate random answer patterns or non-engaged responding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lighthouse ProgramAlso: Lighthouse parenting program, Long programThe 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. | Other | Intervention Group 1-Lighthouse Program |
| Mentalization Based Skills TrainingAlso: (MBST-P), short programThe 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 | Intervention Group 2-Mentalization Based Skills Training for Parents |
| Lighthouse program parenting guidebookAlso: Parenting guideParenting guidebook on the lighthouse-parent training program (Taubner \& Byrne 2026; The Little Boat and its Lighthouse) | Other | Active control group |
Primary outcome
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.
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.
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.
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.
13 secondary outcomes
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)
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)
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)
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).
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).
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).
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).
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).
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).
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)
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)
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)
Children's mental health knowledge
Time frame: Time Frame: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- BackgroundTaubner, 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.
- BackgroundTaubner, 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: PubMed 27105994Schultze-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.
- BackgroundDolhanty, J., Hjemseth, V., Austbø, B., & Vassbø Hagen, A. H. (2022). Emotion Focused Skills Training for Parents. Empty Chair Publisher.
- Background: PubMed 30387373Byrne 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.
- Individual participant dataSharing planned: Yes. Anonymised quantitative participant data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lighthouse Program, Mentalization Based Skills Training and Lighthouse program parenting guidebook in people with Mental Health and Well-being, run by Svenja Taubner at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Lithuania, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Svenja Taubner, Prof.Dr. (+49(0)6221564700, svenja.taubner@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494929, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.