Mental Health, Well-being
Conditions
Keywords
Randomized Control Trial, Parent trainings, Mentalization, Well-Being, Primary school, Mental Health, Prevention
Brief summary
The FLOW project involves the implementation and rigorous evaluation of an evidence-based, multi-level mentalization prevention program targeting social and psychological determinants of well-being in four European countries (Germany, Lithuania, Spain, and Switzerland). Prevention programs will be tailored to the needs of 8-10 year old children in elementary schools and their parents. All children will participate in a project day focused on mental health. Parents will either attend one of two parent trainings of varying lengths or receive a parenting guidebook. A total of 5,000 children, along with their teachers and parents, are included in the survey. To measure long-term effects, surveys are conducted over the course of a whole year. The project examines the following hypotheses: Primary hypotheses: A multilevel mentalization based prevention program will lead to significantly greater improvements in well-being and mental health among children and parents compared to control groups, as measured at the post-intervention assessment. Secondary hypotheses: 1. 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.
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 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. 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.
Interventions
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.
Parenting guidebook on the lighthouse-parent training program (Taubner \& Byrne 2026; The Little Boat and its Lighthouse)
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.
Sponsors
Study design
Intervention model description
Cross-cultural, prospective, randomized controlled trial with a parallel group design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's Positive Mental Health measured by the PMH-Kids (Lippert et al., 2024) | From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months) | 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. |
| Children's stigma towards mental health measured by the PMHSS (McKeague et al., 2015) | From baseline (t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months) | 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. |
| Children's Help-seeking behavior measured by the AHSQ (Rickwood & Braithwaite, 1994) | From baseline (t-1; t0) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months) | 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. |
| Parental Positive Mental Health measured by the PMH (Lukat et al., 2016) | From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months). | 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. |
| Parental stigma towards mental health the PMHSS (McKeague et al., 2015) | From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (F1 after 6 months) to follow-up 2 (F2 after 12 months). | 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. |
| Parents' Help-Seeking Behavior by the GHSQ (Wilson et al., 2005) & AHSQ (Rickwood & Braithwaite, 1994) | 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. |
| Parental Stress measured by the PSS (Berry & Jones, 1995) | 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. |
| Parental efficacy measured by the BPSES (Woolgar et al., 2023) | 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. |
| Parenting practices and parental adjustment measured by the PAFAS (Sanders et al., 2014) | 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. |
| Teacher efficacy measured by the TSES (Scherer et al., 2016) | 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. |
| Perception of classroom climate measured by the TMCI-SF (Sink & Spencer, 2007) | 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. |
| Teacher's stigma towards mental health measured by the PMHSS (McKeague et al., 2015) | 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. |
| Children's mental health knowledge | Time Frame: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months) | 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". |
Countries
Germany, Lithuania, Spain, Switzerland