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Идёт набор NCT07494929

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

Без фазы С лечением Mental Health Well-being

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lighthouse Program, Mentalization Based Skills Training, Lighthouse program parenting guidebook.
Кому может быть актуально
Состояния в реестре: Mental Health, Well-being. Базовые параметры: от 8 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия, Литва, Испания, Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Lighthouse Program
    The Reflective Parenting Lighthouse Program (Byrne et al., 2019; Taubner et al., 2025) consists of 10 weekly group sessions targeting secure attachment parenting behaviors, reflective parenting and dysfunctional parental behavior related to parental mental health problems or trauma.
  • Другое Mentalization Based Skills Training
    The Mentalization Based Skills Training (MBST-P) consists of 6 bi-weekly group sessions and trains essential parental skills on attentional control, emotion regulation and reflective functioning using role plays with the imagined child. The training is based on the EFST-P training (Dolhanty et al., 2022) and adapted by adding a mentalization component for the purpose of the FLOW-study.
  • Другое Lighthouse program parenting guidebook
    Parenting guidebook on the lighthouse-parent training program (Taubner \& Byrne 2026; The Little Boat and its Lighthouse)

Первичные конечные точки

  • Children's well-being measured by the KIDSCREEN-10 (Ravens-Sieberer et al., 2010) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]
Вторичные конечные точки (12)
  • Children's Positive Mental Health measured by the PMH-Kids (Lippert et al., 2024) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From enrollment (t-1) to post (t1 after end of interventions at 3 months) to follow-up 1 (FU1 after 6 months)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Германия · 1 центр
  • Institut für Psychosoziale Prävention-Department für Psychosoziale Medizin, Prävention und — Heidelberg
Литва · 1 центр
  • Developmental Psychopathology Research Center-Institute of Psychology- Faculty of Philosop — Vilnius
Испания · 1 центр
  • Department of Education Sciences-Universidad de La Rioja — Logroño
Швейцария · 1 центр
  • Faculty of Psychology and Educational Sciences-University of Geneva — Geneva

Публикации

  • 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. PMID 27105994
  • Dolhanty, 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. PMID 30387373

Идентификаторы

NCT: NCT07494929 · 539850647 · 539850647 · S-NORFACE-25-1 · PCI2025-163191 · FNS 10NR17_222938

Первоисточники (государственные реестры)

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