{
  "abstract": "Introduction This trial aims to evaluate the impact of the IMPROVA intervention programme in improving mental health, quality of life, and well-being in adolescents enrolled in secondary schools in four European countries.Methods and analysis The IMPROVA intervention will be evaluated using a two-arm parallel group pragmatic cluster randomised controlled trial with an intervention and a wait-list control group. Secondary schools in France, Germany, Romania, and Spain were recruited. Originally, we estimated to enrol a total of 6000 students within 64 schools; that is, 16 schools per country. The IMPROVA programme is a multi-level intervention that provides tailored content for adolescents, families, and school staff. This content creates a unified and supportive framework that promotes mental health and social-emotional development among adolescents. A series of implementation strategies was planned to support the uptake of the programme into the education setting and among participants. Study outcomes were assessed at baseline, mid-term (during the intervention), postintervention (primary end point), and will be assessed at postintervention (secondary end-point; 6 months after postintervention). Overall mental health (Strengths and Difficulties Questionnaire) is the primary outcome. Secondary outcomes include: health-related quality of life, depression, anxiety, social isolation, and self-esteem. The trial will be evaluated regarding its effectiveness, cost-effectiveness, implementation, and social return on investment analysis.Ethics and dissemination This study has received the approval of human research ethics committees in France (Comité de Protection des Personnes Ile-de-France VIII”, No. 2024-A00201-46), Germany (Ulm University Ethics Committee, No. 186-24), Romania (The Research Ethics Subcommittee of the Babeș-Bolyai University of Cluj-Napoca, No. 14.146/23.09.2024), and Spain (CEIm Fundació Sant Joan de Déu, No. PIC-61-24). Results will be disseminated through peer-reviewed open-access publications and presentations at national and international conferences. Non-technical summaries will be shared with public health authorities, participants, and stakeholder organisations. All findings will be reported in aggregate form, ensuring no individual participant can be identified.Trial registration number NCT06556576.",
  "authors": [
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain",
        "Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Rodrigo Antunes Lima"
    },
    {
      "affiliations": [
        "Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany",
        "Partner site Mannheim-Heidelberg-Ulm, German Center for Mental Health (DZPG), Ulm, Germany",
        "Partner site Ulm, German Center for Child and Adolescent Health (DZKJ), Ulm, Germany"
      ],
      "name": "Harald Baumeister"
    },
    {
      "affiliations": [
        "Institute of Medical Data Science, University Hospital Wurzburg, Würzburg, Germany",
        "Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany"
      ],
      "name": "Rüdiger Pryss"
    },
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain",
        "Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany"
      ],
      "name": "Ann-Marie Küchler"
    },
    {
      "affiliations": [
        "Institute of Medical Data Science, University Hospital Wurzburg, Würzburg, Germany",
        "Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany"
      ],
      "name": "Robin Kraft"
    },
    {
      "affiliations": [
        "Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany"
      ],
      "name": "Nils Berghoff"
    },
    {
      "affiliations": [
        "Clinical Psychology and Psychotherapy, University of Ulm, Ulm, Germany"
      ],
      "name": "Luzia Nagel"
    },
    {
      "affiliations": [
        "Institute of Databases and Information Systems, Ulm University, Ulm, BW, Germany"
      ],
      "name": "Manfred Reichert"
    },
    {
      "affiliations": [
        "Institute of Medical Data Science, University Hospital Wurzburg, Würzburg, Germany",
        "Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany"
      ],
      "name": "Abdul Rahman Idrees"
    },
    {
      "affiliations": [
        "Institute of Medical Data Science, University Hospital Wurzburg, Würzburg, Germany",
        "Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany"
      ],
      "name": "Michael Stach"
    },
    {
      "affiliations": [
        "INSERM, Pierre Louis Institute of Epidemiology and Public Health, IPLESP, Social Epidemiology, Mental Health and Addictions, ESSMA, Sorbonne Université, Paris, France"
      ],
      "name": "Maria Melchior"
    },
    {
      "affiliations": [
        "INSERM, Pierre Louis Institute of Epidemiology and Public Health, IPLESP, Social Epidemiology, Mental Health and Addictions, ESSMA, Sorbonne Université, Paris, France"
      ],
      "name": "Camille Davisse-Paturet"
    },
    {
      "affiliations": [
        "INSERM, Pierre Louis Institute of Epidemiology and Public Health, IPLESP, Social Epidemiology, Mental Health and Addictions, ESSMA, Sorbonne Université, Paris, France"
      ],
      "name": "Emma Falkiner"
    },
    {
      "affiliations": [
        "Pierre Louis Institute of Epidemiology and Public Health, IPLESP, Social Epidemiology, Mental Health and Addictions, ESSMA, Sorbonne Université, INSERM, Paris, France"
      ],
      "name": "Judith van der Waerden"
    },
    {
      "affiliations": [
        "Department of Psychology, Babes-Bolyai University, Romania, Cluj-Napoca, Romania"
      ],
      "name": "Adriana Baban"
    },
    {
      "affiliations": [
        "Department of Psychology, Babes-Bolyai University, Romania, Cluj-Napoca, Romania"
      ],
      "name": "Diana Taut"
    },
    {
      "affiliations": [
        "Department of Psychology, Babes-Bolyai University, Romania, Cluj-Napoca, Romania"
      ],
      "name": "Ingrid Danila"
    },
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain",
        "Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain",
        "Departament de Psicologia Clínica i de la Salut, Universitat Autonoma de Barcelona, Bellaterra, Spain"
      ],
      "name": "Mariona Perez-Anton"
    },
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain"
      ],
      "name": "Daniele Porricelli"
    },
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain",
        "Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Julia Sanguesa"
    },
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain",
        "Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Maria Victoria Moneta"
    },
    {
      "affiliations": [
        "Department of Education, University of Deusto, Bilbao, Spain",
        "Ikerbasque, Basque Foundation for Science, Bilbao, Spain"
      ],
      "name": "Rocío García-Carrión"
    },
    {
      "affiliations": [
        "Department of Interdisciplinary Social Science, Utrecht University, Utrecht, Netherlands"
      ],
      "name": "Catrin Finkenauer"
    },
    {
      "affiliations": [
        "Department of Interdisciplinary Social Science, Utrecht University, Utrecht, Netherlands"
      ],
      "name": "Gonneke WJM Stevens"
    },
    {
      "affiliations": [
        "Department of Clinical, Neuro-and Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands"
      ],
      "name": "Lydia Krabbendam"
    },
    {
      "affiliations": [
        "Department of Public Mental Health, Trimbos Instituut, Netherlands Institute of Mental Health and Addiction, Utrecht, Netherlands"
      ],
      "name": "Felix Bolinski"
    },
    {
      "affiliations": [
        "Betthera s.r.o, Hradec Králové, Czech Republic"
      ],
      "name": "Petra Maresova"
    },
    {
      "affiliations": [
        "Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden"
      ],
      "name": "Per Nilsen"
    },
    {
      "affiliations": [
        "Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden"
      ],
      "name": "Nadine Karlsson"
    },
    {
      "affiliations": [
        "Ajuntament de Sant Boi de Llobregat, Sant Boi de Llobregat, Spain"
      ],
      "name": "Natalia Moreno"
    },
    {
      "affiliations": [
        "Cliclab Transformative Agent SL, Barcelona, Spain"
      ],
      "name": "Anaïs Le Corvec"
    },
    {
      "affiliations": [
        "Impact and Prevention of Mental Disorders Research Group, Institut de Recerca Sant Joan de Déu (IRSJD), Esplugues de Llobregat, Spain",
        "Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Josep Maria Haro"
    }
  ],
  "title": "Study protocol of the e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) project: a randomised controlled trial to promote adolescents’ mental health and well-being in four European countries",
  "uid": "94e2e6e8-e44b-5cc0-8f54-3a456be7cd41"
}