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

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dc.contributor.authorAntunes, Rodrigo
dc.contributor.authorBaumeister, Harald
dc.contributor.authorPryss, Rüdiger
dc.contributor.authorKüchler, Ann-Marie
dc.contributor.authorKraft, Robin
dc.contributor.authorBerghoff, Nils
dc.contributor.authorNagel, Luzia
dc.contributor.authorReichert, Manfred
dc.contributor.authorIdrees, Abdul Rahman
dc.contributor.authorStach, Michael
dc.contributor.authorMelchior, Maria
dc.contributor.authorDavisse-Paturet, Camille
dc.contributor.authorFalkiner, Emma
dc.contributor.authorvan der Waerden, Judith
dc.contributor.authorBaban, Adriana
dc.contributor.authorTaut, Diana
dc.contributor.authorDanila, Ingrid
dc.contributor.authorPerez Anton, Mariona
dc.contributor.authorPorricelli, Daniele
dc.contributor.authorSanguesa, Julia
dc.contributor.authorMoneta, María Victoria
dc.contributor.authorGarcía Carrión, Rocío
dc.contributor.authorFinkenauer, Catrin
dc.contributor.authorGonneke Stevens
dc.contributor.authorKrabbendam, Lydia
dc.contributor.authorBolinski, Felix
dc.contributor.authorMaresova, Petra
dc.contributor.authorNilsen, Per
dc.contributor.authorKarlsson, Nadine
dc.contributor.authorMoreno, Natalia
dc.contributor.authorLe Corvec, Anaïs
dc.contributor.authorHaro, Josep Maria
dc.date.accessioned2026-05-25T15:25:47Z
dc.date.available2026-05-25T15:25:47Z
dc.date.issued2026-04-28
dc.date.updated2026-05-25T15:25:47Z
dc.description.abstractINTRODUCTION: 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. en
dc.description.sponsorshipThis work was supported by the European Union’s Horizon Europe research and innovation programme, grant number [101080934]. RAL received the IHMC22/00003, funded by Instituto de Salud Carlos III and Next Generation EU funds, which finance the actions of the Recovery and Resilience Mechanism (RRM)en
dc.identifier.citationLima, R. A., Baumeister, H., Pryss, R., Küchler, A.-M., Kraft, R., Berghoff, N., Nagel, L., Reichert, M., Idrees, A. R., Stach, M., Melchior, M., Davisse-Paturet, C., Falkiner, E., van der Waerden, J., Baban, A., Taut, D., Danila, I., Perez-Anton, M., Porricelli, D., et al. (2026). 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. BMJ open, 16(4), e108674. https://doi.org/10.1136/BMJOPEN-2025-108674
dc.identifier.doi10.1136/BMJOPEN-2025-108674
dc.identifier.eissn2044-6055
dc.identifier.urihttps://hdl.handle.net/20.500.14454/6061
dc.language.isoeng
dc.rights© Author(s) (or their employer(s)) 2026
dc.subject.otherAdolescents
dc.subject.otherCommunity child health
dc.subject.otherEHealth
dc.subject.otherMENTAL HEALTH
dc.subject.otherPsychosocial Intervention
dc.titleStudy 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 countriesen
dc.typejournal article
dcterms.accessRightsopen access
oaire.citation.issue4
oaire.citation.startPagee108674
oaire.citation.titleBMJ open
oaire.citation.volume16
oaire.licenseConditionhttps://creativecommons.org/licenses/by/4.0/
oaire.versionVoR
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