e-Intervention Enhancing Mental Health in Adolescents

The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study will co-design, test, evaluate, and facilitate the upscaling of a modular eHealth intervention platform that aims to improve mental health and wellbeing, early detect mental health problems and prevent common mental problems in adolescents. IMPROVA will be implemented in school settings and will include components for adolescents, parents, teachers, and other school staff in complementary and synergistic modules based on materials designed and tested in \>20 projects carried out by the consortium members. After alpha, beta and pilot testing of the platform, the IMPROVA program will be implemented via a randomised controlled trial in secondary education schools in France, Germany, Romania and Spain, including approximately 6,000 adolescents. A 360º evaluation of IMPROVA will include Effectiveness, Implementation, Economic, and Social Return on Investment analysis. The primary outcome to assess the effectiveness of the IMPROVA program is the overall mental health of adolescents. A series of secondary outcomes will also evaluate the potential impact of the platform on other health-related outcomes (e.g., wellbeing, social isolation, anxiety, life satisfaction). Using implementation science methodology, IMPROVA will co-design transferable evidence-based guidance for scaling up the platform with users and policymakers. IMPROVA aims to provide an evidence-based, innovative, large-scale, comprehensive intervention, and a scale-up plan to promote mental health and prevent mental disorders in adolescents; empower adolescents and families to make better decisions regarding their mental health; and provide schools and the community with tools to achieve a society with better mental health and lower stigma.

NCT Number	NCT06556576
Lead Sponsor	Fundació Sant Joan de Déu Collaborators: Babes-Bolyai University, Linkoeping University, Betthera s.r.o., Wuerzburg University Hospital, University of Ulm, Utrecht University, Ajuntament de Sant Boi de Llobregat, VU University of Amsterdam, Institut National de la Santé Et de la Recherche Médicale, France, Stichting Trimbos-Instituut, University of Deusto, Cliclab Transformative Agent SL
Conditions	Well-Being, Psychological, Depressive Symptoms, Social Isolation
Enrollment	6,000 participants
Start Date	2024-09
Primary Completion	2025-12-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-08-23