e-Intervention Enhancing Mental Health in Adolescents
NCT06556576 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000
Last updated 2024-08-23
Summary
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.
Conditions
- Well-Being, Psychological
- Depressive Symptoms
- Social Isolation
Interventions
- DEVICE
-
IMPROVA Platform
Adolescents, teachers, school staff, and parents will have access to a variety of content aimed at promoting the mental health and well-being of adolescents that can be accessed through the IMPROVA platform, an innovative eHealth solution that can be accessed via app and website. Students: around 20 modules that can be grouped in five categories: Me and My Emotions, Me and My Body, Me and My Relationships, School and Free time, and Finding my Strengths. Teachers and other school staff: 1) pedagogical and health-related modules to support their students and teaching practices; 2) modules to manage their own health; 3) tutoring sessions: resources (lessons plans) for tutors (teachers or other school staff) for carrying out a discussion with students in topics related to the students' health and wellbeing. Parents: contents on promoting positive relationships, emotional and social skills, positive behaviour, behaviours to support wellbeing, and family-school collaboration.
Sponsors & Collaborators
-
Babes-Bolyai University
collaborator OTHER -
Linkoeping University
collaborator OTHER_GOV -
Betthera s.r.o.
collaborator OTHER -
Wuerzburg University Hospital
collaborator OTHER -
University of Ulm
collaborator OTHER -
Utrecht University
collaborator OTHER -
Ajuntament de Sant Boi de Llobregat
collaborator UNKNOWN -
VU University of Amsterdam
collaborator OTHER -
Institut National de la Santé Et de la Recherche Médicale, France
collaborator OTHER_GOV -
Stichting Trimbos-Instituut
collaborator OTHER -
University of Deusto
collaborator OTHER -
Cliclab Transformative Agent SL
collaborator UNKNOWN -
Fundació Sant Joan de Déu
lead OTHER
Principal Investigators
-
Josep Maria Haro, PhD · Fundació Sant Joan de Déu
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-30
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
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