e-Intervention Enhancing Mental Health in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMPROVA Platform.
- Who it may be relevant to
- Registry conditions: Well-Being, Psychological, Depressive Symptoms, Social Isolation. Basic parameters: from 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)
Overview
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.
Detailed description
The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study's main objective is to co-design, test 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.
The IMPROVA program is a universal intervention to be implemented in school settings and will include components for adolescents, parents, teachers, and other school staff. Therefore, teachers and other school staff working in secondary schools in France, Germany, Romania and Spain together with enrolled students and their parents will be invited to access the intervention content via an eHealth platform - The IMPROVA platform.
Users will be able to access the contents via an app or web browser. Each user type will have access to content specifically tailored for them, with the ultimate goal of promoting mental health and wellbeing among adolescents.
* Students will have access to around 20 modules that can be grouped into five categories: Me and My Emotions, Me and My Body, Me and My Relationships, Schools and Free time, and Finding my Strengths. * Teachers and other school staff will have access to pedagogical and health-related modules aiming to support their students and teaching practices (Supporting students), and to modules to manage their health (My own health). In addition, the tutoring sessions are 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 will have access to content on promoting positive relationships, emotional and social skills, positive behaviour, behaviours to support wellbeing, and family-school collaboration.
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) peda
Primary outcome measures
- Strengths and Difficulties Questionnaire (SDQ) [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
Secondary outcome measures (11)
- KIDSCREEN-10 [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Goal-Based Outcome Measure (GBO) [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- PHQ-8 [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- GAD-7 [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Social isolation questionnaire [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Teachers and Classmate Support Scale [Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Cantril Ladder Scale [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Single-Item Self-Esteem Scale (SISE) [Time frame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Revised Self-theory Scale [Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- 15-item School Engagement Scale [Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
- Revised Bully/Victim Questionnaire [Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)]
Eligibility criteria
Inclusion criteria
- Adolescents enrolled in the selected secondary schools will be eligible.
- Parents of adolescents enrolled in the selected schools will be eligible
- Teachers and school staff: All teachers and school staff working in the selected schools will be eligible.
- Participants can be of any gender.
- Teachers and school staff will have to be older than 18 years.
Exclusion criteria
- Apart from not signing the informed consent, no exclusion criteria will be applied.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Lima RA, Baumeister H, Pryss R, Kuchler AM, Kraft R, Berghoff N, Nagel L, Reichert M, Idrees AR, Stach M, Melchior M, Davisse-Paturet C, Falkiner E, van der Waerden J, Baban A, Taut D, Danila I, Perez-Anton M, Porricelli D, Sanguesa J, Moneta MV, Garcia-Carrion R, Finkenauer C, Stevens GW, Krabbendam L, Bolinski F, Maresova P, Nilsen P, Karlsson N, Moreno N, Le Corvec A, Haro JM. Study protocol of PMID 42049303
Identifiers
NCT: NCT06556576 · ORG-100042235