Clinical trial NCT06556576: e-Intervention Enhancing Mental Health in Adolescents
Official title: e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Depressive Symptoms
Social Isolation
Keywords: Adolescents
School-based interventions
Health promotion
Mental health
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Babes-Bolyai University
name: Linkoeping University
name: Betthera s.r.o.
name: Wuerzburg University Hospital
name: University of Ulm
name: Utrecht University
name: Ajuntament de Sant Boi de Llobregat
name: VU University of Amsterdam
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Stichting Trimbos-Instituut
name: University of Deusto
name: Cliclab Transformative Agent SL
First posted: 2024-08-16
Enrollment: 6000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization will occur at the country level. Within each country (France, Germany, Romania, and Spain), schools will be randomized to either the intervention or control group. This means that in each country, schools will be assigned to one of the two groups, and all students, their families, teachers, and other school staff within those schools will be placed in the respective group. The same procedure will be followed independently within each of the four countries.
Primary purpose: PREVENTION

Brief 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.

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.

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.

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
Secondary outcomes:
measure: KIDSCREEN-10
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Goal-Based Outcome Measure (GBO)
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: PHQ-8
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: GAD-7
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Social isolation questionnaire
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Teachers and Classmate Support Scale
timeFrame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Cantril Ladder Scale
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Single-Item Self-Esteem Scale (SISE)
timeFrame: Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Revised Self-theory Scale
timeFrame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: 15-item School Engagement Scale
timeFrame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
measure: Revised Bully/Victim Questionnaire
timeFrame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
Other outcomes:
Locations:
Study officials:
affiliation: Fundació Sant Joan de Déu
name: Josep Maria Haro, PhD
role: PRINCIPAL_INVESTIGATOR
References: