e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)

Fundació Sant Joan de Déu

Status: Not yet enrolling

Conditions: Depressive Symptoms; Social Isolation; Well-Being, Psychological

Treatments: Device: IMPROVA Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06556576

ORG-100042235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

IMPROVA intervention group

Experimental group

Description:

Participants (students, parents, teachers and other school staff) in the IMPROVA group will have access to a series of resources and training with the ultimate goal of promoting mental health and wellbeing among adolescents. This material will be delivered via the IMPROVA platform throughout one school year. IMPROVA platform will be available in app and web-based formats, and participants will be encouraged to utilize it as frequently as possible.

Treatment:

Device: IMPROVA Platform

CONTROL group

No Intervention group

Description:

Participants in the control group will not have access to the IMPROVA platform. Their school routine and the support they usually receive will remain unchanged. After the intervention period (school year 2024/25), schools, teachers, school staff, adolescents and their families in the control group will be able to access the IMPROVA platform during the school year 2025/26 (waiting list control group).