e-Intervention Enhancing Mental Health in Adolescents

NCT06556576 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2024-08-23

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556576 on ClinicalTrials.gov