Skip to main content
Clinical Trials/NCT06556576
NCT06556576
Not Yet Recruiting
N/A

e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)

Fundació Sant Joan de Déu0 sites6,000 target enrollmentSeptember 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Well-Being, Psychological
Sponsor
Fundació Sant Joan de Déu
Enrollment
6000
Primary Endpoint
Strengths and Difficulties Questionnaire (SDQ)
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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)

The SDQ is a brief behavioural screening questionnaire for children and adolescents, typically used to assess various aspects of their behaviour and emotions. It consists of 25 items, divided into five subscales: * Emotional Symptoms * Conduct Problems * Hyperactivity/Inattention * Peer Relationship Problems * Prosocial Behavior Change in the score of the Strengths and Difficulties Questionnaire that ranges from 0 to 40 points (sum of four subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, and Peer Relationship Problems). A higher score indicates a poorer overall mental health. The total score can also be interpreted in the following categories: Normal: 0-13 Borderline: 14-16 Abnormal: 17-40 The Prosocial Behaviour Subscale score ranges from 0 to 10, and is interpreted separately: Normal: 6-10 Borderline: 5 Abnormal: 0-4

Secondary Outcomes

  • KIDSCREEN-10(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)(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(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(Baseline (pre-intervention), mid-term evaluation (during the intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline))
  • Revised Bully/Victim Questionnaire(Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline))
  • GAD-7(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(Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline))
  • Cantril Ladder Scale(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)(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(Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline))
  • 15-item School Engagement Scale(Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline))

Similar Trials