Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556576
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
e-Intervention Enhancing Mental Health in Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
e-Intervention Enhancing Mental Health in Adolescents IMPROVA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVA
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 6000 adolescents A 360ยบ 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 eg 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 studys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None