e-Intervention Enhancing Mental Health in Adolescents

NCT06556576 | Not Yet Recruiting

• 1 other identifier: ORG-100042235
• Study Type: interventional
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Well-Being, Psychological; Depressive Symptoms; Social Isolation

Keywords

Adolescents; School-based interventions; Health promotion; Mental health

Outcome Measures

Primary Outcomes (1)

• Strengths and Difficulties Questionnaire (SDQ)

  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

  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 (11)

• 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)

• 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)

• 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)

Study Arms (2)

IMPROVA intervention group

EXPERIMENTAL

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.

Device: IMPROVA Platform

CONTROL group

NO INTERVENTION

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).

Interventions

IMPROVA Platform DEVICE

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.

IMPROVA intervention group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Babes-Bolyai University: collaborator
• Linkoeping University: collaborator
• Betthera s.r.o.: collaborator
• Wuerzburg University Hospital: collaborator
• University of Ulm: collaborator
• Utrecht University: collaborator
• Ajuntament de Sant Boi de Llobregat: collaborator
• VU University of Amsterdam: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Stichting Trimbos-Instituut: collaborator
• University of Deusto: collaborator
• Cliclab Transformative Agent SL: collaborator

MeSH Terms

Conditions

Psychological Well-Being; Depression; Social Isolation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Social Behavior

Study Officials

• Josep Maria Haro, PhD

  Fundació Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo A Lima, PhD

CONTACT

+34 93 640 63 50; rodrigoantunes.lima@sjd.es

Daniele Porricelli, MSc

CONTACT

daniele.porricelli@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: The Intellectual Property and Dissemination Board (IPDB) of the project will still establish the exact duration of the embargo and this might vary for the different datasets.
• Access Criteria: The procedure for data access by third parties will be in accordance with the procedure to be stablished by the Intellectual Property and Dissemination Board of the project.