e-Intervention Enhancing Mental Health in Adolescents
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorFundació Sant Joan de Déu
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
IMPROVA Platform
DeviceAdolescents, 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.
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: IMPROVA intervention groupExperimental treatment 1 intervention
Group B: CONTROL groupNo intervention 0 interventions
Trial outcomes
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
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)Secondary outcomes
1
KIDSCREEN-10
KIDSCREEN-10 has 10 items and measures general health-related quality of life (HRQoL) for adolescents. Scoring: Each item on the KIDSCREEN-10 is rated on a 5-point Likert scale, reflecting the frequency or intensity of the feelings or behaviours described. The scores for the 10 items are summed to produce a total score. This total score can then be transformed into a T-score or percentile rank, based on normative data, to facilitate interpretation. The higher the total score, the better the reported HRQoL.
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)2
Goal-Based Outcome Measure (GBO)
It is a method used to assess treatment progress and outcomes based on specific goals set by the adolescent. It is designed to capture changes in individuals' functioning and well-being that are meaningful and relevant to them, rather than relying solely on standardized symptom measures. Adolescents will be asked to select three goals they would like to achieve by the end of the current school year, and on a scale from 0 to 10, choose the number that best describes how close they are to reaching their goal on that moment (0 means no progress has been made towards a goal, a score of 10 means a goal has been reached fully).
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)3
PHQ-8
The PHQ-8 consists of 8 items that correspond to the diagnostic criteria for major depressive disorder (MDD) in the DSM-IV and DSM-5. Each item addresses a specific symptom of depression and is rated based on the frequency of the symptom over the past two weeks. Scoring: Each of the 8 items is rated on a 4-point scale. The total score ranges from 0 to 24. The total score is used to determine the severity of depression: 0-4: Minimal or none, 5-9: Mild, 10-14: Moderate, 15-19: Moderately severe, 20-24: Severe
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)4
GAD-7
The GAD-7 consists of 7 items that correspond to the diagnostic criteria for GAD. Each item asks about the frequency of anxiety-related symptoms over the past two weeks. Scoring: Each of the 7 items is rated on a 4-point scale. The total score ranges from 0 to 21. The total score is used to determine the severity of anxiety: 0-4: Minimal anxiety, 5-9: Mild anxiety, 10-14: Moderate anxiety, 15-21: Severe anxiety
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
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
Source ClinicalTrials.gov
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