e-Intervention Enhancing Mental Health in Adolescents
NCT Number: NCT06556576
Acronym: IMPROVA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Well-Being, Psychological|Depressive Symptoms|Social Isolation
Interventions: DEVICE: IMPROVA Platform
Sponsor: Fundació Sant Joan de Déu
Collaborators: Babes-Bolyai University|Linkoeping University|Betthera s.r.o.|Wuerzburg University Hospital|University of Ulm|Utrecht University|Ajuntament de Sant Boi de Llobregat|VU University of Amsterdam|Institut National de la Santé Et de la Recherche Médicale, France|Stichting Trimbos-Instituut|University of Deusto|Cliclab Transformative Agent SL
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 6000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-12-31

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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), 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)., 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, 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, 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, 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, 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, The Social isolation questionnaire is composed of 17 items that can be categorised into three domain: feelings of loneliness, friendships, and family support.

Scoring: score can assume values from 0 to 131, with 0 characterizing an adolescent with a minimum score of social isolation, and 131 an adolescent with a maximum score of social isolation., 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, It is a measure designed to assess the perceived support that students receive from their teachers and classmates.

It consists of two subscales: Teacher Support and classmate support.

Scoring: For each subscale, the scores for the individual items (1 to 5) are summed to obtain a total score (3-15). Higher scores indicate higher perceived support from teachers or classmates., Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)|Cantril Ladder Scale, The Cantril Ladder Scale consists of a visual representation of a ladder with steps numbered from 0 at the bottom to 10 at the top. Adolescents will be asked to imagine that the ladder represents their life in two scenarios: 1) The Present Life Evaluation, and 2) Future Life Expectations

The top of the ladder (step 10) represents the "best possible life" they could imagine.

The bottom of the ladder (step 0) represents the "worst possible life" they could imagine., 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), It is a brief self-report measure designed to assess adolescent's overall self-esteem with a single question.

Adolescents will rate their overall self-esteem on a scale ranging from 1 to 7, with higher numbers indicating higher self-esteem., 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, The Revised Self-theory Scale is a 8-item scale to assess adolescents' beliefs about themselves in relation to their ability to change their mindsets (Fixed or Growth mindset).

Scoring: Likert scale ranging from 1-strongly disagree to 6 strongly agree. The total score range from 8 to 48. The higher the score, the more a fixed mindset, the lower the score, the more of a growth mindset., Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)|15-item School Engagement Scale, The 15-item School Engagement Scale (SES) is a self-report measure used to assess various dimensions of student engagement in the school environment. Developed to capture students' psychological investment in learning and academic activities, the SES evaluates multiple facets of engagement that contribute to positive educational outcomes.

Scoring: Scores on the SES are calculated by summing the responses across all items or within specific subscales (Behavioural, Emotional, Cognitive ). Higher scores indicate greater levels of engagement in the respective dimension., Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)|Revised Bully/Victim Questionnaire, Revised Bully/Victim Questionnaire is a four-item questionnaire to assess to which extend the adolescent engaged or was a victim of bullying/cyberbullying. The items can be answered (and scored) in a 5-point Likert scale, Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)