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NCT Number: NCT06556576

e-Intervention Enhancing Mental Health in Adolescents

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.

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Key information

Conditions

Well-Being, Psychological Behavior Behavioral Symptoms Depression Depressive Symptoms Personal Satisfaction Psychological Well-Being Social Behavior Social Isolation

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. KIDSCREEN-10

    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)

    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.

  2. Goal-Based Outcome Measure (GBO)

    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)

    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).

  3. PHQ-8

    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 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

  4. GAD-7

    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 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

  5. Social isolation questionnaire

    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 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.

  6. Teachers and Classmate Support Scale

    Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)

    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.

  7. Cantril Ladder Scale

    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 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.

  8. Single-Item Self-Esteem Scale (SISE)

    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)

    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.

  9. Revised Self-theory Scale

    Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)

    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.

  10. 15-item School Engagement Scale

    Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)

    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.

  11. Revised Bully/Victim Questionnaire

    Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Porricelli, MSc

CONTACT

[email protected]

Rodrigo A Lima, PhD

CONTACT

[email protected]

+34 93 640 63 50 ext. 12719

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

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

Registry information

Official study title

e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)

Acronym: IMPROVA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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