Well-Being, PsychologicalIMPROVANCT06556576
e-Intervention Enhancing Mental Health in Adolescents
A study testing IMPROVA Platform in people with Well-Being, Psychological and Depressive Symptoms, run by Fundació Sant Joan de Déu.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological, Depressive Symptoms, Social Isolation
- What is being tested?
- IMPROVA Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Apart from not signing the informed consent, no exclusion criteria will be applied.
Trial locations and contacts
No sites are listed yet.
Daniele Porricelli, MSc contact
About this study
Official title: e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)
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.
Read the detailed description
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.
- Being tested
- IMPROVA Platform
- Keywords
- Adolescents, School-based interventions, Health promotion, Mental health
- Medical subject headings
- Psychological Well-Being, Depression, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPROVA PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startSep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Josep Maria Haro, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556576
- Sponsor's protocol ID
- ORG-100042235
- Acronym
- IMPROVA
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study plans to make IPD available, but the concrete plan is not defined yet. IMPROVA will follow the FAIR criteria for research data, and make, at least partially, the research data Findable, Accessible, Interoperable and Re-usable (FAIR). The plan is that third parties (e.g., other researchers) might get access to the IMPROVA anonymised/pseudoanonymised data, however, after a certain embargo period. This embargo period will give the consortium the opportunity to exploit the dataset herself, before allowing others to use the collected data.
Publications
Lima RA, Baumeister H, Pryss R, Kuchler AM, Kraft R, Berghoff N, Nagel L, Reichert M, Idrees AR, Stach M, Melchior M, Davisse-Paturet C, Falkiner E, van der Waerden J, Baban A, Taut D, Danila I, Perez-Anton M, Porricelli D, Sanguesa J, Moneta MV, Garcia-Carrion R, Finkenauer C, Stevens GW, Krabbendam L, Bolinski F, Maresova P, Nilsen P, Karlsson N, Moreno N, Le Corvec A, Haro JM. Study protocol of the e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) project: a randomised controlled trial to promote adolescents' mental health and well-being in four European countries. BMJ Open. 2026 Apr 28;16(4):e108674. doi: 10.1136/bmjopen-2025-108674.
PubMed 42049303
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)
- ClinicalTrials.gov ID
- NCT06556576
- Acronym / sponsor ID
- IMPROVA / ORG-100042235
- Keywords
- Adolescents, School-based interventions, Health promotion, Mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- 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
- Study start
- Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| IMPROVA intervention group | Experimental | Device: IMPROVA PlatformParticipants (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. |
| 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). |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Apart from not signing the informed consent, no exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPROVA PlatformAdolescents, 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. | Device | IMPROVA intervention group |
Primary outcome
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
11 secondary outcomes
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)
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)
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)
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)
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)
Teachers and Classmate Support Scale
Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
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)
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)
Revised Self-theory Scale
Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
15-item School Engagement Scale
Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
Revised Bully/Victim Questionnaire
Time frame: Baseline (pre-intervention), post-intervention (immediately after the intervention), and follow up (13-14 months after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42049303Lima RA, Baumeister H, Pryss R, Kuchler AM, Kraft R, Berghoff N, Nagel L, Reichert M, Idrees AR, Stach M, Melchior M, Davisse-Paturet C, Falkiner E, van der Waerden J, Baban A, Taut D, Danila I, Perez-Anton M, Porricelli D, Sanguesa J, Moneta MV, Garcia-Carrion R, Finkenauer C, Stevens GW, Krabbendam L, Bolinski F, Maresova P, Nilsen P, Karlsson N, Moreno N, Le Corvec A, Haro JM. Study protocol of the e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) project: a randomised controlled trial to promote adolescents' mental health and well-being in four European countries. BMJ Open. 2026 Apr 28;16(4):e108674. doi: 10.1136/bmjopen-2025-108674.
- Individual participant dataSharing planned: Yes. The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study plans to make IPD available, but the concrete plan is not defined yet. IMPROVA will follow the FAIR criteria for research data, and make, at least partially, the research data Findable, Accessible, Interoperable and Re-usable (FAIR). The plan is that third parties (e.g., other researchers) might get access to the IMPROVA anonymised/pseudoanonymised data, however, after a certain embargo period. This embargo period will give the consortium the opportunity to exploit the dataset herself, before allowing others to use the collected data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Porricelli, MSc contact
Josep Maria Haro, PhD principal investigator
Fundació Sant Joan de Déu
Questions about this trial
What is this clinical trial studying?
A study testing IMPROVA Platform in people with Well-Being, Psychological and Depressive Symptoms, run by Fundació Sant Joan de Déu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo A Lima, PhD (+34 93 640 63 50 ext. 12719, rodrigoantunes.lima@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06556576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.