Suicide AttemptNCT06996054
Effects of a Multifaceted School-Based Intervention to Protect Mental Health and Prevent Suicidal Behaviour in Adolescents in Spain
A study testing Multifaceted School-Based Mental Health and Suicide Prevention Program in people with Suicide Attempt and Depression, run by Fundació d'investigació Sanitària de les Illes Balears.
Trial summary
What is this study about? This study aims to find out if a school-based program can help improve mental health and prevent suicidal thoughts and behaviors in teenagers in Spain. Suicide is one of the leading causes of death among young people. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide Attempt, Depression, Adolescent Mental Health
- What is being tested?
- Multifaceted School-Based Mental Health and Suicide Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,280 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in the 2nd or 3rd year of compulsory secondary education during the 2026-2027 academic year in the Balearic Islands, Spain.
- Aged between 12 and 16 years at the time of recruitment.
- Provision of written informed consent from both the student and at least one parent/legal guardian.
- Attending school centres with a student population composed of no more than 75% of a single gender.
- Enrollment in a participating classroom randomly selected for the study.
Who cannot join
- Presence of cognitive, developmental, or language impairments that, in the judgment of school staff or study personnel, would prevent the student from understanding the intervention content or completing the study assessments reliably.
- Students currently receiving intensive psychological or psychiatric treatment for acute suicidality or severe mental health conditions that require individualized clinical management beyond the scope of a school-based programme.
- Students or parents who explicitly decline participation in specific intervention components, such as group discussions on suicide or mental health.
- Participation in a concurrent school-based mental health programme that could confound the effects of the intervention.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DEVELOPMENT AND EVALUATION OF A MULTIFACETED SCHOOL-BASED INTERVENTION TO PROTECT MENTAL HEALTH AND PREVENT SUICIDAL BEHAVIOR AMONG ADOLESCENTS IN SPAIN
What is this study about? This study aims to find out if a school-based program can help improve mental health and prevent suicidal thoughts and behaviors in teenagers in Spain. Suicide is one of the leading causes of death among young people. Many teens who think about or attempt suicide are also struggling with mental health problems like depression. Schools offer a unique opportunity to help because almost all adolescents attend school regularly.
What will happen in the study?
Read more
The study will include about 2,280 students aged 12 to 16 years from 38 secondary schools in the Balearic Islands, Spain. Schools will be randomly assigned to one of two groups:
Intervention group: Students will participate in four weekly classroom sessions led by trained psychologists. These sessions will help students learn about mental health, manage their emotions, recognize signs of distress in themselves or others, and ask for help when needed. At the same time, parents and teachers will follow a digital training program with videos and resources to help them support students' mental health and recognize warning signs.
Control group: Students will receive a minimal intervention, which includes educational posters displayed in classrooms.
What is the purpose of this program? The main goal is to reduce suicidal thoughts and behaviors. The program also aims to improve students' overall mental well-being, reduce depression symptoms, and encourage help-seeking behaviors. It also helps parents and teachers feel more confident in supporting teens who may be at risk.
How will the study be evaluated? Students will complete questionnaires at the start of the study and again after six months. These surveys will ask about mental health, suicidal thoughts, emotional well-being, self-harm, substance use, and experiences with bullying. Parents and teachers will also complete surveys about their knowledge and confidence in supporting students.
Why is this study important? There is an urgent need to find effective ways to prevent suicide and support young people's mental health. This program involves students, families, and schools in working together to create a safe and supportive environment. If the program works, it could be used in schools throughout Spain and possibly in other countries too.
Who is funding this study? The study is funded by Fundación Mutua Madrileña.
Read the detailed description
Background Adolescent suicide is a critical public health concern and one of the leading causes of death among youth globally. In Spain, suicide has been the primary external cause of death since 2008. Rates are especially concerning among adolescents and young adults. Depression and other mental health disorders are major risk factors associated with suicidal thoughts and behaviors in this population.
Schools provide a strategic setting for suicide prevention and mental health promotion, as they offer direct and repeated access to adolescents during a critical stage of emotional development. The involvement of teachers and families is also crucial, as they play a key role in identifying and supporting students at risk.
This study is a two-arm, cluster-randomised controlled trial designed to evaluate the effectiveness of a multifaceted school-based intervention to reduce suicidal ideation and behavior and promote mental health in adolescents aged 12 to 16 years. A total of 38 secondary schools in the Balearic Islands, Spain, will be randomly allocated in a 1:1 ratio to either the intervention or control group, with 2,280 students expected to participate.
Intervention Description
The intervention comprises two components:
- Student-focused psychoeducational program: Delivered by trained psychologists in four weekly classroom sessions (90 minutes each), this component is based on a comprehensive model of suicide prevention and mental health promotion. The sessions include:
- Mental health literacy and stigma reduction
- Emotional regulation and coping strategies
- Recognition of warning signs and crisis response
- Promotion of help-seeking behavior and strengthening of social support networks Sessions incorporate dynamic group activities to enhance engagement and learning. The program is designed to foster a safe environment for sharing and reflection.
- Digital co-intervention for parents and teachers: Delivered through a custom-built digital platform, this component includes four knowledge modules with videos, podcasts, and additional educational resources. The content aligns with the student sessions and aims to improve suicide-related knowledge, reduce stigma, increase self-efficacy, and support identification and referral of at-risk students. Access to the platform is monitored through user self-reports and automated engagement tracking.
The control group will receive a minimal intervention in the form of educational posters on mental health and suicide prevention placed in classrooms.
Outcomes and Data Collection Primary and secondary outcomes will be assessed using validated instruments at baseline and six-month follow-up. Primary outcomes include suicidal ideation and behavior. Secondary outcomes include symptoms of depression, psychological well-being, self-harm, substance use, internet addiction, bullying, and help-seeking behaviors. Teachers and parents will report on suicide-related knowledge, self-efficacy, and student referrals.
Process evaluation will be conducted through qualitative interviews with a subsample of students, parents, and teachers to assess the implementation, acceptability, and perceived impact of the intervention.
Data will be analyzed using generalized linear mixed models to account for the clustering of students within schools. Multiple imputation will be used to address missing data. The primary analysis will follow an intention-to-treat approach.
Significance This study addresses a critical gap in the evidence base for suicide prevention programs in Spain. It aims to provide robust data on the effectiveness of a scalable, cost-effective, and digitally enhanced intervention. If successful, the intervention may support wider implementation in schools and contribute to improved mental health outcomes and suicide prevention strategies at the national level.
- Conditions
- Suicide Attempt, Depression, Adolescent Mental Health, Self-Harm, Suicidal Ideation and Behavior
- Being tested
- Multifaceted School-Based Mental Health and Suicide Prevention Program
- Keywords
- School-based intervention, Suicide prevention, Suicidal ideation, Suicidal behavior, Depression, Adolescents, Mental health promotion, Psychoeducation, Gatekeeper training, Teachers, Parents, Digital health, Cluster randomized controlled trial, Spain, Secondary education, Emotional regulation, Self-harm
- Medical subject headings
- Suicide, Attempted, Depression, Self-Injurious Behavior, Suicidal Ideation, Behavior, Suicide Prevention, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted School-Based Mental Health and Suicide Prevention ProgramBehavioural
Pupils will receive a four-session psychoeducational programme, delivered weekly by trained psychologists during school hours, covering mental health literacy, emotion regulation, identification of suicide risk, and help-seeking skills. Concurrently, parents and teachers will access a digital co-intervention through a custom-designed platform with four multimedia modules.
| Study group | Role | What they receive |
|---|---|---|
| Interventional study | Experimental | Participants in this group will receive a multifaceted school-based intervention designed to prevent suicidal behavior and promote mental health. The intervention includes:
* Psychoeducational sessions for students: Four weekly classroom-based sessions (90 minutes each), led by trained psychologists. Topics include mental health literacy, emotional regulation, identification of suicide risk, and help-seeking skills.
* Digital co-intervention for parents and teachers: Access to a web-based platform delivering four multimedia modules with videos, podcasts, and educational content to improve suicide-related knowledge, self-efficacy, and referral practices. Receives: Behavioral: Multifaceted School-Based Mental Health and Suicide Prevention Program |
| Control | No intervention | Participants in this group will receive a minimal intervention consisting of educational posters about mental health and suicide prevention displayed in classrooms. No additional training or sessions will be provided to students, parents, or teachers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Suicidal Ideation
Change in the severity of suicidal ideation as assessed by the Spanish version of the Suicidal Paykel Scale. This 5-item scale evaluates the presence and intensity of suicidal thoughts over the previous year. Responses are dichotomous (Yes/No) and produce a score ranging from 0 (no ideation) to 5 (high severity). A higher total score indicates greater suicidal ideation severity.
Measured: Baseline and 6-month follow-up
Secondary outcomes (8)
Suicide Attempts
Proportion of students reporting a suicide attempt in the past year, assessed through item 5 of the Suicidal Paykel Scale ("Have you ever tried to end your life?").
Measured: Baseline and 6-month follow-up
Depressive Symptoms
Severity of depressive symptoms measured using the Spanish version of the Beck Depression Inventory-II (BDI-II), a 21-item questionnaire. Scores range from 0 to 63, with higher scores indicating greater symptom severity.
Measured: Baseline and 6-month follow-up
Well-being
Subjective well-being measured using the Spanish version of the WHO-5 Well-Being Index, a 5-item scale with scores ranging from 0 (worst) to 25 (best).
Measured: Baseline and 6-month follow-up
Self-Harm
Incidence and characteristics of self-injury behaviors assessed using the 15-item Spanish version of the Self-Harm Questionnaire (DSHI). Includes method, frequency, motivation, and context of self-harm.
Measured: Baseline and 6-month follow-up
Internet Addiction
Problematic internet use assessed using the Spanish version of the Internet Addiction Test (IAT), a 20-item measure with scores from 20 to 100.
Measured: Baseline and 6-month follow-up
Substance Use
Risk of substance use disorder measured using the Spanish version of the CRAFFT Screening Test. Scores range from 0 to 6; scores ≥2 indicate high risk.
Measured: Baseline and 6-month follow-up
Bullying Involvement
Bullying experiences assessed via the Bull-S Test, which includes peer and teacher nominations to identify victims and aggressors within the classroom.
Measured: Baseline and 6-month follow-up
Help-Seeking Behaviors
Student-reported intentions and behaviors related to seeking help for mental health issues, collected through study-specific questionnaires.
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study startOct 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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 Suicide AttemptStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Collaborators
- University of the Balearic Islands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996054
- Sponsor's protocol ID
- AP-15017/2024
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in published articles will be shared after de-identification. This includes data for all primary and secondary outcome measures (e.g., suicidal ideation, depression scores, self-harm, internet addiction, bullying involvement, and well-being), as well as demographic variables (e.g., age, sex, school characteristics). Data will be shared in a de-identified format to protect participant confidentiality. No data that could directly identify participants will be shared. Data will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee and who agree to sign a data access agreement. Data will be available beginning 12 months after publication of the main results and will remain available for 5 years.
Publications
Riera-Serra P, Serrano-Ripoll MJ, Fiol-deRoque MA, Garcia-Pazo P, Bennasar-Veny M, Yanez-Juan A, Leiva-Rus A, Ginard-Puigserver M, Garcia-Toro M, Sitges C, Balle M, Gervilla E, Gonzalez-Garcia X, Garcia-Buades ME, Blanes MW, Zamanillo-Campos R, Andreu-Rodrigo P, Ricci-Cabello I. Evaluation of the effectiveness of SOM-RIU, a multifaceted, school-based, suicide prevention intervention targeted to Spanish adolescents: study protocol for a cluster-randomised controlled trial. BMC Psychiatry. 2026 Jan 22;26(1):56. doi: 10.1186/s12888-025-07570-0.
PubMed 41572222
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEVELOPMENT AND EVALUATION OF A MULTIFACETED SCHOOL-BASED INTERVENTION TO PROTECT MENTAL HEALTH AND PREVENT SUICIDAL BEHAVIOR AMONG ADOLESCENTS IN SPAIN
- ClinicalTrials.gov ID
- NCT06996054
- Acronym / sponsor ID
- AP-15017/2024
- Conditions
- Suicide Attempt, Depression, Adolescent Mental Health, Self-Harm, Suicidal Ideation and Behavior
- Keywords
- School-based intervention, Suicide prevention, Suicidal ideation, Suicidal behavior, Depression, Adolescents, Mental health promotion, Psychoeducation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,280 participants (estimated)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Collaborators
- University of the Balearic Islands
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 May 2025 (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.
What is this study about? This study aims to find out if a school-based program can help improve mental health and prevent suicidal thoughts and behaviors in teenagers in Spain. Suicide is one of the leading causes of death among young people. Many teens who think about or attempt suicide are also struggling with mental health problems like depression. Schools offer a unique opportunity to help because almost all adolescents attend school regularly.
What will happen in the study?
The study will include about 2,280 students aged 12 to 16 years from 38 secondary schools in the Balearic Islands, Spain. Schools will be randomly assigned to one of two groups:
Intervention group: Students will participate in four weekly classroom sessions led by trained psychologists. These sessions will help students learn about mental health, manage their emotions, recognize signs of distress in themselves or others, and ask for help when needed. At the same time, parents and teachers will follow a digital training program with videos and resources to help them support students' mental health and recognize warning signs.
Control group: Students will receive a minimal intervention, which includes educational posters displayed in classrooms.
What is the purpose of this program? The main goal is to reduce suicidal thoughts and behaviors. The program also aims to improve students' overall mental well-being, reduce depression symptoms, and encourage help-seeking behaviors. It also helps parents and teachers feel more confident in supporting teens who may be at risk.
How will the study be evaluated? Students will complete questionnaires at the start of the study and again after six months. These surveys will ask about mental health, suicidal thoughts, emotional well-being, self-harm, substance use, and experiences with bullying. Parents and teachers will also complete surveys about their knowledge and confidence in supporting students.
Why is this study important? There is an urgent need to find effective ways to prevent suicide and support young people's mental health. This program involves students, families, and schools in working together to create a safe and supportive environment. If the program works, it could be used in schools throughout Spain and possibly in other countries too.
Who is funding this study? The study is funded by Fundación Mutua Madrileña.
Detailed description
Background Adolescent suicide is a critical public health concern and one of the leading causes of death among youth globally. In Spain, suicide has been the primary external cause of death since 2008. Rates are especially concerning among adolescents and young adults. Depression and other mental health disorders are major risk factors associated with suicidal thoughts and behaviors in this population.
Schools provide a strategic setting for suicide prevention and mental health promotion, as they offer direct and repeated access to adolescents during a critical stage of emotional development. The involvement of teachers and families is also crucial, as they play a key role in identifying and supporting students at risk.
This study is a two-arm, cluster-randomised controlled trial designed to evaluate the effectiveness of a multifaceted school-based intervention to reduce suicidal ideation and behavior and promote mental health in adolescents aged 12 to 16 years. A total of 38 secondary schools in the Balearic Islands, Spain, will be randomly allocated in a 1:1 ratio to either the intervention or control group, with 2,280 students expected to participate.
Intervention Description
The intervention comprises two components:
- Student-focused psychoeducational program: Delivered by trained psychologists in four weekly classroom sessions (90 minutes each), this component is based on a comprehensive model of suicide prevention and mental health promotion. The sessions include:
- Mental health literacy and stigma reduction
- Emotional regulation and coping strategies
- Recognition of warning signs and crisis response
- Promotion of help-seeking behavior and strengthening of social support networks Sessions incorporate dynamic group activities to enhance engagement and learning. The program is designed to foster a safe environment for sharing and reflection.
- Digital co-intervention for parents and teachers: Delivered through a custom-built digital platform, this component includes four knowledge modules with videos, podcasts, and additional educational resources. The content aligns with the student sessions and aims to improve suicide-related knowledge, reduce stigma, increase self-efficacy, and support identification and referral of at-risk students. Access to the platform is monitored through user self-reports and automated engagement tracking.
The control group will receive a minimal intervention in the form of educational posters on mental health and suicide prevention placed in classrooms.
Outcomes and Data Collection Primary and secondary outcomes will be assessed using validated instruments at baseline and six-month follow-up. Primary outcomes include suicidal ideation and behavior. Secondary outcomes include symptoms of depression, psychological well-being, self-harm, substance use, internet addiction, bullying, and help-seeking behaviors. Teachers and parents will report on suicide-related knowledge, self-efficacy, and student referrals.
Process evaluation will be conducted through qualitative interviews with a subsample of students, parents, and teachers to assess the implementation, acceptability, and perceived impact of the intervention.
Data will be analyzed using generalized linear mixed models to account for the clustering of students within schools. Multiple imputation will be used to address missing data. The primary analysis will follow an intention-to-treat approach.
Significance This study addresses a critical gap in the evidence base for suicide prevention programs in Spain. It aims to provide robust data on the effectiveness of a scalable, cost-effective, and digitally enhanced intervention. If successful, the intervention may support wider implementation in schools and contribute to improved mental health outcomes and suicide prevention strategies at the national level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional study | Experimental | Behavioral: Multifaceted School-Based Mental Health and Suicide Prevention ProgramParticipants in this group will receive a multifaceted school-based intervention designed to prevent suicidal behavior and promote mental health. The intervention includes: * Psychoeducational sessions for students: Four weekly classroom-based sessions (90 minutes each), led by trained psychologists. Topics include mental health literacy, emotional regulation, identification of suicide risk, and help-seeking skills. * Digital co-intervention for parents and teachers: Access to a web-based platform delivering four multimedia modules with videos, podcasts, and educational content to improve suicide-related knowledge, self-efficacy, and referral practices. |
| Control | No intervention | –Participants in this group will receive a minimal intervention consisting of educational posters about mental health and suicide prevention displayed in classrooms. No additional training or sessions will be provided to students, parents, or teachers. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Students enrolled in the 2nd or 3rd year of compulsory secondary education during the 2026-2027 academic year in the Balearic Islands, Spain.
- Aged between 12 and 16 years at the time of recruitment.
- Provision of written informed consent from both the student and at least one parent/legal guardian.
- Attending school centres with a student population composed of no more than 75% of a single gender.
- Enrollment in a participating classroom randomly selected for the study.
Key exclusion criteria (4 listed)
- Presence of cognitive, developmental, or language impairments that, in the judgment of school staff or study personnel, would prevent the student from understanding the intervention content or completing the study assessments reliably.
- Students currently receiving intensive psychological or psychiatric treatment for acute suicidality or severe mental health conditions that require individualized clinical management beyond the scope of a school-based programme.
- Students or parents who explicitly decline participation in specific intervention components, such as group discussions on suicide or mental health.
- Participation in a concurrent school-based mental health programme that could confound the effects of the intervention.
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 |
|---|---|---|
| Multifaceted School-Based Mental Health and Suicide Prevention ProgramPupils will receive a four-session psychoeducational programme, delivered weekly by trained psychologists during school hours, covering mental health literacy, emotion regulation, identification of suicide risk, and help-seeking skills. Concurrently, parents and teachers will access a digital co-intervention through a custom-designed platform with four multimedia modules. | Behavioural | Interventional study |
Primary outcome
Severity of Suicidal Ideation
Time frame: Baseline and 6-month follow-up
Change in the severity of suicidal ideation as assessed by the Spanish version of the Suicidal Paykel Scale. This 5-item scale evaluates the presence and intensity of suicidal thoughts over the previous year. Responses are dichotomous (Yes/No) and produce a score ranging from 0 (no ideation) to 5 (high severity). A higher total score indicates greater suicidal ideation severity.
8 secondary outcomes
Suicide Attempts
Time frame: Baseline and 6-month follow-up
Depressive Symptoms
Time frame: Baseline and 6-month follow-up
Well-being
Time frame: Baseline and 6-month follow-up
Self-Harm
Time frame: Baseline and 6-month follow-up
Internet Addiction
Time frame: Baseline and 6-month follow-up
Substance Use
Time frame: Baseline and 6-month follow-up
Bullying Involvement
Time frame: Baseline and 6-month follow-up
Help-Seeking Behaviors
Time frame: Baseline and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41572222Riera-Serra P, Serrano-Ripoll MJ, Fiol-deRoque MA, Garcia-Pazo P, Bennasar-Veny M, Yanez-Juan A, Leiva-Rus A, Ginard-Puigserver M, Garcia-Toro M, Sitges C, Balle M, Gervilla E, Gonzalez-Garcia X, Garcia-Buades ME, Blanes MW, Zamanillo-Campos R, Andreu-Rodrigo P, Ricci-Cabello I. Evaluation of the effectiveness of SOM-RIU, a multifaceted, school-based, suicide prevention intervention targeted to Spanish adolescents: study protocol for a cluster-randomised controlled trial. BMC Psychiatry. 2026 Jan 22;26(1):56. doi: 10.1186/s12888-025-07570-0.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in published articles will be shared after de-identification. This includes data for all primary and secondary outcome measures (e.g., suicidal ideation, depression scores, self-harm, internet addiction, bullying involvement, and well-being), as well as demographic variables (e.g., age, sex, school characteristics). Data will be shared in a de-identified format to protect participant confidentiality. No data that could directly identify participants will be shared. Data will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee and who agree to sign a data access agreement. Data will be available beginning 12 months after publication of the main results and will remain available for 5 years.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted School-Based Mental Health and Suicide Prevention Program in people with Suicide Attempt and Depression, run by Fundació d'investigació Sanitària de les Illes Balears.
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 4 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: opening soon, as of the sponsor's last update on 30 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Ricci Cabello, PhD (+34697750971, nacho.ricci.cabello@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Suicidal Ideation (time frame: Baseline and 6-month follow-up). 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 NCT06996054, 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 30 May 2025.