Effects of a Multifaceted School-Based Intervention to Protect Mental Health and Prevent Suicidal Behaviour in Adolescents in Spain
DEVELOPMENT AND EVALUATION OF A MULTIFACETED SCHOOL-BASED INTERVENTION TO PROTECT MENTAL HEALTH AND PREVENT SUICIDAL BEHAVIOR AMONG ADOLESCENTS IN SPAIN
1 other identifier
interventional
2,280
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
May 30, 2025
May 1, 2025
1.7 years
May 21, 2025
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 6-month follow-up
Secondary Outcomes (8)
Suicide Attempts
Baseline and 6-month follow-up
Depressive Symptoms
Baseline and 6-month follow-up
Well-being
Baseline and 6-month follow-up
Self-Harm
Baseline and 6-month follow-up
Internet Addiction
Baseline and 6-month follow-up
- +3 more secondary outcomes
Other Outcomes (2)
Gatekeeper Knowledge of Suicide (Teachers and Parents)
Pre- and post-intervention (6 months)
Gatekeeper Self-Efficacy in Suicide Risk Intervention
Pre- and post-intervention (6 months)
Study Arms (2)
Interventional study
EXPERIMENTALParticipants 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 INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2025
First Posted
May 30, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available beginning 12 months after publication of the main results and will remain available for 5 years.
- Access Criteria
- De-identified individual participant data (IPD) and supporting documentation (e.g., study protocol, statistical analysis plan) will be made available to qualified researchers affiliated with academic institutions, non-profit organizations, or public health agencies. Researchers must submit a methodologically sound proposal outlining the purpose of the analysis, data requirements, and plans for ethical data use. Access will be granted upon approval by an independent review committee. Researchers will be required to sign a data use agreement that includes commitments to: * Use the data only for the approved purpose; * Not attempt to re-identify participants; * Maintain data confidentiality and security. * Approved users will receive access to the data through a secure, password-protected data repository managed by the study sponsor or affiliated institution.
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.