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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06996054
Enrollment
2280
Registered
2025-05-30
Start date
2025-10-31
Completion date
2027-06-30
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Mental Health, Depression, Self-Harm, Suicidal Ideation and Behavior, Suicide Attempt

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

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.

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: 1. 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. 2. 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.

Interventions

BEHAVIORALMultifaceted School-Based Mental Health and Suicide Prevention Program

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.

Sponsors

University of the Balearic Islands
CollaboratorOTHER
Fundació d'investigació Sanitària de les Illes Balears
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Severity of Suicidal IdeationBaseline and 6-month follow-upChange 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.

Secondary

MeasureTime frameDescription
Suicide AttemptsBaseline and 6-month follow-upProportion 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?).
Depressive SymptomsBaseline and 6-month follow-upSeverity 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.
Well-beingBaseline and 6-month follow-upSubjective 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).
Self-HarmBaseline and 6-month follow-upIncidence 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.
Bullying InvolvementBaseline and 6-month follow-upBullying experiences assessed via the Bull-S Test, which includes peer and teacher nominations to identify victims and aggressors within the classroom.
Help-Seeking BehaviorsBaseline and 6-month follow-upStudent-reported intentions and behaviors related to seeking help for mental health issues, collected through study-specific questionnaires.
Internet AddictionBaseline and 6-month follow-upProblematic internet use assessed using the Spanish version of the Internet Addiction Test (IAT), a 20-item measure with scores from 20 to 100.
Substance UseBaseline and 6-month follow-upRisk 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.

Other

MeasureTime frameDescription
Gatekeeper Knowledge of Suicide (Teachers and Parents)Pre- and post-intervention (6 months)Knowledge of suicide risk factors and appropriate intervention strategies among parents and teachers, assessed using a study-specific questionnaire aligned with digital module content.
Gatekeeper Self-Efficacy in Suicide Risk InterventionPre- and post-intervention (6 months)Self-perceived efficacy in identifying and intervening with students at risk of suicide, measured via a 5-item Likert-scale questionnaire.

Contacts

Primary ContactIgnacio Ricci Cabello, PhD
nacho.ricci.cabello@gmail.com+34697750971

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026