Effects of a Multifaceted School-Based Intervention to Protect Mental Health and Prevent Suicidal Behaviour in Adolescents in Spain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorFundació d'investigació Sanitària de les Illes Balears

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Multifaceted School-Based Mental Health and Suicide Prevention Program

    Behavioral

    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.

Treatment groups

2,280 Participants
are divided into 2 treatment groups
Group A: Interventional studyExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline and 6-month follow-up

Secondary outcomes

1

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?").

Time frame
Baseline and 6-month follow-up
2

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.

Time frame
Baseline and 6-month follow-up
3

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).

Time frame
Baseline and 6-month follow-up
4

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.

Time frame
Baseline and 6-month follow-up

Other outcomes

1

Gatekeeper Knowledge of Suicide (Teachers and Parents)

Knowledge of suicide risk factors and appropriate intervention strategies among parents and teachers, assessed using a study-specific questionnaire aligned with digital module content.

Time frame
Pre- and post-intervention (6 months)
2

Gatekeeper Self-Efficacy in Suicide Risk Intervention

Self-perceived efficacy in identifying and intervening with students at risk of suicide, measured via a 5-item Likert-scale questionnaire.

Time frame
Pre- and post-intervention (6 months)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundació d'investigació Sanitària de les Illes Balears

Lead sponsor

University of the Balearic Islands

Collaborator

This trial is not recruiting at the moment. You can still explore other options: