"Youth Aware of Mental Health" in Galicia

NCT ID: NCT06251037

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 4453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2025-06-15

Brief Summary

The goal of this interventional study is to assess the effectiveness of the universal suicide prevention program "Youth Aware of Mental Health" in 3rd-year secondary education students in Galicia.

The main questions it aims to answer are:

• Is the YAM program effective in reducing severe suicidal ideation at 12 months from baseline within the experimental group and compared to the control group?
• Is the YAM program effective in preventing the incidence of new suicidal attempts, 12 months from baseline in the experimental group compared to the control group?

All participants in this study will be asked to:

Complete a survey at baseline and after 12 months, consisting of measures for suicidal ideation and behavior, depressive symptoms, seeking help behaviors, bullying, problematic internet use, and emotional distress.

Only those allocated to the experimental group will be asked to:

Undergo the YAM program, an evidence-based intervention structured into five one-hour class group sessions (45-50 min.), focused on problem-solving by peers. The program consists of interactive presentations, dilemma discussions, role-playing, and reflection, all moderated by a trained YAM instructor.

Twelve months after the intervention, all participants will undergo a re-evaluation using the same protocol. The researchers will compare differences in pre- and post-measures within the experimental and control groups, as well as between both groups, to assess the impact of the YAM intervention on outcomes such as suicidal ideation and attempts.

At the end of the study, those who were allocated to the control group are going to be offered the YAM intervention program.

Detailed Description

This multicenter study will be conducted in selected school centers, including both public and private. These centers were identified through two-stage stratified sampling, based on the population distribution in which they are located and their ownership, to be representative of the Galician population in Secondary Education (ESO). Participant randomization does not take place on an individual level. Each cluster's center is identified by a numerical code and assigned to each group (intervention and control group) using a random number generator.

The operationalization of the study will consist of the following phases:

Preparation:

The educational authorities will convene a meeting with the directors or guidance departments of the respective centers. In this meeting, the coordinator of the YAM Team and the Principal Investigator of this study (AGC) will explain what YAM entails, the implementation strategy, and address any questions regarding deployment and logistics. If deemed necessary, an informative session for the parents/guardians of the students will be scheduled. Subsequently, the YAM instructor will contact the school's guidance counselor to arrange the dates for YAM. In control group schools, the same process will be followed, but instead of the YAM intervention, only the pre-test and post-test measures will be collected.

Evaluation:

An initial survey is going to be conducted to collect the measures of all participants. The domains included in this survey will consist of socio-demographic data and measures of suicidal ideation and behavior, depressive symptoms, seeking help behaviors, bullying, problematic internet use, and emotional distress. Following the criteria used in the HBSC survey (Health Behaviour in School-aged Children), this evaluation is going to be conducted individually, in class, and ensuring participant anonymity.

A specialized survey company using CAWI methodology will conduct the surveys, ensuring compliance with the requirements outlined in Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, regarding the protection of individuals with regard to the processing of personal data and on the free movement of such data, and with Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights. The surveys will be anonymized, each center will be identified with a numerical code, and each participating student will be associated with a number. Each student will receive this code at the time of the survey. Neither the research team nor the teacher will be aware of the association between the student's identity and the code, and no list with such an association will be kept, making it impossible to identify the student later. The participation of minors in the clinical trial is regulated by Royal Decree 1090/2015, of December 4, which states that the authorization of parents, guardians, or legal custodians is mandatory. In addition to this authorization, for those over 12 years old, the authorization of the minor is required, and the intervention must be explained to them in appropriate terms.

Intervention:

Once the initial surveys are completed, the YAM intervention will be carried out in the corresponding centers. YAM is structured into 5 one-hour class sessions (45-50 min.).

• Inaugural Session:

Consists of an interactive slide presentation delivered by the YAM instructor, laying the groundwork for the rest of the program. In this first session, the materials to be used are introduced, 6 posters that will be present throughout the program are displayed in the classroom, and students are given a user manual.

• Second session:

The class group is presented with a series of dilemmas outlined on a set of cards to discuss in small groups. These dilemmas are part of the everyday problems of a current school community. The goal is for students to come to their own conclusions when solving problems, rather than the instructor lecturing or solving dilemmas or problem situations.

• Third and fourth sessions:

Contents related to crisis situations, depression, suicidal ideation, and help-seeking behaviors are addressed through role-playing games, allowing the class to integrate their experiences and newly acquired knowledge about mental health through experiential play, reflection, and group discussion. In the role-play sessions, three dilemmas chosen by the class group are addressed. The objective is to discover:

1. how the decisions made make them feel and what the result of those decisions and actions is,

2. become aware of their own feelings and reflect on how to handle stress and crisis situations,

3. listen to others and be able to talk about depression and suicidal thoughts.

• Closing Session:

A collective summary of the topics is made, and dynamic aspects (relational and emotional) arising during the group experience are addressed.

The YAM intervention is manualized, and all instructors will be recruited from educational and healthcare personnel with clinical experience in adolescents. The instructor group will undergo a 1-week in-person course with the original Swedish team. and a practice period before starting the implementation. YAM instructors will also be specifically trained in the evaluation and management of contingencies related to the appearance of suicidal verbalizations among participants during the implementation of the course. All adverse events will be reported to the school's guidance service and the YAM Team coordinator (AGC), who will jointly decide the steps to be taken in agreement with parents, guardians, or legal custodians following the Action and Prevention Protocol for Suicide Risk in the Health and Educational Environment for Children and Adolescents http://www.edu.xunta.gal/portal/node/38218.

Follow up:

One year after the intervention, the students who participated in the first survey will be re-evaluated using the same system to collect post-measures.

Conditions

Suicide Awareness; Suicidal Ideation; Suicide, Attempted; Depressive Symptoms; Help-Seeking Behavior; Bullying; Cyberbullying

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

The participants in this group will:

Participate in the initial survey; Undergo the YAM program; Participate in the final survey (follow-up).

Group Type: EXPERIMENTAL

Youth Aware of Mental Health in Galicia

Intervention Type: BEHAVIORAL

The program follows a manualized protocol, comprising five interactive one-hour class sessions with adaptations to the Galician school population.

The Inaugural Session consists of an interactive slide presentation, an introduction of materials, the delivery of the manual, and the poster's display. The Second Session involves group discussions on real-life dilemmas. The Third and Fourth Sessions focus on crisis situations, depression, suicidal ideation, and help-seeking behaviors through role-playing games. The Closing Session includes a collective summary of topics and addresses dynamic aspects emerging during the group experience.

No intervention

The participants in this group will:

Participate in the initial survey; Participate in the final survey (follow-up).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Youth Aware of Mental Health in Galicia

The program follows a manualized protocol, comprising five interactive one-hour class sessions with adaptations to the Galician school population.

The Inaugural Session consists of an interactive slide presentation, an introduction of materials, the delivery of the manual, and the poster's display. The Second Session involves group discussions on real-life dilemmas. The Third and Fourth Sessions focus on crisis situations, depression, suicidal ideation, and help-seeking behaviors through role-playing games. The Closing Session includes a collective summary of topics and addresses dynamic aspects emerging during the group experience.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being a 3rd-year secondary education student at one of the participating school centers
• To be between 13 and 16 years old

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Alberto García Caballero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alejandro García Caballero

Role: PRINCIPAL_INVESTIGATOR

Servizo Galego de Saude

Locations

IES Concepción Arenal

Ferrol, A CoruñaA, Spain

IES Rafael Puga Ramón

A Coruña, A Coruña, Spain

CPR Plurilingüe Calasancias

A Coruña, A Coruña, Spain

CPI As Mirandas

Ares, A Coruña, Spain

CPR Plurilingüe Nuestra Señora del Carmen

Betanzos, A Coruña, Spain

IES Francisco Aguiar

Betanzos, A Coruña, Spain

IES David Buján

Cambre, A Coruña, Spain

IES Isidro Parga Pondal

Carballo, A Coruña, Spain

IES Monte Neme

Carballo, A Coruña, Spain

CPR Plurilingüe Montespiño

Culleredo, A Coruña, Spain

CPR Plurilingüe Cristo Rey

Ferrol, A Coruña, Spain

CPR Tirso de Molina

Ferrol, A Coruña, Spain

CPR Plurilingüe Compañía de María

Ferrol, A Coruña, Spain

IES Campo de San Alberto

Noia, A Coruña, Spain

IES Ordes

Ordes, A Coruña, Spain

IES Maruxa Mallo

Ordes, A Coruña, Spain

IES Camilo José Cela

Padrón, A Coruña, Spain

IES Breamo

Pontedeume, A Coruña, Spain

IES Isaac Díaz Pardo

Sada, A Coruña, Spain

CPR Plurilingüe Emma

Santiago, A Coruña, Spain

CPR Plurilingüe La Salle

Santiago, A Coruña, Spain

IES Arcebispo Xelmírez II

Santiago de Compostela, A Coruña, Spain

CPI Plurilingüe de Vedra

Vedra, A Coruña, Spain

IES Monelos

A Coruña, Coruña, Spain

CPI Alcalde Xosé Pichel

Coristanco, Coruña, Spain

IES Ricardo Carvalho Calero

Ferrol, Coruña, Spain

IES Plurilingüe Rosalía de Castro

Santiago de Compostela, Coruña, Spain

IES Perdouro

Burela de Cabo, Lugo, Spain

IES Xoán Montes

Lugo, Lugo, Spain

CPR María Auxiliadora

Lugo, Lugo, Spain

CPR Galén

Lugo, Lugo, Spain

IES Leiras Pulpeiro

Lugo, Lugo, Spain

IES de Monterroso

Monterroso, Lugo, Spain

CPR Plurilingüe Ntra. Sra. de la Asunción

Sarria, Lugo, Spain

IES Gregorio Fernández

Sarria, Lugo, Spain

IES Xograr Afonso Gómez de Sarria

Sarria, Lugo, Spain

IES de Allariz

Allariz, Ourense, Spain

IES San Mamede

Maceda, Ourense, Spain

CPR Plurilingüe Vila do Arenteiro

O Carballiño, Ourense, Spain

IES Manuel Chamoso Lamas

O Carballiño, Ourense, Spain

IES O Couto

Ourense, Ourense, Spain

CPR Seminario Menor Diocesano A Inmaculada

Ourense, Ourense, Spain

CPR Plurilingüe Santa Teresa de Jesús

Ourense, Ourense, Spain

IES Xesús Ferro Couselo

Ourense, Ourense, Spain

IES Lagoa de Antela

Xinzo de Limia, Ourense, Spain

IES A Sangriña

A Guarda, Pontevedra, Spain

IES Primeiro de Marzo

Baiona, Pontevedra, Spain

IES María Soliño

Cangas, Pontevedra, Spain

IES Plurilingüe Terra de Turonio

Gondomar, Pontevedra, Spain

CPR Plurilingüe San Narciso

Marín, Pontevedra, Spain

IES Illa de Tambo

Marín, Pontevedra, Spain

IES Plurilingüe A Paralaia

Moaña, Pontevedra, Spain

CPR Cemar

Mondariz, Pontevedra, Spain

CPR Sek-Atlántico

Poio, Pontevedra, Spain

CPR Plurilingüe Ntra. Sra. de los Dolores

Pontevedra, Pontevedra, Spain

IES Mendiño

Redondela, Pontevedra, Spain

IES de Salvaterra de Miño

Salvatierra de Miño, Pontevedra, Spain

IES de Vilalonga

Sanxenxo, Pontevedra, Spain

IES Soutomaior

Soutomaior, Pontevedra, Spain

IES Antón Alonso Ríos

Tomiño, Pontevedra, Spain

IES do Castro

Vigo, Pontevedra, Spain

CPR Plurilingüe San José de Cluny

Vigo, Pontevedra, Spain

IES Alexandre Bóveda

Vigo, Pontevedra, Spain

IES San Tomé de Freixeiro

Vigo, Pontevedra, Spain

CPR Plurilingüe Labor

Vigo, Pontevedra, Spain

IES Valadares

Vigo, Pontevedra, Spain

IES Pedras Rubias

Vigo, Pontevedra, Spain

Servicio Gallego de Salud (SERGAS)

Santiago de Compostela, , Spain

Countries

Spain

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Related Links

https://www.edu.xunta.gal/portal/sites/web/files/protocolo_risco_suicida-v.12_0.pdf

Description Suicide Risk Protocol

Other Identifiers

YAM

Identifier Type: -

Identifier Source: org_study_id