Clinical trial NCT06251037: "Youth Aware of Mental Health" in Galicia
Official title: Randomized Clinical Trial to Evaluate the Efficacy of the Universal Suicide Prevention Program "Youth Aware of Mental Health" in Galicia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Suicide Awareness
Suicidal Ideation
Suicide, Attempted
Depressive Symptoms
Help-Seeking Behavior
Bullying
Cyberbullying
Keywords: Suicide awareness
Adolescent behavior
Suicide prevention intervention
Mental health literacy
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 4453
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Exclusion Criteria:

* Not meeting the inclusion criteria

Note: The YAM is a universal prevention program, therefore, there are no exclusion criteria. Cases with a history of previous suicide attempts (evaluated by the Paykel Scale) in the initial survey will be excluded from the analysis. However, these students will receive the same intervention as the rest of the students. The YAM is not a treatment program and does not aim to demonstrate its efficacy in cases already diagnosed with mental disorders, but it does not exclude individuals with these problems from any potential benefits that participation in the program may have.

Primary outcomes:
measure: Paykel Suicide Scale
timeFrame: Baseline and Twelve months
measure: Mood an Feelings Questionnaire
timeFrame: Baseline and Twelve months
measure: Help-seeking Behavior Questionnaire
timeFrame: Baseline and Twelve months
Secondary outcomes:
measure: European Bullying Intervention Project Questionnaire (EBIP-Q) - adapted
timeFrame: Baseline and Twelve months
measure: Family Affluence Scale
timeFrame: Baseline and Twelve months
measure: Mobile Phone Problem Use Scale
timeFrame: Baseline and Twelve months
Other outcomes:
measure: Oviedo Response Infrequency Scale-Revised (INF-OV-R)
timeFrame: Baseline and Twelve months
Locations:
city: Ferrol
country: Spain
facility: IES Concepción Arenal
state: A CoruñaA
city: Ares
country: Spain
facility: CPI As Mirandas
state: A Coruña
city: Betanzos
country: Spain
facility: CPR Plurilingüe Nuestra Señora del Carmen
state: A Coruña
city: Betanzos
country: Spain
facility: IES Francisco Aguiar
state: A Coruña
city: Cambre
country: Spain
facility: IES David Buján
state: A Coruña
city: Carballo
country: Spain
facility: IES Isidro Parga Pondal
state: A Coruña
city: Carballo
country: Spain
facility: IES Monte Neme
state: A Coruña
city: Culleredo
country: Spain
facility: CPR Plurilingüe Montespiño
state: A Coruña
city: Ferrol
country: Spain
facility: CPR Plurilingüe Cristo Rey
state: A Coruña
city: Ferrol
country: Spain
facility: CPR Tirso de Molina
state: A Coruña
city: Ferrol
country: Spain
facility: CPR Plurilingüe Compañía de María
state: A Coruña
city: Noia
country: Spain
facility: IES Campo de San Alberto
state: A Coruña
city: Ordes
country: Spain
facility: IES Ordes
state: A Coruña
city: Ordes
country: Spain
facility: IES Maruxa Mallo
state: A Coruña
city: Padrón
country: Spain
facility: IES Camilo José Cela
state: A Coruña
city: Pontedeume
country: Spain
facility: IES Breamo
state: A Coruña
city: Sada
country: Spain
facility: IES Isaac Díaz Pardo
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: IES Arcebispo Xelmírez II
state: A Coruña
city: Santiago
country: Spain
facility: CPR Plurilingüe Emma
state: A Coruña
city: Santiago
country: Spain
facility: CPR Plurilingüe La Salle
state: A Coruña
city: Vedra
country: Spain
facility: CPI Plurilingüe de Vedra
state: A Coruña
city: Coristanco
country: Spain
facility: CPI Alcalde Xosé Pichel
state: Coruña
city: Ferrol
country: Spain
facility: IES Ricardo Carvalho Calero
state: Coruña
city: Santiago De Compostela
country: Spain
facility: IES Plurilingüe Rosalía de Castro
state: Coruña
city: Burela De Cabo
country: Spain
facility: IES Perdouro
state: Lugo
city: Monterroso
country: Spain
facility: IES de Monterroso
state: Lugo
city: Sarria
country: Spain
facility: CPR Plurilingüe Ntra. Sra. de la Asunción
state: Lugo
city: Sarria
country: Spain
facility: IES Gregorio Fernández
state: Lugo
city: Sarria
country: Spain
facility: IES Xograr Afonso Gómez de Sarria
state: Lugo
city: Allariz
country: Spain
facility: IES de Allariz
state: Ourense
city: Maceda
country: Spain
facility: IES San Mamede
state: Ourense
city: O Carballiño
country: Spain
facility: CPR Plurilingüe Vila do Arenteiro
state: Ourense
city: O Carballiño
country: Spain
facility: IES Manuel Chamoso Lamas
state: Ourense
city: Xinzo De Limia
country: Spain
facility: IES Lagoa de Antela
state: Ourense
city: A Guarda
country: Spain
facility: IES A Sangriña
state: Pontevedra
city: Baiona
country: Spain
facility: IES Primeiro de Marzo
state: Pontevedra
city: Cangas
country: Spain
facility: IES María Soliño
state: Pontevedra
city: Gondomar
country: Spain
facility: IES Plurilingüe Terra de Turonio
state: Pontevedra
city: Marín
country: Spain
facility: CPR Plurilingüe San Narciso
state: Pontevedra
city: Marín
country: Spain
facility: IES Illa de Tambo
state: Pontevedra
city: Moaña
country: Spain
facility: IES Plurilingüe A Paralaia
state: Pontevedra
city: Mondariz
country: Spain
facility: CPR Cemar
state: Pontevedra
city: Poio
country: Spain
facility: CPR Sek-Atlántico
state: Pontevedra
city: Redondela
country: Spain
facility: IES Mendiño
state: Pontevedra
city: Salvatierra De Miño
country: Spain
facility: IES de Salvaterra de Miño
state: Pontevedra
city: Sanxenxo
country: Spain
facility: IES de Vilalonga
state: Pontevedra
city: Soutomaior
country: Spain
facility: IES Soutomaior
state: Pontevedra
city: Tomiño
country: Spain
facility: IES Antón Alonso Ríos
state: Pontevedra
city: Vigo
country: Spain
facility: IES do Castro
state: Pontevedra
city: Vigo
country: Spain
facility: CPR Plurilingüe San José de Cluny
state: Pontevedra
city: Vigo
country: Spain
facility: IES Alexandre Bóveda
state: Pontevedra
city: Vigo
country: Spain
facility: IES San Tomé de Freixeiro
state: Pontevedra
city: Vigo
country: Spain
facility: CPR Plurilingüe Labor
state: Pontevedra
city: Vigo
country: Spain
facility: IES Valadares
state: Pontevedra
city: Vigo
country: Spain
facility: IES Pedras Rubias
state: Pontevedra
city: A Coruña
country: Spain
facility: IES Rafael Puga Ramón
city: A Coruña
country: Spain
facility: CPR Plurilingüe Calasancias
city: Coruña
country: Spain
facility: IES Monelos
city: Lugo
country: Spain
facility: IES Xoán Montes
city: Lugo
country: Spain
facility: CPR María Auxiliadora
city: Lugo
country: Spain
facility: CPR Galén
city: Lugo
country: Spain
facility: IES Leiras Pulpeiro
city: Ourense
country: Spain
facility: IES O Couto
city: Ourense
country: Spain
facility: CPR Seminario Menor Diocesano A Inmaculada
city: Ourense
country: Spain
facility: CPR Plurilingüe Santa Teresa de Jesús
city: Ourense
country: Spain
facility: IES Xesús Ferro Couselo
city: Pontevedra
country: Spain
facility: CPR Plurilingüe Ntra. Sra. de los Dolores
city: Santiago De Compostela
country: Spain
facility: Servicio Gallego de Salud (SERGAS)
Study officials:
affiliation: Servizo Galego de Saude
name: Alejandro García Caballero
role: PRINCIPAL_INVESTIGATOR
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citation: Wasserman D, Hoven CW, Wasserman C, Wall M, Eisenberg R, Hadlaczky G, Kelleher I, Sarchiapone M, Apter A, Balazs J, Bobes J, Brunner R, Corcoran P, Cosman D, Guillemin F, Haring C, Iosue M, Kaess M, Kahn JP, Keeley H, Musa GJ, Nemes B, Postuvan V, Saiz P, Reiter-Theil S, Varnik A, Varnik P, Carli V. School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial. Lancet. 2015 Apr 18;385(9977):1536-44. doi: 10.1016/S0140-6736(14)61213-7. Epub 2015 Jan 9.