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Suicide AwarenessYAMNCT06251037

"Youth Aware of Mental Health" in Galicia

A study testing Youth Aware of Mental Health in Galicia in people with Suicide Awareness and Suicidal Ideation, run by Fundacin Biomedica Galicia Sur at 68 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 13 to 16 yearsHealthy volunteers can take part
What is being tested?
Youth Aware of Mental Health in Galicia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,453 participants
Where
68 sitesSpain
Study dates
2 Feb 2024to 15 Jun 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

Spain68 sites
  • IES Rafael Puga Ramón

    A Coruña, A Coruña, 15008

  • CPR Plurilingüe Calasancias

    A Coruña, A Coruña, 15011

  • IES Monelos

    A Coruña, Coruña, 15009

  • IES A Sangriña

    A Guarda, Pontevedra, 36780

  • IES de Allariz

    Allariz, Ourense, 32660

  • CPI As Mirandas

    Ares, A Coruña, 15624

  • IES Primeiro de Marzo

    Baiona, Pontevedra, 36300

  • CPR Plurilingüe Nuestra Señora del Carmen

    Betanzos, A Coruña, 15300

  • IES Francisco Aguiar

    Betanzos, A Coruña, 15300

  • IES Perdouro

    Burela de Cabo, Lugo, 27880

  • IES David Buján

    Cambre, A Coruña, 15181

  • IES María Soliño

    Cangas, Pontevedra, 36949

  • IES Isidro Parga Pondal

    Carballo, A Coruña, 15100

  • IES Monte Neme

    Carballo, A Coruña, 15106

  • CPI Alcalde Xosé Pichel

    Coristanco, Coruña, 15147

  • CPR Plurilingüe Montespiño

    Culleredo, A Coruña, 15008

  • IES Concepción Arenal

    Ferrol, A CoruñaA, 15403

  • CPR Plurilingüe Cristo Rey

    Ferrol, A Coruña, 15401

  • CPR Tirso de Molina

    Ferrol, A Coruña, 15401

  • CPR Plurilingüe Compañía de María

    Ferrol, A Coruña, 15403

  • IES Ricardo Carvalho Calero

    Ferrol, Coruña, 15406

  • IES Plurilingüe Terra de Turonio

    Gondomar, Pontevedra, 36380

  • IES Xoán Montes

    Lugo, Lugo, 27001

  • CPR María Auxiliadora

    Lugo, Lugo, 27002

  • CPR Galén

    Lugo, Lugo, 27003

  • IES Leiras Pulpeiro

    Lugo, Lugo, 27004

  • IES San Mamede

    Maceda, Ourense, 32700

  • CPR Plurilingüe San Narciso

    Marín, Pontevedra, 36900

  • IES Illa de Tambo

    Marín, Pontevedra, 36900

  • IES Plurilingüe A Paralaia

    Moaña, Pontevedra, 36950

  • CPR Cemar

    Mondariz, Pontevedra, 36890

  • IES de Monterroso

    Monterroso, Lugo, 27560

  • IES Campo de San Alberto

    Noia, A Coruña, 15200

  • CPR Plurilingüe Vila do Arenteiro

    O Carballiño, Ourense, 32500

  • IES Manuel Chamoso Lamas

    O Carballiño, Ourense, 32516

  • IES Ordes

    Ordes, A Coruña, 15680

  • IES Maruxa Mallo

    Ordes, A Coruña, 15689

  • IES O Couto

    Ourense, Ourense, 32001

  • CPR Seminario Menor Diocesano A Inmaculada

    Ourense, Ourense, 32002

  • CPR Plurilingüe Santa Teresa de Jesús

    Ourense, Ourense, 32005

  • IES Xesús Ferro Couselo

    Ourense, Ourense, 32005

  • IES Camilo José Cela

    Padrón, A Coruña, 15900

  • CPR Sek-Atlántico

    Poio, Pontevedra, 36005

  • IES Breamo

    Pontedeume, A Coruña, 15600

  • CPR Plurilingüe Ntra. Sra. de los Dolores

    Pontevedra, Pontevedra, 36002

  • IES Mendiño

    Redondela, Pontevedra, 36693

  • IES Isaac Díaz Pardo

    Sada, A Coruña, 15160

  • IES de Salvaterra de Miño

    Salvatierra de Miño, Pontevedra, 36450

  • CPR Plurilingüe Emma

    Santiago, A Coruña, 15703

  • CPR Plurilingüe La Salle

    Santiago, A Coruña, 15704

  • IES Arcebispo Xelmírez II

    Santiago de Compostela, A Coruña, 15705

  • IES Plurilingüe Rosalía de Castro

    Santiago de Compostela, Coruña, 15705

  • Servicio Gallego de Salud (SERGAS)

    Santiago de Compostela

  • IES de Vilalonga

    Sanxenxo, Pontevedra, 36960

  • CPR Plurilingüe Ntra. Sra. de la Asunción

    Sarria, Lugo, 27600

  • IES Gregorio Fernández

    Sarria, Lugo, 27600

  • IES Xograr Afonso Gómez de Sarria

    Sarria, Lugo, 27600

  • IES Soutomaior

    Soutomaior, Pontevedra, 36690

  • IES Antón Alonso Ríos

    Tomiño, Pontevedra, 36740

  • CPI Plurilingüe de Vedra

    Vedra, A Coruña, 15885

  • IES do Castro

    Vigo, Pontevedra, 36203

  • CPR Plurilingüe San José de Cluny

    Vigo, Pontevedra, 36204

  • IES Alexandre Bóveda

    Vigo, Pontevedra, 36209

  • IES San Tomé de Freixeiro

    Vigo, Pontevedra, 36210

  • CPR Plurilingüe Labor

    Vigo, Pontevedra, 36211

  • IES Valadares

    Vigo, Pontevedra, 36315

  • IES Pedras Rubias

    Vigo, Pontevedra, 36472

  • IES Lagoa de Antela

    Xinzo de Limia, Ourense, 32630

Other trials in Spain

About this study

Official title: Randomized Clinical Trial to Evaluate the Efficacy of the Universal Suicide Prevention Program "Youth Aware of Mental Health" in Galicia

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:

Read more
  • 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.

Read the 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.

Being tested
Youth Aware of Mental Health in Galicia
Keywords
Suicide awareness, Adolescent behavior, Suicide prevention intervention, Mental health literacy
Medical subject headings
Suicide Prevention, Suicidal Ideation, Suicide, Attempted, Depression, Help-Seeking Behavior, Bullying, Cyberbullying, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Youth Aware of Mental Health in GaliciaBehavioural

    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.

Study groups in NCT06251037
Study groupRoleWhat they receive
InterventionExperimentalThe participants in this group will: Participate in the initial survey; Undergo the YAM program; Participate in the final survey (follow-up).
Receives: Behavioral: Youth Aware of Mental Health in Galicia
No interventionNo interventionThe participants in this group will: Participate in the initial survey; Participate in the final survey (follow-up).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Paykel Suicide Scale

    This 5 item questionnaire asks about suicidal ideation over the past year. Scores range between 0 and 5. Scores equal to or greater than 4 are suggestive of suicidal ideation. Higher values are indicative of worse outcomes.

    Measured: Baseline and Twelve months

  2. Mood an Feelings Questionnaire

    This 34 item questionnaire assesses symptoms of depression/suicide risk. Scores range from 0 to 66. Scores above 27 points are considered positive for screening. Higher values are indicative of worse outcomes.

    Measured: Baseline and Twelve months

  3. Help-seeking Behavior Questionnaire

    This instrument consists of 7 hypothetical scenarios in vignette format, to which the subject must respond using a 7-point Likert scale, in addition to providing open-ended responses. The questionnaire assesses the subject's willingness to seek help for the 7 depicted mental health cases, evaluating the likelihood of seeking help from a selection of 10 different sources. It also provides a measure of mental health literacy and the perceived need for assistance. Higher values are indicative of better outcomes.

    Measured: Baseline and Twelve months

Secondary outcomes (3)
  1. European Bullying Intervention Project Questionnaire (EBIP-Q) - adapted

    The instrument cointains the European Bullying Intervention Project Questionnaire (14-items) of Likert nature to evaluate behaviors related to bullying. Its original timeframe has been adapted from 2 to 12 months to cover the study period. Two selected questions about cyberbullying extracted from the 'Coexistence Diagnosis Survey 2023' by the Department of Education were added to cover cyberbullying. Higher values are indicative of worse outcomes.

    Measured: Baseline and Twelve months

  2. Family Affluence Scale

    A scale used internationally in the HBSC study, consisting of 6 items that inquire about various household resources such as the number of cars, computers, or bathrooms with a shower in the house. Scores range from 0 to 13. Higher values are indicative of better outcomes.

    Measured: Baseline and Twelve months

  3. Mobile Phone Problem Use Scale

    Selected questions (based on their highest factorial loading) about problematic mobile phone use were extracted from the 'Mobile Phone Problem Use Scale' for adolescent population, a validated instrument in Spain for screening possible problematic mobile phone use. Higher values are indicative of worse outcomes.

    Measured: Baseline and Twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start2 Feb 2024
  3. Primary completion15 Jun 2024
  4. Study completion15 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,453 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06251037
Sponsor's protocol ID
YAM
Acronym
YAM
Status last verified
Mar 2024
First submitted
1 Feb 2024
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Agencia Española de Protección de Datos (AEPD) (2021) Gestión del riesgo y evaluación de impacto en tratamientos de datos personales. Junio, 2021.

  • Barker R, Hartwell G, Bonell C, Egan M, Lock K, Viner RM. Research priorities for mental health in schools in the wake of COVID-19. J Epidemiol Community Health. 2021 Nov 29;76(5):448-50. doi: 10.1136/jech-2021-217902. Online ahead of print.

    PubMed 34845100
  • Crecer saludable(mente): Un análisis sobre la salud mental y el suicidio en la infancia y la adolescencia. Save the Children, 2021. https://www.savethechildren.es/sites/default/files/ 2021-12/Informe_Crecer_saludablemente_DIC_2021.pdf

  • Collishaw S. Annual research review: Secular trends in child and adolescent mental health. J Child Psychol Psychiatry. 2015 Mar;56(3):370-93. doi: 10.1111/jcpp.12372. Epub 2014 Dec 12.

    PubMed 25496340
  • Fernandez-Martinez I, Morales A, Mendez FX, Espada JP, Orgiles M. Spanish Adaptation and Psychometric Properties of the Parent Version of the Short Mood and Feelings Questionnaire (SMFQ-P) in a Non-Clinical Sample of Young School-Aged Children. Span J Psychol. 2020 Nov 5;23:e45. doi: 10.1017/SJP.2020.47.

    PubMed 33148355
  • Fonseca- Pedrero E, Pérez- Albéniz, A. Assessment of Suicidal Behavior in adolescents: The Paykel Suicide Scale. Papeles del psicólogo 2020 Vol. 41(2), pp. 106-115.

  • Gonzalez-Sanguino C, Ausin B, Castellanos MA, Saiz J, Lopez-Gomez A, Ugidos C, Munoz M. Mental Health Consequences of the Coronavirus 2020 Pandemic (COVID-19) in Spain. A Longitudinal Study. Front Psychiatry. 2020 Nov 9;11:565474. doi: 10.3389/fpsyt.2020.565474. eCollection 2020.

    PubMed 33240123
  • Instituto Nacional de Estadística (2021) Estadística de defunciones según la causa de muerte.

  • Lim KS, Wong CH, McIntyre RS, Wang J, Zhang Z, Tran BX, Tan W, Ho CS, Ho RC. Global Lifetime and 12-Month Prevalence of Suicidal Behavior, Deliberate Self-Harm and Non-Suicidal Self-Injury in Children and Adolescents between 1989 and 2018: A Meta-Analysis. Int J Environ Res Public Health. 2019 Nov 19;16(22):4581. doi: 10.3390/ijerph16224581.

    PubMed 31752375
  • Lo Moro G, Soneson E, Jones PB, Galante J. Establishing a Theory-Based Multi-Level Approach for Primary Prevention of Mental Disorders in Young People. Int J Environ Res Public Health. 2020 Dec 16;17(24):9445. doi: 10.3390/ijerph17249445.

    PubMed 33339317
  • Lopez-Fernandez O, Honrubia-Serrano ML, Freixa-Blanxart M. [Spanish adaptation of the "Mobile Phone Problem Use Scale" for adolescent population]. Adicciones. 2012;24(2):123-30. Spanish.

    PubMed 22648315
  • Olivari C, Guzman-Gonzalez M. [Validation of the general help-seeking questionnaire for mental health problems in adolescents]. Rev Chil Pediatr. 2017 Jun;88(3):324-331. doi: 10.4067/S0370-41062017000300003. Spanish.

    PubMed 28737190
  • Ortuño-Sierra, Javier; Fonseca-Pedrero, Eduardo; Inchausti, Félix; Sastre i Riba, Sylvia. Evaluación de dificultades emocionales y comportamentales en población infanto- juvenil: el cuestionario de capacidades y dificultades. (SDQ). Papeles del Psicólogo, vol. 37, núm. 1, 2016, pp. 14-26.

  • Perez A, Thrasher J, Monzon JC, Arillo-Santillan E, Barnoya J, Mejia R. La escala de afluencia familiar en la investigacion sobre inequidades sociales en salud en adolescentes latinoamericanos. Salud Publica Mex. 2021 Jan 15;63(2, Mar-Abr):201-210. doi: 10.21149/11793.

    PubMed 33989488
  • R. Nelson & J. Galas. The power to prevent suicide: A guide for teens helping teens. Free Spirit, 2006.

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