"Youth Aware of Mental Health" in Galicia

NCT06251037 | Enrolling By Invitation

• 1 other identifier: YAM
• Study Type: interventional
• Target: 4,453
• Locations: 1 country
• Sites: 68

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and Twelve months

• 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.

  Baseline and Twelve months

• 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.

  Baseline and Twelve months

Secondary Outcomes (3)

• European Bullying Intervention Project Questionnaire (EBIP-Q) - adapted

  Baseline and Twelve months

• Family Affluence Scale

  Baseline and Twelve months

• Mobile Phone Problem Use Scale

  Baseline and Twelve months

Other Outcomes (1)

• Oviedo Response Infrequency Scale-Revised (INF-OV-R)

  Baseline and Twelve months

Study Arms (2)

Intervention

EXPERIMENTAL

The participants in this group will: Participate in the initial survey; Undergo the YAM program; Participate in the final survey (follow-up).

Behavioral: Youth Aware of Mental Health in Galicia

No intervention

NO INTERVENTION

The participants in this group will: Participate in the initial survey; Participate in the final survey (follow-up).

Interventions

Youth Aware of Mental Health in Galicia 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.

Intervention

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (68)

IES Concepción Arenal

Ferrol, A CoruñaA, 15403, Spain

Location

IES Rafael Puga Ramón

A Coruña, A Coruña, 15008, Spain

Location

CPR Plurilingüe Calasancias

A Coruña, A Coruña, 15011, Spain

Location

CPI As Mirandas

Ares, A Coruña, 15624, Spain

Location

CPR Plurilingüe Nuestra Señora del Carmen

Betanzos, A Coruña, 15300, Spain

Location

IES Francisco Aguiar

Betanzos, A Coruña, 15300, Spain

Location

IES David Buján

Cambre, A Coruña, 15181, Spain

Location

IES Isidro Parga Pondal

Carballo, A Coruña, 15100, Spain

Location

IES Monte Neme

Carballo, A Coruña, 15106, Spain

Location

CPR Plurilingüe Montespiño

Culleredo, A Coruña, 15008, Spain

Location

CPR Plurilingüe Cristo Rey

Ferrol, A Coruña, 15401, Spain

Location

CPR Tirso de Molina

Ferrol, A Coruña, 15401, Spain

Location

CPR Plurilingüe Compañía de María

Ferrol, A Coruña, 15403, Spain

Location

IES Campo de San Alberto

Noia, A Coruña, 15200, Spain

Location

IES Ordes

Ordes, A Coruña, 15680, Spain

Location

IES Maruxa Mallo

Ordes, A Coruña, 15689, Spain

Location

IES Camilo José Cela

Padrón, A Coruña, 15900, Spain

Location

IES Breamo

Pontedeume, A Coruña, 15600, Spain

Location

IES Isaac Díaz Pardo

Sada, A Coruña, 15160, Spain

Location

CPR Plurilingüe Emma

Santiago, A Coruña, 15703, Spain

Location

CPR Plurilingüe La Salle

Santiago, A Coruña, 15704, Spain

Location

IES Arcebispo Xelmírez II

Santiago de Compostela, A Coruña, 15705, Spain

Location

CPI Plurilingüe de Vedra

Vedra, A Coruña, 15885, Spain

Location

IES Monelos

A Coruña, Coruña, 15009, Spain

Location

CPI Alcalde Xosé Pichel

Coristanco, Coruña, 15147, Spain

Location

IES Ricardo Carvalho Calero

Ferrol, Coruña, 15406, Spain

Location

IES Plurilingüe Rosalía de Castro

Santiago de Compostela, Coruña, 15705, Spain

Location

IES Perdouro

Burela de Cabo, Lugo, 27880, Spain

Location

IES Xoán Montes

Lugo, Lugo, 27001, Spain

Location

CPR María Auxiliadora

Lugo, Lugo, 27002, Spain

Location

CPR Galén

Lugo, Lugo, 27003, Spain

Location

IES Leiras Pulpeiro

Lugo, Lugo, 27004, Spain

Location

IES de Monterroso

Monterroso, Lugo, 27560, Spain

Location

CPR Plurilingüe Ntra. Sra. de la Asunción

Sarria, Lugo, 27600, Spain

Location

IES Gregorio Fernández

Sarria, Lugo, 27600, Spain

Location

IES Xograr Afonso Gómez de Sarria

Sarria, Lugo, 27600, Spain

Location

IES de Allariz

Allariz, Ourense, 32660, Spain

Location

IES San Mamede

Maceda, Ourense, 32700, Spain

Location

CPR Plurilingüe Vila do Arenteiro

O Carballiño, Ourense, 32500, Spain

Location

IES Manuel Chamoso Lamas

O Carballiño, Ourense, 32516, Spain

Location

IES O Couto

Ourense, Ourense, 32001, Spain

Location

CPR Seminario Menor Diocesano A Inmaculada

Ourense, Ourense, 32002, Spain

Location

CPR Plurilingüe Santa Teresa de Jesús

Ourense, Ourense, 32005, Spain

Location

IES Xesús Ferro Couselo

Ourense, Ourense, 32005, Spain

Location

IES Lagoa de Antela

Xinzo de Limia, Ourense, 32630, Spain

Location

IES A Sangriña

A Guarda, Pontevedra, 36780, Spain

Location

IES Primeiro de Marzo

Baiona, Pontevedra, 36300, Spain

Location

IES María Soliño

Cangas, Pontevedra, 36949, Spain

Location

IES Plurilingüe Terra de Turonio

Gondomar, Pontevedra, 36380, Spain

Location

CPR Plurilingüe San Narciso

Marín, Pontevedra, 36900, Spain

Location

IES Illa de Tambo

Marín, Pontevedra, 36900, Spain

Location

IES Plurilingüe A Paralaia

Moaña, Pontevedra, 36950, Spain

Location

CPR Cemar

Mondariz, Pontevedra, 36890, Spain

Location

CPR Sek-Atlántico

Poio, Pontevedra, 36005, Spain

Location

CPR Plurilingüe Ntra. Sra. de los Dolores

Pontevedra, Pontevedra, 36002, Spain

Location

IES Mendiño

Redondela, Pontevedra, 36693, Spain

Location

IES de Salvaterra de Miño

Salvatierra de Miño, Pontevedra, 36450, Spain

Location

IES de Vilalonga

Sanxenxo, Pontevedra, 36960, Spain

Location

IES Soutomaior

Soutomaior, Pontevedra, 36690, Spain

Location

IES Antón Alonso Ríos

Tomiño, Pontevedra, 36740, Spain

Location

IES do Castro

Vigo, Pontevedra, 36203, Spain

Location

CPR Plurilingüe San José de Cluny

Vigo, Pontevedra, 36204, Spain

Location

IES Alexandre Bóveda

Vigo, Pontevedra, 36209, Spain

Location

IES San Tomé de Freixeiro

Vigo, Pontevedra, 36210, Spain

Location

CPR Plurilingüe Labor

Vigo, Pontevedra, 36211, Spain

Location

IES Valadares

Vigo, Pontevedra, 36315, Spain

Location

IES Pedras Rubias

Vigo, Pontevedra, 36472, Spain

Location

Servicio Gallego de Salud (SERGAS)

Santiago de Compostela, Spain

Location

Related Publications (18)

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

  BACKGROUND

• 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.

  PMID: 34845100 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25496340 BACKGROUND

• 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.

  PMID: 33148355 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33240123 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31752375 BACKGROUND

• 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.

  PMID: 33339317 BACKGROUND

• 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.

  PMID: 22648315 BACKGROUND

• 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.

  PMID: 28737190 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33989488 BACKGROUND

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

  BACKGROUND

• de Sousa GM, Tavares VDO, de Meiroz Grilo MLP, Coelho MLG, de Lima-Araujo GL, Schuch FB, Galvao-Coelho NL. Mental Health in COVID-19 Pandemic: A Meta-Review of Prevalence Meta-Analyses. Front Psychol. 2021 Sep 21;12:703838. doi: 10.3389/fpsyg.2021.703838. eCollection 2021.

  PMID: 34621212 BACKGROUND

• Vivir la vida. Guía de aplicación para la prevención del suicidio en los países. Washington, D.C.: Organización Panamericana de la Salud; 2021. Licencia: CC BY-NC-SA 3.0 IGO. https:// doi.org/10.37774/9789275324240.

  BACKGROUND

• 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.

  PMID: 25579833 BACKGROUND

Related Links

• Description Suicide Risk Protocol

MeSH Terms

Conditions

Suicide Prevention; Suicidal Ideation; Suicide, Attempted; Depression; Help-Seeking Behavior; Bullying; Cyberbullying; Adolescent Behavior

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Social Behavior; Aggression; Harassment, Non-Sexual

Study Officials

• Alejandro García Caballero

  Servizo Galego de Saude

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: February 2, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-03

Locations

ES (68)