"Youth Aware of Mental Health" in Galicia

Depressive Symptoms Clinical Trial

— YAM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06251037
• Other study ID #: YAM
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: March 2024
• Source: Fundacin Biomedica Galicia Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4453
• Est. completion date: January 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bullying
• Cyberbullying
• Depression
• Depressive Symptoms
• Help-Seeking Behavior
• Suicidal Ideation
• Suicide
• Suicide Prevention
• Suicide, Attempted

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	CPR Plurilingu¨e Calasancias	A Coruña
Spain	IES Rafael Puga Ramón	A Coruña
Spain	IES A Sangriña	A Guarda	Pontevedra
Spain	IES de Allariz	Allariz	Ourense
Spain	CPI As Mirandas	Ares	A Coruña
Spain	IES Primeiro de Marzo	Baiona	Pontevedra
Spain	CPR Plurilingüe Nuestra Señora del Carmen	Betanzos	A Coruña
Spain	IES Francisco Aguiar	Betanzos	A Coruña
Spain	IES Perdouro	Burela De Cabo	Lugo
Spain	IES David Buján	Cambre	A Coruña
Spain	IES María Soliño	Cangas	Pontevedra
Spain	IES Isidro Parga Pondal	Carballo	A Coruña
Spain	IES Monte Neme	Carballo	A Coruña
Spain	CPI Alcalde Xosé Pichel	Coristanco	Coruña
Spain	IES Monelos	Coruña
Spain	CPR Plurilingüe Montespiño	Culleredo	A Coruña
Spain	CPR Plurilingu¨e Cristo Rey	Ferrol	A Coruña
Spain	CPR Plurilingüe Compañía de María	Ferrol	A Coruña
Spain	CPR Tirso de Molina	Ferrol	A Coruña
Spain	IES Concepción Arenal	Ferrol	A CoruñaA
Spain	IES Ricardo Carvalho Calero	Ferrol	Coruña
Spain	IES Plurilingüe Terra de Turonio	Gondomar	Pontevedra
Spain	CPR Galén	Lugo
Spain	CPR María Auxiliadora	Lugo
Spain	IES Leiras Pulpeiro	Lugo
Spain	IES Xoán Montes	Lugo
Spain	IES San Mamede	Maceda	Ourense
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	IES de Monterroso	Monterroso	Lugo
Spain	IES Campo de San Alberto	Noia	A Coruña
Spain	CPR Plurilingüe Vila do Arenteiro	O Carballiño	Ourense
Spain	IES Manuel Chamoso Lamas	O Carballiño	Ourense
Spain	IES Maruxa Mallo	Ordes	A Coruña
Spain	IES Ordes	Ordes	A Coruña
Spain	CPR Plurilingüe Santa Teresa de Jesús	Ourense
Spain	CPR Seminario Menor Diocesano A Inmaculada	Ourense
Spain	IES O Couto	Ourense
Spain	IES Xesús Ferro Couselo	Ourense
Spain	IES Camilo José Cela	Padrón	A Coruña
Spain	CPR Sek-Atlántico	Poio	Pontevedra
Spain	IES Breamo	Pontedeume	A Coruña
Spain	CPR Plurilingüe Ntra. Sra. de los Dolores	Pontevedra
Spain	IES Mendiño	Redondela	Pontevedra
Spain	IES Isaac Díaz Pardo	Sada	A Coruña
Spain	IES Pedras Rubias	Salceda De Caselas	Pontevedra
Spain	IES de Salvaterra de Miño	Salvatierra De Miño	Pontevedra
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	IES Plurilingu¨e Rosalía de Castro	Santiago De Compostela	Coruña
Spain	Servicio Gallego de Salud (SERGAS)	Santiago De Compostela
Spain	IES de Vilalonga	Sanxenxo	Pontevedra
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 Soutomaior	Soutomaior	Pontevedra
Spain	IES Antón Alonso Ríos	Tomiño	Pontevedra
Spain	CPI Plurilingu¨e de Vedra	Vedra	A Coruña
Spain	CPR Plurilingüe Labor	Vigo	Pontevedra
Spain	CPR Plurilingüe San José de Cluny	Vigo	Pontevedra
Spain	IES Alexandre Bóveda	Vigo	Pontevedra
Spain	IES do Castro	Vigo	Pontevedra
Spain	IES San Tomé de Freixeiro	Vigo	Pontevedra
Spain	IES Valadares	Vigo	Pontevedra
Spain	IES Lagoa de Antela	Xinzo De Limia	Ourense

Sponsors (1)

Lead Sponsor	Collaborator
Fundacin Biomedica Galicia Sur

Country where clinical trial is conducted

Spain, 

References & Publications (18)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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.

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oviedo Response Infrequency Scale-Revised (INF-OV-R)	Oviedo Response Infrequency Scale-Revised (INF-OV-R) Is a 10 items self-report measurement with a dichotomous response format (Yes/No) developed to detect those participants who respond randomly, pseudo-randomly, or dishonestly to the administered measuring instruments. The items on this scale are typically intermixed with questions and statements from other self-report measures that are administered together to o enable better detection. Higher values are indicative of random, pseudo-random, or dishonest answers.	Baseline and Twelve months
Primary	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
Primary	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
Primary	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	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.	Baseline and Twelve months
Secondary	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.	Baseline and Twelve months
Secondary	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.	Baseline and Twelve months

External Links

•   Description Suicide Risk Protocol