An interventional study of Youth Aware of Mental Health in Galicia in Suicide Awareness, Suicidal Ideation and Suicide, Attempted, sponsored by Fundacin Biomedica Galicia Sur. Enrolling by invitation at 68 sites in Spain. Open to participants aged 13 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Fundacin Biomedica Galicia Sur · Not applicable, Interventional, and Prevention
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:
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.
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.).
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.
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.
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:
listen to others and be able to talk about depression and suicidal thoughts.
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.
186 studies on the registry are indexed under Suicide Prevention; 92 are open to participants now.
This study's planned enrollment of 4,453 is above the median of 140 across 167 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
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Exclusion 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.
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
The participants in this group will: Participate in the initial survey; Participate in the final survey (follow-up).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Twelve months
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.
Time frame: Baseline and Twelve months
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.
Time frame: Baseline and Twelve months
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.
Time frame: Baseline and Twelve months
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.
Time frame: Baseline and Twelve months
Ran from Feb 2024 to primary completion in Jun 2024, 4 months.
Of 127 non-industry interventional studies with no phase under Suicide Prevention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's 4 months is below that.
Counting every sponsor, half of 129 studies reached it within 28 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Fundacin Biomedica Galicia Sur