Randomized Clinical Trial to Evaluate the Efficacy of the Universal Suicide Prevention Program "Youth Aware of Mental Health" in Galicia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,453
- 试验地点
- 136
- 主要终点
- Paykel Suicide Scale
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a 3rd-year secondary education student at one of the participating school centers
- •To be between 13 and 16 years old
排除标准
- •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.
结局指标
主要结局
Paykel Suicide Scale
时间窗: Baseline and Twelve months
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.
Mood an Feelings Questionnaire
时间窗: Baseline and Twelve months
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.
Help-seeking Behavior Questionnaire
时间窗: Baseline and Twelve months
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.
次要结局
- Mobile Phone Problem Use Scale(Baseline and Twelve months)
- Family Affluence Scale(Baseline and Twelve months)
- European Bullying Intervention Project Questionnaire (EBIP-Q) - adapted(Baseline and Twelve months)
研究者
Alejandro Alberto García Caballero
Principal Investigator
Servicio Gallego de Salud