Prevention Workshop to Address Bullying Behaviors in Schools: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Prevalence of Bullying Behaviors (Victims and/or Aggressors)
研究概览
简要总结
This study, titled APACHES, is a cluster randomized controlled trial aimed at evaluating the effectiveness of a school-based prevention program, "Tous Épanouis à l'École" (TEAL), conducted by healthcare students as part of their mandatory public health service curriculum. The TEAL program consists of five interactive sessions focused on developing psychosocial skills (e.g., communication, empathy, collaboration) among elementary school students (grades CE2-CM1-CM2) in the Grenoble Academy. The primary objective is to assess whether the program reduces the prevalence of bullying behaviors (victims and/or aggressors) compared to standard preventive actions on unrelated themes. The study involves 36 classrooms across 18 schools, with data collected at three time points: before, one month after, and four months after the intervention. Secondary objectives include evaluating social proximity, altruistic behaviors, and qualitative perceptions from students, teachers, and facilitators.
详细描述
Bullying is a critical public health issue with severe consequences for children's psychological development, academic success, and long-term health outcomes. The APACHES study evaluates the effectiveness of the TEAL program, a psychosocial skills training intervention tailored to reduce bullying behaviors and improve classroom climate. The intervention will be delivered by healthcare students (from medicine, midwifery, pharmacy, and nursing) as part of their Service Sanitaire curriculum.
The study follows a pragmatic design with a cluster randomized controlled methodology. Classrooms in participating schools are randomized into two groups: an intervention group receiving the TEAL program and a control group undergoing alternative health education sessions. The TEAL program is structured around active and participatory learning, including sessions on emotional awareness, communication, empathy, and collective problem-solving. A total of 900 students from 36 classrooms (approximately 450 per group) will participate.
Objectives Primary Objective: To determine whether the TEAL program reduces the prevalence of bullying (victims and/or aggressors) by comparing baseline and follow-up outcomes.
Secondary Objectives: To explore improvements in social proximity, altruistic behaviors, and psychosocial skills; to collect qualitative feedback from students, facilitators, and teachers about the intervention.
Data Collection and Outcomes Quantitative data will be collected using validated questionnaires (e.g., Revised Bully/Victim Questionnaire) administered at three time points: pre-intervention (T1), one month post-intervention (T2), and four months post-intervention (T3). Secondary outcomes, including social proximity and altruism, will also be assessed. Qualitative data will be gathered through interviews and focus groups to evaluate participants' experiences and perceptions.
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
盲法说明
Although the study is open-label for participants, care providers, and investigators, the statistician conducting the data analysis will remain blinded to group allocation. This ensures unbiased interpretation of the results.
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students enrolled in grades CE2, CM1, or CM2 in participating schools.
- •Parents or legal guardians have provided signed informed consent for their child to participate in the study.
- •The child is available to attend all scheduled intervention sessions.
排除标准
- •Students whose parents or legal guardians have not provided signed informed consent.
- •Students with medical or behavioral conditions that might prevent full participation in the sessions (e.g., requiring additional support not available during the study).
- •Students not attending the school on a regular basis.
结局指标
主要结局
Prevalence of Bullying Behaviors (Victims and/or Aggressors)
时间窗: Change from baseline (T1) to one month after the intervention (T2).
The proportion of students identified as victims, aggressors, or victim-aggressors based on the Revised Bully/Victim Questionnaire (rBVQ). Measured at three time points: before the intervention (T1), one month after the intervention (T2), and four months after the intervention (T3).
次要结局
- Change in Social Proximity Score(Change from baseline (T1) to one month after the intervention (T2).)
- Change in Psychosocial Skills(Change from baseline (T1) to one month after the intervention (T2).)
- Change in Altruistic Behaviors(Change from baseline (T1) to one month after the intervention (T2).)
- Perception of the Intervention by Healthcare Students (Focus Groups)(Collected one month after the intervention (T2))
- Perception of the Intervention by Elementary School Teachers (Interviews)(Collected one month after the intervention (T2))
- Perception of the Intervention by Students (Interviews)(Collected one month after the intervention (T2))