Randomized Control Trial of the Effectiveness of the Social Competence Promotion Program for Young Adolescents Aimed at Preventing Substance Use Among Students in Chile
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Cigarette use in the last month
研究概览
简要总结
Substance use has become a significant public health problem, given its magnitude and the treatment gap encountered when a dependency disorder has already been installed. Still, to date, there are no studies in Chile that show the effectiveness of a universal preventive program implemented in educational settings, using a randomized controlled clinical trial design.
This study consists of evaluating the effectiveness of the Social Competence Promotion Program among Young Adolescents (SCPP-YA), which aims to postpone the onset of substance use and reduce their consumption.
This is a randomized controlled clinical trial with two arms, including students of 6th grade from high socioeconomic vulnerability schools in Santiago. The primary outcome is the incidence of tobacco consumption in the last month.
The SCPP-YA consists of 16 sessions that will be implemented during the academic year (2020) and complemented with three booster sessions the following year (2021). This intervention mainly provides strategies for self-regulation, problem-solving, and substance use prevention.
The investigators expect that students in the intervention group will delay the onset of any substance use, especially tobacco, alcohol, and marijuana when compared with students in the control group.
详细描述
Chilean adolescents face problems in their mental health and risk behaviors, which compromise their development. Among these behaviors, substance use has become a significant public health problem, given its magnitude and the treatment gap encountered when a dependency disorder has already been installed. In Chile, both prevention and treatment were among the Sanitary Aims of the 2010-2020 decade. For many years, different governmental and non-governmental institutions have implemented preventive initiatives in the school population. Still, to date, there are no studies in Chile that show the effectiveness of a universal preventive program implemented in educational settings, using a randomized controlled clinical trial design.
This study consists of evaluating the effectiveness of the Social Competence Promotion Program among Young Adolescents (SCPP-YA), which aims to postpone the onset of substance use and reduce their consumption.
This is a randomized controlled clinical trial with two arms, including students of 6th grade from high socioeconomic vulnerability schools in Santiago. Ten schools will be randomly allocated to the intervention group and the control group in a 1:1 ratio. Assessments of students will be carried out at baseline, post-intervention, and 12 months after the end of the intervention. The primary outcome is the incidence of tobacco consumption in the last month. The SCPP-YA consists of 10 student sessions providing self-regulation strategies, promotion of prosocial skills, and a method of problem-solving. Additionally, it includes a 6-session module specially designed for substance use prevention. These 16 sessions will be implemented during the academic year (2020) and complemented with three booster sessions the following year (2021).
The investigators expect that students in the intervention group will delay the onset of any substance use, especially tobacco, alcohol, and marijuana when compared with students in the control group.
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
- Single (Outcomes Assessor)
盲法说明
During the assessments, research assistants will be blind to the allocation of schools.
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schools having primary education (Year 1 to Year 8)
- •Schools located in Santiago (Chile)
- •Schools having a vulnerability index (School Vulnerability Index - National System of Equality Allocation (IVE-SINAE)) ≥ 50%*
- •Mixed-sex schools.
- •Schools willing to participate under the conditions of the study before randomization.
- •The IVE-SINAE is built taking into account several students' and parental variables: health, family income, receiving state benefits. This percentage means the proportion of students in a school who are in most need.
排除标准
- •Schools that are implementing other substance use prevention program similar to the contents and methodology of "Mi Mejor Plan" targeting the same grade.
结局指标
主要结局
Cigarette use in the last month
时间窗: Past 30-day period
Measured with the European Drug Addiction Prevention Trial Questionnaire (EU-Dap) validated in Chile. Students will be asked: How many times participants have smoked cigarettes in the last 30 days
次要结局
- Social problem-solving(Last 3 months)
- Socio-emotional skills(Last 3 months)
- Emotional regulation(Last 3 months)
- Alcohol use in the last month(Past 30-day period)
- Sense of school membership(Last 3 months)
- Marijuana use in the last month(Past 30-day period)
研究者
Jorge Gaete
Associate Professor
Universidad de los Andes, Chile