Prevention of Alcohol Abuse in Educational Settings (PRVENALC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Alcohol abuse
研究概览
简要总结
This study corresponds to a pretest-posttest randomized experimental design with two arms. Arm 1 includes Guided Self-Change program, and Arm 2 a psychoeducational program to promote healthy habits. This study aims to analyze the efficacy of a selective and indicated prevention program based on the Guided Self-Change model (GSC) in adolescent alcohol users between 16-18 years. Researchers hypothesize that implementation of GSC therapy will lead to a greater reduction of alcohol drinkers compare with the control condition, and will prevent alcohol abuse after 6 and 12 months.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •16-18 years old.
- •Having inform consent from parents
- •Report using alcohol at least once a month during the previous last three months
排除标准
- •Participants will be excluded if they refer being diagnosed with a severe mental disorder.
- •Have a severe medical illness that will limit participation
- •Being under treatment for a psychological of psychiatric problem.
- •Meet DSM criteria for Drug dependence to illegal drugs.
结局指标
主要结局
Alcohol abuse
时间窗: Change from baseline to week 5, and at 6 and 12 months post intervention.
Alcohol abuse will be assessed using the Rutgers Alcohol Problem Index (White \& Labouvie, 1989). The global score ranges from 0 to 69, where higher scores represent greater level of alcohol-related problems.
Alcohol dependence
时间窗: Change from baseline to week 5, and at 6 and 12 months post intervention.
Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).
Alcohol use change
时间窗: Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention
Alcohol use will be assessed using the Timeline Follow-Back (Sobell \& Sobell, 1992)
次要结局
- Drug use(Change from baseline to week 5, and at 6 and 12 months post intervention.)
- Impulsiveness(Change from baseline to week 5, and at 6 and 12 months post intervention.)
- Sleep quality(Change from baseline to week 5, and at 6 and 12 months post intervention.)
研究者
Jose Luis Carballo Crespo, PhD
Associate Professor and Researcher
Universidad Miguel Hernandez de Elche