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临床试验/NCT05281172
NCT05281172
已完成
不适用

Prevention of Alcohol Abuse in Educational Settings (PRVENALC)

Universidad Miguel Hernandez de Elche1 个研究点 分布在 1 个国家目标入组 800 人2022年3月21日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Alcohol Abuse or Dependence
发起方
Universidad Miguel Hernandez de Elche
入组人数
800
试验地点
1
主要终点
Alcohol abuse
状态
已完成
最后更新
去年

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.

注册库
clinicaltrials.gov
开始日期
2022年3月21日
结束日期
2024年5月15日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jose Luis Carballo Crespo, PhD

Associate Professor and Researcher

Universidad Miguel Hernandez de Elche

入排标准

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.)

研究点 (1)

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