The Canadian Underage Substance Use Prevention 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
- 12,500
- 试验地点
- 8
- 主要终点
- Implementation Facilitation (primary outcome): Severity of substance use problems
研究概览
简要总结
Despite having made some strides with respect to reducing adolescent drinking rates, illicit substance use and substance use disorders (SUDs) remain significantly above national targets for health promotion and disease prevention in Canada and the United States. Now, more than ever, there is a pressing need for effective substance abuse prevention in Canada, particularly for those most at risk of developing substance use problems including prescription drug misuse. Clearly, new approaches to prevention (with lower numbers needed to treat) are needed and which translate new research on addiction vulnerability to personalised prevention and early intervention. The PreVenture Program involves brief cognitive-behavioural interventions targeting personality traits from a neurocognitive perspective. While the personality-targeted approach has been shown to be effective in reducing most substance use behaviors, it has yet to be evaluated for its impact on uptake of prescription drug misuse in adolescents. The Canadian Underage Substance use Prevention (CUSP) Trial aims to evaluate the long-term effects of a personality-targeted school-based prevention program on delaying the onset of drug and alcohol use in adolescence over three years across Canada. This is a hybrid effectiveness [E] and implementation-facilitation [IF] trial on delaying the onset of drug and alcohol use in adolescence. In the [E] part, the effects of a personalized prevention program will be tested against usual school-based prevention curricula. PreVenture is delivered through a TtT implementation model with or without [IF], e.g. with ongoing supervision and web-based support. The [IF] package is designed to support long-term sustainability of PreVenture after a community accesses PreVenture training.
详细描述
Aim:
To evaluate the effectiveness and implementation of the PreVenture program on reducing substance-related problems and substance use behaviours in adolescence when delivered in real-world school settings using a train-the-trainer (TtT) model, with and without implementation facilitation.
Questions:
This hybrid Type II effectiveness-implementation trial examines whether a personality-targeted prevention program, delivered through a TtT model, reduces substance-related problems and substance use behaviours among high-risk adolescents in routine school settings. In the effectiveness [E] part, the effects of PreVenture will be compared with usual school-based prevention curricula. PreVenture is delivered through a TtT implementation model with or without implementation facilitation [IF], consisting of ongoing coaching, supervision, and web-based support. The [IF] package is designed to support long-term sustainability of PreVenture after a community accesses PreVenture training.
[E] questions: Does the PreVenture intervention, when delivered through a TtT model (with or without IF), reduce the severity of substance-related problems among high-risk secondary school students compared with treatment as usual (primary)? Does the intervention reduce substance-related problems, binge drinking, cannabis use, illicit drug use, and non-medical prescription drug use at approximately 12 and 24 months post-baseline (secondary)? Does the intervention demonstrate sustained effects across available follow-up assessments (secondary)?
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
The evaluation team will be blinded to the intervention conditions until 24 months
入排标准
- 年龄范围
- 15 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Survey: All year 10 students with youth consent and parental passive or active consent (depending on local site requirements) will be eligible to participate in the survey
- •PreVenture: Eligibility will include consenting to study protocol and scoring 0.9 or more Standard Deviations (SD) above the school's norm on the 23-item Substance Use Risk Profile Scale (SURPS). The SURPS is a 23-item validated tool that assesses four personality dimensions along the internalizing (hopelessness (HOP) and anxiety sensitivity (AS)) and externalizing (impulsivity (IMP) and sensation seeking (SS)) spectrum. It has been shown to predict specific substance use patterns, including cannabis use and non-medical use of prescription drugs. Of those screened in a given year, approximately 1350 (45%) will report elevated personality profiles and will be eligible for intervention.
排除标准
- •- Students that do not have either the site-specific parental consent/assent or youth consent will not be eligible to participate in the survey or PreVenture
研究组 & 干预措施
PreVenture Training (PTtT)
Schools randomized to this arm will identify 4 staff members to participate in a 2-day training workshop + 3 hours of supervised practice and will be provided with access to screening and PreVenture intervention materials through the local trainer. Local trainers will deliver 2-day workshops and then supervise school staff in the delivery of two 90-minute group sessions (for at least one personality profile).
干预措施: PreVenture Training (PTtT) (Behavioral)
PreVenture Training + Implementation Facilitation (PTtT+IF)
Schools randomized this arm will receive the standard PreVenture TtT protocol plus an additional Implementation Facilitation package that will contain 3 new components designed to increase the likelihood that schools will continue to implement the program with high quality and satisfaction: 1) Youth Engagement, 2) ongoing coaching and supervision for Facilitators, and 3) access to easy-to-use performance metrics.
干预措施: PreVenture Training+Implementation Facilitation (Behavioral)
Control (TAU)
For schools randomized to this arm, students will have usual access to drug and alcohol prevention through the standard curriculum and mental health care provided through student counseling at the participating schools. The schools will be incentivized to participate in the study with the promise of free PreVenture training and materials in subsequent years of the trial. Information on other drug prevention efforts implemented at the school will be collected, but the randomized design should control for any potential differences between intervention conditions on this random factor.
结局指标
主要结局
Implementation Facilitation (primary outcome): Severity of substance use problems
时间窗: 12 months
Compare change in severity of substance use problems as measured by CRAFFT score after the start of PreVenture intervention using Cohort 3 between both conditions. The CRAFFT Screening Test is a short clinical assessment tool designed to screen for substance-related risks and problems in adolescents. CRAFFT stands for the key words of the 6 items in the second section of the assessment - Car, Relax, Alone, Forget, Friends, Trouble. CRAFFT employs a skip pattern: participants whose Part A score is "0" (no use) answer the Car question only of Part B, while those who report any use in Part A also answer Part B's five CRAFFT questions. Each "yes" answer is scored as "1" point and a CRAFFT total score of two or higher identifies "high risk" for a substance use disorder.
Effectiveness (primary outcome): Severity of substance use problems
时间窗: Baseline (pre-intervention), 12 months, 24 months
Compare change in severity of substance use problems as measured by CRAFFT score of both arms of PreVenture against TAU using Cohort 2 in all three conditions. The CRAFFT Screening Test is a short clinical assessment tool designed to screen for substance-related risks and problems in adolescents. CRAFFT stands for the key words of the 6 items in the second section of the assessment - Car, Relax, Alone, Forget, Friends, Trouble. CRAFFT employs a skip pattern: participants whose Part A score is "0" (no use) answer the Car question only of Part B, while those who report any use in Part A also answer Part B's five CRAFFT questions. Each "yes" answer is scored as "1" point and a CRAFFT total score of two or higher identifies "high risk" for a substance use disorder.
Effectiveness (primary): Risk of substance use problems
时间窗: Baseline to 24 months
The primary effectiveness outcome is CRAFFT-positive screening, defined as a CRAFFT total score ≥2, indicating elevated risk of substance-related problems. Effectiveness will be assessed by comparing changes in the proportion of adolescents screening CRAFFT-positive in schools randomized to PreVenture (both implementation arms pooled) versus treatment as usual (TAU). The CRAFFT Screening Test is a short clinical assessment tool designed to screen for substance-related risks and problems in adolescents. CRAFFT stands for the key words of the 6 items in the second section of the assessment - Car, Relax, Alone, Forget, Friends, Trouble. CRAFFT employs a skip pattern: participants whose Part A score is "0" (no use) answer the Car question only of Part B, while those who report any use in Part A also answer Part B's five CRAFFT questions. Each "yes" answer is scored as "1" point and a CRAFFT total score of two or higher identifies elevated risk for a substance use disorder.
次要结局
- Effectiveness (secondary outcome): Prevalence of binge drinking(Baseline (pre-intervention), 12 months, 24 months)
- Implementation Facilitation (secondary outcome): Rate of interventions(24 months)
- Effectiveness (secondary outcome): Frequency of cannabis use(Baseline (pre-intervention), 12 months, 24 months)
- Effectiveness (secondary outcome): Frequency of non-medical prescription drug use(Baseline (pre-intervention), 12 months, 24 months)
- Effectiveness (secondary outcome): Frequency of illicit substance use(Baseline (pre-intervention), 12 months, 24 months)
- Effectiveness (secondary): Binge drinking(Baseline to 24 months)
- Effectiveness (secondary outcome): Cannabis use(Baseline to 24 months)
- Effectiveness (secondary): Non-medical prescription drug use(Baseline to 24 months)
- Effectiveness (secondary outcome): Illicit substance use(Baseline to 24 months)
- Implementation Outcomes: Reach(Baseline to 36 months)
- Implementation Outcomes: Fidelity(Baseline to 36 months)
- Implementation Outcomes: Student-reported acceptability of PreVenture(Baseline to 36 months)
- Implementation Outcomes: Uptake of IF components(Baseline to 36 months)
- Implementation Outcomes: Sustainability(Baseline to 36 months)
研究者
Patricia Conrod
Professor
St. Justine's Hospital