An interventional study of PreVenture Training (PTtT) and PreVenture Training+Implementation Facilitation in Substance Use Disorders, Adolescent Behavior and Adolescent Development, sponsored by St. Justine's Hospital. Active, not recruiting at 4 sites in Canada. Open to participants aged 15 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Prevention
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.
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)?
[IF] questions: Does the addition of the implementation facilitation [IF] package improve implementation outcomes (feasibility, reach, fidelity, sustainability) compared with the standard PreVenture TtT model?
Design:
Three sites (Nova Scotia, Ontario, British Columbia) participated in the trial. Each site recruited up to 9-10 high schools, randomised to one of three intervention conditions. Twenty-nine schools were randomised in total. Schools that withdrew prior to the baseline survey were replaced with another school assuming the same randomised intervention condition.
Each school screened all consenting Grade 10 students using the Substance Use Risk Profile Scale (SURPS). A small number of schools also screened Grade 9 students as part of local implementation decisions. Students were enrolled across three successive cohorts. Cohort 1 completed follow-up assessments at approximately 12 and 24 months post-baseline; Cohort 2 completed a single follow-up at approximately 12 months post-baseline; Cohort 3 contributed baseline screening and implementation data only and did not complete post-baseline effectiveness assessments.
The primary analysis population includes high-risk students - defined as scoring at least 0.9 standard deviations above school-based norms on one or more SURPS subscales - from Cohorts 1 and 2 attending randomised schools that contributed at least one post-baseline assessment. Students will be analysed according to their school's randomised assignment, regardless of intervention participation or level of follow-up completion.
The PreVenture program is a personality-targeted prevention program designed to help youth understand their target personality trait and develop adaptive coping strategies using motivational and cognitive restructuring techniques. Four personality-specific motivational pathways to substance misuse are targeted: hopelessness, anxiety sensitivity, impulsivity, and sensation seeking. PreVenture involves two 90-minute group sessions, with one week separating each session. Sessions use structured manuals incorporating psychoeducational, motivational enhancement, and cognitive-behavioural therapy components.
Main Hypotheses:
[E] Primary hypothesis: Among adolescents identified as high risk based on SURPS personality profiles, assignment to PreVenture delivered via a TtT model (with or without IF) will reduce the probability of screening positive on the CRAFFT tool (score ≥2) at follow-up compared with assignment to treatment as usual.
[E] Secondary hypotheses:
[IF] Outcomes:
Data analyses strategy for [E]:
Primary and secondary effectiveness analyses will include all students identified as high risk at baseline using the SURPS who attended randomised schools contributing at least one post-baseline cluster-level assessment, and who contributed at least one post-baseline individual outcome assessment. Students will be analysed according to the randomised assignment of their school, regardless of intervention participation or level of follow-up completion. For effectiveness analyses, the two intervention arms (PTtT and PTtT+IF) will be pooled into a single arm, as the content of the PreVenture intervention is identical across delivery conditions.
The primary effectiveness outcome is CRAFFT-positive screening, defined as a CRAFFT score ≥2. The primary estimand is the average treatment effect of assignment to PreVenture across all post-baseline assessments, estimated using mixed-effects logistic regression models pooling all available follow-up waves. Models will include a school-level random intercept, an individual-level random intercept (dropped if variance is estimated at zero), and fixed effects for treatment condition, wave, cohort, baseline CRAFFT score, and additional baseline covariates (age, sex, province, SURPS subscale scores). Results will be reported as adjusted odds ratios with 95% confidence intervals, alongside marginal predicted probabilities and risk differences estimated via marginal standardisation. The primary hypothesis will be evaluated at a two-sided α = 0.05. Given the small number of contributing clusters, the Kenward-Roger correction will be applied to adjust degrees of freedom and standard errors.
Secondary behavioural outcomes - including binge drinking, cannabis use, illicit drug use, and non-medical prescription drug use - will be analysed using the same model structure. Binary outcomes will use mixed-effects logistic regression; ordinal frequency outcomes will use proportional odds mixed-effects regression.
Secondary analyses will examine: (1) wave-specific treatment effects in Cohort 1 to assess whether intervention effects are sustained over time; and (2) complier average causal effect (CACE) analyses using school-level randomisation as an instrumental variable for session attendance. Secondary analyses are exploratory and no multiplicity adjustment will be applied.
Missing outcome data will be handled using full maximum likelihood estimation under the missing at random (MAR) assumption, incorporating all available repeated measurements without requiring complete cases. A pre-specified inverse probability weighting (IPW) sensitivity analysis will assess the influence of attrition on study conclusions by upweighting students with observed outcomes whose baseline characteristics resemble those lost to follow-up.
Data analysis strategy for [IF]:
Analyses of implementation outcomes will be descriptive and will focus on fidelity, reach, uptake of IF components, sustainability, and student feedback across intervention arms. Implementation outcomes will be summarised for schools randomised to PTtT+IF and compared descriptively with schools receiving PTtT alone. These analyses will draw primarily on data from Cohorts 2 and 3. The trial was not powered for formal inferential testing of implementation outcomes.
The following implementation outcomes will be assessed:
Structured reflections completed by research staff will be summarised narratively to contextualise quantitative implementation findings and characterise variation in delivery conditions across provinces and cohorts.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 12,500 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
- 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
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).
Behavioral: PreVenture Training (PTtT)
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.
Behavioral: PreVenture Training+Implementation Facilitation
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.
PreVenture TtT model will involve identifying local expert trainers to be trained to train school-based professionals on the PreVenture program. Steps include: 1. PreVenture Facilitator certification: Trainers participate in training workshops and deliver the program to eligible youth in Cohort 1 and are rated on quality of implementation using the PIFA. 2. Reliable use of the PIFA: Each trainer demonstrates convergence with the Montreal Team's ratings on a set of previously-recorded PreVenture sessions. 3. PreVenture Training Workshop Certification: Trainers participate in a one-day TtT workshop to review the main aims and exercises of PreVenture Training. Trainers then record mock TtT sessions in which key components of the PreVenture Training Workshop are delivered to an audience of 4-10 individuals (e.g., class of graduate students). These sessions are rated by the Montreal Team the PreVenture Implementation Fidelity and Adherence-Trainer Scale (PIFA-T).
Also known as: PreVenture
PreVenture TtT model + Implementation Facilitation Package: 1. Youth advisors identified the role of older youth to support program implementation. Youth will help promote PreVenture to students and families and help Facilitators optimize attendance at sessions. 2. Trainer-led coaching sessions will focus on enhancing program fidelity and acceptability by Facilitators. 'Best practice' supervision elements from efficacy trials will be integrated. Fidelity and symptom monitoring will be conducted in real-time during program implementation. 3. Performance metrics have been developed based on youth qualitative feedback to PreVenture sessions in previous trials. Analysis indicates key responses that are predictive of students most likely to benefit from PreVenture on 12-month substance use outcomes and indicates the extent to which Facilitator's interventions are leaving students with impressions consistent with positive long-term outcomes.
Also known as: PreVenture+IF
Effectiveness (primary): Risk of substance use problems
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.
Time frame: Baseline to 24 months
Effectiveness (secondary): Binge drinking
Any binge drinking among adolescents identified as high risk in schools randomised to PreVenture (both intervention arms pooled) versus TAU. Binge drinking will be assessed by a sub-item from the Alcohol Use Disorders Identification Test (AUDIT), asking "How often do you have five or more drinks on one occasion?" A binary indicator will be derived, coded 1 if the student responded "Less than monthly", "Monthly", "Weekly", or "Daily or almost daily", and 0 if the student responded "Never". This reflects any binge drinking in the past 12 months.
Time frame: Baseline to 24 months
Effectiveness (secondary outcome): Cannabis use
Any cannabis use in the past 12 months among adolescents identified as high risk in schools randomised to PreVenture versus TAU. Cannabis use will be assessed by asking: "Have you used cannabis in the last 12 months?" \[options: yes/no\]. A binary indicator will be derived, coded 1 for any use in the past 12 months and 0 for no use.
Time frame: Baseline to 24 months
Effectiveness (secondary): Non-medical prescription drug use
Any non-medical prescription drug (NMPD) use in the past 12 months among adolescents identified as high risk in schools randomised to PreVenture versus TAU. NMPD use will be assessed by asking: "Have you used prescription drugs for non-medical use (without a doctor's prescription) in the last 12 months?" \[options: yes/no\]. A binary indicator will be derived, coded 1 for any use in the past 12 months and 0 for no use.
Time frame: Baseline to 24 months
Effectiveness (secondary outcome): Illicit substance use
Any illicit substance use in the past 12 months among adolescents identified as high risk in schools randomised to PreVenture versus TAU. Illicit substance use will be assessed by asking whether the student used any of the following substances in the last 12 months: solvents, cocaine, MDMA, methamphetamine, heroin, fentanyl, psilocybin, LSD, steroids, or PCP \[options: yes/no for each\]. A binary indicator will be derived, coded 1 if the student reported use of any of these substances in the past 12 months and 0 if no substances were reported.
Time frame: Baseline to 24 months
Implementation Outcomes: Reach
Proportion of eligible high-risk students completing both Preventure sessions between schools receiving PreVenture by standard Train-the-Trainer (PTtT) vs. PTtT with implementation facilitation (IF) support.
Time frame: Baseline to 36 months
Implementation Outcomes: Fidelity
Level of adherence to core program components and overall delivery quality using the PreVenture Intervention Fidelity and Adherence (PIFA) scale between schools receiving PreVenture by standard Train-the-Trainer (PTtT) vs. PTtT with implementation facilitation (IF) support.
Time frame: Baseline to 36 months
Implementation Outcomes: Student-reported acceptability of PreVenture
Alignment of student-reported learning reported in brief student feedback surveys with key Preventure goals using the validated performance-metric theme grid between schools receiving PreVenture by standard Train-the-Trainer (PTtT) vs. PTtT with implementation facilitation (IF) support.
Time frame: Baseline to 36 months
Implementation Outcomes: Uptake of IF components
Proportion of Preventure + IF schools that engaged with youth-promotion activities, coaching/supervision, and performance-metric tools
Time frame: Baseline to 36 months
Implementation Outcomes: Sustainability
Proportion of schools (PreVenture TtT vs. PTtT+IF) that continue to deliver the intervention in Cohort 3 (implementation cohort).
Time frame: Baseline to 36 months
Effectiveness (other pre-specified): Frequency of binge drinking
Frequency of binge drinking among adolescents identified as high risk in schools randomised to PreVenture (both intervention arms pooled) versus TAU. Frequency of binge drinking will be assessed by a sub-item from the Alcohol Use Disorders Identification Test (AUDIT), asking "How often do you have five or more drinks on one occasion?" \[options: 1=Never / 2=Less than monthly / 3=Monthly / 4=Weekly / 5=Daily or almost daily\]. The ordinal response will be analysed using proportional odds mixed-effects regression following the same analytic framework as the primary and secondary effectiveness analyses. Results will be interpreted in terms of direction and magnitude rather than formal hypothesis testing.
Time frame: Baseline to 24 months
Effectiveness (other pre-specified): Frequency of cannabis use
Frequency of cannabis use among adolescents identified as high risk in schools randomised to PreVenture versus TAU, among students reporting any cannabis use in the past 12 months. Among students reporting any cannabis use in the past 12 months, frequency of use will be assessed by asking "How often did you use cannabis in the last 12 months?" \[options: 1=Monthly or less / 2=2-4 times per month / 3=2-3 times per week / 4=4-6 times per week / 5=Every day\]. The ordinal response will be analysed using proportional odds mixed-effects regression following the same analytic framework as the primary and secondary effectiveness analyses. As this analysis is restricted to users only, it should be interpreted with caution as a selected subsample. Results will be interpreted in terms of direction and magnitude rather than formal hypothesis testing.
Time frame: Baseline to 24 months
Plan to share: No
Started Dec 2019 (actual). Primary completion is estimated for Apr 2026, 76 months after the start.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 76 months is above that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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