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Clinical Trials in Canada / NCT04198974
Active, not recruiting Not applicable

The Canadian Underage Substance Use Prevention Trial

NCT04198974 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2019-12-01
Last updated
2026-04-27

Condition(s) studied

Substance Use DisordersAdolescent BehaviorAdolescent Development

Investigational drug(s) / intervention(s)

PreVenture Training (PTtT)PreVenture Training+Implementation Facilitation

PreVenture Training (PTtT): 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).

PreVenture Training+Implementation Facilitation: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
16 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. 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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
University of British Columbia Okanagan Campus Kelowna British Columbia
Dalhousie University Halifax Nova Scotia
Center for Mental Health and Addicitions Toronto Ontario
CHU Sainte-Justine Research Center Montreal Quebec

More St. Justine's Hospital trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04198974 on ClinicalTrials.gov ↗ ← All trials in Canada