The Canadian Underage Substance Use Prevention Trial

NCT04198974 | Active Not Recruiting DMC

• 1 other identifier: CUSP Trial
• Study Type: interventional
• Target: 12,500
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Substance Use Disorders; Adolescent Behavior; Adolescent Development

Keywords

Prevention; Early intervention; Substance Use and Misuse; Mental Health; Personality-targeted Interventions; Adolescence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 24 months

Secondary Outcomes (9)

• 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

Other Outcomes (2)

• Effectiveness (other pre-specified): Frequency of binge drinking

  Baseline to 24 months

• Effectiveness (other pre-specified): Frequency of cannabis use

  Baseline to 24 months

Study Arms (3)

PreVenture Training (PTtT)

EXPERIMENTAL

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)

PreVenture Training + Implementation Facilitation (PTtT+IF)

EXPERIMENTAL

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

Control (TAU)

NO INTERVENTION

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.

Interventions

PreVenture Training (PTtT) BEHAVIORAL

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 Training (PTtT)

PreVenture Training+Implementation Facilitation BEHAVIORAL

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

PreVenture Training + Implementation Facilitation (PTtT+IF)

Eligibility Criteria

• Age: 15 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• University of British Columbia: collaborator
• Center for Addiction and Mental Health: collaborator
• Dalhousie University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

University of British Columbia Okanagan Campus

Kelowna, British Columbia, Canada

Location

Dalhousie University

Halifax, Nova Scotia, Canada

Location

Center for Mental Health and Addicitions

Toronto, Ontario, Canada

Location

CHU Sainte-Justine Research Center

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (4)

• Conrod PJ. Personality-Targeted Interventions for Substance Use and Misuse. Curr Addict Rep. 2016;3(4):426-436. doi: 10.1007/s40429-016-0127-6. Epub 2016 Nov 4.

  PMID: 27909645 BACKGROUND

• Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.

  PMID: 19683400 BACKGROUND

• Conrod PJ, O'Leary-Barrett M, Newton N, Topper L, Castellanos-Ryan N, Mackie C, Girard A. Effectiveness of a selective, personality-targeted prevention program for adolescent alcohol use and misuse: a cluster randomized controlled trial. JAMA Psychiatry. 2013 Mar;70(3):334-42. doi: 10.1001/jamapsychiatry.2013.651.

  PMID: 23344135 BACKGROUND

• O'Leary-Barrett M, Mackie CJ, Castellanos-Ryan N, Al-Khudhairy N, Conrod PJ. Personality-targeted interventions delay uptake of drinking and decrease risk of alcohol-related problems when delivered by teachers. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):954-963.e1. doi: 10.1016/j.jaac.2010.04.011. Epub 2010 Jul 31.

  PMID: 20732631 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Adolescent Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Personal Satisfaction

Study Officials

• Patricia Conrod, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Jürgen Rehm, PhD

  CAMH

  PRINCIPAL INVESTIGATOR

• Hayley Hamilton, PhD

  CAMH

  PRINCIPAL INVESTIGATOR

• Marvin Krank, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Sherry Stewart, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Chris Richardson, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• David Smith, PhD

  Interior Health BC

  PRINCIPAL INVESTIGATOR

• Joanna Henderson, PhD

  CAMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation team will be blinded to the intervention conditions until 24 months
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Hybrid effectiveness/implementation randomized control trial

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 13, 2019
• Study Start: December 1, 2019
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)