The Co-Venture Trial: A Cluster Randomized Trial of Personality-targeted Interventions on Adolesc… (NCT01655615) | Clinical Trial Compass
CompletedNot Applicable
The Co-Venture Trial: A Cluster Randomized Trial of Personality-targeted Interventions on Adolescent Substance Use and Cognitive Outcomes
Canada3,900 participantsStarted 2012-09
Plain-language summary
The Preventure Program is the first and only school-based alcohol and drug prevention program that has been shown to prevent onset and growth in alcohol and substance misuse in British and Canadian youth. Unlike universal programs that tend to promote generic coping skills and balance normative attitudes around substance use, this selected personality-targeted approach is based on a psychosocial model and validated by Dr Patricia Conrod and targets four personality-specific motivational pathways to substance misuse: Hopelessness, Anxiety Sensitivity, Impulsivity and Sensation Seeking, each associated with different motives for substance use, drug use profiles and patterns of non-addictive psychopathology.
As a primary goal of the Coventure project, the investigators propose a long-term trial of this intervention strategy to examine how this evidence-based intervention can reduce onset of substance use disorders in young people and related secondary mental health, academic and cognitive outcomes.
As a secondary goal, the investigators propose to use sensitive neuropsychological measures to examine how this evidence-based intervention can positively impact on cognitive development over the course of adolescence, to tease apart some of the mechanisms involved in the causal pathway from early onset substance use to poor cognitive development and long-term addiction outcomes.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Public or private high school
* Must have a Grade 7 cohort of at least 100 youth (up to 200), providing access to 45-90 high risk students per school Selection of high risk youth: Inclusion criteria for students are that they be enrolled in Grade 7 and that they have provided active assent and passive parental consent to participate in the longitudinal survey and randomised trial phases of this study. Participants who score 1 standard deviation above the school mean on one of four subscales of the Substance Use Risk Profile Scale will be selected to participate in the intervention groups, but all students will be followed on outcomes. There are no other exclusion criteria for participants.
Exclusion Criteria:
* Schools cannot be classified as having a majority of their students coded as special needs students, because these schools are smaller and the intervention protocol would have to be tailored for their particular needs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Growth in Dep Ado: positive screen for substance use disorder
Timeframe: Years 1, 2, 3,4 and 5
2
Growth in Dep Ado: quantity and frequency of alcohol and drug use