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Alcohol Related DisordersNCT01655615

The Co-Venture Trial: A Cluster Randomized Trial of Personality-targeted Interventions on Adolescent Substance Use and Cognitive Outcomes

A study testing Preventure programme in people with Alcohol Related Disorders and Substance Related Disorders, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 yearsHealthy volunteers can take part
What is being tested?
Preventure programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,900 participants
Where
1 siteCanada
Study dates
Sep 2012to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • CHU Sainte-Justine Research Center

    Montreal, Quebec, H3T 1C5

Other trials in Canada

About this study

Official title: A Cluster-randomized Controlled Trial Evaluating the Effects of Delaying Onset of Adolescent Substance Abuse on Cognitive Development and Addiction Following a Selective, Personality-targeted Intervention Programme: the Co-Venture Trial

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.

Read the detailed description

This is a cluster randomized design in which 31 high schools across Montreal, Canada will be randomly assigned to receive training and to deliver the program to two cohorts of Grade 7 students or to be trained and assisted in delivering the program to future Grade 7 cohorts. Assessment of participating students will occur annually from September to May until the end of high school year. Students will be assessed on personality, substance use, mental health and cognitive measures.

The program involves delivering specialized coping skills group workshops to students when they are in the 7th or 8th grade. About 45% of students in a given grade will be invited to participate in the workshops.

The workshops will focus on motivating children to understand how their personality style leads to certain emotional and behavioural reactions. They will be guided in learning cognitive behavioural skills on how to channel their strengths towards their long-term goals. Four different workshops will be run, focusing either on managing impulsivity, sensation seeking, anxiety sensitivity or negative thinking.

The students will first be asked to participate in a 45-60 minutes survey asking them about their personality, their strength and weaknesses, their risk-taking behaviour and their learning style.

Then, if their school has been trained to deliver the program, they might be invited to participate in two 90-minute workshops, delivered at school during class time or lunch hour. All children who agree to participate in the study will be invited to complete the same survey in each subsequent academic year for the next four years.

Primary outcomes:

  1. Short-term: delayed onset of alcohol and substance use (up to two years post intervention)
  2. Long-term: prevention of onset of substance use disorder (at 5th year follow-up).

Secondary intermediate outcomes are neuropsychological functions, for which two hypotheses will be investigated regarding the possible effects of delaying early substance use:

  1. Global Effects Hypothesis: substance use and binge drinking will have global harmful effects on cognition and interventions that successfully prevent substance use onset will result in global improvements in cognitive function in participants who received the intervention relative to those randomized to control condition.
  2. Critical Developmental Period Hypothesis: the toxic effects of alcohol and drug use are developmentally specific, so effects of interventions will be observed on cognitive processes that are maturing in adolescence, namely, executive functions and reward sensitivity, after controlling for general intelligence quotient (IQ) and memory function following procedure described by Séguin, et al (2004).

Secondary outcomes will be measures of poor mental health and functional cognitive measures such as academic achievement and school drop-out.

Being tested
Preventure programme
Keywords
Adolescent cognitive development, mental disorders, Mood disorders, Alcohol-Related disorders, Mental disorders diagnosed in childhood, Substance related disorders
Medical subject headings
Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders, Mood Disorders, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preventure programmeBehavioural

    Also called Personality-targeted cognitive behavioural interventions

    The interventions are conducted using manuals which incorporate psycho-educational, motivational enhancement therapy and cognitive-behavioural (CBT) components, and include real life 'scenarios' shared by local youth in with similar personality profiles. In the first session, participants are guided in a goal-setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are then used to teach participants about the target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse.

Study groups in NCT01655615
Study groupRoleWhat they receive
Preventure programmeExperimentalThe interventions are conducted using manuals which incorporate psycho-educational, motivational enhancement therapy and cognitive-behavioural (CBT) components, and include real life 'scenarios' shared by local youth in with similar personality profiles. In the first session, participants are guided in a goal-setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are then used to teach participants about the target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse.
Receives: Behavioral: Preventure programme
Control ConditionNo interventionSchools administer standard drug prevention strategy as planned without targeted prevention. Schools are not trained on the Preventure Program until the end of the trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth in Dep Ado: positive screen for substance use disorder

    The 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO) is a self-report alcohol and illicit drug use measure in high-risk youth, including onset of drinking, binge drinking and illicit drug use. It calculates overall likelihood of the presence of substance use disorder based on the combination of these self-report variables. This tool has demonstrated good construct validity, internal consistency, test-retest and intermodal execution reliability in Quebec youth.

    Measured: Years 1, 2, 3,4 and 5

  2. Growth in Dep Ado: quantity and frequency of alcohol and drug use

    The 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO) is a self-report alcohol and illicit drug use measure in high-risk youth, including onset of drinking, binge drinking and illicit drug use. This tool has demonstrated good construct validity, internal consistency, test-retest and intermodal execution reliability in Quebec youth. This measure can also be used to quantify frequency of substance use on a continuous scale.

    Measured: Years 1,2,3,4,5

Secondary outcomes (4)
  1. Growth in global cognitive function

    1. A computerised adaptation of the Cultures Figure Task (CFT) is used to measure fluid intelligence. This task is based on two of the sections from Cattell's Culture Fair Intelligence Test: the linear pattern completion and matrix reasoning. ii. A computerised task based on the 'Dot Location' test, a subtest of the Child Memory Scales (CMS) is used to assess spatial memory. In this task, eight dots of the same colour are presented on a grid.

    Measured: Years 1, 2, 3,4 and 5

  2. Executive function

    Two tasks are used to assess executive functioning. i. 'Find the phone' is a spatial working memory task based on the Self-Order Pointing Task and is similar to the spatial working memory task of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

    ii. An adaptation of the Go/No-Go Passive Avoidance Learning Paradigm (PALP) is used to assess cognitive control and response inhibition.

    Measured: Years 1, 2, 3,4 and 5

  3. Functional cognitive measures

    Data regarding academic achievement and school drop-out will be collected from the school administration.

    Measured: Years 1, 2, 3,4 and 5

  4. Growth in mental disorder symptoms

    Depression and anxiety symptom severity over the past 12 months are measured using the Depression and Anxiety subscales from the Brief Symptoms Inventory. Conduct problems and hyperactivity/inattentive symptoms over the past 12 months are assessed according to the conduct and hyperactivity/inattentive subscales of the Strengths and Difficulties Questionnaire.

    Measured: Years 1, 2, 3,4 and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
Cluster randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
3,900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01655615
Sponsor's protocol ID
3427
Status last verified
Apr 2026
First submitted
14 Mar 2012
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data will be shared following submission of a formal request.

Publications

  • O'Leary-Barrett M, Masse B, Pihl RO, Stewart SH, Seguin JR, Conrod PJ. A cluster-randomized controlled trial evaluating the effects of delaying onset of adolescent substance abuse on cognitive development and addiction following a selective, personality-targeted intervention programme: the Co-Venture trial. Addiction. 2017 Oct;112(10):1871-1881. doi: 10.1111/add.13876. Epub 2017 Jul 17.

    PubMed 28544009
  • Bourque J, Afzali MH, O'Leary-Barrett M, Conrod P. Cannabis use and psychotic-like experiences trajectories during early adolescence: the coevolution and potential mediators. J Child Psychol Psychiatry. 2017 Dec;58(12):1360-1369. doi: 10.1111/jcpp.12765. Epub 2017 Jul 5.

    PubMed 28677235
  • Afzali MH, Sunderland M, Carragher N, Conrod P. The Structure of Psychopathology in Early Adolescence: Study of a Canadian Sample: La structure de la psychopathologie au debut de l'adolescence: etude d'un echantillon canadien. Can J Psychiatry. 2018 Apr;63(4):223-230. doi: 10.1177/0706743717737032. Epub 2017 Oct 23.

    PubMed 29061067
  • Lynch SJ, Stewart SH, Conrod P. Selective Personality-Targeted Intervention and the Escalation of Substance Use During Adolescence: A Secondary Analysis of A Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2550176. doi: 10.1001/jamanetworkopen.2025.50176.

    PubMed 41632121
  • Wallace J, Boers E, Ouellet J, Conrod P. A Population-Based Analysis of the Temporal Association of Screen Time and Aggressive Behaviors in Adolescents. JAACAP Open. 2023 Aug 24;1(4):284-294. doi: 10.1016/j.jaacop.2023.08.002. eCollection 2023 Dec.

    PubMed 39553451
  • Boers E, Afzali MH, Conrod P. A longitudinal study on the relationship between screen time and adolescent alcohol use: The mediating role of social norms. Prev Med. 2020 Mar;132:105992. doi: 10.1016/j.ypmed.2020.105992. Epub 2020 Jan 15.

    PubMed 31954144
  • O'Leary-Barrett M, Pihl RO, Conrod PJ. Process variables predicting changes in adolescent alcohol consumption and mental health symptoms following personality-targeted interventions. Addict Behav. 2017 Dec;75:47-58. doi: 10.1016/j.addbeh.2017.06.022. Epub 2017 Jul 4.

    PubMed 28692954

Questions about this trial

What is this clinical trial studying?

A study testing Preventure programme in people with Alcohol Related Disorders and Substance Related Disorders, run by St. Justine's Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth in Dep Ado: positive screen for substance use disorder (time frame: Years 1, 2, 3,4 and 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01655615, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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