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Does Delaying Adolescent Substance Use Lead to Improved Cognitive Function and Reduce Risk for Addiction?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Patricia Conrod, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01655615
First received: March 14, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Alcohol Related Disorders
Substance Related Disorders
Behavioral: Preventure programme

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Co-venture: a Cluster Randomized Trial Investigating the Effects of Selective Intervention on Adolescent Cognitive Development and Addiction

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Dep Ado: onset, frequency and binge items [ Time Frame: Year2, 3,4 and 5 ] [ Designated as safety issue: No ]
    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, within the first two years of the follow-up, and longer-term reductions in substance use disorders in later years, assessed according to a score greater than 20 on the 'Detection of alcohol and drug problems in adolescents' questionnaire. This tool has demonstrated good construct validity, internal consistency, test-retest and intermodal execution reliability in Quebec youth.


Secondary Outcome Measures:
  • Global cognitive function [ Time Frame: Year 2,3,4 and 5 ] [ Designated as safety issue: No ]
    • Adaptation of Raven's progressive matrices
    • Adaptation of the Individual Tasks of Mental Ability
    • Vocabulary subtest
    • Pattern recognition task, spatial recall task

    Executive function:

    - No-Go passive Avoidance learning paradigm Self-ordered pointing task



Estimated Enrollment: 32
Study Start Date: September 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preventure programme
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.
Behavioral: Preventure programme
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.
Other Name: Preventure programme

Detailed Description:

This is a cluster randomized design in which 32 high schools across Montreal, Canada will be randomly assigned to receive training and to deliver the programme to one cohort of Grade 7 students or to be trained and assisted in delivering the programme to a future Year 7 cohort. Evaluations of students will occur annually from September to December until the end of high school. Student 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. Only 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, thrill seeking, anxiety sensitivity or negative thinking.

The students will first be asked to participate in a 45-60 minute 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 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 3 and 4-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 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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655615

Locations
Canada, Quebec
CHU Sainte-Justine Research Center
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Patricia J Conrod, PhD Université de Montréal
  More Information

No publications provided

Responsible Party: Patricia Conrod, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01655615     History of Changes
Other Study ID Numbers: 3427
Study First Received: March 14, 2012
Last Updated: March 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
Adolescent cognitive development
mental disorders
Mood disorders
Alcohol-Related disorders
Mental disorders diagnosed in childhood
Substance related disorders

Additional relevant MeSH terms:
Alcohol-Related Disorders
Disease
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014