CHU Sainte-Justine Research Center
Montreal, Quebec, H3T 1C5, Canada
NCT Number: NCT01655615
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.
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Notify Me12 year–17 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H3T 1C5, Canada
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:
Secondary intermediate outcomes are neuropsychological functions, for which two hypotheses will be investigated regarding the possible effects of delaying early substance use:
Secondary outcomes will be measures of poor mental health and functional cognitive measures such as academic achievement and school drop-out.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Personality-targeted cognitive behavioural interventions
Time frame: Years 1, 2, 3,4 and 5
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.
Time frame: Years 1,2,3,4,5
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.
Time frame: Years 1, 2, 3,4 and 5
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.
Time frame: Years 1, 2, 3,4 and 5
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.
Time frame: Years 1, 2, 3,4 and 5
Data regarding academic achievement and school drop-out will be collected from the school administration.
Time frame: Years 1, 2, 3,4 and 5
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.
St. Justine's Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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