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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,900
- 试验地点
- 2
- 主要终点
- Dep Ado: onset, frequency and binge items
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Data are collected by assessors who are blind to school condition, and the investigators are blind to treatment condition until primary outcomes are analysed. The study will be unblinded at the end of the 5th year of follow-up (post intervention). Individuals receiving targeted interventions are not blind to intervention condition, neither are school administrators and counsellors, but randomization is masked from all other students and staff at the school.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Preventure programme (Behavioral)
Control Condition
Schools administer standard drug prevention strategy as planned without targeted prevention. Schools are not trained on the Preventure Program until the end of the trial
结局指标
主要结局
Dep Ado: onset, frequency and binge items
时间窗: 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. This tool has demonstrated good construct validity, internal consistency, test-retest and intermodal execution reliability in Quebec youth.
Growth in Dep Ado: positive screen for substance use disorder
时间窗: 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.
Growth in Dep Ado: quantity and frequency of alcohol and drug use
时间窗: 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.
次要结局
- Global cognitive function(Years 1, 2, 3,4 and 5)
- Mental disorder symptoms(Years 1, 2, 3,4 and 5)
- Executive function(Years 1, 2, 3,4 and 5)
- Functional cognitive measures(Years 1, 2, 3,4 and 5)
- Growth in global cognitive function(Years 1, 2, 3,4 and 5)
- Growth in mental disorder symptoms(Years 1, 2, 3,4 and 5)
研究者
Patricia Conrod
Full Professor
St. Justine's Hospital