Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 10
- 主要终点
- Intensive Punctual Alcohol
研究概览
简要总结
At the age of 17, in Brittany, 94.9% of adolescents have experimented alcohol consumption 78.1% within a month and 25.5% report repeated episodes of Intensive Punctual Alcohol. Among the potential explanatory factors of this worrying epidemiology, social and cultural factors induce a social valuation of alcohol consumption and drunkenness. There are also individual vulnerability factors, particularly important in adolescence between experimentation and the transition to regular use or even to alcohol use disorders. Despite the extent of the damage, there is currently little reliable data on effective primary prevention strategies for dealing with addictive behavior. Many prevention programs target age range in school settings, to delay or reduce use of psychoactive substances.
A meta-analysis on the impact of this prevention programs in school settings, concluded that most interventions are associated with no or little impact with respect to the goal of reducing psychoactive substances with teenagers.
Among existing programs, "PREVENTURE" has been evaluated in 5 trials with high-risk teenagers identified in schools settings, in different countries (Canada, Europe). The results show a clear and robust effect on reducing alcohol consumption. This program has not been tested outside the school setting and a recent review mention the need to make this program more accessible by targeting vulnerable groups and studying the impact of this program on this population.
The PREVADO study is a prospective, controlled, randomised, open-label study. After inclusion, the adolescent completes the questionnaire SURPS (Substance Use Risk Profile Scale).
The SURPS is self-report questionnaire that assesses four well-validated personality risk factors for substance misuse (Impulsivity, Sensation Seeking, Anxiety Sensitivity, and Hopelessness). There is a 23-item to which adolescents are asked to respond using a 4-point Likert scale ranging from "strongly agree" to "strongly disagree" : Hopelessness (7 items), Anxiety Sensitivity (5 items), Impulsivity (5 items), and Sensation Seeking (6 items).
Adolescents will be randomized into 2 groups (stratification on the 4 predominant risk personality types from the SURPS (Substance Use Risk Profile Scale) and on the recruitment modality) :
- Intervention group : teenagers follow the "PREVENTURE" program and routine cares
- Control group : teenagers follow routine cares
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 14 and 17 years old
- •Patient consulting in one of the participating centres or referred by a school doctor
- •Patient who has had at least one previous experience with alcohol (at least 1 standard unit of alcohol, once in their lifetime)
- •Having access to an internet network and a computer, tablet or telephone
- •Written and informed consent of the parents and the teenager
排除标准
- •Refusal to participate in the study
- •Moderate to Severe Adolescent Substance Use Disorders (other than smoking)
- •Decompensated current psychiatric disorders in adolescents
- •Already followed for severe use disorders and/or severe psychiatric disorders
- •Nonunderstanding of the french language
研究组 & 干预措施
Intervention group
Teenager encounter psychologist for conduct a Substance Use risk Personality Scale (SURPS) assessment to identify personality characteristics that represent a risk for the development of problematic substance use. Only adolescents with at-risk personality traits according to the SURPS will be randomized for further assessment.
If adolescent have not risk personality traits, the patient will go out of the study.
If adolescent have risk personality traits, other tests and scales will be performed to study the intensivity of dependance of substance use and the patient will be randomized.
If he is randomized in intervention group, the patient will follow PREVENTURE program (2 session of 90 min by videoconference), within 3 months after inclusion and will be contacted by phone by the psychologist at 1, 3, 6 and 12 month after sessions to answer the same tests and scales.
干预措施: PREVENTURE Program (Other)
Control group
Teenager encounter psychologist for conduct a Substance Use risk Personality Scale (SURPS) assessment to identify personality characteristics that represent a risk for the development of problematic substance use. Only adolescents with at-risk personality traits according to the SURPS will be randomized for further assessment.
If adolescent have not risk personality traits, the patient will go out of the study.
If adolescent have risk personality traits, other tests and scales will be performed to study the severity of substance use disorders and the patient will be randomized.
If he is randomized in control group, the patient will follow routine care and will be contacted by phone by the psychologist at 1, 3, 6 and 12 month after inclusion to answer the same tests and scales.
干预措施: Routine care (Other)
结局指标
主要结局
Intensive Punctual Alcohol
时间窗: Month 6
The primary endpoint will be the occurrence of at least one Intensive Punctual Alcohol (at least 5 unit standard of alcohol at one time) within the last month (assessed at 6 months) as measured by the Alcohol Timeline Followback (ATLFB). The TLFB is a method for assessing recent drinking behavior. It involves asking clients to retrospectively estimate their daily alcohol consumption over a time period for 30 days prior to the interview.
次要结局
- Evaluation of substance use(Day 0, Month 1, Month 3, Month 6 and Month 12)
- Evaluation of alcohol consumption type(Day 0, Month 6 and Month 12)
- Evaluation of alcohol and drugs consumption type(Day 0, Month 6 and Month 12)
- Evaluation of tobacco consumption type(Day 0, Month 6 and Month 12)
- Evaluation of cannabis consumption type(Day 0, Month 6 and Month 12)
- Evaluation of anxiety and depression(Day 0, Month 1, Month 3, Month 6 and Month 12)
- Evaluation of alcohol-related harm(Day 0, Month 1, Month 3, Month 6 and Month 12)
- Evaluation of quality of life(Day 0, Month 1, Month 3, Month 6 and Month 12)
- Evaluation of acceptability of the study(Day 0, Month 1, Month 3, Month 6 and Month 12)