Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers

Overview

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

Interventions

• Other PREVENTURE Program
  Adolescents will be follow PREVENTURE program (2 session of 90 min).
• Other Routine care
  Adolescents will be follow routine care

Primary outcome measures

• Intensive Punctual Alcohol [Time frame: Month 6]

Secondary outcome measures (9)

• Evaluation of substance use [Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12]
• Evaluation of alcohol consumption type [Time frame: Day 0, Month 6 and Month 12]
• Evaluation of tobacco consumption type [Time frame: Day 0, Month 6 and Month 12]
• Evaluation of cannabis consumption type [Time frame: Day 0, Month 6 and Month 12]
• Evaluation of alcohol and drugs consumption type [Time frame: Day 0, Month 6 and Month 12]
• Evaluation of anxiety and depression [Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12]
• Evaluation of alcohol-related harm [Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12]
• Evaluation of quality of life [Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12]
• Evaluation of acceptability of the study [Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 5 centers

• Loik JOUSNI — Brest
• Morgane GUILLOU - LANDREAT — Brest
• Pascale ROZEC — Landerneau
• Catherine SIMON — Morlaix
• Benoit SCHRECK — Nantes

Publications

• Guillou-Landreat M, Tahmazov E, Benoit S, Grall-Bronnec M, Conrod P, Livet A, Nowak E, Le Reste J-. The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. BMC Public Health. 2021 Apr 23;21(1):783. doi: 10.1186/s12889-021-10795-9. PMID 33892682

Identifiers

NCT: NCT04599270 · 29BRC20.0114

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗