Clinical trial NCT04599270: Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
Official title: Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Addiction, Alcohol
Addiction, Substance
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 700
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


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

Primary outcomes:
measure: Intensive Punctual Alcohol
timeFrame: Month 6
Secondary outcomes:
measure: Evaluation of substance use
timeFrame: Day 0, Month 1, Month 3, Month 6 and Month 12
measure: Evaluation of alcohol consumption type
timeFrame: Day 0, Month 6 and Month 12
measure: Evaluation of tobacco consumption type
timeFrame: Day 0, Month 6 and Month 12
measure: Evaluation of cannabis consumption type
timeFrame: Day 0, Month 6 and Month 12
measure: Evaluation of alcohol and drugs consumption type
timeFrame: Day 0, Month 6 and Month 12
measure: Evaluation of anxiety and depression
timeFrame: Day 0, Month 1, Month 3, Month 6 and Month 12
measure: Evaluation of alcohol-related harm
timeFrame: Day 0, Month 1, Month 3, Month 6 and Month 12
measure: Evaluation of quality of life
timeFrame: Day 0, Month 1, Month 3, Month 6 and Month 12
measure: Evaluation of acceptability of the study
timeFrame: Day 0, Month 1, Month 3, Month 6 and Month 12
Other outcomes:
Locations:
city: Brest
country: France
facility: Loik JOUSNI
city: Brest
country: France
facility: Morgane GUILLOU - LANDREAT
city: Landerneau
country: France
facility: Pascale ROZEC
city: Morlaix
country: France
facility: Catherine SIMON
city: Nantes
country: France
facility: Benoit SCHRECK
Study officials:
affiliation: CHRU Brest
name: Morgane GUILLOU - LANDREAT, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.