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

NCT ID: NCT04599270

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2027-10-01

Brief Summary

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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

Detailed Description

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Conditions

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Addiction, Alcohol Addiction, Substance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PREVENTURE Program

Intervention Type OTHER

Adolescents will be follow PREVENTURE program (2 session of 90 min).

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.

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

Adolescents will be follow routine care

Interventions

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PREVENTURE Program

Adolescents will be follow PREVENTURE program (2 session of 90 min).

Intervention Type OTHER

Routine care

Adolescents will be follow routine care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgane GUILLOU - LANDREAT, Dr

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest

Locations

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Loik JOUSNI

Brest, , France

Site Status RECRUITING

Morgane GUILLOU - LANDREAT

Brest, , France

Site Status RECRUITING

Pascale ROZEC

Landerneau, , France

Site Status RECRUITING

Catherine SIMON

Morlaix, , France

Site Status RECRUITING

Benoit SCHRECK

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Morgane GUILLOU - LANDREAT, Dr

Role: CONTACT

Phone: 029822342348

Email: [email protected]

Facility Contacts

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Loik JOUSNI

Role: primary

Morgane GUILLOU - LANDREAT, Dr

Role: primary

Pascale ROZEC, Dr

Role: primary

Catherine SIMON, Dr

Role: primary

Benoit SCHRECK

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33892682 (View on PubMed)

Other Identifiers

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29BRC20.0114

Identifier Type: -

Identifier Source: org_study_id