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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04599270
Acronym
PREVADO
Enrollment
700
Registered
2020-10-22
Start date
2021-10-01
Completion date
2027-10-01
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addiction, Alcohol, Addiction, Substance

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

Interventions

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

OTHERRoutine care

Adolescents will be follow routine care

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intensive Punctual AlcoholMonth 6The 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.

Secondary

MeasureTime frameDescription
Evaluation of substance useDay 0, Month 1, Month 3, Month 6 and Month 12Criteria for assessing alcohol, tobacco or cannabis use: experimentation / use within the month / regular (more than 10 times a month) 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.
Evaluation of alcohol consumption typeDay 0, Month 6 and Month 12Alcohol consumption type will be evaluated by Alcohol Use Disorders Identification Test (AUDIT) scale. AUDIT is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 8 or more is considered to indicate hazardous or harmful alcohol use.
Evaluation of tobacco consumption typeDay 0, Month 6 and Month 12Tobacco consumption type will be evaluated by Hooked on Nicotine Checklist (HONC) scale. HONC is a 10-item instrument used to determine the onset and strength of tobacco dependence. A positive response to any HONC item signals a loss of autonomy and the onset of dependence.
Evaluation of cannabis consumption typeDay 0, Month 6 and Month 12Cannabis consumption type will be evaluated by Cannabis Abuse Screening Test (CAST) scale. CAST is a 6-item screening tool to assess cannabis consumption and cannabis-related problems. A score between 3 and 6 means a low risk and greater than or equal to 7 means a high risk of addiction.
Evaluation of alcohol and drugs consumption typeDay 0, Month 6 and Month 12Alcohol and drugs consumption type will be evaluated by ADOlescents et Substances Psyhco-Actives (ADOSPA) scale. ADOSPA scale is a simple test for the early detection of risky and harmful use of alcohol or drugs among young people. It consists of 6 items. A score higher than 3 indicates high risk.
Evaluation of anxiety and depressionDay 0, Month 1, Month 3, Month 6 and Month 12Anxiety and depression will be evaluated by Adolescent Depression Rating Scale (ADRS). Adolescent depression rating scale (ADRS) assesses depression in adolescents in 10 items. The items measure insomnia, anxiety, sadness and fatigability. If ADRS score is less than 4 : low risk of depression, between 4 and 8 : moderate risk of depression and superior than 8 : significant risk of depression.
Evaluation of alcohol-related harmDay 0, Month 1, Month 3, Month 6 and Month 12Collected negative events related to alcohol consumption in the past month assessed at at medical interview.
Evaluation of quality of lifeDay 0, Month 1, Month 3, Month 6 and Month 12The quality of life will be evaluated by Pediatric Quality of Life InventoryTM (PedsQL) scale. 3 scores will be calculated : psychosocial health summary score (average score of 15 items), physical health summary score (average score of 8 items) and the total score (average score of all items). Scores are between 0 and 100% and the higher scores indicate better Health-Related Quality of Life.
Evaluation of acceptability of the studyDay 0, Month 1, Month 3, Month 6 and Month 12The evaluation of acceptability of the study by the adolescents was evaluated by the participation rate the adolescents.

Countries

France

Contacts

CONTACTMorgane GUILLOU - LANDREAT, Dr
morgane.guillou@chu-brest.fr029822342348
PRINCIPAL_INVESTIGATORMorgane GUILLOU - LANDREAT, Dr

CHRU BREST

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026