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NCT Number: NCT04599270

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

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

Recruiting

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loik JOUSNI, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREVENTURE Program

Other

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

Routine care

Other

Adolescents will be follow routine care

Primary outcomes

  1. Intensive Punctual Alcohol

    Time frame: 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.

Secondary outcomes

  1. Evaluation of substance use

    Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12

    Criteria 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.

  2. Evaluation of alcohol consumption type

    Time frame: Day 0, Month 6 and Month 12

    Alcohol 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.

  3. Evaluation of tobacco consumption type

    Time frame: Day 0, Month 6 and Month 12

    Tobacco 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.

  4. Evaluation of cannabis consumption type

    Time frame: Day 0, Month 6 and Month 12

    Cannabis 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.

  5. Evaluation of alcohol and drugs consumption type

    Time frame: Day 0, Month 6 and Month 12

    Alcohol 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.

  6. Evaluation of anxiety and depression

    Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12

    Anxiety 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.

  7. Evaluation of alcohol-related harm

    Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12

    Collected negative events related to alcohol consumption in the past month assessed at at medical interview.

  8. Evaluation of quality of life

    Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12

    The 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.

  9. Evaluation of acceptability of the study

    Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12

    The evaluation of acceptability of the study by the adolescents was evaluated by the participation rate the adolescents.

Study contacts

Contact information is provided by the study sponsor or research team.

Morgane GUILLOU - LANDREAT, Dr

CONTACT

[email protected]

029822342348

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PREVADO

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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