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

Addiction, Alcohol Clinical Trial

— PREVADO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04599270
• Other study ID #: 29BRC20.0114 (PREVADO)
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: April 2023
• Source: University Hospital, Brest
• Contact: Morgane GUILLOU - LANDREAT, Dr
• Phone: 029822342348
• Email: morgane.guillou[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction, Alcohol
• Addiction, Substance
• Alcoholism
• Behavior, Addictive
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
France	Loik JOUSNI	Brest
France	Morgane GUILLOU - LANDREAT	Brest
France	Pascale ROZEC	Landerneau
France	Catherine SIMON	Morlaix
France	Benoit SCHRECK	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Punctual Alcohol	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.	Month 6
Secondary	Evaluation of substance use	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.	Day 0, Month 1, Month 3, Month 6 and Month 12
Secondary	Evaluation of alcohol consumption type	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.	Day 0, Month 6 and Month 12
Secondary	Evaluation of tobacco consumption type	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.	Day 0, Month 6 and Month 12
Secondary	Evaluation of cannabis consumption type	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.	Day 0, Month 6 and Month 12
Secondary	Evaluation of alcohol and drugs consumption type	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.	Day 0, Month 6 and Month 12
Secondary	Evaluation of anxiety and depression	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.	Day 0, Month 1, Month 3, Month 6 and Month 12
Secondary	Evaluation of alcohol-related harm	Collected negative events related to alcohol consumption in the past month assessed at at medical interview.	Day 0, Month 1, Month 3, Month 6 and Month 12
Secondary	Evaluation of quality of life	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.	Day 0, Month 1, Month 3, Month 6 and Month 12
Secondary	Evaluation of acceptability of the study	The evaluation of acceptability of the study by the adolescents was evaluated by the participation rate the adolescents.	Day 0, Month 1, Month 3, Month 6 and Month 12