Addiction, Alcohol Clinical Trial
— PREVADOOfficial title:
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04876443 -
Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD)
|
||
Recruiting |
NCT05042180 -
Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR)
|
Phase 2 | |
Recruiting |
NCT05361603 -
Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures
|
||
Recruiting |
NCT04990765 -
Virtual Reality-Assisted Cognitive Behavioral Therapy for Alcohol Dependence (CRAVR-Pilot)
|
Phase 2 | |
Recruiting |
NCT05730504 -
Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder
|
N/A | |
Recruiting |
NCT05434416 -
The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
|
N/A | |
Not yet recruiting |
NCT05134675 -
Does Homebrewing Beer Affect Urinary Tract Symptoms and Bladder Cancer
|
||
Completed |
NCT06114316 -
Recovery of Individuals With Alcohol Use Disorders Based on Roy Adaptation Model
|
N/A | |
Recruiting |
NCT05322226 -
Addiction Intervention in Liver Transplantation Candidates
|
N/A | |
Terminated |
NCT04881500 -
Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology) (DEPREV_Phase 3)
|
N/A | |
Recruiting |
NCT05490589 -
Evaluation of the Implementation of a Parenting Program in Parents With Children Aged 4 to 12 Years and One Parent With an Alcohol Use Disorders
|
N/A | |
Recruiting |
NCT06105853 -
Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder
|
N/A | |
Completed |
NCT03232112 -
Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?
|
Phase 2 | |
Active, not recruiting |
NCT04927455 -
Pilot Study to Evaluate "Intégrer et Accompagner Les Consommations d'Alcool!" (IACA!)'s Impact and Transferability
|