PREVENTURE Program
OtherAdolescents will be follow PREVENTURE program (2 session of 90 min).
NCT Number: NCT04599270
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
Interested in participating?
Request Info14 year–17 year
All sexes
Interventional
Not applicable
Loik JOUSNI, Brest, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adolescents will be follow PREVENTURE program (2 session of 90 min).
Adolescents will be follow routine care
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Acronym: PREVADO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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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