Addiction, AlcoholPREVADONCT04599270
Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
A study testing PREVENTURE Program and Routine care in people with Addiction, Alcohol and Addiction, Substance, run by University Hospital, Brest at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Addiction, Alcohol, Addiction, Substance
- What is being tested?
- PREVENTURE Program and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Oct 2021to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Loik JOUSNI
Brest
Loik JOUSNI
Loik JOUSNI
- Recruiting
Morgane GUILLOU - LANDREAT
Brest
Morgane GUILLOU - LANDREAT, Dr
Catherine THERENE - MOUDEN, Dr
- Recruiting
Pascale ROZEC
Landerneau
Pascale ROZEC, Dr
Pascale ROZEC, Dr
- Recruiting
Catherine SIMON
Morlaix
Catherine SIMON, Dr
Catherine SIMON, Dr
- Recruiting
Benoit SCHRECK
Nantes
Benoit SCHRECK
Benoit SCHRECK
About this study
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.
Read more
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
- Conditions
- Addiction, Alcohol, Addiction, Substance
- Being tested
- PREVENTURE Program, Routine care
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENTURE ProgramOther
Adolescents will be follow PREVENTURE program (2 session of 90 min).
Routine careOther
Adolescents will be follow routine care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Teenager encounter psychologist for conduct a Substance Use risk Personality Scale (SURPS) assessment to identify personality characteristics that represent a risk for the development of problematic substance use. Only adolescents with at-risk personality traits according to the SURPS will be randomized for further assessment.
If adolescent have not risk personality traits, the patient will go out of the study.
If adolescent have risk personality traits, other tests and scales will be performed to study the intensivity of dependance of substance use and the patient will be randomized.
If he is randomized in intervention group, the patient will follow PREVENTURE program (2 session of 90 min by videoconference), within 3 months after inclusion and will be contacted by phone by the psychologist at 1, 3, 6 and 12 month after sessions to answer the same tests and scales. Receives: Other: PREVENTURE Program |
| Control group | Active comparator | Teenager encounter psychologist for conduct a Substance Use risk Personality Scale (SURPS) assessment to identify personality characteristics that represent a risk for the development of problematic substance use. Only adolescents with at-risk personality traits according to the SURPS will be randomized for further assessment.
If adolescent have not risk personality traits, the patient will go out of the study.
If adolescent have risk personality traits, other tests and scales will be performed to study the severity of substance use disorders and the patient will be randomized.
If he is randomized in control group, the patient will follow routine care and will be contacted by phone by the psychologist at 1, 3, 6 and 12 month after inclusion to answer the same tests and scales. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (9)
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.
Measured: Day 0, Month 1, Month 3, Month 6 and Month 12
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.
Measured: Day 0, Month 6 and Month 12
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.
Measured: Day 0, Month 6 and Month 12
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.
Measured: Day 0, Month 6 and Month 12
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.
Measured: Day 0, Month 6 and Month 12
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.
Measured: Day 0, Month 1, Month 3, Month 6 and Month 12
Evaluation of alcohol-related harm
Collected negative events related to alcohol consumption in the past month assessed at at medical interview.
Measured: Day 0, Month 1, Month 3, Month 6 and Month 12
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.
Measured: Day 0, Month 1, Month 3, Month 6 and Month 12
Evaluation of acceptability of the study
The evaluation of acceptability of the study by the adolescents was evaluated by the participation rate the adolescents.
Measured: Day 0, Month 1, Month 3, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Oct 2021
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Addiction, AlcoholStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgane GUILLOU - LANDREAT, Dr, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599270
- Sponsor's protocol ID
- 29BRC20.0114
- Acronym
- PREVADO
- Status last verified
- Jun 2026
- First submitted
- 12 Oct 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Guillou-Landreat M, Tahmazov E, Benoit S, Grall-Bronnec M, Conrod P, Livet A, Nowak E, Le Reste J-. The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. BMC Public Health. 2021 Apr 23;21(1):783. doi: 10.1186/s12889-021-10795-9.
PubMed 33892682
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
- ClinicalTrials.gov ID
- NCT04599270
- Acronym / sponsor ID
- PREVADO / 29BRC20.0114
- Conditions
- Addiction, Alcohol, Addiction, Substance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: PREVENTURE ProgramTeenager encounter psychologist for conduct a Substance Use risk Personality Scale (SURPS) assessment to identify personality characteristics that represent a risk for the development of problematic substance use. Only adolescents with at-risk personality traits according to the SURPS will be randomized for further assessment. If adolescent have not risk personality traits, the patient will go out of the study. If adolescent have risk personality traits, other tests and scales will be performed to study the intensivity of dependance of substance use and the patient will be randomized. If he is randomized in intervention group, the patient will follow PREVENTURE program (2 session of 90 min by videoconference), within 3 months after inclusion and will be contacted by phone by the psychologist at 1, 3, 6 and 12 month after sessions to answer the same tests and scales. |
| Control group | Active comparator | Other: Routine careTeenager encounter psychologist for conduct a Substance Use risk Personality Scale (SURPS) assessment to identify personality characteristics that represent a risk for the development of problematic substance use. Only adolescents with at-risk personality traits according to the SURPS will be randomized for further assessment. If adolescent have not risk personality traits, the patient will go out of the study. If adolescent have risk personality traits, other tests and scales will be performed to study the severity of substance use disorders and the patient will be randomized. If he is randomized in control group, the patient will follow routine care and will be contacted by phone by the psychologist at 1, 3, 6 and 12 month after inclusion to answer the same tests and scales. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENTURE ProgramAdolescents will be follow PREVENTURE program (2 session of 90 min). | Other | Intervention group |
| Routine careAdolescents will be follow routine care | Other | Control group |
Primary outcome
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.
9 secondary outcomes
Evaluation of substance use
Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12
Evaluation of alcohol consumption type
Time frame: Day 0, Month 6 and Month 12
Evaluation of tobacco consumption type
Time frame: Day 0, Month 6 and Month 12
Evaluation of cannabis consumption type
Time frame: Day 0, Month 6 and Month 12
Evaluation of alcohol and drugs consumption type
Time frame: Day 0, Month 6 and Month 12
Evaluation of anxiety and depression
Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12
Evaluation of alcohol-related harm
Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12
Evaluation of quality of life
Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12
Evaluation of acceptability of the study
Time frame: Day 0, Month 1, Month 3, Month 6 and Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 33892682Guillou-Landreat M, Tahmazov E, Benoit S, Grall-Bronnec M, Conrod P, Livet A, Nowak E, Le Reste J-. The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. BMC Public Health. 2021 Apr 23;21(1):783. doi: 10.1186/s12889-021-10795-9.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Morgane GUILLOU - LANDREAT, Dr principal investigator
CHRU BREST
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVENTURE Program and Routine care in people with Addiction, Alcohol and Addiction, Substance, run by University Hospital, Brest at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgane GUILLOU - LANDREAT, Dr (029822342348, morgane.guillou@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Punctual Alcohol (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04599270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.