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

Primary Purpose

Addiction, Alcohol, Addiction, Substance

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PREVENTURE Program
Routine care
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Addiction, Alcohol

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loik JOUSNIRecruiting
  • Morgane GUILLOU - LANDREATRecruiting
  • Pascale ROZECRecruiting
  • Catherine SIMONRecruiting
  • Benoit SCHRECKRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Evaluation of alcohol-related harm
Collected negative events related to alcohol consumption in the past month assessed at at medical interview.
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.
Evaluation of acceptability of the study
The evaluation of acceptability of the study by the adolescents was evaluated by the participation rate the adolescents.

Full Information

First Posted
October 12, 2020
Last Updated
April 27, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04599270
Brief Title
Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
Acronym
PREVADO
Official Title
Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Alcohol, Addiction, Substance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PREVENTURE Program
Intervention Description
Adolescents will be follow PREVENTURE program (2 session of 90 min).
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Adolescents will be follow routine care
Primary Outcome Measure Information:
Title
Intensive Punctual Alcohol
Description
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
Month 6
Secondary Outcome Measure Information:
Title
Evaluation of substance use
Description
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 1, Month 3, Month 6 and Month 12
Title
Evaluation of alcohol consumption type
Description
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
Title
Evaluation of tobacco consumption type
Description
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
Title
Evaluation of cannabis consumption type
Description
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
Title
Evaluation of alcohol and drugs consumption type
Description
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 6 and Month 12
Title
Evaluation of anxiety and depression
Description
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
Title
Evaluation of alcohol-related harm
Description
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
Title
Evaluation of quality of life
Description
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
Title
Evaluation of acceptability of the study
Description
The evaluation of acceptability of the study by the adolescents was evaluated by the participation rate the adolescents.
Time Frame
Day 0, Month 1, Month 3, Month 6 and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morgane GUILLOU - LANDREAT, Dr
Phone
029822342348
Email
morgane.guillou@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morgane GUILLOU - LANDREAT, Dr
Organizational Affiliation
CHRU Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loik JOUSNI
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loik JOUSNI
First Name & Middle Initial & Last Name & Degree
Loik JOUSNI
First Name & Middle Initial & Last Name & Degree
Christophe LEMEY
Facility Name
Morgane GUILLOU - LANDREAT
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgane GUILLOU - LANDREAT, Dr
First Name & Middle Initial & Last Name & Degree
Catherine THERENE - MOUDEN, Dr
First Name & Middle Initial & Last Name & Degree
Clémence LE CHAPELAIN
First Name & Middle Initial & Last Name & Degree
Hélène LE BLOND
First Name & Middle Initial & Last Name & Degree
Marion CHRISTIEN
Facility Name
Pascale ROZEC
City
Landerneau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale ROZEC, Dr
First Name & Middle Initial & Last Name & Degree
Pascale ROZEC, Dr
Facility Name
Catherine SIMON
City
Morlaix
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine SIMON, Dr
First Name & Middle Initial & Last Name & Degree
Catherine SIMON, Dr
First Name & Middle Initial & Last Name & Degree
Juliette HÉRON-OUVRARD
Facility Name
Benoit SCHRECK
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit SCHRECK
First Name & Middle Initial & Last Name & Degree
Benoit SCHRECK
First Name & Middle Initial & Last Name & Degree
Marie GRALL BRONNEC

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available beginning 51 month and ending 15 years following the final study report completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Citations:
PubMed Identifier
33892682
Citation
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.
Results Reference
derived

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

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