NCT04110626

Brief Summary

The study is a realistic evaluation of the Expériences Animées school-based programme. The aim is to precisely characterize i) the effects in terms of alcohol and cannabis consumption, the use of health professionals in case of problematic use of those two substances; ii) the context and underpinning mechanisms triggered by the program in terms of changes of alcohol and cannabis representations and life skills development. This evaluation could allow to produce the key functions of the programme: how the intervention works, in which conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,026

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

2.7 years

First QC Date

September 26, 2019

Last Update Submit

October 11, 2022

Conditions

Keywords

AddictionPrimary preventionSchool-based programme

Outcome Measures

Primary Outcomes (9)

  • Daily, alcohol consumption

    Alcohol consumption per day at study entry, after 1 year and after 2 years

    3 years

  • Weekly, alcohol consumption

    Alcohol consumption per week at study entry, after 1 year and after 2 years

    3 years

  • Monthly, alcohol consumption

    Alcohol consumption per month at study entry, after 1 year and after 2 years

    3 years

  • Number of episodes of heavy drinking

    An episode of heavy drinking : at least 5 drinks per occasion at study entry, after 1 year and after 2 years

    3 years

  • Number of drunkenness episodes

    Number of episodes at study entry, after 1 year and after 2 years

    3 years

  • Weekly, cannabis consumption

    Number of cannabis consumption per week at study entry, after 1 year and after 2 years

    3 years

  • Monthly, cannabis consumption

    Number of cannabis consumption per month at study entry, after 1 year and after 2 years

    3 years

  • Yearly, cannabis consumption

    Number of cannabis consumption per year at study entry, after 1 year and after 2 years

    3 years

  • Number of consultation of a healthcare professional to discuss about a problematic use of alcohol and/or cannabis

    Number of times at study entry, after 1 year and after 2 years

    3 years

Study Arms (1)

Expériences Animées Programme

The Expériences Animées programme involves supervised short movies and talks with secondary school and high school pupils about the use of psychoactive substances.

Other: QuestionnairesOther: Non-directive Interviews

Interventions

The questionnaires are completed at the 3 survey times (T0, T1 and T2) by all pupils involved. Collected data are quantitative

Expériences Animées Programme

The interviews are conducted with 80 pupils/year randomly selected (i.e. 2 per class and 8 per establishment/year). Collected data are qualitative

Expériences Animées Programme

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pupils from 10 secondary and hugh schools in the department of Charente (France)

You may qualify if:

  • Pupils :
  • Pupils from the 10 secondary and high schools selected in the department of Charente, in 2nd and 5th years in 2019/2020 academic year,
  • Others :
  • Non-opposition to participate of 3 Education professionals per establishment in the 10 secondary and high schools selected in the department of Charente,
  • Non-opposition to participate of 2 session leaders,
  • Non-opposition to participate of 3 funders.

You may not qualify if:

  • \- Participants under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC1401-EC - CHU de Bordeaux Centre Inserm U1219

Bordeaux, 33000, France

Location

Related Publications (1)

  • Martin-Fernandez J, Affret A, Martel E, Gallard R, Merchadou L, Moinot L, Termote M, Dejarnac V, Alla F, Cambon L. Realist evaluation of a theory-based life skills programme aiming to prevent addictive behaviours in adolescents: the ERIEAS study protocol. BMJ Open. 2020 Jun 29;10(6):e034530. doi: 10.1136/bmjopen-2019-034530.

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • François ALLA, MD PhD

    CIC1401-EC, Inserm-CHU de Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 1, 2019

Study Start

September 30, 2019

Primary Completion

June 16, 2022

Study Completion

June 16, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations