Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine (ERIEAS)

October 11, 2022 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Detailed Description

  • Alcohol consumption represents the second main modifiable risk factor for cancer and the second preventable mortality cause in France, after tobacco use. It is mainly during adolescence, which corresponds to a period of integration with peers and a period of detachment from parents, that alcohol use starts. In France, alcohol remains the substance that adolescents most experiment with. A 2014 report shows that nearly half (49.4%) of first-year secondary school pupils have already tried an alcoholic drink and about one in seven secondary school pupils' reports having been drunk. The impact of cannabis consumption is wide as it can affect the social environment, the brain and the psychology of the consumers. Adolescence is a period during which the brain undergoes profound remodelling in areas that are high in cannabinoid receptors and that mediate cognitive control and emotion regulation. Therefore, childhood and adolescence are important stages of life on which preventive efforts may be focused, also because events occurring in the earliest stages of human development (before birth and during childhood) are known to be related to further risk for cancer, other chronic diseases and adult conditions.
  • Among addiction prevention programmes, those that focus on life skills have been mentioned in the literature as being effective. In this context, the French organization "Association Ressources et Initiatives Addictions" (ARIA) has developed Expériences Animées programme (animated experiences) based on the above features, with the aim to help adolescents to change their representations and strengthen their life skills. This is a grassroots innovation. It has to be evaluated.
  • The Expériences Animées programme involves supervised short movies and talks with secondary and high school pupils about the use of psychoactive substances. The movies are made specifically for the programme. The sessions are facilitated by two professionals including at least a clinical psychologist. In a given secondary/high school, one session per term is delivered for each class (40 classes). Three to five films are shown at each session. Each film aims to work on 2 to 3 life skills allowing to build protective behaviors against addictions. This programme is implemented since 2015.
  • The investigators will collect quantitative and qualitative data to appraise the outcomes (O), mechanisms (M) and contextual elements (C), including the interventional elements) in order to verify the initial theories (hypothesis of causal pathways) by i) Questionnaires to collect outcomes in terms of consumption and health care, and some mechanisms: 2/ Non-directive interviews to collect mechanisms and contextual factors 3/ Observations to collect contextual elements during the sessions. The investigators will design the survey instruments in line with the initial middle-range theories identified.

Study Type

Observational

Enrollment (Actual)

1026

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33000
        • CIC1401-EC - CHU de Bordeaux Centre Inserm U1219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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,
  • Pupils not opposite to participate and holders of parental authority not opposite to the participation of the child (no later than the day of inclusion)

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.

Exclusion Criteria:

- Participants under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
The questionnaires are completed at the 3 survey times (T0, T1 and T2) by all pupils involved. Collected data are quantitative
The interviews are conducted with 80 pupils/year randomly selected (i.e. 2 per class and 8 per establishment/year). Collected data are qualitative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily, alcohol consumption
Time Frame: 3 years
Alcohol consumption per day at study entry, after 1 year and after 2 years
3 years
Weekly, alcohol consumption
Time Frame: 3 years
Alcohol consumption per week at study entry, after 1 year and after 2 years
3 years
Monthly, alcohol consumption
Time Frame: 3 years
Alcohol consumption per month at study entry, after 1 year and after 2 years
3 years
Number of episodes of heavy drinking
Time Frame: 3 years
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
Time Frame: 3 years
Number of episodes at study entry, after 1 year and after 2 years
3 years
Weekly, cannabis consumption
Time Frame: 3 years
Number of cannabis consumption per week at study entry, after 1 year and after 2 years
3 years
Monthly, cannabis consumption
Time Frame: 3 years
Number of cannabis consumption per month at study entry, after 1 year and after 2 years
3 years
Yearly, cannabis consumption
Time Frame: 3 years
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
Time Frame: 3 years
Number of times at study entry, after 1 year and after 2 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: François ALLA, MD PhD, CIC1401-EC, Inserm-CHU de Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

June 16, 2022

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CHUBX 2018/75

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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