- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110626
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
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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