Clinical trial NCT04110626: Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine
Official title: Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addiction
Keywords: Addiction
Primary prevention
School-based programme
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-10-01
Enrollment: 1026
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pupils from 10 secondary and hugh schools in the department of Charente (France)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily, alcohol consumption
timeFrame: 3 years
measure: Weekly, alcohol consumption
timeFrame: 3 years
measure: Monthly, alcohol consumption
timeFrame: 3 years
measure: Number of episodes of heavy drinking
timeFrame: 3 years
measure: Number of drunkenness episodes
timeFrame: 3 years
measure: Weekly, cannabis consumption
timeFrame: 3 years
measure: Monthly, cannabis consumption
timeFrame: 3 years
measure: Yearly, cannabis consumption
timeFrame: 3 years
measure: Number of consultation of a healthcare professional to discuss about a problematic use of alcohol and/or cannabis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CIC1401-EC - CHU de Bordeaux Centre Inserm U1219
Study officials:
affiliation: CIC1401-EC, Inserm-CHU de Bordeaux
name: François ALLA, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.