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

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ClinicalTrials.gov Identifier: NCT04110626
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
CMG-EC U1219 Inserm
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment
Addiction Other: Questionnaires Other: Non-directive Interviews

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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

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




Primary Outcome Measures :
  1. Daily, alcohol consumption [ Time Frame: 3 years ]
    Alcohol consumption per day at study entry, after 1 year and after 2 years

  2. Weekly, alcohol consumption [ Time Frame: 3 years ]
    Alcohol consumption per week at study entry, after 1 year and after 2 years

  3. Monthly, alcohol consumption [ Time Frame: 3 years ]
    Alcohol consumption per month at study entry, after 1 year and after 2 years

  4. 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

  5. Number of drunkenness episodes [ Time Frame: 3 years ]
    Number of episodes at study entry, after 1 year and after 2 years

  6. Weekly, cannabis consumption [ Time Frame: 3 years ]
    Number of cannabis consumption per week at study entry, after 1 year and after 2 years

  7. Monthly, cannabis consumption [ Time Frame: 3 years ]
    Number of cannabis consumption per month at study entry, after 1 year and after 2 years

  8. Yearly, cannabis consumption [ Time Frame: 3 years ]
    Number of cannabis consumption per year at study entry, after 1 year and after 2 years

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pupils from 10 secondary and hugh schools in the department of Charente (France)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110626


Contacts
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Contact: Linda CAMBON (0)557571769 ext +33 Linda.cambon@u-bordeaux.fr
Contact: Judith MARTIN (0)557571043 ext +33 judith.martin@chu-bordeaux.fr

Locations
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France
CIC1401-EC - CHU de Bordeaux Centre Inserm U1219
Bordeaux, France, 33000
Contact: Linda CAMBON    (0)557571769 ext +33    linda.cambon@u-bordeaux.fr   
Contact: Judith MARTIN    (0)557571043 ext +33    judith.martin@chu-bordeaux.fr   
Principal Investigator: François ALLA, MD PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
CMG-EC U1219 Inserm
Investigators
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Principal Investigator: François ALLA, MD PhD CIC1401-EC, Inserm-CHU de Bordeaux
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04110626    
Other Study ID Numbers: CHUBX 2018/75
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Addiction
Primary prevention
School-based programme
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior