- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04110626
Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine (ERIEAS)
11 oktober 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
- 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.
Studietyp
Observationell
Inskrivning (Faktisk)
1026
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bordeaux, Frankrike, 33000
- CIC1401-EC - CHU de Bordeaux Centre Inserm U1219
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Pupils from 10 secondary and hugh schools in the department of Charente (France)
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Övrig
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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.
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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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Daily, alcohol consumption
Tidsram: 3 years
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Alcohol consumption per day at study entry, after 1 year and after 2 years
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3 years
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Weekly, alcohol consumption
Tidsram: 3 years
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Alcohol consumption per week at study entry, after 1 year and after 2 years
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3 years
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Monthly, alcohol consumption
Tidsram: 3 years
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Alcohol consumption per month at study entry, after 1 year and after 2 years
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3 years
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Number of episodes of heavy drinking
Tidsram: 3 years
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An episode of heavy drinking : at least 5 drinks per occasion at study entry, after 1 year and after 2 years
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3 years
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Number of drunkenness episodes
Tidsram: 3 years
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Number of episodes at study entry, after 1 year and after 2 years
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3 years
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Weekly, cannabis consumption
Tidsram: 3 years
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Number of cannabis consumption per week at study entry, after 1 year and after 2 years
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3 years
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Monthly, cannabis consumption
Tidsram: 3 years
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Number of cannabis consumption per month at study entry, after 1 year and after 2 years
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3 years
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Yearly, cannabis consumption
Tidsram: 3 years
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Number of cannabis consumption per year at study entry, after 1 year and after 2 years
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3 years
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Number of consultation of a healthcare professional to discuss about a problematic use of alcohol and/or cannabis
Tidsram: 3 years
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Number of times at study entry, after 1 year and after 2 years
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3 years
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: François ALLA, MD PhD, CIC1401-EC, Inserm-CHU de Bordeaux
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 september 2019
Primärt slutförande (Faktisk)
16 juni 2022
Avslutad studie (Faktisk)
16 juni 2022
Studieregistreringsdatum
Först inskickad
26 september 2019
Först inskickad som uppfyllde QC-kriterierna
27 september 2019
Första postat (Faktisk)
1 oktober 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 oktober 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 oktober 2022
Senast verifierad
1 oktober 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUBX 2018/75
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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