Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

11. oktober 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

  • 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1026

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Andet
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily, alcohol consumption
Tidsramme: 3 years
Alcohol consumption per day at study entry, after 1 year and after 2 years
3 years
Weekly, alcohol consumption
Tidsramme: 3 years
Alcohol consumption per week at study entry, after 1 year and after 2 years
3 years
Monthly, alcohol consumption
Tidsramme: 3 years
Alcohol consumption per month at study entry, after 1 year and after 2 years
3 years
Number of episodes of heavy drinking
Tidsramme: 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
Tidsramme: 3 years
Number of episodes at study entry, after 1 year and after 2 years
3 years
Weekly, cannabis consumption
Tidsramme: 3 years
Number of cannabis consumption per week at study entry, after 1 year and after 2 years
3 years
Monthly, cannabis consumption
Tidsramme: 3 years
Number of cannabis consumption per month at study entry, after 1 year and after 2 years
3 years
Yearly, cannabis consumption
Tidsramme: 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
Tidsramme: 3 years
Number of times at study entry, after 1 year and after 2 years
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: François ALLA, MD PhD, CIC1401-EC, Inserm-CHU de Bordeaux

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. september 2019

Primær færdiggørelse (Faktiske)

16. juni 2022

Studieafslutning (Faktiske)

16. juni 2022

Datoer for studieregistrering

Først indsendt

26. september 2019

Først indsendt, der opfyldte QC-kriterier

27. september 2019

Først opslået (Faktiske)

1. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUBX 2018/75

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

3
Abonner