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AddictionERIEASNCT04110626

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

An observational study of Addiction, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Addiction
What is being tested?
Questionnaires and Non-directive Interviews
How many people
1,026 participants
Where
1 siteFrance
Study dates
30 Sep 2019to 16 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Participants under legal protection

Trial locations and contacts

1 site in 1 country.

France1 site

  • CIC1401-EC - CHU de Bordeaux Centre Inserm U1219

    Bordeaux, 33000

Other trials in France

About this study

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.

Read the 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.
Conditions
Addiction
Being tested
Questionnaires, Non-directive Interviews
Keywords
Addiction, Primary prevention, School-based programme
Medical subject headings
Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

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

  • Non-directive InterviewsOther

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

Study groups in NCT04110626
Study groupRoleWhat they receive
Expériences Animées ProgrammeThe Expériences Animées programme involves supervised short movies and talks with secondary school and high school pupils about the use of psychoactive substances.
Receives: Other: Questionnaires; Other: Non-directive Interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily, alcohol consumption

    Alcohol consumption per day at study entry, after 1 year and after 2 years

    Measured: 3 years

  2. Weekly, alcohol consumption

    Alcohol consumption per week at study entry, after 1 year and after 2 years

    Measured: 3 years

  3. Monthly, alcohol consumption

    Alcohol consumption per month at study entry, after 1 year and after 2 years

    Measured: 3 years

  4. Number of episodes of heavy drinking

    An episode of heavy drinking : at least 5 drinks per occasion at study entry, after 1 year and after 2 years

    Measured: 3 years

  5. Number of drunkenness episodes

    Number of episodes at study entry, after 1 year and after 2 years

    Measured: 3 years

  6. Weekly, cannabis consumption

    Number of cannabis consumption per week at study entry, after 1 year and after 2 years

    Measured: 3 years

  7. Monthly, cannabis consumption

    Number of cannabis consumption per month at study entry, after 1 year and after 2 years

    Measured: 3 years

  8. Yearly, cannabis consumption

    Number of cannabis consumption per year at study entry, after 1 year and after 2 years

    Measured: 3 years

  9. Number of consultation of a healthcare professional to discuss about a problematic use of alcohol and/or cannabis

    Number of times at study entry, after 1 year and after 2 years

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start30 Sep 2019
  3. Primary completion16 Jun 2022
  4. Study completion16 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,026 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110626
Sponsor's protocol ID
CHUBX 2018/75
Acronym
ERIEAS
Status last verified
Oct 2022
First submitted
26 Sep 2019
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32601111

Questions about this trial

What is this clinical trial studying?

An observational study of Addiction, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily, alcohol consumption (time frame: 3 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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