Dataset Information

The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol.

ABSTRACT:

Background

Alcohol use is a major public health challenge in France, where at the age of 17 half the young people report an episode of severe alcohol intoxication in the month preceding the survey. Numerous prevention programmes have a general objective, but in adolescence individual vulnerabilities towards addictions differ significantly with personality traits. Prevention targeting personality traits enables work on risk factors for addictive behaviours, and has shown genuine efficacy. Among existing programmes, PREVENTURE has shown an effect on the reduction in alcohol consumption by targeting four personality traits: impulsivity, sensation-seeking, negative thoughts and anxiety. This programme has been tested on samples recruited in adolescent populations in school environments, identifying adolescents at risk, but it has not been tested on a more targeted recruitment of adolescents seen in consultation.

Methods

The main hypothesis of this study is that the targeted prevention programme PREVENTURE will have an impact on the prevalence of binge-drinking episodes. The secondary hypotheses explore other factors such as associated substance use, anxiety and depression, as well as the acceptability of the programme. This article presents the study protocol of "PREVADO" study. We intend to assess the impact of the targeted intervention programme PREVENTURE on the prevalence of binge-drinking episodes among adolescents aged 14 to 17 years consulting in one of the participating centres or referred by a school doctor. The study will be prospective, randomised, controlled and open-label, and will comprise an intervention group and a control group. The adolescents will then be followed and assessed 1, 3, 6 and 12 months after the intervention. The study needs to include 700 subjects in order to reach 340 adolescents randomised, 170 in each group. It will concern 33 centres.

Discussion

This project could favour the targeting of addictive behaviours among vulnerable adolescents, and its application on a larger scale could be envisaged.

Trial registration

The Trial registration number is NCT04599270 , and it was registered on the ClinicalTrials.gov public website.

SUBMITTER: Guillou-Landreat M

PROVIDER: S-EPMC8063443 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionAdolescence is a sensitive life stage during which tobacco, alcohol and cannabis are used as ways to learn and adopt roles. There is a great deal of interest in substance use (SU) prevention programmes for young people that work to change representations of these products and help with mobilisation of life skills. Unfortunately, few existing programmes are evidence-based.In France, a programme called Expériences Animées (EA, Animated Experiences) has been developed, inspired by life skills development programmes that have been proven to be successful. The EA programme uses animated short movies and talks with high school and secondary school pupils about the use of psychoactive substances and addictions. By allowing life skills mobilisation and modifying representations and beliefs about SU, it is aimed at delaying initiation of use of psychoactive substances, preventing adolescents from becoming regular consumers, reducing the risks and harms related to the use of these substances and opening the way for adapted support measures.We are interested in understanding how, under what circumstances, through which mechanisms and among which adolescents the EA programme works. Therefore, we have developed the ERIEAS study ('Evaluation Réaliste de l'Intervention Expériences Animées en milieu Scolaire'; Realist Evaluation of the EA Intervention in Schools).Methods and analysisEA will be conducted in 10 schools. A multi-case approach will be adopted with the aim of developing and adjusting an intervention theory. The study comes under the theory-driven evaluation framework. The investigation methodology will include four stages: (i) elaboration of a middle-range theory; (ii) data collection for validating/adjusting the theory; (iii) data analysis; and (iv) refinement and adjustment of the middle-range theory and definition of the programme's key functions.Ethics and disseminationThe study will provide evidence-based results to health authorities to help in the rollout of health promotion strategies in schools. It will provide knowledge about the strategic configurations most suitable for leading to life skills mobilisation and change young people's representations about SU. The project will be carried out with full respect of current relevant legislation (eg, the Charter of Fundamental Rights of the European Union) and international conventions (eg, Helsinki Declaration). It follows the relevant French legislation of the research category on interventional research protocol involving the human person. The protocol was approved by the Comité et Protection des Personnes (CPP), that is, Committee for the Protection of Persons CPP SUD-EST VI n°: AU 1525 and was reported to the Agence Française de Sécurité Sanitaire des Produits de Santé (ANSM) that is, the French National Agency for the Safety of Health Products. It is in conformity with reference methodology MR003 of Bordeaux University Hospital (CNIL n° 2 026 779 v0).Trial registration detailsThis research has been registered on ClinicalTrials.gov (No. NCT04110626).The research project is registered in the European database ID-RCB (No. 2019-A01003-54).