Clinical trial NCT03759626: I2S-Health Prevention
Official title: Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study Requirements
Keywords: alcohol
youth
prevention
comparative study
reflexive model
impulsive model
para-social connection
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2018-11-30
Enrollment: 486
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Alcohol is the psychoactive substance most experienced by young people. It benefits from positive representations that are reinforced by marketing strategies where advertisers integrate their products into TV series. Our project takes into account the reflexive and impulsive model developed by Strack \& Deutsch (2004). We will compare the impulsive intervention to an educational module based on information and reflection that uses the individual's reflexive system with 30 classes in the Loire and Rhône departments. The intervention framework developed uses a modeling system that includes several concepts that work together. These concepts describe the influence of media messages on young people's opinions and behaviours. Given that the objective is to reduce the positive representations of alcohol among young people by means of an educational module based on information and reflection (reflexive model) and a module based on the impulsive system where the para-social connection is involved. The Alcohol Expectancies Scale will be proposed as a judgment criterion and will be administered before and after the intervention.

Detailed description: Alcohol is recognized as responsible for 50,000 premature deaths per year and as the second most preventable cause of death in France. In adolescence, the brain is in a period of maturation. Many synaptic connections are established making the brain more vulnerable to toxic substances. Alcohol is the psychoactive substance most experienced by young people. In 2015, 40% of adolescents and young adults reported drinking alcohol every week. Advertisers are increasingly integrating their products into popular television series. These representations of alcohol in cultural products bypass existing regulations and make it possible to reach a target group that is difficult to reach through traditional advertising: young people. During a previous research project, the Centre Hygée research team, in partnership with American University, carried out a quantitative and qualitative assessment of the images of alcohol in the media viewed by the young public (IMAJe). Within television series, there are many messages inherent to alcohol consumption. Not only is alcohol twice as prevalent in television series as other beverages, but also, alcohol scenes are mainly based on positive results where alcohol refers to celebration and fun. On the other hand, the regularity and stability of the main characters in the series contribute to the viewer's attachment to the series and its characters. This attachment can lead the adolescent to identify with the situations constructed and exposed by developing a "para-social relationship" with the media characters. This connection influences the viewer's appropriation of the messages. This mode of action on opinions and behaviours is to be related to the impulsive model described by Strack \& Deutsch (2004).

The main objective of the project is to reduce the positive representations of alcohol among young people by means of an educational module based on information and reflection (reflexive model) and a module based on the impulsive system where the para-social connection is involved.

The intervention framework developed uses a modeling system that includes several concepts that work together. These concepts describe the influence of media messages on young people's opinions and behaviours. This will take into account 1) variables associated with the adolescent's connection to the series and his characters (para-social connection), 2) variables justifying individual differences such as psychological reactance, 3) sociocultural variables. The Alcohol Expectancies Scale will be used before and after the intervention and is proposed as a primary outcome criterion.

Schoolchildren of the Lyon Academy aged between 15 and 19 years old.

There are currently few successful prevention interventions on alcohol representations among young people. The Centre Hygée proposes an original study because it allows the comparison of two logics of prevention intervention but also because the only mobilization of the impulsive system is little used in the prevention sector. The methodology adopted makes it possible to reach validated and effective conclusions for prevention stakeholders.

Eligibility criteria: Inclusion Criteria:

* be enrolled in second grade in one of the high schools included
* Have been informed of the study and have not objected to participating
* To be in a general secondary school of general education, of public status
* To be in a high school located in the Auvergne-Rhône Alpes region.

Exclusion Criteria:

* Having a disability that does not allow a good understanding of the study requirements
* Student who opposed participation in the study
* High school without a general education section
* High school included in another research protocol

Primary outcomes:
measure: Alcohol consumption level of reprensentation
timeFrame: month 2
Secondary outcomes:
measure: The level of intention to consume alcohol
timeFrame: month 2
measure: Alcohol consumers level of representation
timeFrame: month 2
measure: level of reactance
timeFrame: month 2
measure: level of sensation-seeking of individuals
timeFrame: month 2
measure: level of socio-economic status
timeFrame: month 2
measure: Consumption of Television Programming
timeFrame: month 2
Other outcomes:
Locations:
city: Washington
country: United States
facility: Americain University of Washington
state: Massachusetts
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Saint-Étienne
country: France
facility: Mutualité Française de la Loire
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Véronique Régnier-Denois
role: STUDY_DIRECTOR
References: