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I2S-Health Prevention (I2S)

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ClinicalTrials.gov Identifier: NCT03759626
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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.

Condition or disease Intervention/treatment Phase
Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study Requirements Behavioral: Impulsive intervention Behavioral: Reflective Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : May 29, 2019
Estimated Study Completion Date : June 29, 2019

Arm Intervention/treatment
Active Comparator: pupils benefiting from the impulsive intervention
Secondary school pupils from general secondary schools
Behavioral: Impulsive intervention
As part of the IMAJe project, a 20 min TV series pilot for teenagers was developed by C. Russel of Washington University : "Tom in the making". The results of the study show that the mere diffusion of this pilot mobilizes the individual's impulsive system described in the theoretical model developed by Strack and Deutsch. 2 different versions have been developed. Both have the same basic story in three acts with the same main characters. Only the last acts vary according to the consequences of alcohol consumption. The first version shows a positive representation of alcoholization, the other highlights the negative consequences generated by this behaviour. Our tool will be the so-called "negative" version of the episode where alcohol consumption causes harmful consequences in the young person's life. Following this 20 min episode, a 25 min debate focusing on the characters in the series will be conducted using a questionnaire grid with 8 questions.

Active Comparator: pupils benefiting from the reflective intervention
Second year students from general high schools.
Behavioral: Reflective Intervention

This intervention uses modules of the "KOTTABOS ®" system produced by the National Association for the Prevention of Alcohol and Addiction 59 (ANPAA) and validated by the Interministerial Mission to Combat Drugs and Drug Addiction (MILT). For young people, this educational tool aims to develop an understanding of the mechanisms of blood alcohol levels, the effects and immediate risks associated with alcohol consumption.

It encourages individual and collective reflection on the effects of alcohol on physical, cognitive and intellectual abilities in order to increase individual skills in making risk-appropriate behavioural choices. This pedagogical tool is based on a participatory and experimental approach. 5 devices of the "KOTTABOS ®" tool were selected and tested with 2 test groups of adolescents of the same school level as the students in the study.





Primary Outcome Measures :
  1. Alcohol consumption level of reprensentation [ Time Frame: month 2 ]

    This main criterion will be measured by the "Alcohol Expectancies Scale" translated into French and validated during our previous IMAJe research project. This scale reflects beliefs about the risks and benefits of excessive alcohol consumption (Grube and Agostellino, 1999).

    This 5-point scale with 1 = "very unlikely" and 5 = "very likely" contains 16 items.



Secondary Outcome Measures :
  1. The level of intention to consume alcohol [ Time Frame: month 2 ]

    The level of their intention to consume alcohol will be assessed through the selection of items related to this theme in the questionnaire used in the HBSC (Health Behaviour in School Aged Children) survey.

    This 7-point scale with 1 = "no chance" and 7 = "certain" has 2 items.


  2. Alcohol consumers level of representation [ Time Frame: month 2 ]

    Representations to alcohol consumers will complement the previous measure. They will be evaluated using a scale proposed in the IMAJe questionnaire that has shown excellent psychometric properties.

    This 5-point scale with 1 = "bad" and 5 = "good" contains 6 items.


  3. level of reactance [ Time Frame: month 2 ]

    The level of psychological reactance of individuals will be measured using a validated reactance scale, translated from the Hong's Psychological Reactance Scale (HPRS).

    This 5-point scale with 1 = "not at all" and 5 = "completely" contains 7 items.


  4. level of sensation-seeking of individuals [ Time Frame: month 2 ]

    The level of their sensation seeking will be measured via Zuckermann's "Sensation Seeking Scale". This scale is used to identify individuals with psychological sensation-seeking traits.

    This 5-point scale with 1 = "strongly disagree" and 5 = "strongly agree" has 6 items.


  5. level of socio-economic status [ Time Frame: month 2 ]

    Adolescents' perceptions of social status will be collected with the "Development and Evaluation of a New Indicator".

    This 5-point scale, with 1 = "very comfortable" and 5 = "not at all comfortable" has only 1 item


  6. Consumption of Television Programming [ Time Frame: month 2 ]

    the relationship to media content will be measured using the parasocial connection of individuals via the French version of the parasocial connection scale established by Russel et al.

    This 5-point scale with 1 = "strongly disagree" and 5 = "strongly agree" has 16 items.




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759626


Contacts
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Contact: Véronique Régnier-Denois 04.77.91.74.75 veronique.regnier@icloire.fr

Locations
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United States, Massachusetts
Americain University of Washington Not yet recruiting
Washington, Massachusetts, United States, 20016
Contact: Antonia Russel Cristel         
Principal Investigator: Antonia Russel Cristel         
France
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Véronique Régnier-Denois    04.77.91.74.75    veronique.regnier@icloire.fr   
Principal Investigator: Véronique Régnier-Denois         
Mutualité Française de la Loire Not yet recruiting
Saint-Étienne, France, 42100
Contact: Véronique Decommer         
Principal Investigator: Véronique Decommer         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
National Cancer Institute, France
Investigators
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Study Director: Véronique Régnier-Denois Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03759626     History of Changes
Other Study ID Numbers: 2018-1101SP
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Cancérologie de la Loire:
alcohol
youth
prevention
comparative study
reflexive model
impulsive model
para-social connection