<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759626</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1101SP</org_study_id>
    <nct_id>NCT03759626</nct_id>
  </id_info>
  <brief_title>I2S-Health Prevention</brief_title>
  <acronym>I2S</acronym>
  <official_title>Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Cancérologie de la Loire</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alcohol is the psychoactive substance most experienced by young people. It benefits from&#xD;
      positive representations that are reinforced by marketing strategies where advertisers&#xD;
      integrate their products into TV series. Our project takes into account the reflexive and&#xD;
      impulsive model developed by Strack &amp; Deutsch (2004). We will compare the impulsive&#xD;
      intervention to an educational module based on information and reflection that uses the&#xD;
      individual's reflexive system with 30 classes in the Loire and Rhône departments. The&#xD;
      intervention framework developed uses a modeling system that includes several concepts that&#xD;
      work together. These concepts describe the influence of media messages on young people's&#xD;
      opinions and behaviours. Given that the objective is to reduce the positive representations&#xD;
      of alcohol among young people by means of an educational module based on information and&#xD;
      reflection (reflexive model) and a module based on the impulsive system where the para-social&#xD;
      connection is involved. The Alcohol Expectancies Scale will be proposed as a judgment&#xD;
      criterion and will be administered before and after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol is recognized as responsible for 50,000 premature deaths per year and as the second&#xD;
      most preventable cause of death in France. In adolescence, the brain is in a period of&#xD;
      maturation. Many synaptic connections are established making the brain more vulnerable to&#xD;
      toxic substances. Alcohol is the psychoactive substance most experienced by young people. In&#xD;
      2015, 40% of adolescents and young adults reported drinking alcohol every week. Advertisers&#xD;
      are increasingly integrating their products into popular television series. These&#xD;
      representations of alcohol in cultural products bypass existing regulations and make it&#xD;
      possible to reach a target group that is difficult to reach through traditional advertising:&#xD;
      young people. During a previous research project, the Centre Hygée research team, in&#xD;
      partnership with American University, carried out a quantitative and qualitative assessment&#xD;
      of the images of alcohol in the media viewed by the young public (IMAJe). Within television&#xD;
      series, there are many messages inherent to alcohol consumption. Not only is alcohol twice as&#xD;
      prevalent in television series as other beverages, but also, alcohol scenes are mainly based&#xD;
      on positive results where alcohol refers to celebration and fun. On the other hand, the&#xD;
      regularity and stability of the main characters in the series contribute to the viewer's&#xD;
      attachment to the series and its characters. This attachment can lead the adolescent to&#xD;
      identify with the situations constructed and exposed by developing a &quot;para-social&#xD;
      relationship&quot; with the media characters. This connection influences the viewer's&#xD;
      appropriation of the messages. This mode of action on opinions and behaviours is to be&#xD;
      related to the impulsive model described by Strack &amp; Deutsch (2004).&#xD;
&#xD;
      The main objective of the project is to reduce the positive representations of alcohol among&#xD;
      young people by means of an educational module based on information and reflection (reflexive&#xD;
      model) and a module based on the impulsive system where the para-social connection is&#xD;
      involved.&#xD;
&#xD;
      The intervention framework developed uses a modeling system that includes several concepts&#xD;
      that work together. These concepts describe the influence of media messages on young people's&#xD;
      opinions and behaviours. This will take into account 1) variables associated with the&#xD;
      adolescent's connection to the series and his characters (para-social connection), 2)&#xD;
      variables justifying individual differences such as psychological reactance, 3) sociocultural&#xD;
      variables. The Alcohol Expectancies Scale will be used before and after the intervention and&#xD;
      is proposed as a primary outcome criterion.&#xD;
&#xD;
      Schoolchildren of the Lyon Academy aged between 15 and 19 years old.&#xD;
&#xD;
      There are currently few successful prevention interventions on alcohol representations among&#xD;
      young people. The Centre Hygée proposes an original study because it allows the comparison of&#xD;
      two logics of prevention intervention but also because the only mobilization of the impulsive&#xD;
      system is little used in the prevention sector. The methodology adopted makes it possible to&#xD;
      reach validated and effective conclusions for prevention stakeholders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Anticipated">June 29, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol consumption level of reprensentation</measure>
    <time_frame>month 2</time_frame>
    <description>This main criterion will be measured by the &quot;Alcohol Expectancies Scale&quot; 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).&#xD;
This 5-point scale with 1 = &quot;very unlikely&quot; and 5 = &quot;very likely&quot; contains 16 items.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The level of intention to consume alcohol</measure>
    <time_frame>month 2</time_frame>
    <description>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.&#xD;
This 7-point scale with 1 = &quot;no chance&quot; and 7 = &quot;certain&quot; has 2 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumers level of representation</measure>
    <time_frame>month 2</time_frame>
    <description>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.&#xD;
This 5-point scale with 1 = &quot;bad&quot; and 5 = &quot;good&quot; contains 6 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of reactance</measure>
    <time_frame>month 2</time_frame>
    <description>The level of psychological reactance of individuals will be measured using a validated reactance scale, translated from the Hong's Psychological Reactance Scale (HPRS).&#xD;
This 5-point scale with 1 = &quot;not at all&quot; and 5 = &quot;completely&quot; contains 7 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of sensation-seeking of individuals</measure>
    <time_frame>month 2</time_frame>
    <description>The level of their sensation seeking will be measured via Zuckermann's &quot;Sensation Seeking Scale&quot;. This scale is used to identify individuals with psychological sensation-seeking traits.&#xD;
This 5-point scale with 1 = &quot;strongly disagree&quot; and 5 = &quot;strongly agree&quot; has 6 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of socio-economic status</measure>
    <time_frame>month 2</time_frame>
    <description>Adolescents' perceptions of social status will be collected with the &quot;Development and Evaluation of a New Indicator&quot;.&#xD;
This 5-point scale, with 1 = &quot;very comfortable&quot; and 5 = &quot;not at all comfortable&quot; has only 1 item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of Television Programming</measure>
    <time_frame>month 2</time_frame>
    <description>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.&#xD;
This 5-point scale with 1 = &quot;strongly disagree&quot; and 5 = &quot;strongly agree&quot; has 16 items.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">486</enrollment>
  <condition>Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study Requirements</condition>
  <arm_group>
    <arm_group_label>pupils benefiting from the impulsive intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Secondary school pupils from general secondary schools</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pupils benefiting from the reflective intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Second year students from general high schools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Impulsive intervention</intervention_name>
    <description>As part of the IMAJe project, a 20 min TV series pilot for teenagers was developed by C. Russel of Washington University : &quot;Tom in the making&quot;. 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 &quot;negative&quot; 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.</description>
    <arm_group_label>pupils benefiting from the impulsive intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reflective Intervention</intervention_name>
    <description>This intervention uses modules of the &quot;KOTTABOS ®&quot; 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.&#xD;
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 &quot;KOTTABOS ®&quot; tool were selected and tested with 2 test groups of adolescents of the same school level as the students in the study.</description>
    <arm_group_label>pupils benefiting from the reflective intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be enrolled in second grade in one of the high schools included&#xD;
&#xD;
          -  Have been informed of the study and have not objected to participating&#xD;
&#xD;
          -  To be in a general secondary school of general education, of public status&#xD;
&#xD;
          -  To be in a high school located in the Auvergne-Rhône Alpes region.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a disability that does not allow a good understanding of the study requirements&#xD;
&#xD;
          -  Student who opposed participation in the study&#xD;
&#xD;
          -  High school without a general education section&#xD;
&#xD;
          -  High school included in another research protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Véronique Régnier-Denois</last_name>
    <role>Study Director</role>
    <affiliation>Institut de Cancérologie Lucien Neuwirth</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Véronique Régnier-Denois</last_name>
    <phone>04.77.91.74.75</phone>
    <email>veronique.regnier@icloire.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Americain University of Washington</name>
      <address>
        <city>Washington</city>
        <state>Massachusetts</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antonia Russel Cristel</last_name>
    </contact>
    <investigator>
      <last_name>Antonia Russel Cristel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie Lucien Neuwirth</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Véronique Régnier-Denois</last_name>
      <phone>04.77.91.74.75</phone>
      <email>veronique.regnier@icloire.fr</email>
    </contact>
    <investigator>
      <last_name>Véronique Régnier-Denois</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mutualité Française de la Loire</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Véronique Decommer</last_name>
    </contact>
    <investigator>
      <last_name>Véronique Decommer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>alcohol</keyword>
  <keyword>youth</keyword>
  <keyword>prevention</keyword>
  <keyword>comparative study</keyword>
  <keyword>reflexive model</keyword>
  <keyword>impulsive model</keyword>
  <keyword>para-social connection</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759626
org study id: 2018-1101SP
nct id: NCT03759626
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Alcohol consumption level of reprensentation
time frame: month 2
description: 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.
measure: The level of intention to consume alcohol
time frame: month 2
description: 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.
measure: Alcohol consumers level of representation
time frame: month 2
description: 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.
measure: level of reactance
time frame: month 2
description: 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.
measure: level of sensation-seeking of individuals
time frame: month 2
description: 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.
measure: level of socio-economic status
time frame: month 2
description: 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
measure: Consumption of Television Programming
time frame: month 2
description: 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.
arm group label: pupils benefiting from the impulsive intervention
arm group type: Active Comparator
description: Secondary school pupils from general secondary schools
arm group label: pupils benefiting from the reflective intervention
arm group type: Active Comparator
description: Second year students from general high schools.
intervention type: Behavioral
intervention name: Impulsive intervention
description: 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.
arm group label: pupils benefiting from the impulsive intervention
intervention type: Behavioral
intervention name: Reflective Intervention
description: 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.
arm group label: pupils benefiting from the reflective intervention
criteria: 
gender: All
minimum age: 15 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Véronique Régnier-Denois
role: Study Director
affiliation: Institut de Cancérologie Lucien Neuwirth
last name: Véronique Régnier-Denois
phone: 04.77.91.74.75
email: veronique.regnier@icloire.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: France
country: United States
responsible party type: Sponsor
sharing ipd: No