Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study RequirementsI2SNCT03759626
I2S-Health Prevention
A study testing Impulsive intervention and Reflective Intervention in people with Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study Requirements, run by Institut de Cancérologie de la Loire at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study Requirements
- What is being tested?
- Impulsive intervention and Reflective Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Feb 2019to 29 Jun 2019
- Phase
- Interventional
- 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites, 2 recruiting
- Not yet recruiting
Mutualité Française de la Loire
Saint-Etienne, 42100
Véronique Decommer
Véronique Decommer
- Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
Véronique Régnier-Denois, 04.77.91.74.75, veronique.regnier@icloire.fr
Véronique Régnier-Denois
United States1 site, 1 recruiting
- Not yet recruiting
Americain University of Washington
Washington, Massachusetts, 20016
Antonia Russel Cristel
Antonia Russel Cristel
About this study
Official title: Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)
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.
Read the 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.
- Being tested
- Impulsive intervention, Reflective Intervention
- Keywords
- alcohol, youth, prevention, comparative study, reflexive model, impulsive model, para-social connection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impulsive interventionBehavioural
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.
Reflective InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| pupils benefiting from the impulsive intervention | Active comparator | Secondary school pupils from general secondary schools Receives: Behavioral: Impulsive intervention |
| pupils benefiting from the reflective intervention | Active comparator | Second year students from general high schools. Receives: Behavioral: Reflective Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption level of reprensentation
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.
Measured: month 2
Secondary outcomes (6)
The level of intention to consume alcohol
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.
Measured: month 2
Alcohol consumers level of representation
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.
Measured: month 2
level of reactance
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.
Measured: month 2
level of sensation-seeking of individuals
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.
Measured: month 2
level of socio-economic status
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
Measured: month 2
Consumption of Television Programming
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.
Measured: month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start6 Feb 2019
- Primary completion29 May 2019 (estimated)
- Study completion29 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study RequirementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Véronique Régnier-Denois, Study director, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759626
- Sponsor's protocol ID
- 2018-1101SP
- Acronym
- I2S
- Status last verified
- Feb 2019
- First submitted
- 28 Nov 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)
- ClinicalTrials.gov ID
- NCT03759626
- Acronym / sponsor ID
- I2S / 2018-1101SP
- Keywords
- alcohol, youth, prevention, comparative study, reflexive model, impulsive model, para-social connection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 29 May 2019 (estimated)
- Study completion
- 29 Jun 2019 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pupils benefiting from the impulsive intervention | Active comparator | Behavioral: Impulsive interventionSecondary school pupils from general secondary schools |
| pupils benefiting from the reflective intervention | Active comparator | Behavioral: Reflective InterventionSecond year students from general high schools. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impulsive interventionAs 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. | Behavioural | pupils benefiting from the impulsive intervention |
| Reflective InterventionThis 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. | Behavioural | pupils benefiting from the reflective intervention |
Primary outcome
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.
6 secondary outcomes
The level of intention to consume alcohol
Time frame: month 2
Alcohol consumers level of representation
Time frame: month 2
level of reactance
Time frame: month 2
level of sensation-seeking of individuals
Time frame: month 2
level of socio-economic status
Time frame: month 2
Consumption of Television Programming
Time frame: month 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Régnier-Denois study director
Institut de Cancérologie Lucien Neuwirth
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impulsive intervention and Reflective Intervention in people with Secondary School Student in General High School Who Does Not Have a Disability That Does Not Allow a Good Understanding of the Study Requirements, run by Institut de Cancérologie de la Loire at 3 sites in 2 countries.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Véronique Régnier-Denois (04.77.91.74.75, veronique.regnier@icloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol consumption level of reprensentation (time frame: month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2019.