TabagismSCOTTNCT04888208
Prevention in a Virtual Community Game
A study testing Behavioral in people with Tabagism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of the SCOTT project is to reduce tobacco experimentation of teenagers through an online intervention based on social networking and empowerment of users. Specific objectives of this emerging project are : 1. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Tabagism
- What is being tested?
- Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 15 Nov 2020
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Players of the French-speaking HABBO community;
- Informed and consentent to the study;
- Agreeing to complete the baseline study questionnaire.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Set up a Community Online in a Virtual Community Game for Tobacco Prevention in Teenagers
The main objective of the SCOTT project is to reduce tobacco experimentation of teenagers through an online intervention based on social networking and empowerment of users.
Specific objectives of this emerging project are : 1. To develop or identify an online community dedicated to teenagers where the investigators will develop anti-smoking skills and norms. It will be based on social cognitive theory and will combine multiple functionalities based on the current practices and preferences of adolescents on internet and mobile; ensuring user safety, regulatory and ethical issues ; 2. To analyse the adoption, acceptance and the usability of SCOTT among users in a limited scale 3.To develop SCOTT process and impact assessment methodology.
Research hypothesis Providing access to prevention in an online community will: 1) Strengthen anti-smoking skills 2) Enhance the empowerment of users 3) Allow the implementation of health interventions 4) Improve indicators of tobacco consumption in young people Methods The overall methodology of the project relies on a multidisciplinary approach with a consortium of French experts in public health (health promotion and epidemiology), education science, information and communication technologies, medical informatics, adolescent medicine, adolescent addictology, social sciences, ethics and law. The project will be led in 3 parts: 1) Development of the intervention - using the Integrate, Design, Assess, and Share (IDEAS) framework. Using qualitative methods (individual interview, focus groups), multidisciplinary team brainstorming, works meeting and quantitative assessment of SCOTT quality; the investigators will (a) empathize with target users, (b) specify target behavior, (c) ground in behavioral theory, (d) ideate implementation strategies, (e) prototype potential products, (f) gather user feedback, (g) build a minimum viable product, 2) Pilot study : (h) SCOTT will be deploying on a small scale to assess its usability; 3) Development of the large-scale evaluation protocol - following the recommendations of the Medical Research Council concerning the evaluation of complex interventions. The investigators will (i) develop, based on the results of the pilot test, the SCOTT process evaluation methodology, (j) develop the SCOTT impact / effectiveness evaluation methodology.
Read the detailed description
Scientific context The SCOTT project stems from the "m-Health" Initiative launched in 2012 by the WHO and the International Telecommunication Union for the fight against non-communicable diseases (NCDs). The project is based on: 1) In 2014, in France, a third of high school students of all ages said they had already had the opportunity to smoke a cigarette. Smoking cigarettes is multiplied by 5 during the high school years, with one student in two who has already smoked at least once a cigarette in the last year. 2) In France the rate of computer equipment is 97% in the 12-17 and 81% have smartphones. Teenagers of 11-14 are 67% to have a social network account that they used mainly to watch videos, chat with friends and family and publish and share 3) Essential elements of risk-taking prevention programs for adolescents have been identified: using social behavior theories; using interactive skill-building methods, focusing on the social influences that encourage behavior, including peers and the media; offering multiple-component interventions; including a strong peer education or support component.
Objectives The main objective of the SCOTT project is to reduce tobacco experimentation of teenagers through an online intervention based on social networking and empowerment of users.
Specific objectives of this emerging project are : 1. To develop or identify an online community dedicated to teenagers where the investogators will develop anti-smoking skills and norms. It will be based on social cognitive theory and will combine multiple functionalities based on the current practices and preferences of adolescents on internet and mobile; ensuring user safety, regulatory and ethical issues ; 2. To analyse the adoption, acceptance and the usability of SCOTT among users in a limited scale 3.To develop SCOTT process and impact assessment methodology.
Research hypothesis Providing access to prevention in an online community will: 1) Strengthen anti-smoking skills 2) Enhance the empowerment of users 3) Allow the implementation of health interventions 4) Improve indicators of tobacco consumption in young people Methods The overall methodology of the project relies on a multidisciplinary approach with a consortium of French experts in public health (health promotion and epidemiology), education science, information and communication technologies, medical informatics, adolescent medicine, adolescent addictology, social sciences, ethics and law. The project will be led in 3 parts: 1) Development of the intervention - using the Integrate, Design, Assess, and Share (IDEAS) framework. Using qualitative methods (individual interview, focus groups), multidisciplinary team brainstorming, works meeting and quantitative assessment of SCOTT quality; the investigators will (a) empathize with target users, (b) specify target behavior, (c) ground in behavioral theory, (d) ideate implementation strategies, (e) prototype potential products, (f) gather user feedback, (g) build a minimum viable product, 2) Pilot study : (h) SCOTT will be deploying on a small scale to assess its usability; 3) Development of the large-scale evaluation protocol - following the recommendations of the Medical Research Council concerning the evaluation of complex interventions. The investigators will (i) develop, based on the results of the pilot test, the SCOTT process evaluation methodology, (j) develop the SCOTT impact / effectiveness evaluation methodology.
Expected public health impact Risk behaviors that appear in adolescence explain 17% of the total burden of disease -mainly non-communicable diseases. With SCOTT young people will gain greater control of their state of health and well-being through proactive, participatory and informative aspects of our project. Empowerment and acquisition of resilience skills will minimise the risk factors of risk behaviors, especially smoking.
Perspectives 1. To deploy and evaluate at the national level SCOTT's effectiveness in reducing experimentation and regular tobacco use among college students 2. To use data for public health research on adolescents' health and well-being in order to strengthen research towards e-health and m-health evidence using data collected from the platform and by the implementation of surveys and interventional studies.
- Conditions
- Tabagism
- Being tested
- Behavioral
- Keywords
- Primary prevention, Adolescents, Internet, Empowerment, Community participation
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
The intervention group will benefit from discussion sessions on tobacco within the virtual world, with a group of pairs and 2 facilitators (public health researchers).
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | The intervention group will benefit from discussion sessions on tobacco within the virtual world, with a group of pairs and 2 facilitators (public health researchers). Receives: Behavioral: Behavioral |
| Control Arm | No intervention | The control group will be offered sources of conventional health information (government and institutional websites) on a terminal located in the virtual world. |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking behaviors perception
questionnaires build on the validated questionnaire of P2P trial (F. Coussin Gélie, BMC Public Health, 2018) derived from elements of Theory of Planned Behavior related to tabagism
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Oct 2020
- Primary completion22 Oct 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TabagismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Alberti, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888208
- Sponsor's protocol ID
- APHP-INSERM
- Acronym
- SCOTT
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin P, Chapoton B, Bourmaud A, Dumas A, Kivits J, Eyraud C, Dubois C, Alberti C, Le Roux E. Health Promotion in Popular Web-Based Community Games Among Young People: Proposals, Recommendations, and Applications. JMIR Serious Games. 2023 Jun 9;11:e39465. doi: 10.2196/39465.
PubMed 37294609
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Set up a Community Online in a Virtual Community Game for Tobacco Prevention in Teenagers
- ClinicalTrials.gov ID
- NCT04888208
- Acronym / sponsor ID
- SCOTT / APHP-INSERM
- Conditions
- Tabagism
- Keywords
- Primary prevention, Adolescents, Internet, Empowerment, Community participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 17 May 2021 (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.
The main objective of the SCOTT project is to reduce tobacco experimentation of teenagers through an online intervention based on social networking and empowerment of users.
Specific objectives of this emerging project are : 1. To develop or identify an online community dedicated to teenagers where the investigators will develop anti-smoking skills and norms. It will be based on social cognitive theory and will combine multiple functionalities based on the current practices and preferences of adolescents on internet and mobile; ensuring user safety, regulatory and ethical issues ; 2. To analyse the adoption, acceptance and the usability of SCOTT among users in a limited scale 3.To develop SCOTT process and impact assessment methodology.
Research hypothesis Providing access to prevention in an online community will: 1) Strengthen anti-smoking skills 2) Enhance the empowerment of users 3) Allow the implementation of health interventions 4) Improve indicators of tobacco consumption in young people Methods The overall methodology of the project relies on a multidisciplinary approach with a consortium of French experts in public health (health promotion and epidemiology), education science, information and communication technologies, medical informatics, adolescent medicine, adolescent addictology, social sciences, ethics and law. The project will be led in 3 parts: 1) Development of the intervention - using the Integrate, Design, Assess, and Share (IDEAS) framework. Using qualitative methods (individual interview, focus groups), multidisciplinary team brainstorming, works meeting and quantitative assessment of SCOTT quality; the investigators will (a) empathize with target users, (b) specify target behavior, (c) ground in behavioral theory, (d) ideate implementation strategies, (e) prototype potential products, (f) gather user feedback, (g) build a minimum viable product, 2) Pilot study : (h) SCOTT will be deploying on a small scale to assess its usability; 3) Development of the large-scale evaluation protocol - following the recommendations of the Medical Research Council concerning the evaluation of complex interventions. The investigators will (i) develop, based on the results of the pilot test, the SCOTT process evaluation methodology, (j) develop the SCOTT impact / effectiveness evaluation methodology.
Detailed description
Scientific context The SCOTT project stems from the "m-Health" Initiative launched in 2012 by the WHO and the International Telecommunication Union for the fight against non-communicable diseases (NCDs). The project is based on: 1) In 2014, in France, a third of high school students of all ages said they had already had the opportunity to smoke a cigarette. Smoking cigarettes is multiplied by 5 during the high school years, with one student in two who has already smoked at least once a cigarette in the last year. 2) In France the rate of computer equipment is 97% in the 12-17 and 81% have smartphones. Teenagers of 11-14 are 67% to have a social network account that they used mainly to watch videos, chat with friends and family and publish and share 3) Essential elements of risk-taking prevention programs for adolescents have been identified: using social behavior theories; using interactive skill-building methods, focusing on the social influences that encourage behavior, including peers and the media; offering multiple-component interventions; including a strong peer education or support component.
Objectives The main objective of the SCOTT project is to reduce tobacco experimentation of teenagers through an online intervention based on social networking and empowerment of users.
Specific objectives of this emerging project are : 1. To develop or identify an online community dedicated to teenagers where the investogators will develop anti-smoking skills and norms. It will be based on social cognitive theory and will combine multiple functionalities based on the current practices and preferences of adolescents on internet and mobile; ensuring user safety, regulatory and ethical issues ; 2. To analyse the adoption, acceptance and the usability of SCOTT among users in a limited scale 3.To develop SCOTT process and impact assessment methodology.
Research hypothesis Providing access to prevention in an online community will: 1) Strengthen anti-smoking skills 2) Enhance the empowerment of users 3) Allow the implementation of health interventions 4) Improve indicators of tobacco consumption in young people Methods The overall methodology of the project relies on a multidisciplinary approach with a consortium of French experts in public health (health promotion and epidemiology), education science, information and communication technologies, medical informatics, adolescent medicine, adolescent addictology, social sciences, ethics and law. The project will be led in 3 parts: 1) Development of the intervention - using the Integrate, Design, Assess, and Share (IDEAS) framework. Using qualitative methods (individual interview, focus groups), multidisciplinary team brainstorming, works meeting and quantitative assessment of SCOTT quality; the investigators will (a) empathize with target users, (b) specify target behavior, (c) ground in behavioral theory, (d) ideate implementation strategies, (e) prototype potential products, (f) gather user feedback, (g) build a minimum viable product, 2) Pilot study : (h) SCOTT will be deploying on a small scale to assess its usability; 3) Development of the large-scale evaluation protocol - following the recommendations of the Medical Research Council concerning the evaluation of complex interventions. The investigators will (i) develop, based on the results of the pilot test, the SCOTT process evaluation methodology, (j) develop the SCOTT impact / effectiveness evaluation methodology.
Expected public health impact Risk behaviors that appear in adolescence explain 17% of the total burden of disease -mainly non-communicable diseases. With SCOTT young people will gain greater control of their state of health and well-being through proactive, participatory and informative aspects of our project. Empowerment and acquisition of resilience skills will minimise the risk factors of risk behaviors, especially smoking.
Perspectives 1. To deploy and evaluate at the national level SCOTT's effectiveness in reducing experimentation and regular tobacco use among college students 2. To use data for public health research on adolescents' health and well-being in order to strengthen research towards e-health and m-health evidence using data collected from the platform and by the implementation of surveys and interventional studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: BehavioralThe intervention group will benefit from discussion sessions on tobacco within the virtual world, with a group of pairs and 2 facilitators (public health researchers). |
| Control Arm | No intervention | –The control group will be offered sources of conventional health information (government and institutional websites) on a terminal located in the virtual world. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Players of the French-speaking HABBO community;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BehavioralThe intervention group will benefit from discussion sessions on tobacco within the virtual world, with a group of pairs and 2 facilitators (public health researchers). | Behavioural | Behavioral |
Primary outcome
smoking behaviors perception
Time frame: 4 weeks
questionnaires build on the validated questionnaire of P2P trial (F. Coussin Gélie, BMC Public Health, 2018) derived from elements of Theory of Planned Behavior related to tabagism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 37294609Martin P, Chapoton B, Bourmaud A, Dumas A, Kivits J, Eyraud C, Dubois C, Alberti C, Le Roux E. Health Promotion in Popular Web-Based Community Games Among Young People: Proposals, Recommendations, and Applications. JMIR Serious Games. 2023 Jun 9;11:e39465. doi: 10.2196/39465.
- 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.
Corinne Alberti, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Tabagism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoking behaviors perception (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888208, which also lists 1 linked publication.
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 17 May 2021.