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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

France1 site
  • Robert Debré Hospital

    Paris, 75019

Other trials in France

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 groups in NCT04888208
Study groupRoleWhat they receive
BehavioralExperimentalThe 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 ArmNo interventionThe 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.

  1. 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.

  1. First posted17 May 2021
  2. Study start1 Oct 2020
  3. Primary completion22 Oct 2020
  4. Study completion15 Nov 2020

Resources

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)
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

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.

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