Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04888208 |
| Other study ID # |
APHP-INSERM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
November 15, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
