NCT04888208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

April 1, 2021

Enrollment Period

21 days

First QC Date

April 29, 2021

Last Update Submit

May 14, 2021

Conditions

Keywords

Primary preventionAdolescentsInternetEmpowermentCommunity participation

Outcome Measures

Primary Outcomes (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

    4 weeks

Study Arms (2)

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).

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.

Interventions

BehavioralBEHAVIORAL

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).

Behavioral

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Players of the French-speaking HABBO community;
  • Informed and consentent to the study;
  • Agreeing to complete the baseline study questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Corinne Alberti, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 17, 2021

Study Start

October 1, 2020

Primary Completion

October 22, 2020

Study Completion

November 15, 2020

Last Updated

May 17, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations