Smoking Cessation Program Among Adolescents in Vocational Training Centers (TABADO)
Recruitment status was: Recruiting
Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.
Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.
The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of a Smoking Cessation Program Among ADOlescents in Vocational Training Centers|
- The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Overall prevalence of tobacco use in the institutions concerned at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Students' motivation to quit smoking (motivational score) and frequency of attempts to quit within the 12 months after the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Rate of withdrawal from the program among the volunteers after 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: "Intervention" group
The "intervention" group benefits from the TABADO program
Behavioral: TABADO program
The intervention takes place in 3 stages: (i) a general information session on tobacco consumption is delivered to all teenagers, both smokers and nonsmokers. (ii) For smokers wishing to join the program, this session is followed by individualized consultations with a team of tobacco addiction physicians. (iii) The volunteers then benefit from a small group approach, consisting of discussion sessions to share experiences, strengthen motivation, and prevent relapse. There will be 4 sessions in total, comprising individual counseling and work in groups spread over 3 months (taking into account the availability of the trainees because of their alternate-week training schedule).
No Intervention: "Control" group
The "control" group not benefit from any specific intervention other than the treatment and education usually available
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973570
|Nancy, Lorraine, France, 54000|
|Principal Investigator:||François ALLA, MD/ PhD||Institut National de la Santé Et de la Recherche Médicale, France|