F17.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Schools in the Berlin districts of Neukölln, Mitte, Reinickendorf, Lichtenberg, Friedrichshain-Kreuzberg and Spandau will be included in the study. The eligible schools included elementary school and comprehensive schools with grades 5 and 6. Grade 5 classes will be eligible to be enrolled (thus, age of individual students may vary). Schools with mixed-grade classes (i.e., classes that are usually being taught in age-mixed groups) will be included in the study provided that new class groups will be formed for the teaching of the prevention program (only 5th and 6th graders). In order to include individual students from a participating school class in the study, informed written consent for data collection will be required from both the students and their parents.
Exclusion criteria
Exclusion criteria: Schools are required to provide written consent not to engage other external providers for smoking prevention among the target group of 5th graders. If schools should refuse to consent to it, they must at least agree to notify the study team of any external providers involved in smoking prevention work with the classes. Schools that are unwilling to agree to either of those conditions (abstain or notify) will not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome for this study is the difference in students’ intention to be vape- and smoke-free (i.e., to abstain from using any vaping or tobacco product) between intervention and control groups (primary endpoint measured at T4, 12 months post-intervention), measured by two items, each of them using a 5-Point-Likert-Scale, i. e.: “I want to be smoke-free (that is, not to smoke) for the next six months” (1 = strongly disagree, 5 = fully agree) (Ajzen, 2009). Before students are being surveyed, the instructors familiarize them with the survey-specific terminology (i.e., “smoking” or “being smoke-free” as umbrella terms for use of/abstinence from any tobacco or vaping product). Ajzen MF Icek. Predicting and changing behavior: The reasoned action approach. New York: Psychology Press; 2009. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: Susceptibility to vaping or smoking: Assessed based on items used in previous research (Pierce et. al, 1996; Choi et. al, 2001; Stroong et. al, 2015) and coded binarily (0 = Committed non-vapers and non-smokers, 1 = Susceptible to vape/smoke). Students will be asked to report their expected behavior in three scenarios, i.e.: “Do you think you will try smoking in the future?”, using a 4-Point-Likert scale (1 = definitely not, 4 = definitely). Students will be considered committed non-vapers and non-smokers (vs. susceptible to vaping/smoking) only if they report “definitely yes” on all questions. Vaping/smoking prevalence (Lifetime prevalence, 12-months prevalence, 30-day prevalence, binary coding) and Vaping/smoking frequency (30-day-frequency; current smoking, binarily defined as reporting any current consumption, including only occasional use during the last month; regular vaping/smoking, binarily defined as vaping or smoking more than once a week during the last month): Assessed using adjusted measures from the KiGGS (German Health Interview and Examination Survey for Children and Adolescents, Wave 1; Kuntz et. al, 2015; Lampert et. al, 2008); assessed separately for individual product categories (i.e., cigarettes, disposable e-cigarettes, reusable/refillable e-cigarettes, hookah, tobacco heater, cigars/ cigarillos, pipe); aggregated to calculate prevalence/frequencies across products for the main analysis. Pierce JP, Choi WS, Gilpin EA, Farkas AJ, Merritt RK. Validation of susceptibility as a predictor of which adolescents take up smoking in the United States. Health Psychology. 1996;15:355–61. Choi WS, Gilpin EA, Farkas AJ, Pierce JP. Determining the probability of future smoking among adolescents. Addiction. 2001;96:313–23. Strong DR, Hartman SJ, Nodora J, Messer K, James L, White M, et al. Predictive Validity of the Expanded Susceptibility to Smoke Index. Nicotine & Tobacco Research. 2015;17:862–9. Kuntz B, Lampert T | — |
Countries
Germany
Contacts
Geschlechterforschung in der Medizin, Charité - Universitätsmedizin Berlin