Plain English Summary
Background and study aims
In Denmark, as well as in most Westernized countries, smoking is now more prevalent among adolescents from lower socioeconomic positions (SEP). Only eight percent of 15-year old Danish adolescents from higher social classes smoke daily or sometimes, whereas up to 37% of adolescents whose parents live from welfare benefits are smokers. Furthermore, adolescents from low SEP seem less likely to quit smoking in adulthood. Programmes addressing health and health behaviour in childhood or adolescence have the potential to prevent or decrease socioeconomic inequalities in health behaviours later in life, and public health interventions to reduce risk behaviours e.g. smoking, should aim at being equally effective across socioeconomic groups, or at being especially effective among individuals from low socioeconomic position. In order to develop effective interventions which work across social groups, it is important to study the social patterning of the effect of intervention methods. The X:IT I study was a school- based study to prevent smoking among 13- to 15-year old students targeting all students. The X:IT I study was the first large-scale Danish smoking intervention to be effective in reducing uptake of smoking in adolescents in Denmark. The qualitative process evaluation found that the X:IT I study did not reach students and parents from low social classes. Therefore, all X:IT I materials have been revised and specifically directed at adolescents and parents from lower social classes and at those who might have academic challenges. The aims of this study include: investigate the social patterning of the implementation and effects of the X:IT I study, based on the knowledge acquired from the X:IT I study, develop and implement a smoking intervention especially focusing on adolescents and parents from low socioeconomic background, the X:IT II study and to conduct scientific process and effect evaluations of X:IT II including studies of social differences in the implementation and effects.
Who can participate?
Students in grade seven, eight, and nine (aged 13 years to 15 years).
What does the study involve?
All schools receive the same programme. X:IT II include three main intervention components: smoke-free school grounds, parental involvement comprising two dimensions including smoke-free contract between the pupil and an adult person, preferably a parent and smoke-free dialogues, and finally a smoke-free curriculum based on self-efficacy training and outcome expectancies. Students from high and low social classes are compared in a difference-in-difference design.
What are the possible benefits and risks of participating?
Participants may benefit from the benefits of not smoking with prevention of the well-known risks of smoking. There are no direct risks of participating, although some indirect risks can be mentioned such as being marginalized if you are a smoker and the psychosocial consequences of this.
Where is the study run from?
This study is being run by the National Institute of Public Health University of Southern Denmark (Denmark) and takes place in schools in Denmark.
When is the study starting and how long is it expected to run for?
January 2017 to July 2020
Who is funding the study?
The Danish Cancer Society (Denmark)
Who is the main contact?
Mrs Anette Andersen
anan@niph.dk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Anette Andersen
ORCID ID
Contact details
University of Southern Denmark
National Institute of Public Health
Øster Farimagsgade 5A
Copenhagen
1353
Denmark
+45 65507879
anan@niph.dk
Type
Scientific
Additional contact
Mrs Lotus Sofie Bast
ORCID ID
Contact details
University of Southern Denmark
National Institute of Public Health
Øster Farimagsgade 5A
Copenhagen
1353
Denmark
+45 65507809
loni@niph.dk
Type
Scientific
Additional contact
Prof Pernille Due
ORCID ID
Contact details
University of Southern Denmark
National Institute of Public Health
Øster Farimagsgade 5A
Copenhagen
1353
Denmark
+45 65507880
pdu@niph.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
71199
Study information
Scientific title
The X:IT II Study - A Smoking Intervention aimed at adolescents from low social class background
Acronym
X:IT II
Study hypothesis
Hypotheses:
1. The X:IT intervention material, carefully developed to take into account the intellectual skills and academic performance of adolescents’ and their parents’, will improve the reach of the intervention among low SEP
2. The X:IT study will have an overall effect of a 25% reduction in smoking uptake at age 13
3. The X:IT study will reduce smoking uptake among low SEP adolescents to the same extent or more than among adolescents with a high SEP background
Ethics approval
There is no formal institution for ethical assessment and approval of questionnaire-based population studies in Denmark. When inviting the schools to participate, headteachers received written information about the study. Students and their parents were informed about the study. They were informed that participation was voluntary, that their information would be used for research purposes only and treated confidentially. The study is registered at the Danish Data Protection Agency, ref: 17/53093.
Study design
School-based intervention study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Condition
Smoking prevention
Intervention
The X:IT intervention includes three main components:
1. Completely smoke-free school grounds for both students and teachers during school hours and other school-related events. Law on Smoke-free institutions was given in Denmark in 2012. The literature showed that higher levels of perceived enforcement of anti-smoking policy at the school level were inversely associated with the prevalence of past-30-day smoking behaviors among students. Therefore, the intervention also includes enforcement of this law.
2. Parents are to be involved in two ways – by signing a smoke-free contracts between the student and an adult person, preferably a parent, each year for all three intervention years (in grad 7, 8, and 9), and by conducting smoke-free dialogues with the child. By signing a smoke-free contract the adolescent promises to stay smoke free for the next year. Signing the contract is a manifestation of an active choice of non-smoking. One of the parents or another adult co-signs the contract. With the contract, the signatory promises to conduct a smoke-free dialogue with the adolescent and to support the adolescent’s choice of staying smoke-free. Having a smoke-free dialogue involves that the parent clearly takes exception to adolescent smoking, asks the child about thoughts about and experiences with tobacco. This kind of constructive communication has shown to be effective. The adolescents are motivated to make a personal choice, and engaging the parents communicates a clear opposition to adolescent smoking. Students remaining smoke-free for one year are able to win a prize.
3. A smoke-free curriculum based on self-efficacy training and outcome expectancies is supposed to take place at school for at least 8 hours each year for three years. The literature showed that information-giving curriculum incorporated in multi-modal programs seem to be successful. Programs based on social influence approaches, including aspects like:
3.1. Correcting adolescents’ perceptive overestimation of the smoking prevalence
3.2. Recognizing high-risk situations
3.3. Increasing awareness of media, peer, and family influences
3.4. teaching and practicing refusal skills
5.3. Making public commitments not to smoke more effective.
The teaching program for the X:IT intervention was developed based on the above awareness. The actual educational material, “Gå op i røg” (Up in Smoke), was developed in conjunction with scholars who had educational experience. The teachers can choose methods of teaching as well as supplementary exercises and materials. The material targets students, 13 to 15 years of age. It is designed to be used in diverse subjects such as science, humanities and social science. Goals in the National Executive Order of Education can be fulfilled by using the material.
Smoke-free contracts are provided to the students at school to bring home for signing with a parent. Copies can be downloaded here: www.xit-web.dk. A webpage designed for the parents with inspiration for these talks are available. The webpage has four entrances, one with general information, one for parents who smoke themselves, one for parents with smoking children, and one for parents and children who wants to learn more about smoking: http://www.snakomtobak.dk/
All materials for teaching, including detailed information for teachers, are available online : www.xit-web.dk
Smoke-free school grounds: enforcement must be discussed at the school board.
Smoke-free curriculum: a school coordinator must keep track of what and how much each school-class has been taught. The individual teachers in the diverse subjects must deliver the actual teaching.
A one-day work-shop to initiate the intervention is held for head-teachers, school coordinators, and teachers.
The teaching is provided during school hours either as 2-hour sessions or as workshop days.The intervention takes place at local public or private schools in Denmark. Smoke-free contracts will be signed once a year for three years (year 7, 8, and 9). The smoke-free curriculum has to take place for at least 8 hours each year for three years (year 7, 8, and 9)
The intervention is for all students and parents. As smoking is more prevalent in low social class, the educational material and parent information is developed and designed to secure that all groups will be reached.
Implementation fidelity will be assessed by four domains: adherence, dose, quality of delivery, and participant responsiveness according to the theory by Dusenbury et al (2003). Questionnaire data obtained from students and teachers will be used.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Frequency of smokers at grade seven, eight and nine measured at baseline, 1,2 and 3 follow-up by student self-reported questionnaires
1.2. Frequency of smoking will be analyzed at individual, class and school level, and stratified by gender and socioeconomic level
2. Degree of implementation after first, second, and third year of intervention by student self-reported questionnaires and project coordinator questionnaires
Secondary outcome measures
Intermediate outcomes of the intervention:
1. Individual outcomes:
1.1. Enhanced self-efficacy for smoking
1.2. Increased knowledge about smoking
1.3. Change in norms and attitudes towards smoking
1.4. Performed smoke-free dialogue with parents
2. Group level outcomes
2.1. Increased probability of smoke-free environments at home and at schools
2.2. Changed norms and attitudes against smoking at schools
2.3. Reduced availability of tobacco
2.4. Increased probability of not being exposed to smoking students, teachers and parents
Analyses in the project will have a special focus on subgroup analyses especially gender and socioeconomic position.
3. Sustainability
3.1. At second follow-up it will be measured whether participation in Project X:IT has initiated environmental changes and capacity building by questionnaires to project coordinators at schools and in municipalities. Furthermore, we will measure whether the project continues at intervention schools and is initiated at control schools.
4. Differences in frequency of drunkenness and marijuana use between intervention and control schools
5. Differences in students’ wellbeing between intervention and control schools
Overall trial start date
01/01/2017
Overall trial end date
01/07/2020
Reason abandoned
Eligibility
Participant inclusion criteria
All students at participating schools enrolled in grade 7 (age 13 years to 15 years).
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
60 clusters (schools), around 50 students grade 7 in each school
Participant exclusion criteria
Schools for children with special needs.
Recruitment start date
01/03/2017
Recruitment end date
01/09/2017
Locations
Countries of recruitment
Denmark
Trial participating centre
National Institute of Public Health, University of Southern Denmark
Øster Farimagsgade 5A
Copenhagen
1353
Denmark
Sponsor information
Organisation
University of Southern Denmark
Sponsor details
National Institute of Public Health
Øster Farimagsgade 5A
Copenhagen
1353
Denmark
+45 65507777
sif@si-folkesundhed.dk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Danish Cancer Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The following publications are planned in a high-impact peer reviewed journals:
June 2018: Design paper X:IT II
December 2018: Paper on process evaluation
June 2019: Paper on differential effects after year 1
June 2019: Paper on differential implementation after year 1
December 2019: Paper on school differences in implementation
December 2020: Paper on differential effects after year 3
December 2020: Paper on differential implementation after year 3
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary