Contact information
Type
Scientific
Primary contact
Dr Maria Rosaria Galanti
ORCID ID
Contact details
Department of Public Health Sciences
Karolinska Institutet
Stockholm
17176
Sweden
+46 (0)8 524 801 11
rosaria.galanti@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Cluster randomised controlled trial of tobacco prevention and cessation among students in junior high grades
Acronym
SOTIS
Study hypothesis
To evaluate whether structured counselling conducted by school nurses, based on motivational interview and tailored on stage of tobacco use, achieves higher rates of tobacco abstainers than usual counselling, both among the youths undergoing the intervention and at the school level as a whole.
Ethics approval
Regional Ethical Board in Stockholm gave approval on the 3rd September 2008 (ref: 2008/1081-31/5)
Study design
Cluster randomised controlled trial, with schools as units of randomisation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)
Condition
Tobacco use and dependence
Intervention
Structured individual counselling based on motivational interview and stage of tobacco use (1 - 5 sessions) versus usual nurse-administered counselling (one session, unstructured).
The opening counselling is scheduled to be approximately 5 minutes, depending on the average between the time needed for a non-user of tobacco and that needed for a user. The following counselling occasions (1 - 4) are scheduled only for users, and determined to last an average of 15 minutes. The intervention is tailored on stage of use, therefore the total duration is not equal for all subjects. The follow-up will also vary, depending on time of recruitment (November 2008 - May 2009). All tobacco users undergoing intervention will be surveyed for tobacco use in May 2009.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Prevalence of abstainers from tobacco among students receiving the counselling, assessed by personal interview by the school nurses at each counselling occasion and at the end of follow-up (May 2009). Data will be registered on a paper data form (SOTIK4).
Secondary outcome measures
Prevalence of abstainers from tobacco in the whole students population, assessed during a survey employing a structured questionnaire (SOTIK3), administered to all students in a random sample of classes in each school, before the intervention start (October 2008) and at the end of the school year (May 2009).
Overall trial start date
01/09/2008
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All students (aged 13 - 15 years, either sex) in junior high grades in the randomised school
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
3200 (intervention and control arm together)
Participant exclusion criteria
Refusal to participate
Recruitment start date
01/09/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Public Health Sciences
Stockholm
17176
Sweden
Sponsor information
Organisation
Stockholm County Council (Sweden)
Sponsor details
Health Care Board (Hälso- och Sjukvårdsnämnden)
Box 6909
Stockholm
102 39
Sweden
cecilia.lindvall@sll.se
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Sweden) - Public Health Grant (ref: HSN 0802-0318)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary