Evaluation of school-based counselling for tobacco use prevention and cessation among adolescents

ISRCTN	ISRCTN45129574
DOI	https://doi.org/10.1186/ISRCTN45129574
Secondary identifying numbers	N/A

Submission date: 26/11/2008
Registration date: 08/01/2009
Last edited: 08/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Maria Rosaria Galanti
Scientific

Department of Public Health Sciences
Karolinska Institutet
Stockholm
17176
Sweden

Phone	+46 (0)8 524 801 11
Email	rosaria.galanti@ki.se

Study information

Study design	Cluster randomised controlled trial, with schools as units of randomisation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)
Scientific title	Cluster randomised controlled trial of tobacco prevention and cessation among students in junior high grades
Study acronym	SOTIS
Study objectives	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(s)	Regional Ethical Board in Stockholm gave approval on the 3rd September 2008 (ref: 2008/1081-31/5)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2008
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	13 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	3200 (intervention and control arm together)
Key inclusion criteria	All students (aged 13 - 15 years, either sex) in junior high grades in the randomised school
Key exclusion criteria	Refusal to participate
Date of first enrolment	01/09/2008
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Public Health Sciences

Stockholm
17176
Sweden

Sponsor information

Stockholm County Council (Sweden)
Government

Health Care Board (Hälso- och Sjukvårdsnämnden)
Box 6909
Stockholm
102 39
Sweden

Email	cecilia.lindvall@sll.se
Website	http://www.sll.se/
"ROR"	https://ror.org/02zrae794

Funders

Funder type

Government

Stockholm County Council (Sweden) - Public Health Grant (ref: HSN 0802-0318)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan