Condition category
Mental and Behavioural Disorders
Date applied
26/11/2008
Date assigned
08/01/2009
Last edited
08/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sll.se/

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

Publication citations

Additional files

Editorial Notes