Evaluation of school-based counselling for tobacco use prevention and cessation among adolescents
| ISRCTN | ISRCTN45129574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45129574 |
| Protocol serial number | N/A |
| Sponsor | Stockholm County Council (Sweden) |
| Funder | Stockholm County Council (Sweden) - Public Health Grant (ref: HSN 0802-0318) |
- 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
Scientific
Department of Public Health Sciences
Karolinska Institutet
Stockholm
17176
Sweden
| Phone | +46 (0)8 524 801 11 |
|---|---|
| rosaria.galanti@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial, with schools as units of randomisation |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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(s) |
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). |
| Key secondary outcome measure(s) |
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). |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 3200 |
| 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
17176
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
