|
ISRCTN
|
ISRCTN26354360
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
To examine whether a year long programme incorporating three sessions using an expert system computer programme and three whole class lessons based on the transtheoretical model (TTM) of behaviour change could reduce the prevalence of teenage smoking.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Mental and behavioural disorders: Addiction
|
|
Participants - inclusion criteria
|
52 schools in the West Midlands region.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/09/1997
|
|
Anticipated end date
|
31/03/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
8352
|
|
Interventions
|
The intervention group received six sessions of two types: one computer session and one class lesson for each of the three terms of year 9 (autumn 1997 to summer 1998). For the computer session, the research team set up a classroom with about 30 computers and removed these at the end of the day. Whole classes came in turns and each student used a computer with headphones. The computer program was based on that developed by Prochaska and colleagues, containing questionnaires measuring the key concepts of the transtheoretical model. After each questionnaire students received feedback both through the headphones and on screen of how their temptations, for example, compared to stage based data collected by Pallonen et al (normative feedback) and in second and third sessions, what change had occurred since last time (ipsative feedback). The questionnaires were interspersed with video clips of young people talking about their thoughts about smoking that were relevant to the stage of change of the student concerned. The other transtheoretical model intervention was a one hour lesson delivered by ordinary class teachers. The teachers attended a two day training course organised by Public Management Associates, who had developed licensed training and lesson plans in consultation with Prochaska and colleagues. The three lessons developed the young people's understanding of the stages of change and how the pros and cons of smoking would vary in different stages, and the lessons got young people to use these concepts. More details of how we delivered the intervention are available.
Our aim for students in the control group was that they would be exposed to no intervention other than the normal health education on tobacco, which is part of the English national curriculum. However, as a reward for participation, teachers in control group schools were given three lesson plans and handouts on smoking. These lessons consisted of quizzes on facts about tobacco and one lesson on different ways of persuading someone to stop smoking. The content of the lessons was all taken from generally available teaching support material. The lesson plans and materials were provided to all control group schools, but teachers in these schools received no training in smoking issues or delivery of the lessons and it was up to the individual schools whether or not they used the materials.
|
|
Primary outcome measure(s)
|
Prevalence of teenage smoking and proportion of positive stage movements 12 months after the start of the intervention.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
NHS Executive West Midlands (UK)
|
|
Trial website
|
|
|
Publications
|
Results:
1. http://www.ncbi.nlm.nih.gov/pubmed/12560019
2. http://www.ncbi.nlm.nih.gov/pubmed/12453720
3. http://www.ncbi.nlm.nih.gov/pubmed/11570836
4. http://www.ncbi.nlm.nih.gov/pubmed/10514156
|
|
Contact name
|
Dr
Paul
Aveyard
|
|
Address
|
Department of Public Health and Epidemiology
University of Birmingham
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B15 2TT
|
|
Country
|
United Kingdom
|
|
Email
|
P.N.Aveyard@bham.ac.uk
|
|
Sponsor
|
NHS R&D Regional Programme Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
23/01/2004
|
|
Last edited
|
22/02/2008
|
|
Date ISRCTN assigned
|
23/01/2004
|
