Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools

ISRCTN	ISRCTN26354360
DOI	https://doi.org/10.1186/ISRCTN26354360
Secondary identifying numbers	N/A

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 10/11/2022

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Aveyard
Scientific

Department of Public Health and Epidemiology
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Email	P.N.Aveyard@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and behavioural disorders: Addiction
Intervention	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.
Intervention type	Other
Primary outcome measure	Prevalence of teenage smoking and proportion of positive stage movements 12 months after the start of the intervention.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/1997
Completion date	31/03/2000

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target number of participants	8352
Key inclusion criteria	52 schools in the West Midlands region.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/1997
Date of final enrolment	31/03/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Public Health and Epidemiology

Birmingham
B15 2TT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive West Midlands (UK)

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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article		09/10/1999	Yes	No
Results article	2 year follow up	01/10/2001	Yes	No
Other publications	Can the stages of change for smoking acquisition be measured reliably in adolescents?	01/10/2002	Yes	No
Other publications	The risk of smoking in relation to engagement with a school-based smoking intervention	01/02/2003	Yes	No

Editorial Notes

10/11/2022: Internal review.