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Trial protocol and preliminary results for a cluster randomised trial of behavioural support versus brief advice for smoking cessation in adolescents

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Markham, Wolfgang A., Bridle, Christopher, Grimshaw, G. M., Stanton, Alan and Aveyard, Paul. (2010) Trial protocol and preliminary results for a cluster randomised trial of behavioural support versus brief advice for smoking cessation in adolescents. BMC Research Notes, Vol.3 (No.336). ISSN 1756-0500

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Official URL: http://dx.doi.org/10.1186/1756-0500-3-336

Abstract

Background: Many young people report they want to stop smoking and have tried to do so, but most of their
quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates.
However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit.
Findings: A cluster randomised trial for young people trying to stop smoking to compare the efficacy of a schoolbased
9 week intensive group behavioural support course versus a school-based 7 week brief advice only course.
Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT) was used if it
was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred
participants from approximately ten schools.
The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard.
Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit
attempts and 1) psychological assessments of dependence prior to quitting 2) salivary cotinine concentration prior
to quitting and 3) sociodemographic characteristics would also have been assessed. The proportion of participants
who stopped smoking in each arm of the trial were compared using Chi square tests.
The trial was stopped shortly after it had started because funding to support the therapists running the stop
smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed
(two group support courses and one brief advice pharmacotherapy course). Seventeen participants in total entered
the trial. At the end of the courses, one participant (10%) attending the group support programme had stopped
smoking and no participant attending the brief advice programme had stopped smoking.
Discussion: The trial was stopped so we were unable to determine whether group support helped more young
people to stop smoking than brief advice. Engagement and recruitment of participants proved much more difficult
than had been anticipated. Fifteen of the seventeen participants reported that quitting smoking was either pretty
important or very important to them. Thus, the stop smoking success rate could, nevertheless, be considered
disappointing.
Trial registration: Current Controlled Trials ISRCTN25181936

Item Type:

Journal Article

Subjects:

H Social Sciences > HV Social pathology. Social and public welfare

Divisions:

Faculty of Social Sciences > School of Health and Social Studies
Faculty of Medicine > Warwick Medical School

Library of Congress Subject Headings (LCSH):

Smoking cessation -- Great Britain, Preventive health services for children -- Great Britain, Group counseling for children -- Great Britain

Journal or Publication Title:

BMC Research Notes

Publisher:

BioMed Central Ltd.

ISSN:

1756-0500

Official Date:

14 December 2010

Dates:

Date	Event
14 December 2010	Published

Volume:

Vol.3

Number:

No.336

Identification Number:

10.1186/1756-0500-3-336

Status:

Peer Reviewed

Access rights to Published version:

Open Access

Funder:

Cancer Research UK (CRUK)

References:

1. Hajek P: Withdrawal-oriented therapy for smokers. Brit J Addiction 1989,
84:591-598.
2. Bandura A: Social foundations of thought and action: a social cognitive
theory. New York: Prentice Hall; 1976.
3. Becher H: Smoking prevalence and cigarette consumption. In Smoking,
drinking, and drug use among young people in England in 2000. Edited by:
Boreham R, Shaw A. London: The Stationary Office; 2001:21-32.
4. National Centre for Social Research/National Foundation for Educational
Research: Drug use, smoking and drinking among young people in
England in 2003: Headline figures. 2004 [http://www.dh.gov.uk/assetRoot/
04/07/96/61/04079661.pdf].
5. Foulds J: Smoking cessation in young people. Should we do more to help
young smokers to quit? London: Health Development Agency; 2000.
6. Grimshaw G, Stanton A: Tobacco cessation interventions for young
people. Cochrane Database Syst Rev 2010, CD003289.
7. National Institute for Health and Clinical Excellence: Guidance on smoking
cessation..
8. Michie S, Abraham C: Identifying techniques that promote health
behaviour change: evidence based or evidence inspired? Psychol Health
2004, 19:29-49.
9. Michie S, Jochelson K, Markham WA, Bridle C: Low income groups and
behaviour change Interventions: A review of intervention content,
effectiveness and theoretical frameworks. Journal of Epidemiol Commun H
2009, 63:610-622.
10. DiFranza JR, Rigotti NA, McNeill AD, Ockene JK, Savageau JA, St Cyr D,
Coleman M: Initial symptoms of nicotine dependence in adolescents. Tob
Control 2000, 9:313-319.
11. O’Loughlin J, Tarasuk J, Difranza J, Paradis G: Reliability of selected
measures of nicotine dependence among adolescents. Ann Epidemiol
2002, 12:353-362.
12. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO: The Fagerstrom
Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance
Questionnaire. Brit J Addiction 1991, 86:1119-1127.
13. West R, Hajek P: Evaluation of the mood and physical symptoms scale
(MPSS) to assess cigarette withdrawal. Psychopharmacology 2004,
177:195-199.
14. West R, Hajek P, Stead L, Stapleton J: Outcome criteria in smoking
cessation trials: proposal for a common standard. Addiction 2005,
100:299-303.
15. NHS Stop Smoking Services: Service and monitoring guidance. 2007, 1-26
[http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/
PublicationsPolicyAndGuidance/DH079644].
16. Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE:
Measures and abstinence in clinical trials: issues and recommendations.
NicotineTob Res 2003, 5:13-25.
17. Stead LF, Lancaster T: Group behaviour therapy programmes for smoking
cessation. Cochrane Database Syst Rev 2000, CD001007.
18. Amos A, Wiltshire S, Haw S, McNeill A: Ambivalence and uncertainty:
experiences of and attitudes towards addiction and smoking cessation
in the mid-to-late teens. Health Educ Res 2006, 21:181-191, 19.
19. Grimshaw G, Stanton A, Blackburn C, Andrews K, Grimshaw C,
Vinogradova Y, Robertson W: Patterns of smoking, quit attempts and
services for a cohort of 15 to 19 year olds. Child Care Hlth Dev 2003,
29:457-464.
20. McNeill A, Amos A: The challenges of getting youth cessation services
right. Addiction 2007, 102:1023-1024.
21. Molyneux A, Lewis S, Coleman T, McNeill A, Godfrey C, Madeley R, Britton J:
Designing smoking cessation services for school-age smokers: a survey
and qualitative study. Nicotine Tob Res 2006, 8:539-546.
22. Roddy E, Romilly N, Challenger A, Lewis S, Britton J: Use of nicotine
replacement therapy in socioeconomically deprived young smokers: a
community-based pilot randomised controlled trial. Tob Control 2006,
15:373-376.
23. Gnich W, Sheehy C, Amos A, Bitel M, Platt S: A Scotland-wide pilot
programme of smoking cessation services for young people: process
and outcome evaluation. Addiction 2008, 103:1866-1874.
24. Hollis JF, Polen MR, Whitlock EP, Lichtenstein E, Mullooly JP, Velicer WF,
Redding CA: Teen reach: outcomes from a randomized, controlled trial
of a tobacco reduction program for teens seen in primary medical care.
Pediatrics 2005, 115:981-989.
25. Dino G, Horn K, Goldcamp J, Fernandes A, Kalsekar I, Massey C: A 2-year
efficacy study of Not On Tobacco in Florida: An overview of program
successes in changing teen smoking behavior. Prev Med 2001, 33:600-605.
26. Horn K, Dino G, Kalsekar I, Mody R: The impact of Not On Tobacco on
Teen Smoking Cessation: End-of-Program Evaluation Results, 1998 to
2003. J Adolescent Res 2005, 20:640-661.
27. Horn KA, Dino GA, Kalsekar ID, Fernandes AW: Appalachian teen smokers:
Not On Tobacco 15 months later. Am J Public Health 2004, 94:181-184.
28. Aveyard P, Cheng KK, Almond J, Sherratt E, Lancashire R, Lawrence T,
Griffin C, Evans O: Cluster randomised controlled trial of expert system
based on the transtheoretical ("stages of change”) model for smoking
prevention and cessation in schools. BMJ 1999, 319:948-953.
29. Markham WA, Aveyard P, Thomas H, Charlton A, Lopez ML, De Vries H:
What determines future smoking intentions of 12-13 year old UK African
Caribbean, Indian, Pakistani and white young people. Health Educ Res
2004, 19:15-28.
30. Markham WA, Lopez ML, Aveyard P, Herrero P, Bridle C, Comas A,
Charlton A, Thomas H: Mediated, moderated and direct effects of
country of residence, age, and gender on the cognitive and social
determinants of adolescent smoking in Spain and the UK: a crosssectional
study. BMC Public Health 2009, 9:173.