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ISRCTN
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ISRCTN27596806
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DOI
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10.1186/ISRCTN27596806
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Investigation of a Smoking Prevention intervention for Young People
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Scientific title
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Smoking prevention in young people: a cluster randomised controlled trial of implementation intentions
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Acronym
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SPYP
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Serial number at source
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N/A
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Study hypothesis
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1. Can repeated implementation intentions related to refusing offers of cigarettes reduce smoking initiation rates in 11-16 year olds relative to a control group of adolescents?
The research question will be addressed using a cluster randomised controlled trial. Participants will be randomised to either an intervention or control condition, and will be compared on objective and self reported smoking outcomes.
Objectively-assessed and self-reported smoking will be measured in data collection sessions at twelve month intervals over a four year time period (i.e., a total of 5 occasions from baseline to 4 years post-baseline). Objectively-assessed smoking at the final time point will be our primary outcome measure, while self-reported smoking will be our secondary outcome measure.
2. What is the cost effectiveness of such an intervention?
Careful recording of the time and costs involved in implementing the intervention will allow us to conduct a full-cost effectiveness (i.e., health economic) analysis.
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Lay summary
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Lay summary under review 2
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Ethics approval
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University of Leeds Research Ethics Committee, 20 September 2012, ref: 12-0155
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Study design
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Phase III cluster randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Smoking initiation
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Participants - inclusion criteria
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1. Year 7 female and male high school students (starting high school in October 2012) from the Leeds and Staffordshire area.
2. At baseline students will be aged between 11-12 years. At the end of the study participants will be aged between 15-16 years.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/10/2012
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Anticipated end date
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31/12/2016
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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4320
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Interventions
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There are two conditions: intervention and control. The research involves teachers delivering either an intervention OR control session every six months over a period of four years between the ages of 11-12 and 15-16 years (8 occasions).
Intervention - Smoking Prevention Condition
The intervention involves of asking adolescents to read simple anti-smoking messages and then forming an implementation intention by planning how, where, and when to resist smoking (i.e., refuse the offer of a cigarette).
The anti-smoking messages focus on simple to understand negative consequences of starting smoking and the positive consequences of remaining a never smoker. The implementation intervention is designed to give adolescents simple responses for how to refuse a cigarette. It is also designed to link this simple response to likely situations where a cigarette might be offered. Five options will be provided for how they could refuse the offer of a cigarette or resist the temptation to smoke (e.g., ‘No thanks, I don’t want to smoke; No thanks, I don’t want the habit; No cancer sticks for me; No thanks, smoking makes you smell bad; No, it’s bad for your health’). Participants are required to check the options they plan to use or to write in an additional response. Similarly participants will be required to check where they would not smoke (e.g., ‘I will not smoke at school; I will not smoke at home; I will not smoke at a party; I will not smoke with my friends; I will not smoke if offered a cigarette’) and when they would not smoke (e.g., ‘I think I can make sure I don’t smoke’) and to agree to their plan.
Control - Homework Condition
The design is similar to the intervention condition except the control condition involves asking adolescents to read simple pro-homework messages and then forming an implementation intention by planning how, where, and when to compete homework.
The pro-homework messages focus on simple techniques used to help students feel more positive about completing homework. The implementation intervention is designed to give adolescents simple responses on how to complete homework. Five options will be provided for how they could complete their homework (e.g., ‘Do the homework when it is given to me; Do the homework in a quiet place without distractions; Do homework with friends; Do the homework and ask for help if it is difficult; Do the homework in stages by
planning it out’). Participants are required to check the options they plan to use or to write in an additional response. Similarly participants will be required to check where they would complete homework (e.g., ‘When I get up in the morning; When I get home from school; After I’ve had my tea; Last thing at night; At lunchtime at school.’) and when they would complete homework (e.g., ‘I think I can get all my homework done’) and to agree to their plan.
Both conditions
Students in both conditions (intervention and control) will complete a smoking questionnaire and carbon monoxide (CO) test at one year intervals over a four year period (baseline and four separate time points: 12, 24, 36 and 48 months post baseline).
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Primary outcome measure(s)
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Smoking initiation based on objective measures: carbon monoxide (CO) test. CO will be assessed at baseline and at 12, 24, 36 and 48 months post baseline in order to explore the time periods over which the intervention might be best targeted. The primary outcome will be the data from the final time point.
Our objective measure of smoking will be obtained from breath carbon monoxide monitors (Micro+ Smokerlyzer® CO Monitor, Bedfont Scientific Limited, Kent, England). This instrument gives a measure of carbon monoxide in the breath in parts per million (ppm) accurate to within 2% based upon exhaling one breath into the device and has been adapted for use in adolescent samples.
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Secondary outcome measure(s)
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Self-reported smoking is our secondary outcome measure. Self-reported smoking and measures of cognitions will be collected via questionnaire completed individually but in a classroom setting (assessed at baseline, 12, 24, 36, and 48 months post baseline). The key secondary outcome measure will be self-reported smoking at the final time point.
Self-reported smoking will be assessed by standard measures (as used in national surveys and our previous research; Conner & Higgins, 2010; Jarvis, 1997). We will also measure smoking cognitions (e.g., beliefs about smoking, attitudes to smoking, intentions to resist smoking, self-efficacy over resisting, family smoking and friends smoking).
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Sources of funding
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Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) Phase 4 (UK) ref: MR/J000264/1
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Trial website
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http://www.psyc.leeds.ac.uk/10/research/hlth/smoking
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Publications
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1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23332020
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Contact name
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Prof
Mark
Conner
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Address
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Professor of Applied Social Psychology
University of Leeds
Institute of Psychological Sciences
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City/town
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Leeds
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Zip/Postcode
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LS2 9JT
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Country
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United Kingdom
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Tel
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+44 (0)113 3435720
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Fax
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+44 (0)113 3435749
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Email
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m.t.conner@leeds.ac.uk
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Sponsor
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University of Leeds (UK)
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Address
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c/o Clare Skinner
Faculty Head of Research Support
Faculty of Medicine and Health
Worsley Building
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City/town
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Leeds
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Zip/Postcode
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LS2 9LN
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Country
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United Kingdom
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Tel
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+44 (0)113 343 4897
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Email
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c.e.skinner@leeds.ac.uk
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Sponsor website:
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http://www.leeds.ac.uk/
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Date applied
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26/10/2012
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Last edited
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24/01/2013
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Date ISRCTN assigned
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30/11/2012
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