Plain English Summary
Background and study aims
Smoking remains the leading cause of ill health and early death in the UK. Preventing young people from taking up smoking is vital to improving public health. More than 1.5 million 16-18 year olds now attend further education (FE) courses in the UK, typically in sixth form colleges and general FE colleges. For many young people, this is the time in their lives when they begin smoking as they make new friends and become more independent from their parents; over 40% of adult smokers say that they started the habit when aged between 16-19 years old. Despite this, there has been little investment in smoking prevention activities in either general FE colleges or sixth form colleges. Here, we will test the Filter FE Challenge, a new smoking prevention project for 16-18 year olds that has been designed to be run in the FE college environment. To do this, we will work with Action on Smoking and Health (ASH) Wales and six colleges (including large FE colleges and smaller sixth form colleges) in Wales. At the moment we don t know if it will be possible to carry out all of the activities of the Filter FE Challenge in full in different types of FE colleges, or if these activities will prove acceptable to staff and students. There may even be unintended consequences that no-one has anticipated and the project may need to be revised. We will therefore assess if the activities were run as intended, if and how this varied in different colleges, and find out people’s views about the process and consequences of this. We also don’t know whether colleges will be willing to be allocated to a control group at random, so we will assess this, and also how many young people are willing to take part in the study. We will also try to estimate the costs of these smoking prevention activities prior to any further research. If the project activities and research are delivered as planned then we intend to proceed to a much larger evaluation to see if the project reduces the uptake of smoking among 16-18 year-olds, by how much, and at what cost.
Who can participate?
Students aged between 16-18 attending one of the FE colleges taking part in the study
What does the study involve?
The colleges taking part in the study are randomly allocated into one of two groups. Those in group 1 run the the Filter FE Challenge project. Those in group 2 continue as usual and act as a control group. At the three colleges where the project is run, ASH Wales provide project managers, education officers, social media experts and trained youth workers to help these colleges to put in place a range of new smoking prevention activities. This includes ensuring those under age 18 cannot buy tobacco products in local shops, implement smoke-free policies and teaching college staff to teach students about the harms of smoking. Existing web-based information, social media campaigns and online services designed for young people are also integrated with the college’s website and social media. Youth workers also provide credible messages about smoking and resisting peer pressure, and signpost support services.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Cardiff University (UK)
When is the study starting and how long is it expected to run for?
September 2014 to October 2015
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Adam Fletcher
FletcherA@cf.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Adam Fletcher
ORCID ID
Contact details
1-3 Museum Place
Cardiff
CF10 3BD
United Kingdom
-
FletcherA@cf.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PHR 13/42/02
Study information
Scientific title
The Filter FE Challenge: pilot trial and process evaluation of a multi-level smoking prevention intervention in further education settings: a pilot clustered randomised controlled trial
Acronym
Study hypothesis
This study aims to evaluate the feasibility and acceptability of implementing and trialling The Filter FE Challenge (a new smoking prevention intervention).
Ethics approval
Cardiff University School of Social Sciences Research Ethics Committee, July 2014, ref: SREC/1271
Study design
A pilot clustered randomised controlled trial (RCT) and embedded process evaluation of The Filter FE Challenge to evaluate intervention and trial feasibility and acceptability.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Smoking prevention
Intervention
The Filter FE Challenge is a universal, multi-level smoking prevention intervention that is intended to be adaptable for use in all FE settings (i.e. general FE colleges/campuses, sixth form colleges, etc.), delivered by trained staff, using resources developed by ASH Wales for The Filter youth project. Informed by evidence of effective smoking prevention methods and approaches, the intervention aims to prevent the uptake of smoking among FE students aged 16-18 at multiple levels via:
1. Restricting the sale of tobacco to under 18 year-olds
2. Implementing tobacco-free campus policies
3. Training FE staff to deliver anti-smoking messages and support institutional change
4. Publicising The Filter youth project s online social marketing campaigns, advice and support services
5. Youth work activities to provide credible educational messages, modify perceived norms, and promote social/situational resistance skills, as well signposting cessation services if necessary
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The pilot primary outcome is regular smoking (defined as smoking at least one cigarette weekly or more). Collected September 2014 (baseline) and September 2015 (follow-up)
Secondary outcome measures
1. Lifetime smoking (ONS GHS item)
2. Frequent cannabis use (3 or more times in last 30 days), using the EMCDDA European Model Questionnaire (EMQ) items
3. High risk alcohol use, using the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) measure
4. Health-related quality of life (HRQoL), using the EQ-5D-5L measure.
The following are additional pilot secondary outcomes for baseline smokers:
1. Cessation (ONS GHS item)
2. Number of cigarettes/week (ONS GHS item)
3. Nicotine dependence using the Heaviness of Smoking Index (HSI) items
Collected September 2014 (baseline) and September 2015 (follow-up)
Overall trial start date
01/09/2014
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Six further education (FE) settings in south Wales will be purposively sampled for a pilot trial to examine delivery and trial methods in a range of institutional contexts. The following diversity/matching criteria will be used to recruit six FE Settings:
1. Sixth form colleges attached to schools (n=2)
2. Small FE colleges/campuses (new intake fewer than 500) (n=2)
3. Large FE colleges/campuses (new intake more than 500) (n=2)
Students are eligible for selection if:
1. They are aged between 16 and 18 years old
2. They begin further education studies in one of the participant institutions in September 2014
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
Six FE settings will participate in the trial: 3 intervention group; 3 control group. The estimated sample is 2500.
Participant exclusion criteria
1. Private institutions
2. Small sites (with fewer than 100 students)
3. Sixth forms at schools where fewer than 10% of students are entitled to free school meals (FSM)
4. Students who report being older or younger that 16-18
Recruitment start date
01/09/2014
Recruitment end date
31/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiff University
Cardiff
CF10 3BD
United Kingdom
Sponsor information
Organisation
Cardiff University Research & Commercial Division (UK)
Sponsor details
c/o Dr Kathy Pittard-Davies
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
-
davieskp2@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Public Health Research Programme (PHR 13/42/02)
Alternative name(s)
NIHR Public Health Research Programme, PHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29072889