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Trial registered on ANZCTR


Registration number
ACTRN12616000314426
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
10/03/2016
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a pre-release group-based abstinence program on extending prisoners' smoking abstinence post release from smoke-free prisons in Queensland.
Scientific title
Efficacy of a pre-release group-based abstinence program on extending prisoners' smoking abstinence post release from smoke-free prisons in Queensland: a randomised controlled trial.
Secondary ID [1] 288627 0
None known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Smoking 297785 0
Condition category
Condition code
Public Health 297969 297969 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised controlled trial.

Intervention group participants will receive four weekly group sessions of the intervention, in the four weeks prior to their release. They will be assigned to a group depending on their release date to ensure all members of each group are due for release at approximately the same time. Each group will consist of between four and six participants. Each intervention session will be about 40-60 minutes in duration, and will be arranged at dates and times that are convenient to the prisoners and prison officials.
As per the study design by Clarke and colleagues (2013), sessions one and four will be based on principles of Motivational Interviewing (MI), and sessions two and three on Cognitive Behavioural Therapy (CBT). MI sessions will be based on encouraging empathy, providing useful information, reflection, open-ended questioning, and aiding the development of self-efficacy and personal choice. The CBT sessions will teach participants to recognise specific environmental and event triggers to smoking and identify behavioural and coping strategies in response to these triggers. The intervention session plan is based on the successful WISE intervention delivered by Clarke and colleagues (2013). Each participant's attendance at group sessions will be recorded.

Sessions will be delivered by the primary researcher, Cheneal Puljevic, who has a background in psychology and counselling, and she will receive refresher training from Associate Professor Grant Devilly, a registered psychologist with extensive experience in forensic settings.
Intervention code [1] 294037 0
Treatment: Other
Intervention code [2] 294152 0
Behaviour
Comparator / control treatment
Prisoners in the control group will receive a pamphlet at the end of the baseline assessment, as well as a brief (1 to 2 minutes) verbal explanation of the pamphlet. The pamphlet highlights the advantages of staying abstinent from smoking post-release, and provides tips for doing so. The purpose of the pamphlet is so that all prisoners receive some kind of benefit from participation, and to reduce discussion between participants about the nature of the research study.
Control group
Active

Outcomes
Primary outcome [1] 297494 0
Resumption of tobacco use by self-report to parole officers during parole meetings.
Timepoint [1] 297494 0
One month post release
Secondary outcome [1] 321209 0
Quantity of tobacco consumed by self-report to parole officers during parole meetings.
Timepoint [1] 321209 0
One month post release

Eligibility
Key inclusion criteria
18 years old or older; male; incarcerated after the smoking ban was introduced (5 May 2014); have been incarcerated continuously for at least 4 weeks (so as to have passed tobacco withdrawal); and will be released to a minimum of one month of court-ordered parole.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years of age, incarcerated before the smoking ban was introduced (i.e. prior to 5 May 2014), were released and then reincarcerated, incarcerated for less than 4 weeks, not released to court-ordered parole.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation using opaque stickers over a column of a spreadsheet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once the baseline assessment has been completed, participants will be randomly assigned to intervention and control groups using block randomisation. The list will be divided into randomly permuted blocks. Within each block, an equal number of intervention and control conditions will be assigned. Use of random permuted blocks ensures balance during assignment and helps to prevent participants from guessing which condition they have been assigned to. At this stage, the number of prisoners who intend to remain abstinent from smoking after release is unknown. To account for the unlikely possibility that all 300 participants intend to remain abstinent, the list needs to reflect double the intended sample size.
The list is also stratified by intention to quit. Literature shows that those prisoners who have an intention to quit are more likely to remain abstinent post-release, making it important to have equal numbers of those who do and do not intend to remain abstinent from smoking post-release in both the intervention and control groups. Thus, at the end of the baseline assessment, the researcher will ask the participant if they intend to stay quit from tobacco smoking post-release or not. Depending on their answer, the researcher will peel a sticker off the randomisation list, and they will be automatically and randomly assigned to either the intervention or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be an intention to treat analysis (ITT), with a p-value of <0.05 considered statistically significant. This involves comparing rates of smoking abstinence for all participants, regardless of actual participation in the intervention; it ignores participant dropout, noncompliance, or protocol deviations. The secondary analysis will be a per protocol analysis, which will exclude intervention group participants who did not receive the intervention, in other words excluding those who dropped out of the study. The absolute difference in point prevalence of smoking abstinence at one month post-release will be compared between the intervention and control groups. A discrete time survival analysis will then be performed to examine group differences in relapse to smoking over time.

The target sample size is 300 participants. The sample size was selected to allow analysis at an alpha of .05 one-tailed and a power level of at least .80. The primary dependent variable used in the power analysis is point-prevalence abstinence (self-report of abstinence). The estimated abstinence rates used are 23% for the intervention group and 14% for the control group, based on the analysis by Clarke and colleagues (2013). They based these estimates on three Cochrane Database of Systematic Reviews and a very extensive meta-analysis of approximately 8,700 studies that addressed assessment and treatment of tobacco dependence. The resulting desired sample size was 282 participants, which has been rounded up to a total of 300 participants.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
12/04/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292988 0
University
Name [1] 292988 0
Griffith University
Country [1] 292988 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Road
Mount Gravatt
QLD 4122
Country
Australia
Secondary sponsor category [1] 291760 0
None
Name [1] 291760 0
None
Address [1] 291760 0
None
Country [1] 291760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294496 0
Griffith University Human Ethics Committee
Ethics committee address [1] 294496 0
Ethics committee country [1] 294496 0
Australia
Date submitted for ethics approval [1] 294496 0
29/07/2015
Approval date [1] 294496 0
22/09/2015
Ethics approval number [1] 294496 0
GU Ref No: 2015/581

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63910 0
Ms Cheneal Puljevic
Address 63910 0
1.13 M07
Griffith University Mount Gravatt Campus
176 Messines Ridge Road
Mount Gravatt
QLD 4122
Country 63910 0
Australia
Phone 63910 0
+61737356851
Fax 63910 0
Email 63910 0
c.puljevic@griffith.edu.au
Contact person for public queries
Name 63911 0
Cheneal Puljevic
Address 63911 0
1.13 M07
Griffith University Mount Gravatt Campus
176 Messines Ridge Road
Mount Gravatt
QLD 4122
Country 63911 0
Australia
Phone 63911 0
+61737356851
Fax 63911 0
Email 63911 0
c.puljevic@griffith.edu.au
Contact person for scientific queries
Name 63912 0
Cheneal Puljevic
Address 63912 0
1.13 M07
Griffith University Mount Gravatt Campus
176 Messines Ridge Road
Mount Gravatt
QLD 4122
Country 63912 0
Australia
Phone 63912 0
+61737356851
Fax 63912 0
Email 63912 0
c.puljevic@griffith.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.