Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ANZCTR |
Last refreshed on:
|
13 January 2020 |
Main ID: |
ACTRN12616000314426 |
Date of registration:
|
10/03/2016 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
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. |
Date of first enrolment:
|
12/04/2016 |
Target sample size:
|
300 |
Recruitment status: |
Withdrawn |
URL:
|
https://anzctr.org.au/ACTRN12616000314426.aspx |
Study type:
|
Interventional |
Study design:
|
Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
Australia
| | | | | | | |
Contacts
|
Name:
|
Ms Cheneal Puljevic
|
Address:
|
1.13 M07
Griffith University Mount Gravatt Campus
176 Messines Ridge Road
Mount Gravatt
QLD 4122
Australia |
Telephone:
|
+61737356851 |
Email:
|
c.puljevic@griffith.edu.au |
Affiliation:
|
|
|
Name:
|
Ms Cheneal Puljevic
|
Address:
|
1.13 M07
Griffith University Mount Gravatt Campus
176 Messines Ridge Road
Mount Gravatt
QLD 4122
Australia |
Telephone:
|
+61737356851 |
Email:
|
c.puljevic@griffith.edu.au |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
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.
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.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Males
|
Health Condition(s) or Problem(s) studied
|
Tobacco Smoking; Tobacco Smoking
|
Public Health - Health promotion/education
|
Intervention(s)
|
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.
|
Primary Outcome(s)
|
Resumption of tobacco use by self-report to parole officers during parole meetings. [One month post release]
|
Secondary Outcome(s)
|
Quantity of tobacco consumed by self-report to parole officers during parole meetings.[One month post release]
|
Secondary ID(s)
|
None known
|
Source(s) of Monetary Support
|
Griffith University
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Griffith University Human Ethics Committee
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|