Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000640707
Ethics application status
Approved
Date submitted
30/05/2013
Date registered
6/06/2013
Date last updated
3/12/2020
Date data sharing statement initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ability of the Australian Centre for Arson Research and Treatment (ACART) firesetting treatment program to reduce psychological risk factors in participants aged 14 years and above who have a history of deliberate firesetting.
Scientific title
The ability of the Australian Centre for Arson Research and Treatment (ACART) Firesetters Program to reduce psychological risk factors for firesetting in participants aged 14 and above who have a history of unauthorised firesetting
Secondary ID [1] 282600 0
Nil
Universal Trial Number (UTN)
U1111-1143-7670
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unauthorised firesetting behaviour in people over the age of 14. 289294 0
Condition category
Condition code
Mental Health 289621 289621 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Firesetter Treatment Program utlises cognitive behaviour therapy to address risk factors for firesetting. Participants will work through a number of exercises, with specially trained clinicians, which have been designed to change their thinking patterns, resolve interpersonal issues and increase skills in problem solving, communication, mood management, and self control. The program involves 14-16 sessions of two hours’ duration, and number of sessions is determined by the complexity of treatment needs identified in the assessment phase. Sessions are usually conducted weekly, however the flexibility of the program allows clinicians to vary this regime as required. It is expected that all participants will complete the program within a 20 week period.
Intervention code [1] 287269 0
Behaviour
Comparator / control treatment
N/A - This is a single group study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289707 0
Primary outcome 1: significant reduction in Identification with Fire Scale (Gannon & O' Ciardha, 2011) score
Timepoint [1] 289707 0
At baseline and at 18 and 30 weeks after intervention commencement
Primary outcome [2] 289708 0
Significant reduction in The Novaco Anger Scale and Provocation Inventory (NAS-PI; Novaco, 2003)
Timepoint [2] 289708 0
At baseline and at 18, and 30 weeks post intervention commencement
Primary outcome [3] 289709 0
Significant decrease in The Revised UCLA Loneliness Scale (UCLA-LS; Russell, Peplau, & Cutrona, 1980)
Timepoint [3] 289709 0
At baseline and at 18, and 30 weeks post intervention
Secondary outcome [1] 303060 0
Significant reduction in The Boredom Proneness Scale-Short Form (BPS-SF; Vodanovich, Wallace, & Kass, 2005)
Timepoint [1] 303060 0
At baseline, and at 18 and 30 weeks after intervention commencement
Secondary outcome [2] 303061 0
Significant increase in The Culture-Free Self-Esteem Inventory (CFSEI; Battle, 1992)
Timepoint [2] 303061 0
At baseline, and at 18 and 30 weeks after intervention commencement
Secondary outcome [3] 303062 0
Significant decrease in scores on The Measure of Criminal Attitudes and Associates-Part B (MCAA-Part B; Mills & Kroner, 1999)
Timepoint [3] 303062 0
At baseline, and at 18 and 30 week post intervention
Secondary outcome [4] 303063 0
Significant increase in scores on The Simple Rathus Assertiveness Schedule—Short Form (SRAS-SF; Jenerette & Dixon, 2010)
Timepoint [4] 303063 0
At baseline, and at 18 and 30 weeks post intervention commencement

Eligibility
Key inclusion criteria
Participants over the age of 14 with a history of at least one unauthorised firesetting incident, assessed as having no significant cognitive impairment or unmanaged serious mental illness at baseline
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under the age of 14, significant cognitive impairment or unmanaged serious mental health diagnosis

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a repeated measures design, a sample size of 50-100 participants has been deemed sufficient to investigate significant treatment effects from baseline to post-intervention using participants' own data for statistical comparisons.
Data analysis will utilise ANOVA to investigate the significant effects of time of assessment (pre and post assessments) on the treatment area of interest (eg fire interest, social competency, anger). Age, and social desirability will also be co-varied out of analysis to control for possible confounds.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/04/2013
Date of last participant enrolment
Anticipated
30/12/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287380 0
Government body
Name [1] 287380 0
Commonwealth Attorney General's Departmentl
Country [1] 287380 0
Australia
Primary sponsor type
University
Name
Bond University
Address
University Drive, Robina, Queensland, 4229
Country
Australia
Secondary sponsor category [1] 286127 0
None
Name [1] 286127 0
Address [1] 286127 0
Country [1] 286127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289354 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 289354 0
Ethics committee country [1] 289354 0
Australia
Date submitted for ethics approval [1] 289354 0
Approval date [1] 289354 0
05/04/2012
Ethics approval number [1] 289354 0
RO1441

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

Contacts
Principal investigator
Name 40446 0
A/Prof Katarina Fritzon
Address 40446 0
Faculty of Society and Design, Bond University, University Drive, Robina QLD 4229
Country 40446 0
Australia
Phone 40446 0
+61755952681
Fax 40446 0
Email 40446 0
[email protected]
Contact person for public queries
Name 40447 0
Katarina Fritzon
Address 40447 0
Faculty of Humanities and Social Sciences
Bond University
University Drive
Robina
QLD 4229
Country 40447 0
Australia
Phone 40447 0
+61755952681
Fax 40447 0
Email 40447 0
[email protected]
Contact person for scientific queries
Name 40448 0
Katarina Fritzon
Address 40448 0
Faculty of Humanities and Social Sciences
Bond University
University Drive
Robina
QLD 4229
Country 40448 0
Australia
Phone 40448 0
+61755952681
Fax 40448 0
Email 40448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have given consent limited to the current study, and data is sensitive (e.g. pertaining to children under the age of 18 years old


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9952Study protocol  [email protected]
9953Informed consent form  [email protected]
9954Ethical approval  [email protected]



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.