Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001058167
Ethics application status
Approved
Date submitted
23/05/2019
Date registered
29/07/2019
Date last updated
29/07/2019
Date data sharing statement initially provided
29/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aboriginal and non-Aboriginal women perpetrators of violence: a trial of a prison-based intervention (Beyond Violence)
Scientific title
A trial of a prison-based intervention (Beyond Violence) to reduce re-offending in Aboriginal and non-Aboriginal women.
Secondary ID [1] 296881 0
APP1108115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
violence 310813 0
substance abuse 310814 0
mental health 310815 0
Condition category
Condition code
Public Health 309487 309487 0 0
Health service research
Mental Health 309488 309488 0 0
Addiction
Mental Health 309489 309489 0 0
Depression
Mental Health 309490 309490 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Beyond Violence (BV) is an evidence-based intensive program developed specifically for female violent offenders to target co-morbid substance use disorder, post-traumatic stress disorder and women’s experiences and perpetration of violence. The BV treatment employs trauma theory as a basis for the intervention.
A manualised intervention, BV is a tertiary prevention program which utilises a multi-level approach through a variety of evidence-based therapeutic strategies (i.e. psycho-education, role playing, mindfulness activities, cognitive-behavioural restructuring, and grounding skills for trauma triggers) to address issues of mental health, substance abuse, trauma histories, and anger regulation.
BV is an intensive program run over 20 x 2 hour sessions, delivered face-to-face in prison in groups of 8-10 (INTERVENTION GROUP). The intervention is provided by two co-facilitators (one Aboriginal and one non-Aboriginal woman). Facilitators will record session attendance and make brief clinical notes. To measure satisfaction with treatment, at the end of each session, participants complete a survey to assess the helpfulness of session components and satisfaction levels.
Recruitment to the intervention will occur through identification of potentially eligible participants from administrative databases of offenders, and self-referral (word-of-mouth, posters displayed in prison clinics). Allocation to the treatment group will occur on a first come basis.
The CONTROL GROUP will comprise women who meet the inclusion criteria who may participate in other programs offered in the prison setting (i.e. ‘Treatment as usual’ (TAU)) but do not receive the intervention. To avoid contamination we will initially recruit controls over one year then, over the following year, recruit for and administer the intervention at the same sites.

Intervention code [1] 313156 0
Treatment: Other
Intervention code [2] 314741 0
Behaviour
Comparator / control treatment
The control group will comprise women who meet the inclusion criteria, who may participate in other programs offered in the prison setting (i.e. ‘Treatment as usual’).
Control group
Active

Outcomes
Primary outcome [1] 308446 0
Re-offending within 15 months post-release defined as a conviction (which could include re-incarceration) for any offence. The primary endpoint (re-offending) will be determined objectively from court record outcomes of convictions obtained from administrative data collections.
Timepoint [1] 308446 0
Re-offending will be assessed 15 months post-release from prison.
Secondary outcome [1] 354983 0
Depression (Beck Depression Inventory)
Timepoint [1] 354983 0
Assessed at baseline, 3 months, 9 months and 15 months.
Secondary outcome [2] 371758 0
PTSD (Posttraumatic Stress Disorder Checklist),
Timepoint [2] 371758 0
Assessed at baseline, 3 months, 9 months and 15 months.
Secondary outcome [3] 371760 0
Anger (Anger Irritability and Aggression Questionnaire),
Timepoint [3] 371760 0
Assessed at baseline, 3 months, 9 months and 15 months.
Secondary outcome [4] 371761 0
Substance use/dependence (Alcohol Use Disorder Identification Test).
Timepoint [4] 371761 0
Assessed at baseline, 3 months, 9 months and 15 months.
Secondary outcome [5] 372931 0
Impulsivity (Barratt Impulsiveness Scale-11)
Timepoint [5] 372931 0
Assessed at baseline, 3 months, 9 months and 15 months.

Eligibility
Key inclusion criteria
Adult Women, aged 18 and above; at least one conviction for a violent offence (current and/or historical); minimum of 3 months of their sentence remaining (for the intervention arm) and no more than 6 months left to serve; medium to high-risk offenders (LS/RNR); able to provide informed consent; willingness to be re-interviewed at 6, 12 and 24 months post-release; willingness to allow follow-up using data-linkage of offending records; able to provide future contact details for community follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe active mental illness or profound cognitive impairment; conviction for sex-related violent offences only; inability to communicate in English; deportation on release or release to very remote areas.

Study design
Purpose of the study
Treatment
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
Other
Other design features
The proposed study is a before-and-after trial, conducted over five years designed to measure the effectiveness of the multi-component violence prevention intervention among female offenders with a current and/or historical violent offences.

Contamination: Passage of intervention material to contemporaneous control prisoners within the same prison as the intervention group could, by providing a diluted form of the intervention to ‘controls’, bias the study and lead to a systematic underestimation of the true effect size. To avoid contamination as described by Zlotnick (2009), we will initially recruit controls over one year then, over the following year, recruit for and administer the intervention at the same sites.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome: The incidence rates of reoffending, the primary endpoint of interest, will be calculated and compared between two arms. For each member of the cohort, person-years at risk will be measured from the start date of release until the date of first offence. Kaplan-Meier methods will be used to assess the cumulative probability of offending after release. We will use Cox proportional hazard models to assess factors associated with offending. We will use an ‘intent-to-continue-treatment’ approach. A similar approach will be adopted for offences resulting in re-incarceration, a secondary outcome.

Secondary outcome: Repeated measure linear mixed models, with unstructured covariance matrix for random effects will be used to assess mental health and substance use responses to intervention during different time periods. By considering individual random slopes and intercepts, this model allows one to examine the influence of covariates over time. We also use an unstructured covariance matrix for random effects, allowing a correlation between the individual baseline level and the slopes for the mental health measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
207
Accrual to date
108
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment postcode(s) [1] 26099 0
6102 - Bentley
Recruitment postcode(s) [2] 26100 0
6055 - West Swan
Recruitment postcode(s) [3] 26101 0
6718 - Roebourne

Funding & Sponsors
Funding source category [1] 301452 0
Government body
Name [1] 301452 0
National Health and Medical Research Council
Country [1] 301452 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
UNSW Australia
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 301142 0
None
Name [1] 301142 0
Address [1] 301142 0
Country [1] 301142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303002 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 303002 0
Ethics committee country [1] 303002 0
Australia
Date submitted for ethics approval [1] 303002 0
06/05/2016
Approval date [1] 303002 0
12/05/2016
Ethics approval number [1] 303002 0
HR88/2016
Ethics committee name [2] 303003 0
West Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 303003 0
Ethics committee country [2] 303003 0
Australia
Date submitted for ethics approval [2] 303003 0
21/03/2016
Approval date [2] 303003 0
06/04/2016
Ethics approval number [2] 303003 0
HREC 704
Ethics committee name [3] 303004 0
Department of Corrective Services
Ethics committee address [3] 303004 0
Ethics committee country [3] 303004 0
Australia
Date submitted for ethics approval [3] 303004 0
03/05/2016
Approval date [3] 303004 0
27/01/2017
Ethics approval number [3] 303004 0
Project ID - 395
Ethics committee name [4] 303009 0
NSW Aboriginal Health and Medical Research Council
Ethics committee address [4] 303009 0
Ethics committee country [4] 303009 0
Australia
Date submitted for ethics approval [4] 303009 0
16/10/2018
Approval date [4] 303009 0
Ethics approval number [4] 303009 0
Ethics committee name [5] 303010 0
Corrective Services NSW
Ethics committee address [5] 303010 0
Ethics committee country [5] 303010 0
Australia
Date submitted for ethics approval [5] 303010 0
25/10/2017
Approval date [5] 303010 0
Ethics approval number [5] 303010 0

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

Contacts
Principal investigator
Name 89410 0
Prof Tony Butler
Address 89410 0
Level 6, Wallace Wurth Building
High Street, UNSW Australia
Kensington NSW 2052
Country 89410 0
Australia
Phone 89410 0
+61 (2) 9385 9257
Fax 89410 0
Email 89410 0
[email protected]
Contact person for public queries
Name 89411 0
Tony Butler
Address 89411 0
Level 6, Wallace Wurth Building
High Street, UNSW Australia
Kensington NSW 2052
Country 89411 0
Australia
Phone 89411 0
+61 (2) 9385 9257
Fax 89411 0
Email 89411 0
[email protected]
Contact person for scientific queries
Name 89412 0
Tony Butler
Address 89412 0
Level 6, Wallace Wurth Building
High Street, UNSW Australia
Kensington NSW 2052
Country 89412 0
Australia
Phone 89412 0
+61 (2) 9385 9257
Fax 89412 0
Email 89412 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
The data being collected are very sensitive and as such cannot be released to the public.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2989Ethical approval  [email protected]
2990Study protocol  [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.