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Trial registered on ANZCTR


Registration number
ACTRN12612000708853
Ethics application status
Approved
Date submitted
19/06/2012
Date registered
3/07/2012
Date last updated
6/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Internet-based Intervention to Improve Mental Health Outcomes for Abused Women
Scientific title
For women currently experiencing intimate partner violence the effectiveness of an Internet-based safety decision aid intervention compared to Internet-based resources only to improve mental health outcomes and reduce exposure to repeat violence
Secondary ID [1] 280699 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
isafe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partner Violence 286737 0
Condition category
Condition code
Mental Health 287037 287037 0 0
Depression
Public Health 287038 287038 0 0
Other public health
Injuries and Accidents 287071 287071 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women will have access to an online intervention website for a period of 12 months. Women will be directed to the website at measurement points (baseline and 3, 6 and 12 months post-randomisation) and invited to access at her discretion throughout the year. Components of the website include: safety-seeking behaviours, safety decision priorities, danger assessment, and a personalised safety action plan. The website provides automated, individualised feedback about decision priorities and level of danger. The woman develops a tailored action plan with community resources and tips about safety for her and her children.
Intervention code [1] 285117 0
Behaviour
Comparator / control treatment
Women will have access to the online control website for a period of 12 months. Women will be directed to the website at measurement points (baseline and 3, 6 and 12 months post-randomisation) and invited to access at her discretion throughout the year. The website includes a resource list with a range of internet and community resources (e.g., Women’s Refuge, It’s Not OK, mental health services, legal services, housing, drug and alcohol treatment, child health, batterer intervention programmes, and general health and welfare services). Resources are not individualised to the safety needs of the woman.
Control group
Active

Outcomes
Primary outcome [1] 287371 0
Depression assessed using the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R)
Timepoint [1] 287371 0
Primary endpoint 1: CESD-R at 12 months after randomisation
Other timepoints: baseline and at 3 and 6 months after randomisation.
Primary outcome [2] 287372 0
Violence assessed using the Severity Violence Against Women Scale (SVAWS)
Timepoint [2] 287372 0
Primary endpoint 1: SVAWS at 12 months after randomisation
Other timepoints: baseline and at 3 and 6 months after randomisation
Secondary outcome [1] 298015 0
PTSD Checklist, Civilian Version
Timepoint [1] 298015 0
baseline and at 6 and 12 months after randomisation
Secondary outcome [2] 298016 0
Women's Experiences with Battering
Timepoint [2] 298016 0
baseline and at 6 and 12 months after randomisation
Secondary outcome [3] 298017 0
Alcohol Use Disorder Identification Test (AUDIT)
Timepoint [3] 298017 0
baseline and at 6 and 12 months after randomisation
Secondary outcome [4] 298018 0
Drug Abuse Screening Tool (DAST-10)
Timepoint [4] 298018 0
baseline and at 6 and 12 months after randomisation
Secondary outcome [5] 298019 0
Decisional Conflict Scale
Timepoint [5] 298019 0
baseline and at 3, 6 and 12 months after randomisation
Secondary outcome [6] 298020 0
Safety Checklist (adapted from Sullivan et al 1999; Parker et al, 1999; and McFarlane et al 2004)
Timepoint [6] 298020 0
baseline and at 3, 6 and 12 months after randomisation
Secondary outcome [7] 298021 0
Danger Assessment (Campbell, 2003)
Timepoint [7] 298021 0
baseline and 12 months after randomisation

Eligibility
Key inclusion criteria
1. women
2. at least 16 years of age
3. in a current relationship (with a male or female)
4. experiencing partner abuse within in the past 6 months including:

(a) hit, kicked, punched, chocked or otherwise physically hurt;
(b) forced into sexual activities or coerced into sexual activities with threats;
(c) threatened to harm physically; or
(d) feel unsafe
5. live in New Zealand
6. safe computer and internet access
7. safe email address
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Male, unable to understand English, unable to use computer.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants enrol online and those who meet entry criteria are randomised to one of two groups. Allocation is automatically computer generated centrally. The randomisation algorithm uses two random factors in addition to a stratified block scheme. These random factors greatly reduce the predictability of the next random allocation thereby promoting concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a minimisation scheme with two stratification factors (severity of violence and children) and 2 random factors each with 2 equiprobable levels. Severity of violence factor is dichotomous, based on one positive response to the current intimate partner violence eligibility items versus two or more. The children factor is also dichotomous, the woman having one or more children versus none. The computerised randomisation is merged with the online application system so that eligible applicants are automatically assigned.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2012
Actual
17/09/2012
Date of last participant enrolment
Anticipated
Actual
20/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
412
Recruitment outside Australia
Country [1] 4371 0
New Zealand
State/province [1] 4371 0

Funding & Sponsors
Funding source category [1] 285469 0
Government body
Name [1] 285469 0
Health Research Council of New Zealand
Country [1] 285469 0
New Zealand
Primary sponsor type
University
Name
Interdisciplinary Trauma Research Centre, Auckland University of Technology
Address
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284322 0
None
Name [1] 284322 0
Address [1] 284322 0
Country [1] 284322 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287481 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [1] 287481 0
Ethics committee country [1] 287481 0
New Zealand
Date submitted for ethics approval [1] 287481 0
Approval date [1] 287481 0
12/03/2012
Ethics approval number [1] 287481 0
AUTEC 12/51

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

Contacts
Principal investigator
Name 34335 0
Prof Jane Koziol-McLain
Address 34335 0
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 34335 0
New Zealand
Phone 34335 0
+64 9 921 9670
Fax 34335 0
Email 34335 0
jane.koziol-mclain@aut.ac.nz
Contact person for public queries
Name 17582 0
Christine McLean
Address 17582 0
Interdisciplinary Trauma Research Centre
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 17582 0
New Zealand
Phone 17582 0
+64,9,921 9999,7114
Fax 17582 0
+64,9,921 9796
Email 17582 0
christine.mclean@aut.ac.nz
Contact person for scientific queries
Name 8510 0
Professor Jane Koziol-McLain
Address 8510 0
Interdisciplinary Trauma Research Centre
Auckland University of Technology
Private Bag 92006
Auckland 1142
Country 8510 0
New Zealand
Phone 8510 0
+ 64, 9, 921 9670
Fax 8510 0
+64, 9, 921 9796
Email 8510 0
jane.koziol-mclain@aut.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseA web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.2015https://dx.doi.org/10.1186/s12889-015-1395-0
EmbaseParticipant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence.2016
EmbaseEfficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial.2018https://dx.doi.org/10.2196/jmir.8617
N.B. These documents automatically identified may not have been verified by the study sponsor.