A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol

Abstract

BackgroundIntimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent.Methods/DesignIn a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline.Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship.DiscussionThis trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates. The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet. Finally, the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment, eligibility screening, consent and retention procedures.Trial registrationTrial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853.

Participant Recruitment and Engagement in Automated eHealth Trial Registration: Challenges and Opportunities for Recruiting Women Who Experience Violence

“…Women were provided a NZ $30 gift voucher at each measurement point in appreciation of their contribution. While the study protocol was previously published [15], in this paper we iterate and expand on the recruitment plan and automated registration process. The study protocol was approved by the Auckland University of Technology ethics committee (AUTEC 12/51) with trial registration (ACTRN12612000708853).…”

“…In developing this evidence base, it is critical to examine the processes of recruiting women who are experiencing abuse for Web-based trials. In this study we examined the recruitment experience for the New Zealand isafe trial [15] that tested a Web-based safety decision aid for women who experience abuse.…”

Safety in Online Research With Women Experiencing Intimate Partner Violence: What About the Children?

“…This decision MUST BE MADE in consultation with team members and the [principal investigator]. (Koziol-McLain et al, 2015) The isafe kaupapa supports the goal of advancing knowledge, identifying principles of "striving for scientific excellence and integrity" and "disseminating and translating research and findings" within the research kaupapa. However, in line with principles of beneficence and World Health Organization guidelines, such research goals are held secondary to ethical obligations outlined.…”

“…Any additional communication with the team will be treated as confidential, but please be aware that we have an ethical obligation to ensure as far as possible you and your dependents are safe and supported and in some situations we may engage with you and others to discuss safety plans and referrals. (Koziol-McLain et al, 2015) The distinction between information collected in the course of the study and additional communication may seem ambiguous to those unfamiliar with the tool. However, the tool is entirely online, requiring no communication with the isafe team, and therefore in practice this distinction between the course of the study in the tool and additional communication is clear.…”

“…The isafe's protocol therefore mentions seeking to develop safety plans and referrals to appropriate agencies. The terminology of the child safety consent point has been a point of deliberation in the team, stating that if the research team has concerns about child safety they will discuss these concerns with the participant first (Koziol-McLain et al, 2015). In emergency situations in which the research team cannot make contact with the participant, referral to police or emergency services would be required (see Scenario 2).…”