Isafe Is 120.1

[Mohammed Faerber]

Intimatepartner 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.

In 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.

This 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.

Intimate partner violence (IPV) is a widespread problem with significant negative health outcomes for survivors and their families [1-3]. Beyond the well-known negative physical health impacts, research consistently demonstrates a strong association between IPV and increased rates of depression, post-traumatic stress disorder (PTSD), substance abuse and suicide [4-6]. One of the most widely recommended interventions for abused women is safety planning [7-9]. The safety process involves a woman considering complex individual, cultural and community factors, such as financial needs and well-being of children. The challenge is to help women experiencing abuse to identify safety priorities and develop a personalised safety plan while considering staying or leaving an abusive relationship. In response to the challenge, USA researchers developed and are testing the first interactive, web-based safety decision aid for women experiencing IPV [10]. Preliminary findings suggest that women randomised to the safety decision aid reported less decisional conflict about their safety in the abusive intimate relationship after one use compared to women randomised to the usual safety planning condition [11]. While the USA-based IRIS study is the first trial to report on the evaluation of a decision aid for IPV survivors, the initial findings are consistent with a Cochrane systematic review that identified 115 trials testing health related decision aids [12]. The review reported that decision aids improve knowledge, create more accurate expectations of possible harms and benefits, increase active decision-making, and reduce the proportion of participants who report being undecided.

The New Zealand (isafe) research study is part of an international collaborative and concurrent replication of the USA IRIS trial (NCT01312103) testing the effectiveness of an interactive web-based safety decision aid in improving mental health and reducing IPV exposure. In the first phase of the New Zealand study, focus groups with service providers and women experiencing IPV informed regionalising the IRIS safety decision aid for the New Zealand context [13]. In addition to cultural tailoring [14], the New Zealand trial advances the IRIS study by offering women fully automated online trial recruitment, eligibility screening, consent and retention procedures.

Primary hypotheses are that: At 12 months post-baseline the intervention group (safety decision aid), in comparison to the control group (usual safety planning), will have: (1) improved mental health and (2) reduced IPV exposure. Secondary hypotheses are: At 3 and 6 months post-baseline the intervention group, in comparison to the control group, will have: (1*) improved mental health and (2*) reduced IPV exposure. At 3, 6 and 12 months post-baseline the intervention group, in comparison to the control group, will have: (3) increased safety-seeking behaviours and (4) less decisional conflict related to safety. Also, (5) increased benefit (improved mental health and reduced IPV exposure) from the intervention will occur under increased safety-seeking behaviours and less decisional-conflict at 3, 6 and 12 months. The effects on each outcome of the interaction between time and intervention arm, and of safety decision aid usage level, will form additional secondary hypotheses.

Eligible women need to express comfort with their ability to access a safe and secure computer to login to the trial website. They also need access to a safe email, meaning they are the only one with password access to the account, to send and receive study-related information.

Women are recruited to the fully automated web-based study by registering on the trial site at www.isafe.aut.ac.nz. Strategies alerting women to the trial include referral to the site by community partners (specialist domestic violence agencies and police) and a range of social media advertisements which request volunteers for a confidential research study on safety in relationships. Such advertisements are made available on healthcare site-based TV, YouTube, Twitter and domestic violence and general social media websites. A free phone number is available for women to call with queries.

A data monitoring committee (DMC) meets 6 monthly during the trial. A DMC Charter outlines responsibility for safeguarding the interests of trial participants, assessing the safety and efficacy of the interventions during the trial, and for monitoring the overall conduct of the trial. Any unanticipated problems potentially related to isafe are reported to the DMC and AUTEC chairpersons.

Participants enrol in the study by accessing a secure New Zealand registration trial website (www.isafe.aut.ac.nz). The site provides a full description of the trial with potential risks and benefits. A participant is considered enrolled if they have visited the registration website and: met eligibility criteria (16 years or older, English language, current IPV), consented to participate, provided contact information, and been validated as a female resident in New Zealand. During registration, women are asked how they may be safely contacted and details for a contact person who would be able and willing to safely pass on a message to her should we lose connection with her during the 12-month follow up period.

Completion of study measures and either the safety decision aid or usual safety planning is estimated to take 45 to 60 minutes at each time point, a feasible time for participants to have web access and not be regarded as overly burdensome [13,20,21]. If women have to quit during a session they are able to log-in to the site at a later time. As a token of appreciation for participation, women provide a safe postal address to receive a $30 gift voucher at each measurement point (baseline, 3, 6 and 12 months).

Women randomly assigned to the safety decision aid intervention group will be able to access the safety decision aid throughout the one-year study period via the secure password-protected trial website. The intervention includes three components: safety priority setting, danger assessment [22] and personalised safety action plan. The safety priority setting activity is based on a multi-criteria decision model [10]. The five criteria (priorities) listed in Table 1 were evaluated for the New Zealand context [13] with minor wording changes made to the descriptions. Women move a sliding bar toward the priority that is most important for all possible pairwise combinations. Through a series of matrix computations using the Analytic Hierarchy Process, the programme provides feedback to the woman, summarising her priorities.

The third and final safety decision aid intervention component is an interactive process using an underlying matrix of resources to help women develop an individually tailored action plan. The action plan lays out local, regional or national resources and tips about safety for the women and their children based on their safety priorities and DA scores. For example, women who screen positive for suicidality will receive messages with referral to their health provider as well as suicide prevention resources (Depression Helpline 0800 111 757 or Lifeline 0800 111 777). If women determine it is safe, they can print a copy of the personalised report with their action plan.

Women randomly assigned to the control group will be able to access a list of contact details for key sources of support for partner violence throughout the one-year study period via the secure password-protected trial website. All control group women receive the same standardised list of resources and a standardised emergency safety plan, like those usually provided by domestic violence advocates, national hotlines or websites. Resources are not individualised to the safety needs of the woman as they do not complete the safety priority setting activity nor do they complete the DA. They are not provided with individualised feedback for an action plan.

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