Evaluation of a Healthy Relationship Smartphone App With Indigenous Young People: Protocol for a Co-designed Stepped Wedge Randomized Trial.

BACKGROUND: We co-designed a smartphone app, Harmonised, with taitamariki (young people aged 13-17 years) to promote healthy intimate partner relationships. The app also provides a pathway for friends and family, or whanau (indigenous Maori extended family networks), to learn how to offer better support to taitamariki. OBJECTIVE: The aim of our taitamariki- and Maori-centered study is to evaluate the implementation of the app in secondary schools. The study tests the effectiveness of the app in promoting taitamariki partner relationship self-efficacy (primary outcome). METHODS: We co-designed a pragmatic, randomized, stepped wedge trial (retrospectively registered on September 12, 2019) for 8 Aotearoa, New Zealand, secondary schools (years 9 through 13). The schools were randomly assigned to implement the app in 1 of the 2 school terms. A well-established evaluation framework (RE-AIM [Reach, Effectiveness, Adoption, Implementation, Maintenance]) guided the selection of mixed data collection methods. Our target sample size is 600 taitamariki enrolled across the 8 schools. Taitamariki will participate by completing 5 web-based surveys over a 15-month trial period. Taitamariki partner relationship self-efficacy (primary outcome) and well-being, general health, cybersafety management, and connectedness (secondary outcomes) will be assessed with each survey. The general effectiveness hypotheses will be tested by using a linear mixed model with nested participant, year-group, and school random effects. The primary analysis will also include testing effectiveness in the Maori subgroup. RESULTS: The study was funded by the New Zealand Ministry of Business, Innovation, and Employment in October 2015 and approved by the Auckland University of Technology Ethics Committee on May 3, 2017 (application number: 17/71). CONCLUSIONS: This study will generate robust evidence evaluating the impact of introducing a healthy relationship app in secondary schools on taitamariki partner relationship self-efficacy, well-being, general health, cybersafety management, and connectedness. This taitamariki- and indigenous Maori-centered research fills an important gap in developing and testing strengths-based mobile health interventions in secondary schools. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001262190; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377584. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/24792.

Efficacy of a Web-Based Safety Decision Aid for Women Experiencing Intimate Partner Violence: Randomized Controlled Trial.

BACKGROUND: Intimate partner violence (IPV) is a human rights violation and leading health burden for women. Safety planning is a hallmark of specialist family violence intervention, yet only a small proportion of women access formal services. A Web-based safety decision aid may reach a wide audience of women experiencing IPV and offer the opportunity to prioritize and plan for safety for themselves and their families. OBJECTIVE: The aim of this study was to test the efficacy of a Web-based safety decision aid (isafe) for women experiencing IPV. METHODS: We conducted a fully automated Web-based two-arm parallel randomized controlled trial (RCT) in a general population of New Zealand women who had experienced IPV in the past 6 months. Computer-generated randomization was based on a minimization scheme with stratification by severity of violence and children. Women were randomly assigned to the password-protected intervention website (safety priority setting, danger assessment, and tailored action plan components) or control website (standard, nonindividualized information). Primary endpoints were self-reported mental health (Center for Epidemiologic Studies Depression Scale-Revised, CESD-R) and IPV exposure (Severity of Violence Against Women Scale, SVAWS) at 12-month follow-up. Analyses were by intention to treat. RESULTS: Women were recruited from September 2012 to September 2014. Participants were aged between 16 and 60 years, 27% (111/412) self-identified as Maori (indigenous New Zealand), and 51% (210/412) reported at baseline that they were unsure of their future plans for their partner relationship. Among the 412 women recruited, retention at 12 months was 87%. The adjusted estimated intervention effect for SVAWS was -12.44 (95% CI -23.35 to -1.54) for Maori and 0.76 (95% CI -5.57 to 7.09) for non-Maori. The adjusted intervention effect for CESD-R was -7.75 (95% CI -15.57 to 0.07) for Maori and 1.36 (-3.16 to 5.88) for non-Maori. No study-related adverse events were reported. CONCLUSIONS: The interactive, individualized Web-based isafe decision aid was effective in reducing IPV exposure limited to indigenous Maori women. Discovery of a treatment effect in a population group that experiences significant health disparities is a welcome, important finding. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by Webcite at http://www.webcitation/61MGuVXdK).

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

BACKGROUND: Automated eHealth Web-based research trials offer people an accessible, confidential opportunity to engage in research that matters to them. eHealth trials may be particularly useful for sensitive issues when seeking health care may be accompanied by shame and mistrust. Yet little is known about people's early engagement with eHealth trials, from recruitment to preintervention autoregistration processes. A recent randomized controlled trial that tested the effectiveness of an eHealth safety decision aid for New Zealand women in the general population who experienced intimate partner violence (isafe) provided the opportunity to examine recruitment and preintervention participant engagement with a fully automated Web-based registration process. The trial aimed to recruit 340 women within 24 months. OBJECTIVE: The objective of our study was to examine participant preintervention engagement and recruitment efficiency for the isafe trial, and to analyze dropout through the registration pathway, from recruitment to eligibility screening and consent, to completion of baseline measures. METHODS: In this case study, data collection sources included the trial recruitment log, Google Analytics reports, registration and program metadata, and costs. Analysis included a qualitative narrative of the recruitment experience and descriptive statistics of preintervention participant engagement and dropout rates. A Koyck model investigated the relationship between Web-based online marketing website advertisements (ads) and participant accrual. RESULTS: The isafe trial was launched on September 17, 2012. Placement of ads in an online classified advertising platform increased the average number of recruited participants per month from 2 to 25. Over the 23-month recruitment period, the registration website recorded 4176 unique visitors. Among 1003 women meeting eligibility criteria, 51.55% (517) consented to participate; among the 501 women who enrolled (consented, validated, and randomized), 412 (82.2%) were accrued (completed baseline assessments). The majority (n=52, 58%) of the 89 women who dropped out between enrollment and accrual never logged in to the allocated isafe website. Of every 4 accrued women, 3 (314/412, 76.2%) identified the classified ad as their referral source, followed by friends and family (52/412, 12.6%). Women recruited through a friend or relative were more likely to self-identify as indigenous Maori and live in the highest-deprivation areas. Ads increased the accrual rate by a factor of 74 (95% CI 49-112). CONCLUSIONS: Print advertisements, website links, and networking were costly and inefficient methods for recruiting participants to a Web-based eHealth trial. Researchers are advised to limit their recruitment efforts to Web-based online marketplace and classified advertising platforms, as in the isafe case, or to social media. Online classified advertising in "Jobs-Other-volunteers" successfully recruited a diverse sample of women experiencing intimate partner violence. Preintervention recruitment data provide critical information to inform future research and critical analysis of Web-based eHealth trials. CLINICALTRIAL: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000708853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000708853 (Archived by WebCite at http://www.webcitation/6lMGuVXdK).

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

BACKGROUND: Intimate 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .

A randomized controlled trial of a brief emergency department intimate partner violence screening intervention.

STUDY OBJECTIVE: We evaluate the efficacy of emergency department (ED) brief intimate partner violence screening intervention in reducing short-term revictimization. METHODS: A randomized controlled trial with blinded 3-month follow-up was conducted in an urban New Zealand ED. Participants included 399 nonacute, English-speaking women aged 16 years and older, 199 randomly assigned to the treatment group and 200 to the control group. Participants in both groups received usual emergency health care. Women assigned to the treatment group received a standardized 3-item intimate partner violence screen, statements about the unacceptability of violence, risk assessment, and referral by a health professional research assistant. The main outcome measure was self-reported intimate partner violence exposure. Secondary outcomes included self-care strategies (use of safety behaviors and community resources). RESULTS: Forty-four of 344 (12.8%) women reported intimate partner violence during the 3-month follow-up period: 24 of 177 (13.6.%) among women in the usual care group and 20 of 167 (12.0%) among women in the treatment group. The adjusted odds ratio, controlling for design effects and covariates, was 0.86 (95% confidence interval 0.39 to 1.92). CONCLUSION: This brief intimate partner violence screening intervention did not significantly reduce short-term violence exposure. Continuing work is needed to maximize intervention effectiveness and monitor medium- and long-term outcomes.