NCT01312103

Brief Summary

The purpose for this trial is to test the effectiveness of the first interactive internet-based safety decision aid on abused women's exposure to repeat intimate partner violence (IPV) and mental health outcomes. An improved safety decision-making process (e.g., knowing the advantages and disadvantages of the relationship, having enough information to make a decision) will increase safety-seeking behaviors which in turn will decrease exposure to repeat IPV and improve mental health outcomes. Findings from the development and initial test of our computerized safety decision aid suggests that it offered abused women privacy to consider personalized safety options, informed them about danger in their relationship and would be used again if they had access to it through a safe internet site. The investigators are conducting a five year experimental trial in four states (Oregon, Maryland, Missouri, and Arizona) to address the following aims:

  1. 1.Test the effectiveness of an interactive internet-based safety decision aid on abused women's safety seeking behaviors and exposure to violence compared to women assigned to control websites. The investigators hypothesize that at three, six, and 12 months post-baseline the intervention group will have increased safety seeking behaviors and reduced IPV exposure in comparison to the control group.
  2. 2.Test the effectiveness of an interactive internet-based safety decision aid on abused women's mental health compared to women assigned to control websites. The investigators hypothesize that at three, six, and 12 months post-baseline the intervention group will have improved mental health in comparison to the control group.
  3. 3.Test if the effect of an interactive internet-based safety decision aid on abused women's mental health and exposure to violence is mediated by the safety decision making process and safety-seeking behaviors. The investigators hypothesize that the intervention group will have a better decision making process and have greater safety seeking behavior over the year in comparison to the control group, and that this better decision process and increased safety seeking behavior will mediate improvement in mental health and exposure to violence at 12 months post baseline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3.2 years

First QC Date

March 9, 2011

Last Update Submit

March 1, 2017

Conditions

Domestic Violence

Keywords

Safety Planning

Outcome Measures

Primary Outcomes (4)

  • Severity of Violence Against Women

    This 46-item scale has been widely used with ethnically diverse women. It is designed to address types and severity of physical and sexual violence, including the threat of violence. The frequency of violence is based on a four-point scale (1=never to 4=many times) and the participants rank the severity of violence from mild to serious.

    6 months

  • Women's Experience with Battering

    The WEB is a 10-item scale designed to capture a wide variety of abuse behaviors women experience from an intimate partner, including emotional abuse.

    6 months

  • Safety Behavior Checklist

    This includes a checklist of safety steps abused women may use (asking for help, removing gun from home, hiding important papers) and utilization of community resources. Questions will be asked about women's access and use of criminal justice, health, and social resources and how helpful the safety steps are in coping with abuse.

    6 months

  • Decisional Conflict Scale

    The DCS consists of twelve items, with each question having three response options (yes, no, and unsure). The DCS provides a total score, which is a measure of the decision process, as well as scores for four subscales (feeling informed, certainty about decision, values clarity, and support), with higher scores on the DCS indicating a greater degree of decisional conflict (indicative of a poorer decision process).

    6 months

Secondary Outcomes (2)

  • Center for Epidemiologic Studies Depression Scale, Revised

    6 months

  • PTSD Checklist

    6 months

Study Arms (2)

Internet Based Safety Decision Aid

EXPERIMENTAL
Behavioral: Internet-based safety decision aid

Control Website

ACTIVE COMPARATOR
Behavioral: Usual Care Safety Plan

Interventions

Internet-based safety decision aidBEHAVIORAL

Participants will log into the the intervention website at baseline, 3 months, 6 months, and 12 months post baseline and receive: * Setting of priorities for safety; a "sliding bar" allows participants to establish priorities by making pairwise comparisons of importance between factors. * Danger Assessment; asks women to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger. * Personalized action plan. Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented to her. The participant is given the option to print her results and the personalized plan.

Internet Based Safety Decision Aid
Usual Care Safety PlanBEHAVIORAL

Participants will log into a control website at baseline, 3 months, 6 months and 12 months post baseline. Website will include the "usual services" provided to IPV survivors looking for safety planning resources on the internet. Participants will receive: * Danger Assessment, will see risk factors associated with lethal violence, but will not receive a score or feedback. * A brief emergency safety plan with links to national and state domestic violence resources as well as a suicide resource.

Control Website

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • English or Spanish speaking
  • years of age
  • Report current physical, or sexual intimate partner violence or emotional abuse within the context of threats of physical or sexual intimate partner violence
  • Live in one of the target states (Oregon, Arizona, Missouri, or Maryland)
  • Express comfort with and access to a safe computer with internet

You may not qualify if:

  • Male
  • Younger than 18 years of age
  • Older than 64 years of age
  • Cannot read/speak English/Spanish
  • Live outside targeted 4 states
  • No access to safe computer with internet
  • Uncomfortable with computers
  • Does not report past year violence from an intimate partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

University of Missouri

Columbia, Missouri, 65233, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • Glass N, Eden KB, Bloom T, Perrin N. Computerized aid improves safety decision process for survivors of intimate partner violence. J Interpers Violence. 2010 Nov;25(11):1947-64. doi: 10.1177/0886260509354508. Epub 2009 Dec 29.

    PMID: 20040709BACKGROUND

  • Koziol-McLain J, Vandal AC, Nada-Raja S, Wilson D, Glass NE, Eden KB, McLean C, Dobbs T, Case J. A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol. BMC Public Health. 2015 Jan 31;15:56. doi: 10.1186/s12889-015-1395-0.

    PMID: 25637195DERIVED

  • Eden KB, Perrin NA, Hanson GC, Messing JT, Bloom TL, Campbell JC, Gielen AC, Clough AS, Barnes-Hoyt JS, Glass NE. Use of online safety decision aid by abused women: effect on decisional conflict in a randomized controlled trial. Am J Prev Med. 2015 Apr;48(4):372-83. doi: 10.1016/j.amepre.2014.09.027. Epub 2014 Dec 26.

    PMID: 25547929DERIVED

Study Officials

  • Nancy Glass, PhD

    Johns Hopkins University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 10, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

February 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

US(4)