NCT02258841

Brief Summary

The purpose of this study is to assess the effectiveness of an interactive, online safety decision aid among diverse Canadian women who are experiencing intimate partner violence (IPV). The investigators will also explore how the online intervention works, and whether it has different effects for different groups of women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 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

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

October 2, 2014

Last Update Submit

April 23, 2019

Conditions

Keywords

domestic violencemental healthsafety planning

Outcome Measures

Primary Outcomes (2)

  • Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised

    20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder

    baseline, 12 months

  • Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)

    17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting DSM-IV diagnostic criterial for PTSD

    baseline, 12 months

Secondary Outcomes (6)

  • Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale

    baseline, immediately post-intervention

  • Changes in use of safety strategies on a Safety Behavior Checklist

    baseline, 6 months

  • Changes in use of safety strategies on a Safety Behavior Checklist

    baseline, 12 months

  • Change in Mastery on Pearlin's Mastery Scale

    baseline, 12 months

  • changes in self-efficacy for safety planning on investigator developed scales

    baseline, 6 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Severity of violence on the Composite Abuse Scale

    baseline, 6, 12 months

  • Social support on the Medical Outcomes Study Social Support Survey

    baseline, 3, 6, 12 months

  • Helpfulness of the online tool to decision making on the Preparation for Decision making scale

    immediately post-intervention, 6, 12 months

  • +1 more other outcomes

Study Arms (2)

Personalized online Safety Decision Aid

EXPERIMENTAL

Setting priorities for safety; Danger Assessment; Personalized Action Plan

Behavioral: Setting Priorities for SafetyBehavioral: Danger AssessmentBehavioral: Personalized Action Plan

General Online Risk/Safety Information

ACTIVE COMPARATOR

General Risk and Safety Information; Basic Emergency Safety Plan

Behavioral: General risk and safety informationBehavioral: Basic Emergency Safety Plan

Interventions

Participants rate the importance of 5 priorities to decision-making about their unsafe relationship by comparing the relative importance of each pair of priorities. Weights for each priority are computed and provided to the woman, along with examples of safety strategies that fit with her top ranked priority.

Personalized online Safety Decision Aid

Participants complete a calendar to show episodes of physical and/or sexual violence they have experienced in the past 12, along with 20 questions assessing risk of serious or lethal violence. A standardized weighted score is provided, along with a brief explanation about her level of danger and appropriate actions she may take.

Personalized online Safety Decision Aid

Women create a tailored action plan for themselves by selecting strategies from 8 different groups, including those which are recommended to them based on their responses to previous questions.

Personalized online Safety Decision Aid

Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.

General Online Risk/Safety Information

Participants are provided with a basic emergency plan including information about local DV resources. The information is not personalized but is consistent with online information which women could find on their own (usual care)

General Online Risk/Safety Information

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • years and older,
  • English-speaking,
  • Living in Ontario, New Brunswick, or British Columbia,
  • Reports current physical, sexual or emotional abuse in the context of coercive control from a current or former partner (boyfriend, girlfriend, husband, wife, or intimate/sexual partner)
  • Expresses comfort with and access to a safe computer with internet
  • Access to safe email and mailing address

You may not qualify if:

  • Men
  • Under 19 years of age
  • Cannot read/speak English
  • Living outside of the 3 study sites
  • Uncomfortable using a computer or internet
  • No access to a safe computer with internet
  • No access to safe email and mailing address
  • Does not report current violence from an intimate partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, Canada

Location

University of New Brunswick

Fredericton, New Brunswick, N5X 1V5, Canada

Location

Western University

London, Ontario, N6A 3C1, Canada

Location

Related Publications (2)

  • Ford-Gilboe M, Varcoe C, Scott-Storey K, Perrin N, Wuest J, Wathen CN, Case J, Glass N. Longitudinal impacts of an online safety and health intervention for women experiencing intimate partner violence: randomized controlled trial. BMC Public Health. 2020 Feb 26;20(1):260. doi: 10.1186/s12889-020-8152-8.

  • Ford-Gilboe M, Varcoe C, Scott-Storey K, Wuest J, Case J, Currie LM, Glass N, Hodgins M, MacMillan H, Perrin N, Wathen CN. A tailored online safety and health intervention for women experiencing intimate partner violence: the iCAN Plan 4 Safety randomized controlled trial protocol. BMC Public Health. 2017 Mar 21;17(1):273. doi: 10.1186/s12889-017-4143-9.

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Safety

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Marilyn Ford-Gilboe, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Women's Health Research Chair in Rural Health

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 8, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations