Domestic ViolenceNCT02258841
Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence
A study testing Setting Priorities for Safety, Danger Assessment and Personalized Action Plan in people with Domestic Violence, run by Western University, Canada at 3 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Setting Priorities for Safety, Danger Assessment and Personalized Action Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women
- 19 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of New Brunswick
Fredericton, New Brunswick, N5X 1V5
Western University
London, Ontario, N6A 3C1
University of British Columbia
Vancouver, British Columbia
About this study
Official title: Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence
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.
Read the detailed description
1 in 3 Canadian women experience IPV in their lifetimes. Over time, chronic stress of living in an abusive relationship has been shown to contribute to depression, anxiety and PTSD. Safety planning to reduce the risk of physical and emotional harm in abusive situations is one of the most widely recommended interventions for women in abusive relationship. However, fewer than 1 in 5 Canadian women access support from violence services to assist them in safety planning. Rural, Aboriginal, racialized, immigrant, sexual minority women and women who prioritize their privacy face particular barriers to accessing information and support for safety planning.
We adapted an interactive, online safety decision aid (SDA) recently developed and tested in the U.S. (Glass and colleagues, 2010) so that it applies to diverse groups of Canadian women, and extends the focus on emotional safety. The tool was revised based on a pilot testing for content and usability with 30 women (15 women who had experienced IPV and 15 service providers/experts). In this study, we test the effectiveness of this new tool, called "I CAN Plan 4 Safety" in a sample of 450 women from 3 provinces (ON, BC, New Brunswick). Women will be randomly assigned to complete either the personalized online safety decision aid (intervention) or an online tool which contains general risk and safety information (usual care control). Both tools are located on a confidential, password protected website. After initial completion of the online tools, they will be asked to login to the websites 3, 6 and 12 months later to complete standard outcome assessments. Women may access the information and resources in the online tools at any time for a 12 month period after they enrol in the study.
- Conditions
- Domestic Violence
- Being tested
- Setting Priorities for Safety, Danger Assessment, Personalized Action Plan, General risk and safety information, Basic Emergency Safety Plan
- Keywords
- domestic violence, mental health, safety planning
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Setting Priorities for SafetyBehavioural
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.
Danger AssessmentBehavioural
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 Action PlanBehavioural
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.
General risk and safety informationBehavioural
Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.
Basic Emergency Safety PlanBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Personalized online Safety Decision Aid | Experimental | Setting priorities for safety; Danger Assessment; Personalized Action Plan Receives: Behavioral: Setting Priorities for Safety; Behavioral: Danger Assessment; Behavioral: Personalized Action Plan |
| General Online Risk/Safety Information | Active comparator | General Risk and Safety Information; Basic Emergency Safety Plan Receives: Behavioral: General risk and safety information; Behavioral: Basic Emergency Safety Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline, 12 months
Secondary outcomes (6)
Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group.
Measured: baseline, immediately post-intervention
Changes in use of safety strategies on a Safety Behavior Checklist
self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
Measured: baseline, 6 months
Changes in use of safety strategies on a Safety Behavior Checklist
self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
Measured: baseline, 12 months
Change in Mastery on Pearlin's Mastery Scale
Measured: baseline, 12 months
changes in self-efficacy for safety planning on investigator developed scales
2 self-report items which assess self-efficacy in making a safety plan for self and for children on a 100 mm visual analogue scale (range 0-100).
Measured: baseline, 6 months
changes in self-efficacy for safety planning on investigator developed scales
2 self-report items which assess self-efficacy in making a safety plan for self and for children on a 100 mm visual analogue scale (range 0-100).
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of British Columbia, University of New Brunswick, McMaster University, Johns Hopkins University, Kaiser Permanente
- Responsible party
- Principal investigator, Marilyn Ford-Gilboe, Western University, Canada
- Investigators
- Marilyn Ford-Gilboe, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258841
- Sponsor's protocol ID
- HSREB 105436
- Status last verified
- Apr 2019
- First submitted
- 2 Oct 2014
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32098633Ford-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.
PubMed 28327116
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT02258841
- Acronym / sponsor ID
- HSREB 105436
- Conditions
- Domestic Violence
- Keywords
- domestic violence, mental health, safety planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of British Columbia, University of New Brunswick, McMaster University, Johns Hopkins University, Kaiser Permanente
- Study start
- Oct 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
1 in 3 Canadian women experience IPV in their lifetimes. Over time, chronic stress of living in an abusive relationship has been shown to contribute to depression, anxiety and PTSD. Safety planning to reduce the risk of physical and emotional harm in abusive situations is one of the most widely recommended interventions for women in abusive relationship. However, fewer than 1 in 5 Canadian women access support from violence services to assist them in safety planning. Rural, Aboriginal, racialized, immigrant, sexual minority women and women who prioritize their privacy face particular barriers to accessing information and support for safety planning.
We adapted an interactive, online safety decision aid (SDA) recently developed and tested in the U.S. (Glass and colleagues, 2010) so that it applies to diverse groups of Canadian women, and extends the focus on emotional safety. The tool was revised based on a pilot testing for content and usability with 30 women (15 women who had experienced IPV and 15 service providers/experts). In this study, we test the effectiveness of this new tool, called "I CAN Plan 4 Safety" in a sample of 450 women from 3 provinces (ON, BC, New Brunswick). Women will be randomly assigned to complete either the personalized online safety decision aid (intervention) or an online tool which contains general risk and safety information (usual care control). Both tools are located on a confidential, password protected website. After initial completion of the online tools, they will be asked to login to the websites 3, 6 and 12 months later to complete standard outcome assessments. Women may access the information and resources in the online tools at any time for a 12 month period after they enrol in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized online Safety Decision Aid | Experimental | Behavioral: Setting Priorities for Safety, Behavioral: Danger Assessment, Behavioral: Personalized Action PlanSetting priorities for safety; Danger Assessment; Personalized Action Plan |
| General Online Risk/Safety Information | Active comparator | Behavioral: General risk and safety information, Behavioral: Basic Emergency Safety PlanGeneral Risk and Safety Information; Basic Emergency Safety Plan |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- 19 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)
Key exclusion criteria (8 listed)
- Men
- Under 19 years of age
- Cannot read/speak English
- Living outside of the 3 study sites
- Uncomfortable using a computer or internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Setting Priorities for SafetyParticipants 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. | Behavioural | Personalized online Safety Decision Aid |
| Danger AssessmentParticipants 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. | Behavioural | Personalized online Safety Decision Aid |
| Personalized Action PlanWomen 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. | Behavioural | Personalized online Safety Decision Aid |
| General risk and safety informationParticipants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence. | Behavioural | General Online Risk/Safety Information |
| Basic Emergency Safety PlanParticipants 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) | Behavioural | General Online Risk/Safety Information |
Primary outcome
Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Time frame: baseline, 12 months
20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder
Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)
Time frame: baseline, 12 months
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
6 secondary outcomes
Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
Time frame: baseline, immediately post-intervention
Changes in use of safety strategies on a Safety Behavior Checklist
Time frame: baseline, 6 months
Changes in use of safety strategies on a Safety Behavior Checklist
Time frame: baseline, 12 months
Change in Mastery on Pearlin's Mastery Scale
Time frame: baseline, 12 months
changes in self-efficacy for safety planning on investigator developed scales
Time frame: baseline, 6 months
changes in self-efficacy for safety planning on investigator developed scales
Time frame: baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 32098633Ford-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.
- Derived from this study: PubMed 28327116Ford-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Ford-Gilboe, PhD principal investigator
Western University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Setting Priorities for Safety, Danger Assessment and Personalized Action Plan in people with Domestic Violence, run by Western University, Canada at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (time frame: baseline, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258841, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.