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Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence

23. april 2019 opdateret af: Marilyn Ford-Gilboe, Western University, Canada

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

462

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
    • New Brunswick
      • Fredericton, New Brunswick, Canada, N5X 1V5
        • University of New Brunswick
    • Ontario
      • London, Ontario, Canada, N6A 3C1
        • Western University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Personalized online Safety Decision Aid
Setting priorities for safety; Danger Assessment; Personalized Action Plan
Adfærdsmæssigt: Setting Priorities for Safety
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.
Adfærdsmæssigt: Danger Assessment
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.
Adfærdsmæssigt: Personalized Action Plan
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.
Aktiv komparator: General Online Risk/Safety Information
General Risk and Safety Information; Basic Emergency Safety Plan
Adfærdsmæssigt: General risk and safety information
Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.
Adfærdsmæssigt: Basic Emergency Safety Plan
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Tidsramme: 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
baseline, 12 months
Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)
Tidsramme: 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
baseline, 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
Tidsramme: baseline, immediately post-intervention
The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group.
baseline, immediately post-intervention
Changes in use of safety strategies on a Safety Behavior Checklist
Tidsramme: baseline, 6 months
self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
baseline, 6 months
Changes in use of safety strategies on a Safety Behavior Checklist
Tidsramme: baseline, 12 months
self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
baseline, 12 months
Change in Mastery on Pearlin's Mastery Scale
Tidsramme: baseline, 12 months
baseline, 12 months
changes in self-efficacy for safety planning on investigator developed scales
Tidsramme: baseline, 6 months
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).
baseline, 6 months
changes in self-efficacy for safety planning on investigator developed scales
Tidsramme: baseline, 12 months
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).
baseline, 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of violence on the Composite Abuse Scale
Tidsramme: baseline, 6, 12 months
30 item validated measure of severity of intimate partner violence
baseline, 6, 12 months
Social support on the Medical Outcomes Study Social Support Survey
Tidsramme: baseline, 3, 6, 12 months
5 item self-report measure of perceived social support, adapted by McCarrier et al (2011) from the MOS-SS scale
baseline, 3, 6, 12 months
Helpfulness of the online tool to decision making on the Preparation for Decision making scale
Tidsramme: immediately post-intervention, 6, 12 months
10 item self-report measure of helpfulness of the online tool, adapted to IPV context by Glass et al (2010) from the standardized measure developed by the Ottawa Patient Decision Aids Research Group.
immediately post-intervention, 6, 12 months
Coercive control on the Women's Experiences of Battering Scale (WEB)
Tidsramme: baseline, 3, 6, 12 months
10 item self-report measure of women's responses to partner violence which is a proxy for current level of coercive control
baseline, 3, 6, 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Western University, Canada

Samarbejdspartnere

Johns Hopkins University
University of British Columbia
Canadian Institutes of Health Research (CIHR)
McMaster University
Kaiser Permanente
University of New Brunswick

Efterforskere

  • Ledende efterforsker: Marilyn Ford-Gilboe, PhD, Western University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

2. oktober 2014

Først indsendt, der opfyldte QC-kriterier

7. oktober 2014

Først opslået (Skøn)

8. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HSREB 105436

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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