Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence
23. dubna 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
462
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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British Columbia
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Vancouver, British Columbia, Kanada
- University of British Columbia
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New Brunswick
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Fredericton, New Brunswick, Kanada, N5X 1V5
- University of New Brunswick
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Ontario
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London, Ontario, Kanada, N6A 3C1
- Western University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
19 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Personalized online Safety Decision Aid
Setting priorities for safety; Danger Assessment; Personalized Action Plan
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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.
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.
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.
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Aktivní komparátor: General Online Risk/Safety Information
General Risk and Safety Information; Basic Emergency Safety Plan
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Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.
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)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Časové okno: baseline, 12 months
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20 item self-report measure used to measure depressive symptoms in community samples and assess the probability of meeting criteria for major depressive disorder
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baseline, 12 months
|
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Changes in PTSD symptomology on the PTSD Checklist (Civilian Version)
Časové okno: 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
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baseline, 12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
Časové okno: baseline, immediately post-intervention
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The low literacy version of the Decisional Conflict Scale is an established, self-report measure developed by the Ottawa Patient Decision Aids Research Group.
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baseline, immediately post-intervention
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Changes in use of safety strategies on a Safety Behavior Checklist
Časové okno: baseline, 6 months
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self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
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baseline, 6 months
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Changes in use of safety strategies on a Safety Behavior Checklist
Časové okno: baseline, 12 months
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self-report measure of use and helpfulness of strategies to deal with violence, adapted from Goodman et als (2003) Intimate Partner Violence Strategies Index
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baseline, 12 months
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Change in Mastery on Pearlin's Mastery Scale
Časové okno: baseline, 12 months
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baseline, 12 months
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changes in self-efficacy for safety planning on investigator developed scales
Časové okno: baseline, 6 months
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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).
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baseline, 6 months
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changes in self-efficacy for safety planning on investigator developed scales
Časové okno: baseline, 12 months
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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).
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baseline, 12 months
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Severity of violence on the Composite Abuse Scale
Časové okno: baseline, 6, 12 months
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30 item validated measure of severity of intimate partner violence
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baseline, 6, 12 months
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Social support on the Medical Outcomes Study Social Support Survey
Časové okno: baseline, 3, 6, 12 months
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5 item self-report measure of perceived social support, adapted by McCarrier et al (2011) from the MOS-SS scale
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baseline, 3, 6, 12 months
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Helpfulness of the online tool to decision making on the Preparation for Decision making scale
Časové okno: immediately post-intervention, 6, 12 months
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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.
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immediately post-intervention, 6, 12 months
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Coercive control on the Women's Experiences of Battering Scale (WEB)
Časové okno: baseline, 3, 6, 12 months
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10 item self-report measure of women's responses to partner violence which is a proxy for current level of coercive control
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baseline, 3, 6, 12 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Marilyn Ford-Gilboe, PhD, Western University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2014
Primární dokončení (Aktuální)
1. ledna 2017
Dokončení studie (Aktuální)
1. března 2017
Termíny zápisu do studia
První předloženo
2. října 2014
První předloženo, které splnilo kritéria kontroly kvality
7. října 2014
První zveřejněno (Odhad)
8. října 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- HSREB 105436
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .