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

23 de abril de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

462

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

19 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Personalized online Safety Decision Aid
Setting priorities for safety; Danger Assessment; Personalized Action Plan
Comportamental: 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.
Comportamental: 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.
Comportamental: 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.
Comparador Ativo: General Online Risk/Safety Information
General Risk and Safety Information; Basic Emergency Safety Plan
Comportamental: 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.
Comportamental: 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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: baseline, 12 months
baseline, 12 months
changes in self-efficacy for safety planning on investigator developed scales
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Severity of violence on the Composite Abuse Scale
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Western University, Canada

Colaboradores

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

Investigadores

  • Investigador principal: Marilyn Ford-Gilboe, PhD, Western University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2014

Conclusão Primária (Real)

1 de janeiro de 2017

Conclusão do estudo (Real)

1 de março de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

2 de outubro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de outubro de 2014

Primeira postagem (Estimativa)

8 de outubro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de abril de 2019

Última verificação

1 de abril de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • HSREB 105436

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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