- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02258841
Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence
Testing an Internet-based Safety Decision Aid for Women Experiencing Intimate Partner Violence
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Personalized online Safety Decision Aid
Setting priorities for safety; Danger Assessment; Personalized Action Plan
|
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.
|
Comparador activo: General Online Risk/Safety Information
General Risk and Safety Information; Basic Emergency Safety Plan
|
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)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in depressive symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in Decisional Conflict on the low literacy version of the Decisional Conflict Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: baseline, 12 months
|
baseline, 12 months
|
|
changes in self-efficacy for safety planning on investigator developed scales
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Severity of violence on the Composite Abuse Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Marilyn Ford-Gilboe, PhD, Western University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HSREB 105436
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .