- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566821
Scaling up Trauma and Violence-Informed Outreach With Women Affected by Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Using collaborative research activities, an advanced model of the STRENGTH intervention developed in earlier community-based studies is being tested. That evidence showed that women have unique strengths and abilities in navigating their safety, health and well-being, and that a strengths-based approach is critical to communicate respect and build trusting relationships. Trust facilitates women's engagement and retention in health and social care and enhances their capacities to independently navigate these systems. Appropriate, safe, and responsive outreach can effectively improve safety, reduce overdose deaths, and enhance engagement with health and social care.
The study involves a case-based mixed method design to test an empirically driven model for outreach with women affected by violence, through a series of longitudinal studies with diverse sub-groups of women in differing social and geographical contexts. The two-year intervention study is embedded in a larger 7-year national project aimed at building capacity of outreach programs to prevent and mitigate the effects of gender-based violence and advance the theory and practice of community-based, participatory action research.
Intervention-specific Research Questions:
How effective is this outreach program in:
- building trusting relationships with women?
- supporting women to achieve their self-identified priorities and goals (short-term, medium-term, and long-term goals) in ways that foster safety, autonomy and rights to self-determination?
- What factors enable or confound the success of the outreach intervention?
Project Objectives
To generate new knowledge about program delivery to effectively engage with women to:
- Build trusting relationships between women and short-term, medium-term and long-term supports
- Enhance women's capacity for autonomy, ability and confidence in achieving short-, medium-, and long-term goals
- To generate new knowledge about how to enhance delivery of health and social care services that are non-harmful and non-traumatizing
This research will provide important knowledge about how to more effectively design, implement and evaluate programs and practices that can increase social and health supports and mitigate the effects of gender-based and structural violence. It tests how an empirically driven model of outreach combined with enhanced service integration supports women to identify their priority needs and can bridge the gap in service needs and access with women affected by violence and inequities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T2B5
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-identify as a woman, therefore the study is trans-inclusive
- Have some degree of English proficiency in understanding and communication
- Live and/or spend significant time for work and/or health and social services in the service area of one of the participating community organizations
- Age 18 or over
Exclusion Criteria:
- Individuals not meeting the inclusion criteria listed above will be excluded from participation.
- In addition, women already enrolled in another program with wrap-around supports and who are able to independently navigate health and social care will not be eligible to participate in the outreach program intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STRENGTH Outreach Intervention
Participants enrolled in STRENGTH intervention elements
|
The STRENGTH outreach intervention is a community-led, strengths-based, and trauma- and violence-informed program to support self-identifying women who experience interpersonal and structural gender-based violence.
The outreach intervention aims to support individuals to achieve self-identified priorities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in trust from baseline to 3 months
Time Frame: Baseline (6 weeks post-enrollment) & 3 months
|
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 3 months post-baseline
|
Baseline (6 weeks post-enrollment) & 3 months
|
|
Change in trust from baseline to 6 months
Time Frame: Baseline (6 weeks post-enrollment) & 6 months
|
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 6 months post-baseline
|
Baseline (6 weeks post-enrollment) & 6 months
|
|
Change in trust from baseline to 9 months
Time Frame: Baseline (6 weeks post-enrollment) & 9 months
|
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 9 months post-baseline
|
Baseline (6 weeks post-enrollment) & 9 months
|
|
Change in trust from baseline to 12 months
Time Frame: Baseline (6 weeks post-enrollment) & 12 months
|
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 12 months post-baseline
|
Baseline (6 weeks post-enrollment) & 12 months
|
|
Safety in Care Encounters at Baseline
Time Frame: Baseline (6 weeks post-enrollment)
|
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
|
Baseline (6 weeks post-enrollment)
|
|
Safety in Care Encounters at 3 months
Time Frame: 3 months post-baseline
|
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
|
3 months post-baseline
|
|
Safety in Care Encounters at 6 months
Time Frame: 6 months post-baseline
|
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
|
6 months post-baseline
|
|
Safety in Care Encounters at 9 months
Time Frame: 9 months post-baseline
|
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
|
9 months post-baseline
|
|
Safety in Care Encounters at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
|
12 months post-baseline
|
|
Safety in Home Setting at Baseline
Time Frame: Baseline (6-weeks post-enrollment)
|
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
Baseline (6-weeks post-enrollment)
|
|
Safety in Home Setting at 3 months
Time Frame: 3 months post-baseline
|
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
3 months post-baseline
|
|
Safety in Home Setting at 6 months
Time Frame: 6 months post-baseline
|
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
6 months post-baseline
|
|
Safety in Home Setting at 9 months
Time Frame: 9 months post-baseline
|
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
9 months post-baseline
|
|
Safety in Home Setting at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
12 months post-baseline
|
|
Safety in Community Setting at Baseline
Time Frame: Baseline (6-weeks post-enrollment)
|
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
Baseline (6-weeks post-enrollment)
|
|
Safety in Community Setting at 3 months
Time Frame: 3 months post-baseline
|
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
3 months post-baseline
|
|
Safety in Community Setting at 6 months
Time Frame: 6 months post-baseline
|
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
6 months post-baseline
|
|
Safety in Community Setting at 9 months
Time Frame: 9 months post-baseline
|
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
9 months post-baseline
|
|
Safety in Community Setting at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
|
12 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Priorities achieved at 3 months
Time Frame: 3 months
|
Were participants' self-identified priorities achieved after 3 months of intervention (yes/no)
|
3 months
|
|
Priorities achieved at 6 months
Time Frame: 6 months
|
Were participants' self-identified priorities achieved after 6 months of intervention (yes/no)
|
6 months
|
|
Priorities achieved at 9 months
Time Frame: 9 months
|
Were participants' self-identified priorities achieved after 9 months of intervention (yes/no)
|
9 months
|
|
Priorities achieved at 12 months
Time Frame: 12 months
|
Were participants' self-identified priorities achieved after 12 months of intervention (yes/no)
|
12 months
|
|
Priorities achieved at 18 months
Time Frame: 18 months
|
Were participants' self-identified priorities achieved after 18 months of intervention (yes/no)
|
18 months
|
|
Priorities achieved at 21 months
Time Frame: 21 months
|
Were participants' self-identified priorities achieved after 21 months of intervention (yes/no)
|
21 months
|
|
Priorities achieved at 24 months
Time Frame: 24 months
|
Were participants' self-identified priorities achieved after 24 months of intervention (yes/no)
|
24 months
|
|
Priorities achieved at 15 months
Time Frame: 15 months
|
Were participants' self-identified priorities achieved after 15 months of intervention (yes/no)
|
15 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vicky Bungay, PhD, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22-01197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.