- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144216
Scaling up Trauma-Informed Outreach With People Affected by Violence - CLOE Intervention
Scaling up Trauma-Informed Outreach With People Affected by Violence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Using community-based participatory research approaches, we implement and test an empirically driven model of outreach with people affected by violence to determine the effectiveness of the model for participants' trust in service providers, safety, and access to appropriate health and social care. The study represents a community-academic partnership between the PI, co-applicants and the Central Okanagan Elizabeth Fry Society (COEFS) and the Welcome Centre Shelter for Women and Families.
There are 4 primary research questions:
- How effective is the intervention to achieve participant trust in the outreach service program?
- How effective is the outreach intervention in facilitating participant connection to (a) health services; (b) social services; and (c) legal services?
- How effective is the outreach intervention in achieving participant safety plans for (a) material, (b) psychological and (c) physical safety?
- What are the environmental factors that enable or confound the success of the outreach intervention to achieve effectiveness for (a) trust, (b) service connections and (c) safety?
Research Method:
This study is part of a broader program of research utilizing a case-based, intervention study design that employs mixed methods of both quantitative and qualitative data. The outreach intervention consists of 1-1 outreach service provided by trained outreach interventionists to enrolled and consented participants.
Participants will be assigned an outreach interventionist for a one year period. During this time, interventionists and participants will complete a strengths-based assessment to identify participants' current resources and the types of health and social support (e.g., housing, legal, health care access, financial assistance) required. The interventionist and participant will then co-develop a plan to prioritize needs and work collaboratively to address these needs. Plans and progress will be documented by the interventionist in a participant file. Surveys will be conducted at baseline and 4 month intervals by a trained research assistant to measure changes over time in core outcome measures associated with this study (e.g., trust, safety planning, attainment of priority needs). 1-1 qualitative interviews will be conducted at time point 12 months to enable richer understanding of the factors influencing intervention effectiveness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6T 2B5
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- have been referred to community partner organization for services
- able to communicate in English
- age 12-18 (gender inclusive)
- 19 years or older (self-identifying women)
Exclusion Criteria:
- Self-identifying men 19 years or older who experience violence will be excluded as the study aims to address gender-based violence with self-identifying women and youth (as per the funded SSHRC grant objectives). Community partner organizations will enable referral for any men to appropriate services.
- People who do not have a referral for service delivery within the two community partner organizations.
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: CLOE Outreach Intervention
Participants enrolled in CLOE intervention
|
The CLOE outreach intervention is a community-led, strengths-based, and trauma-informed program to support self-identifying women and youth who experience interpersonal and structural gender-based violence.
Outreach services are designed to mitigate the effects of gender-based violence, build trusting relationships with service providers, and improve safety, well-being and engagement with health and social care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in trust from baseline to 4 months
Time Frame: Baseline & 4 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 4 months post-baseline
|
Baseline & 4 months
|
Change in trust from baseline to 8 months
Time Frame: Baseline & 8 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 8 months post-baseline
|
Baseline & 8 months
|
Change in trust from baseline to 12 months
Time Frame: Baseline & 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 & 12 months
|
Safety in home setting at baseline
Time Frame: Baseline
|
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
|
Baseline
|
Safety in home setting at 4 months
Time Frame: 4 months post-baseline
|
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
|
4 months post-baseline
|
Safety in home setting at 8 months
Time Frame: 8 months post-baseline
|
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
|
8 months post-baseline
|
Safety in home setting at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in current home setting 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
|
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
|
Baseline
|
Safety in community setting at 4 months
Time Frame: 4 months post-baseline
|
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
|
4 months post-baseline
|
Safety in community setting at 8 months
Time Frame: 8 months post-baseline
|
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
|
8 months post-baseline
|
Safety in community setting at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
|
12 months post-baseline
|
Safety in health care encounters at baseline
Time Frame: Baseline
|
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
|
Baseline
|
Safety in health care encounters at 4 months
Time Frame: 4 months post-baseline
|
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
|
4 months post-baseline
|
Safety in health care encounters at 8 months
Time Frame: 8 months post-baseline
|
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
|
8 months post-baseline
|
Safety in health care encounters at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
|
12 months post-baseline
|
Safety in socio-legal service encounters at baseline
Time Frame: Baseline
|
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
|
Baseline
|
Safety in socio-legal service encounters at 4 months
Time Frame: 4 months post-baseline
|
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
|
4 months post-baseline
|
Safety in socio-legal service encounters at 8 months
Time Frame: 8 months post-baseline
|
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
|
8 months post-baseline
|
Safety in socio-legal service encounters at 12 months
Time Frame: 12 months post-baseline
|
Self-reported safety in socio-legal service encounters 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 |
---|---|---|
Program facilitates connection to services from baseline to 4 months
Time Frame: Baseline & 4 months
|
Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)
|
Baseline & 4 months
|
Program facilitates connection to services from baseline to 8 months
Time Frame: Baseline & 8 months
|
Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)
|
Baseline & 8 months
|
Program facilitates connection to services from baseline to 12 months
Time Frame: Baseline & 12 months
|
Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)
|
Baseline & 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Victoria Bungay, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H23-02810
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.
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