Scaling up Trauma-Informed Outreach With People Affected by Violence - CLOE Intervention

November 16, 2023 updated by: Victoria Bungay, University of British Columbia

Scaling up Trauma-Informed Outreach With People Affected by Violence

This mixed methods, community-based study examines the implementation and outcomes of the Community-Led Outreach and Engagement Model (CLOE) for women and youth affected by 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. Over a 2-year implementation period, we will test how outreach, combined with enhanced service integration, supports participants to identify priority needs and can bridge the gap in accessible and appropriate service with people affected by violence.

Study Overview

Status

Enrolling by invitation

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:

  1. How effective is the intervention to achieve participant trust in the outreach service program?
  2. How effective is the outreach intervention in facilitating participant connection to (a) health services; (b) social services; and (c) legal services?
  3. How effective is the outreach intervention in achieving participant safety plans for (a) material, (b) psychological and (c) physical safety?
  4. 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

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Victoria Bungay, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 21, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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