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

Sponsor
University of British Columbia (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06144216
Collaborator
Social Sciences and Humanities Research Council of Canada (Other), Michael Smith Health Research BC (Other), University of Windsor (Other), Dalhousie University (Other)
400
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33.3
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CLOE Outreach Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Scaling up Trauma-Informed Outreach With People Affected by Violence
Actual Study Start Date :
Nov 21, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CLOE Outreach Intervention

Participants enrolled in CLOE intervention

Other: CLOE Outreach 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.

Outcome Measures

Primary Outcome Measures

  1. Change in trust from baseline to 4 months [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

  2. Change in trust from baseline to 8 months [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

  3. Change in trust from baseline to 12 months [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

  4. Safety in home setting at baseline [Baseline]

    Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety

  5. Safety in home setting at 4 months [4 months post-baseline]

    Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety

  6. Safety in home setting at 8 months [8 months post-baseline]

    Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety

  7. Safety in home setting at 12 months [12 months post-baseline]

    Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety

  8. Safety in community setting at baseline [Baseline]

    Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety

  9. Safety in community setting at 4 months [4 months post-baseline]

    Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety

  10. Safety in community setting at 8 months [8 months post-baseline]

    Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety

  11. Safety in community setting at 12 months [12 months post-baseline]

    Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety

  12. Safety in health care encounters at baseline [Baseline]

    Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety

  13. Safety in health care encounters at 4 months [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

  14. Safety in health care encounters at 8 months [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

  15. Safety in health care encounters at 12 months [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

  16. Safety in socio-legal service encounters at baseline [Baseline]

    Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety

  17. Safety in socio-legal service encounters at 4 months [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

  18. Safety in socio-legal service encounters at 8 months [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

  19. Safety in socio-legal service encounters at 12 months [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

Secondary Outcome Measures

  1. Program facilitates connection to services from baseline to 4 months [Baseline & 4 months]

    Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)

  2. Program facilitates connection to services from baseline to 8 months [Baseline & 8 months]

    Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)

  3. Program facilitates connection to services from baseline to 12 months [Baseline & 12 months]

    Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of British Columbia Vancouver British Columbia Canada V6T 2B5

Sponsors and Collaborators

  • University of British Columbia
  • Social Sciences and Humanities Research Council of Canada
  • Michael Smith Health Research BC
  • University of Windsor
  • Dalhousie University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Victoria Bungay, Professor, University of British Columbia
ClinicalTrials.gov Identifier:
NCT06144216
Other Study ID Numbers:
  • H23-02810
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Victoria Bungay, Professor, University of British Columbia

Study Results

No Results Posted as of Nov 24, 2023