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Completed

NCT Number: NCT06144216

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

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.

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Key information

Conditions

Gender-Based Violence Outreach Intervention

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CLOE Outreach Intervention

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

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

Registry information

Official study title

Scaling up Trauma-Informed Outreach With People Affected by Violence

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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