NCT06144216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

November 16, 2023

Last Update Submit

April 21, 2026

Conditions

Keywords

Gender-based ViolenceOutreach InterventionTrauma-informed

Outcome Measures

Primary Outcomes (19)

  • Change in trust from baseline to 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (3)

  • Program facilitates connection to services from baseline to 4 months

    Baseline & 4 months

  • Program facilitates connection to services from baseline to 8 months

    Baseline & 8 months

  • Program facilitates connection to services from baseline to 12 months

    Baseline & 12 months

Study Arms (1)

CLOE Outreach Intervention

EXPERIMENTAL

Participants enrolled in CLOE intervention

Other: CLOE Outreach Intervention

Interventions

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.

CLOE Outreach Intervention

Eligibility Criteria

Age12 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsYouth (ages 12-18) of all genders, self-identifying women 19 \& over
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • have been referred to community partner organization for services
  • able to communicate in English
  • age 12-18 (gender inclusive)
  • years or older (self-identifying women)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

Study Officials

  • Victoria Bungay, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

November 21, 2023

Primary Completion

December 11, 2025

Study Completion

December 31, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations