NCT05566821

Brief Summary

Using a participatory action research design, this study examines the process and impact of implementing an evidence-informed, strengths-based, trauma- and violence-informed outreach program with women at greatest risk of health and social inequities to mitigate the effects of multiple forms of violence in their lives. Through collaboration among community service leaders and staff, women with lived or living experience of gender-based violence, and researchers, this project aims to improve the capacity of organizations to build and sustain effective and trusting relationships with women in order to foster health, well-being, safety, and increased ability to independently navigate their support needs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

September 22, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 5, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

September 22, 2022

Last Update Submit

November 16, 2023

Conditions

Keywords

Gender-based ViolenceTrauma-informedOutreach Intervention

Outcome Measures

Primary Outcomes (19)

  • Change in trust from baseline to 3 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 3 months post-baseline

    Baseline (6 weeks post-enrollment) & 3 months

  • Change in trust from baseline to 6 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 6 months post-baseline

    Baseline (6 weeks post-enrollment) & 6 months

  • Change in trust from baseline to 9 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 9 months post-baseline

    Baseline (6 weeks post-enrollment) & 9 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 (6 weeks post-enrollment) & 12 months

  • Safety in Care Encounters at Baseline

    Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety

    Baseline (6 weeks post-enrollment)

  • Safety in Care Encounters at 3 months

    Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety

    3 months post-baseline

  • Safety in Care Encounters at 6 months

    Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety

    6 months post-baseline

  • Safety in Care Encounters at 9 months

    Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety

    9 months post-baseline

  • Safety in Care Encounters at 12 months

    Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety

    12 months post-baseline

  • Safety in Home Setting at Baseline

    Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    Baseline (6-weeks post-enrollment)

  • Safety in Home Setting at 3 months

    Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    3 months post-baseline

  • Safety in Home Setting at 6 months

    Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    6 months post-baseline

  • Safety in Home Setting at 9 months

    Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    9 months post-baseline

  • Safety in Home Setting at 12 months

    Self-reported safety in current home setting for the previous three months 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 for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    Baseline (6-weeks post-enrollment)

  • Safety in Community Setting at 3 months

    Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    3 months post-baseline

  • Safety in Community Setting at 6 months

    Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    6 months post-baseline

  • Safety in Community Setting at 9 months

    Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    9 months post-baseline

  • Safety in Community Setting at 12 months

    Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety

    12 months post-baseline

Secondary Outcomes (8)

  • Priorities achieved at 3 months

    3 months

  • Priorities achieved at 6 months

    6 months

  • Priorities achieved at 9 months

    9 months

  • Priorities achieved at 12 months

    12 months

  • Priorities achieved at 15 months

    15 months

  • +3 more secondary outcomes

Study Arms (1)

STRENGTH Outreach Intervention

EXPERIMENTAL

Participants enrolled in STRENGTH intervention elements

Behavioral: STRENGTH Outreach Intervention

Interventions

The STRENGTH outreach intervention is a community-led, strengths-based, and trauma- and violence-informed program to support self-identifying women who experience interpersonal and structural gender-based violence. The outreach intervention aims to support individuals to achieve self-identified priorities.

STRENGTH Outreach Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identifying women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as a woman, therefore the study is trans-inclusive
  • Have some degree of English proficiency in understanding and communication
  • Live and/or spend significant time for work and/or health and social services in the service area of one of the participating community organizations
  • Age 18 or over

You may not qualify if:

  • In addition, women already enrolled in another program with wrap-around supports and who are able to independently navigate health and social care will not be eligible to participate in the outreach program intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T2B5, Canada

Location

Study Officials

  • Vicky Bungay, PhD

    Professor

    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

September 22, 2022

First Posted

October 4, 2022

Study Start

October 5, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations