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

Gender-based Violence Clinical Trial

Official title:

Scaling up Trauma-Informed Outreach With People Affected by Violence

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06144216
• Other study ID #: H23-02810
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gender-based Violence

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.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Dalhousie University, Michael Smith Health Research BC, Social Sciences and Humanities Research Council of Canada, University of Windsor

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Program facilitates connection to services from baseline to 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
Secondary	Program facilitates connection to services from baseline to 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
Secondary	Program facilitates connection to services from baseline to 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