Clinical trial NCT06144216: Scaling Up Trauma-Informed Outreach with People Affected by Violence - CLOE Intervention
Official title: Scaling Up Trauma-Informed Outreach with People Affected by Violence
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gender-based Violence
Outreach Intervention
Keywords: Gender-based Violence
Outreach Intervention
Trauma-informed
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
name: Michael Smith Health Research BC
name: University of Windsor
name: Dalhousie University
First posted: 2023-11-22
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in trust from baseline to 4 months
timeFrame: Baseline & 4 months
measure: Change in trust from baseline to 8 months
timeFrame: Baseline & 8 months
measure: Change in trust from baseline to 12 months
timeFrame: Baseline & 12 months
measure: Safety in home setting at baseline
timeFrame: Baseline
measure: Safety in home setting at 4 months
timeFrame: 4 months post-baseline
measure: Safety in home setting at 8 months
timeFrame: 8 months post-baseline
measure: Safety in home setting at 12 months
timeFrame: 12 months post-baseline
measure: Safety in community setting at baseline
timeFrame: Baseline
measure: Safety in community setting at 4 months
timeFrame: 4 months post-baseline
measure: Safety in community setting at 8 months
timeFrame: 8 months post-baseline
measure: Safety in community setting at 12 months
timeFrame: 12 months post-baseline
measure: Safety in health care encounters at baseline
timeFrame: Baseline
measure: Safety in health care encounters at 4 months
timeFrame: 4 months post-baseline
measure: Safety in health care encounters at 8 months
timeFrame: 8 months post-baseline
measure: Safety in health care encounters at 12 months
timeFrame: 12 months post-baseline
measure: Safety in socio-legal service encounters at baseline
timeFrame: Baseline
measure: Safety in socio-legal service encounters at 4 months
timeFrame: 4 months post-baseline
measure: Safety in socio-legal service encounters at 8 months
timeFrame: 8 months post-baseline
measure: Safety in socio-legal service encounters at 12 months
timeFrame: 12 months post-baseline
Secondary outcomes:
measure: Program facilitates connection to services from baseline to 4 months
timeFrame: Baseline & 4 months
measure: Program facilitates connection to services from baseline to 8 months
timeFrame: Baseline & 8 months
measure: Program facilitates connection to services from baseline to 12 months
timeFrame: Baseline & 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Victoria Bungay, PhD
role: PRINCIPAL_INVESTIGATOR
References: