Clinical trial NCT05574192: The Social Engagement Project: Addressing Isolation with Women Affected by Violence
Official title: Building Supportive Social Networks to Advance the Mental Health of Women Affected by Violence in Vancouver's Downtown East Side
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Social Support
Social Isolation
Keywords: peer-led intervention
mixed-method
community-based
vulnerable women
supportive social networks
gender-based violence
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Inner-City Women's Initiatives Society
name: Vancouver Foundation
First posted: 2022-10-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed-method participatory action research design
Primary purpose: OTHER

Brief summary: The goal of this study is to test a pilot intervention aimed at improving social connectedness among women affected by gender-based violence in a resource-restricted, urban context. The intervention will specifically address barriers to building and sustaining supportive social networks to reduce women's risks for worsening mental health associated with isolation, with a focus on barriers stemming from gender-based violence and poverty. The main question it aims to answer are:

* How acceptable is the intervention to women affected by gender-based violence including the benefits, burdens and appropriateness in the context of their everyday lives?
* How feasible is the intervention and study protocol?
* What are the effects of a peer-led social engagement intervention to develop and sustain supportive social networks and reduce isolation among women affected by gender-based violence?

Participants will engage in social activities with trained peer workers over a one-year period.

Detailed description: This study is designed to assess feasibility, acceptability, and preliminary effects of a behavioral intervention aimed at improving social connectedness among women affected by gender-based violence in a resource-restricted, urban context through a pilot intervention using a case study design informed by principles of community-based participator action research. The intervention is a peer-led social visiting program delivered over a 12 month period. Primary outcomes include feasibility (recruitment, retention) and acceptability (timing and frequency of social activities, perceived satisfaction). The investigators will also determine whether the intervention shows the potential to increase social connectedness over a 12-month period.

Population Adult women living in a dense, urban context where poverty, precarious housing and problematic substance use are evident who are at risk of or living with gender-based violence.

Objectives The goal of this work is to test the feasibility, acceptability and preliminary effects of the intervention on social connectedness among women affected by gender-based violence.

The primary objectives are to assess:

1. Acceptability of the intervention to participants, peer-support workers, and staff.
2. Feasibility of delivering the intervention within a resource-restricted setting where participants are experiencing severe poverty and other forms of disadvantage such as mental health challenges, complex physical health concerns, and violence.

The secondary objectives are to measure the intervention's effect on social connectedness and its related elements (loneliness, socializing, social support, and sense of belonging) at 12-months.

Endpoints

The endpoints for the primary objectives:

1. Quantitative and qualitative reports of intervention acceptability among participants; quantitative and qualitative reports of acceptability among peer-support workers (intervention providers); qualitative reports of acceptability among staff managing the peer-support workers.
2. Measures of feasibility include recruitment, retention, intervention participation, financial cost, and fidelity of intervention delivery.

The endpoints for the secondary objective are specific to the elements of social connectedness and include qualitative and quantitative reports of perceived sense of loneliness, social support, and sense of belonging; quantitative reports of attendance at social activities; quantitative reports of social networks.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. Self-identify as a woman (trans-inclusive);
3. Able to verbally communicate in English;
4. Have a consistent place to live that is not a temporary shelter;
5. Have lived in the same place for at least one month;
6. Live and/or spend significant time for work and/or health and social services in the study catchment area
7. Able and willing to provide adequate contact information Age 18 or over
8. Willing and able to provide consent

Exclusion Criteria:

1. planning to travel away from the study catchment area for a time period that would interfere with study participation;
2. is experiencing a condition that, in the opinion of the site PI, would preclude informed consent or make study participation unsafe.

Primary outcomes:
measure: Acceptability of the intervention - qualitative data from participants
timeFrame: 2 months
measure: Acceptability of the intervention - qualitative data from participants
timeFrame: 12 months
measure: Acceptability of the intervention - quantitative data from participants [survey tool]
timeFrame: 6 months
measure: Acceptability of the intervention - quantitative data from participants [survey tool]
timeFrame: 12 months
measure: Acceptability of intervention - qualitative data from peer workers
timeFrame: 3 months
measure: Acceptability of intervention - qualitative data from peer workers
timeFrame: 12 months
measure: Acceptability of the intervention - qualitative data from staff
timeFrame: 12 months
measure: Feasibility of the intervention - Retention - forms
timeFrame: 12 months
measure: Feasibility of the intervention - process fidelity - forms
timeFrame: throughout the study; 12 months
measure: Feasibility of the intervention - financial cost - forms
timeFrame: 12 months
measure: Feasibility of the Intervention - qualitative data from staff
timeFrame: 12 months
Secondary outcomes:
measure: Social Connectedness - survey tool
timeFrame: 2 weeks
measure: Social Connectedness - survey tool
timeFrame: 6 months
measure: Social Connectedness - survey tool
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Victoria Bungay
role: PRINCIPAL_INVESTIGATOR
References: