The Social Engagement Project: Addressing Isolation With Women Affected by Violence (SEP)

Building Supportive Social Networks to Advance the Mental Health of Women Affected by Violence in Vancouver's Downtown East Side

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Loneliness; Social Support; Social Isolation
• Intervention / Treatment: Behavioral: Social Engagement Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Bungay; Phone Number: 1-604-822-7933; Email: vicky.bungay@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Social Engagement Intervention; The social engagement intervention includes in-person visits by peer-workers to undertake accompanied social activities with enrolled participants. Each visit will last one hour, occur two times per month over a 12 month period. Activity categories will be self-selected by participants based on physical abilities and interests. Categories include: a) arts based activity; b) physical activity.

Behavioral: Social Engagement Intervention; The intervention includes social visiting with women affected by violence. Social visiting is carried out by trained peer-workers. Peers are women who share life histories with the target study population. Peer-workers will establish a visiting schedule (day/time) and provide a detailed list of activities in two categories: arts-based activities.; physical activities. The peer will meet with the participant at the scheduled place and times to accompany the participant and engage in the activities with the participant. Participation in scheduled social activities that target the interest and ability of women affected by violence is considered to improve social connectedness by increasing the quality and quantity of a woman's social interactions with a supportive, trained person who shares life experiences. Shared, consistent and reliable social activities also are hypothesized to reduce loneliness by contributing to a sense of belonging and sense of being cared for.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention - qualitative data from participants	Acceptability measures include qualitative reports of intervention acceptability among participants. These will include in-depth interviews to explore goals and rationale for enrolling in the intervention as well as expectations and perspectives about initial social engagement activities	2 months
Acceptability of the intervention - qualitative data from participants	Acceptability measures include qualitative reports of the intervention acceptability among participants. Upon intervention completion, in-depth qualitative interviews covering topics such as satisfaction with the content, length, and delivery of the intervention as well as reported impact on participants' life	12 months
Acceptability of the intervention - quantitative data from participants [survey tool]	Satisfaction with intervention content,delivery, length, using a survey tool and measured on a likert scale response 1 to 5 with higher indicating higher satisfaction and as open ended response options	6 months
Acceptability of the intervention - quantitative data from participants [survey tool]	Satisfaction with intervention content,delivery, length, using a survey tool and measured on a likert scale response 1 to 5 with higher indicating higher satisfaction an as open ended responses	12 months
Acceptability of intervention - qualitative data from peer workers	Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews about the delivery and length of the intervention.	3 months
Acceptability of intervention - qualitative data from peer workers	Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews	12 months
Acceptability of the intervention - qualitative data from staff	Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews about the implementation process, the content, timing and delivery of the intervention.	12 months
Feasibility of the intervention - Retention - forms	proportion of participants who complete initial enrollment, retention is >75% at 12 months	12 months
Feasibility of the intervention - process fidelity - forms	observations of intervention delivery capturing activities administered;	throughout the study; 12 months
Feasibility of the intervention - financial cost - forms	calculated total cost for intervention activities; total cost calculated using cash amounts for salaries of providers and intervention activities. Time frame. 12 months	12 months
Feasibility of the Intervention - qualitative data from staff	Feasibility includes qualitative reports of the strengths and challenges experienced implementing a behavioural intervention in a community setting. In-depth interviews with staff will explore the specific experiences of implementing peer-led initiatives with women affected by violence who are living in extreme poverty and experience numerous physical and mental health challenges.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Connectedness - survey tool	Self-report experiences of social connectedness in the past 3 months using questions about frequency of social activities with others (total number experienced), sense of belonging in community (likert scale response with higher being greater sense of belonging), and perceived social support with questions about the quality of relationships with others (likert scale with lower score indicating higher quality).	2 weeks
Social Connectedness - survey tool	Self-report experiences of social connectedness in the past 3 months using questions about frequency of social activities with others in the past 3 months (total number experienced), sense of belonging in community (likert scale response with higher being greater sense of belonging), and perceived social support with questions on questions about the quality of relationships with others (likert scale with lower score indicating higher quality).	6 months
Social Connectedness - survey tool	Self-report experiences of social connectedness in the past 3 months using questions about frequency of social activities with others in the past 3 months (total number experienced), sense of belonging in community (likert scale response with higher being greater sense of belonging), and perceived social support with questions on questions about the quality of relationships with others (likert scale with lower score indicating higher quality).	12 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Foundation; Inner-City Women's Initiatives Society
• Investigators: Principal Investigator: Victoria Bungay, The University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: community-based; gender-based violence; mixed-method; peer-led intervention; vulnerable women; supportive social networks
• Other Study ID Numbers: H22-02504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No