Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-27 @ 4:16 AM
Study NCT ID:
NCT05574192
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2022-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Social Engagement Project: Addressing Isolation with Women Affected by Violence
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Building Supportive Social Networks to Advance the Mental Health of Women Affected by Violence in Vancouver's Downtown East Side
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEP
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: