The Social Engagement Project: Addressing Isolation with Women Affected by Violence

NCT05574192 | Completed

• 1 other identifier: H22-02504
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness; Social Support; Social Isolation

Keywords

peer-led intervention; mixed-method; community-based; vulnerable women; supportive social networks; gender-based violence

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• Social Connectedness - survey tool

  2 weeks

• Social Connectedness - survey tool

  6 months

• Social Connectedness - survey tool

  12 months

Study Arms (1)

Social Engagement Intervention

OTHER

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

Interventions

Social Engagement Intervention BEHAVIORAL

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: 1. arts-based activities. 2. 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.

Social Engagement Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants self-identify as a woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Inner-City Women's Initiatives Society: collaborator
• Vancouver Foundation: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Victoria Bungay

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mixed-method participatory action research design

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 10, 2022
• Study Start: October 17, 2022
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)