LonelinessSEPNCT05574192
The Social Engagement Project: Addressing Isolation with Women Affected by Violence
A study testing Social Engagement Intervention in people with Loneliness and Social Support, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Social Support, Social Isolation
- What is being tested?
- Social Engagement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 17 Oct 2022to 10 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
Official title: 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.
Read the 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:
- Acceptability of the intervention to participants, peer-support workers, and staff.
- 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:
- 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.
- 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.
- Conditions
- Loneliness, Social Support, Social Isolation
- Being tested
- Social Engagement Intervention
- Keywords
- peer-led intervention, mixed-method, community-based, vulnerable women, supportive social networks, gender-based violence
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Engagement InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Social Engagement Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 months
Feasibility of the intervention - Retention - forms
proportion of participants who complete initial enrollment, retention is >75% at 12 months
Measured: 12 months
Feasibility of the intervention - process fidelity - forms
observations of intervention delivery capturing activities administered;
Measured: 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
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start17 Oct 2022
- Primary completion10 Apr 2024
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed-method participatory action research design
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Inner-City Women's Initiatives Society, Vancouver Foundation
- Responsible party
- Principal investigator, Victoria Bungay, University of British Columbia
- Investigators
- Victoria Bungay, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574192
- Sponsor's protocol ID
- H22-02504
- Acronym
- SEP
- Status last verified
- Nov 2024
- First submitted
- 29 Sep 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Supportive Social Networks to Advance the Mental Health of Women Affected by Violence in Vancouver's Downtown East Side
- ClinicalTrials.gov ID
- NCT05574192
- Acronym / sponsor ID
- SEP / H22-02504
- Conditions
- Loneliness, Social Support, Social Isolation
- Keywords
- peer-led intervention, mixed-method, community-based, vulnerable women, supportive social networks, gender-based violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Inner-City Women's Initiatives Society, Vancouver Foundation
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Acceptability of the intervention to participants, peer-support workers, and staff.
- 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:
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed-method participatory action research design
| Arm | Type | Receives |
|---|---|---|
| Social Engagement Intervention | Other | Behavioral: Social Engagement InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Engagement InterventionThe 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. | Behavioural | Social Engagement Intervention |
Primary outcome
Acceptability of the intervention - qualitative data from participants
Time frame: 2 months
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
Acceptability of the intervention - qualitative data from participants
Time frame: 12 months
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
Acceptability of the intervention - quantitative data from participants [survey tool]
Time frame: 6 months
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
Acceptability of the intervention - quantitative data from participants [survey tool]
Time frame: 12 months
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
Acceptability of intervention - qualitative data from peer workers
Time frame: 3 months
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.
Acceptability of intervention - qualitative data from peer workers
Time frame: 12 months
Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews
Acceptability of the intervention - qualitative data from staff
Time frame: 12 months
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.
Feasibility of the intervention - Retention - forms
Time frame: 12 months
proportion of participants who complete initial enrollment, retention is >75% at 12 months
Feasibility of the intervention - process fidelity - forms
Time frame: throughout the study; 12 months
observations of intervention delivery capturing activities administered;
Feasibility of the intervention - financial cost - forms
Time frame: 12 months
calculated total cost for intervention activities; total cost calculated using cash amounts for salaries of providers and intervention activities. Time frame. 12 months
Feasibility of the Intervention - qualitative data from staff
Time frame: 12 months
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.
3 secondary outcomes
Social Connectedness - survey tool
Time frame: 2 weeks
Social Connectedness - survey tool
Time frame: 6 months
Social Connectedness - survey tool
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Bungay principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Engagement Intervention in people with Loneliness and Social Support, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention - qualitative data from participants (time frame: 2 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.