Gender-based ViolenceNCT05566821
Scaling up Trauma and Violence-Informed Outreach With Women Affected by Violence
A study testing STRENGTH Outreach Intervention in people with Gender-based Violence and Outreach Intervention, run by University of British Columbia at 1 site in Canada.
Trial summary
Using a participatory action research design, this study examines the process and impact of implementing an evidence-informed, strengths-based, trauma- and violence-informed outreach program with women at greatest risk of health and social inequities to mitigate the effects of multiple forms of violence in their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender-based Violence, Outreach Intervention
- What is being tested?
- STRENGTH Outreach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2022to 30 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as a woman, therefore the study is trans-inclusive
- Have some degree of English proficiency in understanding and communication
- Live and/or spend significant time for work and/or health and social services in the service area of one of the participating community organizations
- Age 18 or over
Who cannot join
- Individuals not meeting the inclusion criteria listed above will be excluded from participation.
- In addition, women already enrolled in another program with wrap-around supports and who are able to independently navigate health and social care will not be eligible to participate in the outreach program intervention.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T2B5
About this study
Using a participatory action research design, this study examines the process and impact of implementing an evidence-informed, strengths-based, trauma- and violence-informed outreach program with women at greatest risk of health and social inequities to mitigate the effects of multiple forms of violence in their lives. Through collaboration among community service leaders and staff, women with lived or living experience of gender-based violence, and researchers, this project aims to improve the capacity of organizations to build and sustain effective and trusting relationships with women in order to foster health, well-being, safety, and increased ability to independently navigate their support needs.
Read the detailed description
Using collaborative research activities, an advanced model of the STRENGTH intervention developed in earlier community-based studies is being tested. That evidence showed that women have unique strengths and abilities in navigating their safety, health and well-being, and that a strengths-based approach is critical to communicate respect and build trusting relationships. Trust facilitates women's engagement and retention in health and social care and enhances their capacities to independently navigate these systems. Appropriate, safe, and responsive outreach can effectively improve safety, reduce overdose deaths, and enhance engagement with health and social care.
The study involves a case-based mixed method design to test an empirically driven model for outreach with women affected by violence, through a series of longitudinal studies with diverse sub-groups of women in differing social and geographical contexts. The two-year intervention study is embedded in a larger 7-year national project aimed at building capacity of outreach programs to prevent and mitigate the effects of gender-based violence and advance the theory and practice of community-based, participatory action research.
Intervention-specific Research Questions:
- How effective is this outreach program in:
- building trusting relationships with women?
- supporting women to achieve their self-identified priorities and goals (short-term, medium-term, and long-term goals) in ways that foster safety, autonomy and rights to self-determination?
- What factors enable or confound the success of the outreach intervention?
Project Objectives
To generate new knowledge about program delivery to effectively engage with women to:
- Build trusting relationships between women and short-term, medium-term and long-term supports
- Enhance women's capacity for autonomy, ability and confidence in achieving short-, medium-, and long-term goals
- To generate new knowledge about how to enhance delivery of health and social care services that are non-harmful and non-traumatizing
This research will provide important knowledge about how to more effectively design, implement and evaluate programs and practices that can increase social and health supports and mitigate the effects of gender-based and structural violence. It tests how an empirically driven model of outreach combined with enhanced service integration supports women to identify their priority needs and can bridge the gap in service needs and access with women affected by violence and inequities.
- Conditions
- Gender-based Violence, Outreach Intervention
- Being tested
- STRENGTH Outreach Intervention
- Keywords
- Gender-based Violence, Trauma-informed, Outreach Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRENGTH Outreach InterventionBehavioural
The STRENGTH outreach intervention is a community-led, strengths-based, and trauma- and violence-informed program to support self-identifying women who experience interpersonal and structural gender-based violence. The outreach intervention aims to support individuals to achieve self-identified priorities.
| Study group | Role | What they receive |
|---|---|---|
| STRENGTH Outreach Intervention | Experimental | Participants enrolled in STRENGTH intervention elements Receives: Behavioral: STRENGTH Outreach Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trust from baseline to 3 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 3 months post-baseline
Measured: Baseline (6 weeks post-enrollment) & 3 months
Change in trust from baseline to 6 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 6 months post-baseline
Measured: Baseline (6 weeks post-enrollment) & 6 months
Change in trust from baseline to 9 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 9 months post-baseline
Measured: Baseline (6 weeks post-enrollment) & 9 months
Change in trust from baseline to 12 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 12 months post-baseline
Measured: Baseline (6 weeks post-enrollment) & 12 months
Safety in Care Encounters at Baseline
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Measured: Baseline (6 weeks post-enrollment)
Safety in Care Encounters at 3 months
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Measured: 3 months post-baseline
Safety in Care Encounters at 6 months
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Measured: 6 months post-baseline
Safety in Care Encounters at 9 months
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Measured: 9 months post-baseline
Safety in Care Encounters at 12 months
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Measured: 12 months post-baseline
Safety in Home Setting at Baseline
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: Baseline (6-weeks post-enrollment)
Safety in Home Setting at 3 months
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 3 months post-baseline
Safety in Home Setting at 6 months
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 6 months post-baseline
Safety in Home Setting at 9 months
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 9 months post-baseline
Safety in Home Setting at 12 months
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 12 months post-baseline
Safety in Community Setting at Baseline
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: Baseline (6-weeks post-enrollment)
Safety in Community Setting at 3 months
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 3 months post-baseline
Safety in Community Setting at 6 months
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 6 months post-baseline
Safety in Community Setting at 9 months
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 9 months post-baseline
Safety in Community Setting at 12 months
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Measured: 12 months post-baseline
Secondary outcomes (8)
Priorities achieved at 3 months
Were participants' self-identified priorities achieved after 3 months of intervention (yes/no)
Measured: 3 months
Priorities achieved at 6 months
Were participants' self-identified priorities achieved after 6 months of intervention (yes/no)
Measured: 6 months
Priorities achieved at 9 months
Were participants' self-identified priorities achieved after 9 months of intervention (yes/no)
Measured: 9 months
Priorities achieved at 12 months
Were participants' self-identified priorities achieved after 12 months of intervention (yes/no)
Measured: 12 months
Priorities achieved at 15 months
Were participants' self-identified priorities achieved after 15 months of intervention (yes/no)
Measured: 15 months
Priorities achieved at 18 months
Were participants' self-identified priorities achieved after 18 months of intervention (yes/no)
Measured: 18 months
Priorities achieved at 21 months
Were participants' self-identified priorities achieved after 21 months of intervention (yes/no)
Measured: 21 months
Priorities achieved at 24 months
Were participants' self-identified priorities achieved after 24 months of intervention (yes/no)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start5 Oct 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender-based ViolenceStudies 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
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Inner-City Women's Initiatives Society, Social Sciences and Humanities Research Council of Canada, Michael Smith Foundation for Health Research
- Responsible party
- Principal investigator, Victoria Bungay, University of British Columbia
- Investigators
- Vicky Bungay, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566821
- Sponsor's protocol ID
- H22-01197
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2022
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Trauma and Violence-Informed Outreach With Women Affected by Violence
- ClinicalTrials.gov ID
- NCT05566821
- Acronym / sponsor ID
- H22-01197
- Conditions
- Gender-based Violence, Outreach Intervention
- Keywords
- Gender-based Violence, Trauma-informed, Outreach Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Inner-City Women's Initiatives Society, Social Sciences and Humanities Research Council of Canada, Michael Smith Foundation for Health Research
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 4 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.
Using a participatory action research design, this study examines the process and impact of implementing an evidence-informed, strengths-based, trauma- and violence-informed outreach program with women at greatest risk of health and social inequities to mitigate the effects of multiple forms of violence in their lives. Through collaboration among community service leaders and staff, women with lived or living experience of gender-based violence, and researchers, this project aims to improve the capacity of organizations to build and sustain effective and trusting relationships with women in order to foster health, well-being, safety, and increased ability to independently navigate their support needs.
Detailed description
Using collaborative research activities, an advanced model of the STRENGTH intervention developed in earlier community-based studies is being tested. That evidence showed that women have unique strengths and abilities in navigating their safety, health and well-being, and that a strengths-based approach is critical to communicate respect and build trusting relationships. Trust facilitates women's engagement and retention in health and social care and enhances their capacities to independently navigate these systems. Appropriate, safe, and responsive outreach can effectively improve safety, reduce overdose deaths, and enhance engagement with health and social care.
The study involves a case-based mixed method design to test an empirically driven model for outreach with women affected by violence, through a series of longitudinal studies with diverse sub-groups of women in differing social and geographical contexts. The two-year intervention study is embedded in a larger 7-year national project aimed at building capacity of outreach programs to prevent and mitigate the effects of gender-based violence and advance the theory and practice of community-based, participatory action research.
Intervention-specific Research Questions:
- How effective is this outreach program in:
- building trusting relationships with women?
- supporting women to achieve their self-identified priorities and goals (short-term, medium-term, and long-term goals) in ways that foster safety, autonomy and rights to self-determination?
- What factors enable or confound the success of the outreach intervention?
Project Objectives
To generate new knowledge about program delivery to effectively engage with women to:
- Build trusting relationships between women and short-term, medium-term and long-term supports
- Enhance women's capacity for autonomy, ability and confidence in achieving short-, medium-, and long-term goals
- To generate new knowledge about how to enhance delivery of health and social care services that are non-harmful and non-traumatizing
This research will provide important knowledge about how to more effectively design, implement and evaluate programs and practices that can increase social and health supports and mitigate the effects of gender-based and structural violence. It tests how an empirically driven model of outreach combined with enhanced service integration supports women to identify their priority needs and can bridge the gap in service needs and access with women affected by violence and inequities.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STRENGTH Outreach Intervention | Experimental | Behavioral: STRENGTH Outreach InterventionParticipants enrolled in STRENGTH intervention elements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as a woman, therefore the study is trans-inclusive
- Have some degree of English proficiency in understanding and communication
- Live and/or spend significant time for work and/or health and social services in the service area of one of the participating community organizations
- Age 18 or over
Key exclusion criteria (2 listed)
- Individuals not meeting the inclusion criteria listed above will be excluded from participation.
- In addition, women already enrolled in another program with wrap-around supports and who are able to independently navigate health and social care will not be eligible to participate in the outreach program intervention.
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 |
|---|---|---|
| STRENGTH Outreach InterventionThe STRENGTH outreach intervention is a community-led, strengths-based, and trauma- and violence-informed program to support self-identifying women who experience interpersonal and structural gender-based violence. The outreach intervention aims to support individuals to achieve self-identified priorities. | Behavioural | STRENGTH Outreach Intervention |
Primary outcome
Change in trust from baseline to 3 months
Time frame: Baseline (6 weeks post-enrollment) & 3 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 3 months post-baseline
Change in trust from baseline to 6 months
Time frame: Baseline (6 weeks post-enrollment) & 6 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 6 months post-baseline
Change in trust from baseline to 9 months
Time frame: Baseline (6 weeks post-enrollment) & 9 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 9 months post-baseline
Change in trust from baseline to 12 months
Time frame: Baseline (6 weeks post-enrollment) & 12 months
Change in trust achieved by the program with participants, measured using participants' self-rated trust in program rated from 1 to 5, with higher scores indicating higher trust and comparing baseline to 12 months post-baseline
Safety in Care Encounters at Baseline
Time frame: Baseline (6 weeks post-enrollment)
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Safety in Care Encounters at 3 months
Time frame: 3 months post-baseline
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Safety in Care Encounters at 6 months
Time frame: 6 months post-baseline
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Safety in Care Encounters at 9 months
Time frame: 9 months post-baseline
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Safety in Care Encounters at 12 months
Time frame: 12 months post-baseline
Self-reported safety in clinical care encounters over the past three months using rating of 1 to 5 with higher scores being higher safety
Safety in Home Setting at Baseline
Time frame: Baseline (6-weeks post-enrollment)
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Home Setting at 3 months
Time frame: 3 months post-baseline
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Home Setting at 6 months
Time frame: 6 months post-baseline
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Home Setting at 9 months
Time frame: 9 months post-baseline
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Home Setting at 12 months
Time frame: 12 months post-baseline
Self-reported safety in current home setting for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Community Setting at Baseline
Time frame: Baseline (6-weeks post-enrollment)
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Community Setting at 3 months
Time frame: 3 months post-baseline
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Community Setting at 6 months
Time frame: 6 months post-baseline
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Community Setting at 9 months
Time frame: 9 months post-baseline
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
Safety in Community Setting at 12 months
Time frame: 12 months post-baseline
Self-reported safety in community for the previous three months using a rating of 1 to 5 with higher scores being higher safety
8 secondary outcomes
Priorities achieved at 3 months
Time frame: 3 months
Priorities achieved at 6 months
Time frame: 6 months
Priorities achieved at 9 months
Time frame: 9 months
Priorities achieved at 12 months
Time frame: 12 months
Priorities achieved at 15 months
Time frame: 15 months
Priorities achieved at 18 months
Time frame: 18 months
Priorities achieved at 21 months
Time frame: 21 months
Priorities achieved at 24 months
Time frame: 24 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 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Gender-based Violence
Not yet recruiting
Group Cognitive Processing Therapy for Women Survivors of Gender-Based Violence: Feasibility Study
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Comparison of Escape Room and Branching Scenario Games in Nursing Education
Gender Prediction, Dating Violence
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Active, not recruiting
Mpata Yathu Trial for Young Women in Zambia
HIV, Common Mental Health Problems
Active, not recruiting
Pathways to Improved Adolescent Mental Health in Conflict Affected Families
Mental Health Issue, Gender Equality
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.
Vicky Bungay, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRENGTH Outreach Intervention in people with Gender-based Violence and Outreach Intervention, 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 4 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 18 Nov 2023. 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?
Change in trust from baseline to 3 months (time frame: Baseline (6 weeks post-enrollment) & 3 months). The study lists 19 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 18 Nov 2023.