Gender-based ViolenceNCT06144216
Scaling up Trauma-Informed Outreach With People Affected by Violence - CLOE Intervention
A study testing CLOE Outreach Intervention in people with Gender-based Violence and Outreach Intervention, run by University of British Columbia at 1 site in Canada.
Trial summary
This mixed methods, community-based study examines the implementation and outcomes of the Community-Led Outreach and Engagement Model (CLOE) for women and youth affected by violence. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Gender-based Violence, Outreach Intervention
- What is being tested?
- CLOE Outreach Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2023to 31 Dec 2025
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have been referred to community partner organization for services
- able to communicate in English
- age 12-18 (gender inclusive)
- 19 years or older (self-identifying women)
Who cannot join
- Self-identifying men 19 years or older who experience violence will be excluded as the study aims to address gender-based violence with self-identifying women and youth (as per the funded SSHRC grant objectives). Community partner organizations will enable referral for any men to appropriate services.
- People who do not have a referral for service delivery within the two community partner organizations.
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: Scaling up Trauma-Informed Outreach With People Affected by Violence
This mixed methods, community-based study examines the implementation and outcomes of the Community-Led Outreach and Engagement Model (CLOE) for women and youth affected by violence. Outreach services are designed to mitigate the effects of gender-based violence, build trusting relationships with service providers, and improve safety, well-being and engagement with health and social care. Over a 2-year implementation period, we will test how outreach, combined with enhanced service integration, supports participants to identify priority needs and can bridge the gap in accessible and appropriate service with people affected by violence.
Read the detailed description
Using community-based participatory research approaches, we implement and test an empirically driven model of outreach with people affected by violence to determine the effectiveness of the model for participants' trust in service providers, safety, and access to appropriate health and social care. The study represents a community-academic partnership between the PI, co-applicants and the Central Okanagan Elizabeth Fry Society (COEFS) and the Welcome Centre Shelter for Women and Families.
There are 4 primary research questions:
- How effective is the intervention to achieve participant trust in the outreach service program?
- How effective is the outreach intervention in facilitating participant connection to (a) health services; (b) social services; and (c) legal services?
- How effective is the outreach intervention in achieving participant safety plans for (a) material, (b) psychological and (c) physical safety?
- What are the environmental factors that enable or confound the success of the outreach intervention to achieve effectiveness for (a) trust, (b) service connections and (c) safety?
Research Method:
This study is part of a broader program of research utilizing a case-based, intervention study design that employs mixed methods of both quantitative and qualitative data. The outreach intervention consists of 1-1 outreach service provided by trained outreach interventionists to enrolled and consented participants.
Participants will be assigned an outreach interventionist for a one year period. During this time, interventionists and participants will complete a strengths-based assessment to identify participants' current resources and the types of health and social support (e.g., housing, legal, health care access, financial assistance) required. The interventionist and participant will then co-develop a plan to prioritize needs and work collaboratively to address these needs. Plans and progress will be documented by the interventionist in a participant file. Surveys will be conducted at baseline and 4 month intervals by a trained research assistant to measure changes over time in core outcome measures associated with this study (e.g., trust, safety planning, attainment of priority needs). 1-1 qualitative interviews will be conducted at time point 12 months to enable richer understanding of the factors influencing intervention effectiveness.
- Conditions
- Gender-based Violence, Outreach Intervention
- Being tested
- CLOE Outreach Intervention
- Keywords
- Gender-based Violence, Outreach Intervention, Trauma-informed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLOE Outreach InterventionOther
The CLOE outreach intervention is a community-led, strengths-based, and trauma-informed program to support self-identifying women and youth who experience interpersonal and structural gender-based violence. Outreach services are designed to mitigate the effects of gender-based violence, build trusting relationships with service providers, and improve safety, well-being and engagement with health and social care.
| Study group | Role | What they receive |
|---|---|---|
| CLOE Outreach Intervention | Experimental | Participants enrolled in CLOE intervention Receives: Other: CLOE 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 4 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 4 months post-baseline
Measured: Baseline & 4 months
Change in trust from baseline to 8 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 8 months post-baseline
Measured: Baseline & 8 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 & 12 months
Safety in home setting at baseline
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
Measured: Baseline
Safety in home setting at 4 months
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
Measured: 4 months post-baseline
Safety in home setting at 8 months
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
Measured: 8 months post-baseline
Safety in home setting at 12 months
Self-reported safety in current home setting 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 using a rating of 1 to 5 with higher scores being higher safety
Measured: Baseline
Safety in community setting at 4 months
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
Measured: 4 months post-baseline
Safety in community setting at 8 months
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
Measured: 8 months post-baseline
Safety in community setting at 12 months
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
Measured: 12 months post-baseline
Safety in health care encounters at baseline
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: Baseline
Safety in health care encounters at 4 months
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: 4 months post-baseline
Safety in health care encounters at 8 months
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: 8 months post-baseline
Safety in health care encounters at 12 months
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: 12 months post-baseline
Safety in socio-legal service encounters at baseline
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: Baseline
Safety in socio-legal service encounters at 4 months
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: 4 months post-baseline
Safety in socio-legal service encounters at 8 months
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: 8 months post-baseline
Safety in socio-legal service encounters at 12 months
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Measured: 12 months post-baseline
Secondary outcomes (3)
Program facilitates connection to services from baseline to 4 months
Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)
Measured: Baseline & 4 months
Program facilitates connection to services from baseline to 8 months
Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)
Measured: Baseline & 8 months
Program facilitates connection to services from baseline to 12 months
Connection to services facilitated by outreach intervention, measured using participants' self-assessment of services needed and ability to connect (yes/no)
Measured: Baseline & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start21 Nov 2023
- Primary completion11 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Michael Smith Health Research BC, University of Windsor, Dalhousie University
- Responsible party
- Principal investigator, Victoria Bungay, University of British Columbia
- Investigators
- Victoria Bungay, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144216
- Sponsor's protocol ID
- H23-02810; H24-01477
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bungay V, Long PM, Guta A, Comber S, Laforet L, Tait P. Trends in Trust, Safety, and Health Service Access Among Women Participating in an Antiviolence Outreach Program: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2026 Apr 27;15:e88265. doi: 10.2196/88265.
PubMed 42044313
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling up Trauma-Informed Outreach With People Affected by Violence
- ClinicalTrials.gov ID
- NCT06144216
- Acronym / sponsor ID
- H23-02810; H24-01477
- Conditions
- Gender-based Violence, Outreach Intervention
- Keywords
- Gender-based Violence, Outreach Intervention, Trauma-informed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Michael Smith Health Research BC, University of Windsor, Dalhousie University
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Nov 2023 (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.
This mixed methods, community-based study examines the implementation and outcomes of the Community-Led Outreach and Engagement Model (CLOE) for women and youth affected by violence. Outreach services are designed to mitigate the effects of gender-based violence, build trusting relationships with service providers, and improve safety, well-being and engagement with health and social care. Over a 2-year implementation period, we will test how outreach, combined with enhanced service integration, supports participants to identify priority needs and can bridge the gap in accessible and appropriate service with people affected by violence.
Detailed description
Using community-based participatory research approaches, we implement and test an empirically driven model of outreach with people affected by violence to determine the effectiveness of the model for participants' trust in service providers, safety, and access to appropriate health and social care. The study represents a community-academic partnership between the PI, co-applicants and the Central Okanagan Elizabeth Fry Society (COEFS) and the Welcome Centre Shelter for Women and Families.
There are 4 primary research questions:
- How effective is the intervention to achieve participant trust in the outreach service program?
- How effective is the outreach intervention in facilitating participant connection to (a) health services; (b) social services; and (c) legal services?
- How effective is the outreach intervention in achieving participant safety plans for (a) material, (b) psychological and (c) physical safety?
- What are the environmental factors that enable or confound the success of the outreach intervention to achieve effectiveness for (a) trust, (b) service connections and (c) safety?
Research Method:
This study is part of a broader program of research utilizing a case-based, intervention study design that employs mixed methods of both quantitative and qualitative data. The outreach intervention consists of 1-1 outreach service provided by trained outreach interventionists to enrolled and consented participants.
Participants will be assigned an outreach interventionist for a one year period. During this time, interventionists and participants will complete a strengths-based assessment to identify participants' current resources and the types of health and social support (e.g., housing, legal, health care access, financial assistance) required. The interventionist and participant will then co-develop a plan to prioritize needs and work collaboratively to address these needs. Plans and progress will be documented by the interventionist in a participant file. Surveys will be conducted at baseline and 4 month intervals by a trained research assistant to measure changes over time in core outcome measures associated with this study (e.g., trust, safety planning, attainment of priority needs). 1-1 qualitative interviews will be conducted at time point 12 months to enable richer understanding of the factors influencing intervention effectiveness.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLOE Outreach Intervention | Experimental | Other: CLOE Outreach InterventionParticipants enrolled in CLOE intervention |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- have been referred to community partner organization for services
- able to communicate in English
- age 12-18 (gender inclusive)
- 19 years or older (self-identifying women)
Key exclusion criteria (2 listed)
- Self-identifying men 19 years or older who experience violence will be excluded as the study aims to address gender-based violence with self-identifying women and youth (as per the funded SSHRC grant objectives). Community partner organizations will enable referral for any men to appropriate services.
- People who do not have a referral for service delivery within the two community partner organizations.
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 |
|---|---|---|
| CLOE Outreach InterventionThe CLOE outreach intervention is a community-led, strengths-based, and trauma-informed program to support self-identifying women and youth who experience interpersonal and structural gender-based violence. Outreach services are designed to mitigate the effects of gender-based violence, build trusting relationships with service providers, and improve safety, well-being and engagement with health and social care. | Other | CLOE Outreach Intervention |
Primary outcome
Change in trust from baseline to 4 months
Time frame: Baseline & 4 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 4 months post-baseline
Change in trust from baseline to 8 months
Time frame: Baseline & 8 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 8 months post-baseline
Change in trust from baseline to 12 months
Time frame: Baseline & 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 home setting at baseline
Time frame: Baseline
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
Safety in home setting at 4 months
Time frame: 4 months post-baseline
Self-reported safety in current home setting using a rating of 1 to 5 with higher scores being higher safety
Safety in home setting at 8 months
Time frame: 8 months post-baseline
Self-reported safety in current home setting 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 using a rating of 1 to 5 with higher scores being higher safety
Safety in community setting at baseline
Time frame: Baseline
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
Safety in community setting at 4 months
Time frame: 4 months post-baseline
Self-reported safety in community using a rating of 1 to 5 with higher scores being higher safety
Safety in community setting at 8 months
Time frame: 8 months post-baseline
Self-reported safety in community 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 using a rating of 1 to 5 with higher scores being higher safety
Safety in health care encounters at baseline
Time frame: Baseline
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in health care encounters at 4 months
Time frame: 4 months post-baseline
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in health care encounters at 8 months
Time frame: 8 months post-baseline
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in health care encounters at 12 months
Time frame: 12 months post-baseline
Self-reported safety in clinical and health care encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in socio-legal service encounters at baseline
Time frame: Baseline
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in socio-legal service encounters at 4 months
Time frame: 4 months post-baseline
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in socio-legal service encounters at 8 months
Time frame: 8 months post-baseline
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
Safety in socio-legal service encounters at 12 months
Time frame: 12 months post-baseline
Self-reported safety in socio-legal service encounters using a rating of 1 to 5 with higher scores being higher safety
3 secondary outcomes
Program facilitates connection to services from baseline to 4 months
Time frame: Baseline & 4 months
Program facilitates connection to services from baseline to 8 months
Time frame: Baseline & 8 months
Program facilitates connection to services from baseline to 12 months
Time frame: Baseline & 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 24 Apr 2026.
- Derived from this study: PubMed 42044313Bungay V, Long PM, Guta A, Comber S, Laforet L, Tait P. Trends in Trust, Safety, and Health Service Access Among Women Participating in an Antiviolence Outreach Program: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2026 Apr 27;15:e88265. doi: 10.2196/88265.
- 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, PhD principal investigator
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 CLOE 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 24 Apr 2026. 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 4 months (time frame: Baseline & 4 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?
On the ClinicalTrials.gov record for NCT06144216, which also lists 1 linked publication.
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 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.