ViolenceNCT06455943
Evaluation of Thriving, Substance Use, Mental Health, and Repeat Injury Among Participants in the THRIVE Program
An observational study of Violence and Assault, run by Unity Health Toronto.
Trial summary
The goal of this observational study is to determine the impact of a hospital-based violence intervention program on a person's capacity to thrive and recurrent intentional injury. The aims of this study are: 1. Read more about this study
- Who is it for?
- Ages 14 to 29 years
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Youth injured by interpersonal violence who present at the emergency department of Unity Health Toronto - St. Michael's Hospital will be offered the hospital-based violence intervention program called THRIVE. THRIVE case managers connect with youth and provide supports in-hospital and in the community following discharge, providing wrap-around care with a strengths-based approach.
Who may be able to join
- ages 14-29
- presentation with an injury due to violence (defined as a gun shot wound, stab wound, blunt or bodily force, inflicted by someone else)
- participant in the THRIVE Program
Who cannot join
- unable to consent due to language barrier or brain injury
- sexual assault
- child abuse
- self-inflicted injury
- residence >1 hour from Toronto city limits
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Thriving, Substance Use, Mental Health and Repeat Injury Among Participants in the THRIVE Program
The goal of this observational study is to determine the impact of a hospital-based violence intervention program on a person's capacity to thrive and recurrent intentional injury. The aims of this study are:
- To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive using:
Read more
- Established measure changes in positive psychology and clinical metrics
- A qualitative interview using thematic content analysis
- Plot the methodology proposed to measure the impact of THRIVE on subsequent injuries using administrative data sources
Participants will complete surveys, participate in a semi-structured interview, and have their rate of recurrent intentional injury tracked over time.
Researchers will compare the rates of intentional reinjury between participants in the THRIVE program and those who present at other hospitals with similar injuries to see if there is a difference in the rate of recurrent intentional injury a 1, 5, and 10 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive.
To evaluate changes in thriving, substance use, and mental health, validated measures and qualitative measures will be used. Quantitative measures collected using validated instruments will provide objective measures of change over time; while context-specific and nuanced growth will be captured through a semi-structured interview.
Measured: July 2024 - December 2025
To pilot the methodology proposed to measure the impact of THRIVE on subsequent injuries within 1 year using administrative data sources
After 1.5 years of enrolment in THRIVE, study participants will be deterministically linked. Linkage will provide a wealth of baseline characteristics (demographics, income/marginalization), injury characteristics (ICD-10 coding patterns which can be contrasted to THRIVE documentation), as well as the capacity to follow these linked patients administratively over time and identify subsequent ED presentations and admission across any hospital in Ontario.
Measured: March - Sept 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolyn Snider, MD, FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455943
- Sponsor's protocol ID
- THRIVE001
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thriving, Substance Use, Mental Health and Repeat Injury Among Participants in the THRIVE Program
- ClinicalTrials.gov ID
- NCT06455943
- Acronym / sponsor ID
- THRIVE001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 13 Jun 2024 (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 observational study is to determine the impact of a hospital-based violence intervention program on a person's capacity to thrive and recurrent intentional injury. The aims of this study are:
- To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive using:
- Established measure changes in positive psychology and clinical metrics
- A qualitative interview using thematic content analysis
- Plot the methodology proposed to measure the impact of THRIVE on subsequent injuries using administrative data sources
Participants will complete surveys, participate in a semi-structured interview, and have their rate of recurrent intentional injury tracked over time.
Researchers will compare the rates of intentional reinjury between participants in the THRIVE program and those who present at other hospitals with similar injuries to see if there is a difference in the rate of recurrent intentional injury a 1, 5, and 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth injured by interpersonal violence who present at the emergency department of Unity Health Toronto - St. Michael's Hospital will be offered the hospital-based violence intervention program called THRIVE. THRIVE case managers connect with youth and provide supports in-hospital and in the community following discharge, providing wrap-around care with a strengths-based approach.
Key inclusion criteria (3 listed)
- ages 14-29
- presentation with an injury due to violence (defined as a gun shot wound, stab wound, blunt or bodily force, inflicted by someone else)
- participant in the THRIVE Program
Key exclusion criteria (5 listed)
- unable to consent due to language barrier or brain injury
- sexual assault
- child abuse
- self-inflicted injury
- residence >1 hour from Toronto city limits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive.
Time frame: July 2024 - December 2025
To evaluate changes in thriving, substance use, and mental health, validated measures and qualitative measures will be used. Quantitative measures collected using validated instruments will provide objective measures of change over time; while context-specific and nuanced growth will be captured through a semi-structured interview.
To pilot the methodology proposed to measure the impact of THRIVE on subsequent injuries within 1 year using administrative data sources
Time frame: March - Sept 2026
After 1.5 years of enrolment in THRIVE, study participants will be deterministically linked. Linkage will provide a wealth of baseline characteristics (demographics, income/marginalization), injury characteristics (ICD-10 coding patterns which can be contrasted to THRIVE documentation), as well as the capacity to follow these linked patients administratively over time and identify subsequent ED presentations and admission across any hospital in Ontario.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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.
Carolyn Snider, MD, FRCPC principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Violence and Assault, run by Unity Health Toronto.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Dekker, MSc (437-331-8644, jennifer.dekker@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive. (time frame: July 2024 - December 2025). The study lists 2 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 13 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.