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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455943
Other study ID # THRIVE001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date July 1, 2035

Study information

Verified date June 2024
Source Unity Health Toronto
Contact Jennifer Dekker, MSc
Phone 437-331-8644
Email jennifer.dekker@unityhealth.to
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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 2. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date July 1, 2035
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 29 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - unable to consent due to language barrier or brain injury - sexual assault - child abuse - self-inflicted injury - residence >1 hour from Toronto city limits

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Unity Health Toronto

Outcome

Type Measure Description Time frame Safety issue
Primary 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. July 2024 - December 2025
Primary 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. March - Sept 2026
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