- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152970
F.Y.I.: Flint Youth Injury Study (FYI)
August 8, 2016 updated by: Rebecca Cunningham, University of Michigan
Substance Use Among Violently Injured Youth in Urban ER: Services & Outcomes
The provision of medical services in an inner city Emergency Department (ED) provides a critical opportunity to identify and characterize future timing and pattern of service use among youth with drug use, who may be missed in school-based samples, and who may not yet be in the criminal justice system.
Currently, there is a paucity of data on the timing, pattern, barriers, and trajectory of youth with multiple risks (illicit drug use and ED visit for acute violence related injury) in terms of their intersection with health services (substance use treatment, mental health, medical) and criminal justice system, which limits the development of optimal timing and setting for interventions.
Youth treated in the ED may have exacerbated rates of illicit drug use, and other risk behaviors (i.e.
delinquency, HIV risk behaviors, weapon carriage) and different trajectories of outcomes and interactions with service use sectors based on presentation for intentional injury as compared to other complaints (medical, unintentional injuries).
Understanding the outcomes and service utilization among inner-city youth with drug use with and without acute violent injury is critically important in developing prevention and treatment services to address these multiple risk factors.
The investigators propose a prospective observational study over a two-year period to identify a high risk group of youth with past year illicit drug use (N=650) seeking care in an inner city ED.
The specific aims of the study, chosen to obtain data necessary to determine the location and content of subsequent interventions, are: (1) To describe characteristics of youth (ages 14-24; n=650) who report illicit drug use presenting to an urban ED for an acute violent injury (n=350), compared to youth with drug use who seek non-violence related ED care (n=300), including demographic characteristics, problem severity (e.g., substance use, violence, HIV risk behaviors, etc.), enabling factors, and service utilization (i.e., substance use treatment, mental health, and medical); (2) To identify the trajectories of participants' interactions with health services during the two years following their ED visit and the key characteristics (i.e., predisposing, enabling, and need factors) associated with types of service use (substance abuse treatment, mental health, and medical/ ED) and barriers to these services; and, (3) To measure two-year outcomes for this cohort and to identify key demographic and clinical characteristics of youth with drug use, who have poor outcomes in the two years after ED visit for intentional injury and other medical care.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
638
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Flint, Michigan, United States, 48503
- Hurley Medical Center Emergency Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients ages 14-24 seeking treatment at the Hurley Medical Center (HMC) Emergency Department (ED) located in Flint, MI will be recruited for this study.
Description
Inclusion Criteria:
Inclusion criteria for screening:
- youth (ages 14-24) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);
- access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).
Positive substance use screen criteria: Youth will be eligible for the longitudinal study if they endorse on self-report computer survey past year use of illicit drugs (e.g. marijuana, cocaine, inhalants, non-prescribed use of psychoactive prescription drugs, etc).-
Exclusion Criteria:
- youth who do not understand English
- youth deemed unable to provide informed assent/consent by ED or research staff
- prisoners at time of ED presentation.
- youth who present to the ED as victims of sexual abuse or child abuse -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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drug-using youth with violent injury
Youth(ages 14-24) who report illicit drug use and who present to an urban ED for an acute violent injury
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drug-using youth with non-violent injury
Youth(ages 14-24) who report illicit drug use and who present to an urban ED for non-violence related care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
substance use as assessed with both the Mini-International Neuropsychiatric Interview
Time Frame: Change from baseline substance use at 24 month
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Change from baseline substance use at 24 month
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substance use as assessed with the National Institute on Drug Abuse- Modified Alcohol, Smoking and Substance Involvement Screening Test
Time Frame: Change from baseline substance use at 24 month
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Change from baseline substance use at 24 month
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violence behaviors as assessed with the modified Conflict Tactic Scale
Time Frame: Change from baseline violence behaviors at 24 month
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Change from baseline violence behaviors at 24 month
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HIV risk behaviors as assessed with the Risk Assessment Battery
Time Frame: Change from baseline HIV risk behaviors at 24 month
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Change from baseline HIV risk behaviors at 24 month
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trajectories of participants' interactions with health services during the two years following their ED visit for an acute violent injury or for non-violence related care
Time Frame: through the study completion, over 24 months
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Services will include substance abuse treatment, mental health services, and medical services including ED recidivism and HIV testing as assessed through chart review
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through the study completion, over 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca Cunningham, MD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carter PM, Dora-Laskey AD, Goldstick JE, Heinze JE, Walton MA, Zimmerman MA, Roche JS, Cunningham RM. Arrests Among High-Risk Youth Following Emergency Department Treatment for an Assault Injury. Am J Prev Med. 2018 Dec;55(6):812-821. doi: 10.1016/j.amepre.2018.07.003. Epub 2018 Oct 19.
- Carter PM, Walton MA, Roehler DR, Goldstick J, Zimmerman MA, Blow FC, Cunningham RM. Firearm violence among high-risk emergency department youth after an assault injury. Pediatrics. 2015 May;135(5):805-15. doi: 10.1542/peds.2014-3572. Epub 2015 Apr 6.
- Cunningham RM, Ranney M, Newton M, Woodhull W, Zimmerman M, Walton MA. Characteristics of youth seeking emergency care for assault injuries. Pediatrics. 2014 Jan;133(1):e96-105. doi: 10.1542/peds.2013-1864. Epub 2013 Dec 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
June 28, 2010
First Submitted That Met QC Criteria
June 28, 2010
First Posted (Estimate)
June 29, 2010
Study Record Updates
Last Update Posted (Estimate)
August 10, 2016
Last Update Submitted That Met QC Criteria
August 8, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- DA024646 01A2
- R01DA024646-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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