Drug UsageFYINCT01152970
F.Y.I.: Flint Youth Injury Study
An observational study of Drug Usage, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Usage
- How many people
- 638 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2013
- Phase
- Observational
- 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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).-
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
Hurley Medical Center Emergency Department
Flint, Michigan, 48503
About this study
Official title: 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.
- Conditions
- Drug Usage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
substance use as assessed with both the Mini-International Neuropsychiatric Interview
Measured: Change from baseline substance use at 24 month
substance use as assessed with the National Institute on Drug Abuse- Modified Alcohol, Smoking and Substance Involvement Screening Test
Measured: Change from baseline substance use at 24 month
violence behaviors as assessed with the modified Conflict Tactic Scale
Measured: Change from baseline violence behaviors at 24 month
HIV risk behaviors as assessed with the Risk Assessment Battery
Measured: Change from baseline HIV risk behaviors at 24 month
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
Services will include substance abuse treatment, mental health services, and medical services including ED recidivism and HIV testing as assessed through chart review
Measured: through the study completion, over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug UsageStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Rebecca Cunningham, University of Michigan
- Investigators
- Rebecca Cunningham, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152970
- Sponsor's protocol ID
- DA024646 01A2
- Other IDs
- R01DA024646-01A2
- Acronym
- FYI
- Status last verified
- Aug 2016
- First submitted
- 28 Jun 2010
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30344036Carter 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.
PubMed 25847808Cunningham 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.
PubMed 24323994
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Among Violently Injured Youth in Urban ER: Services & Outcomes
- ClinicalTrials.gov ID
- NCT01152970
- Acronym / sponsor ID
- FYI / DA024646 01A2
- Conditions
- Drug Usage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- 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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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).-
Key exclusion criteria (4 listed)
- 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 -
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
substance use as assessed with both the Mini-International Neuropsychiatric Interview
Time frame: Change from baseline substance use at 24 month
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
violence behaviors as assessed with the modified Conflict Tactic Scale
Time frame: Change from baseline violence behaviors at 24 month
HIV risk behaviors as assessed with the Risk Assessment Battery
Time frame: Change from baseline HIV risk behaviors at 24 month
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
Services will include substance abuse treatment, mental health services, and medical services including ED recidivism and HIV testing as assessed through chart review
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 10 Aug 2016.
- Derived from this study: PubMed 30344036Carter 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.
- Derived from this study: PubMed 25847808Carter 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.
- Derived from this study: PubMed 24323994Cunningham 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.
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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.
Rebecca Cunningham, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Usage, run by University of Michigan at 1 site in United States.
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 4 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 10 Aug 2016. 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 United States. 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?
substance use as assessed with both the Mini-International Neuropsychiatric Interview (time frame: Change from baseline substance use at 24 month). The study lists 5 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 NCT01152970, which also lists 3 linked publications.
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 10 Aug 2016.