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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Michigan
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center Emergency Department

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. 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);
  2. 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:

  1. youth who do not understand English
  2. youth deemed unable to provide informed assent/consent by ED or research staff
  3. prisoners at time of ED presentation.
  4. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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
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
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
through the study completion, over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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