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Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER)

Primary Purpose

Violence, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adapted Motivational Interviewing & Skills Training
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Violence focused on measuring Alcohol, Violence, Alcohol consumption, Alcohol, drinking

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adolescents (ages 14-18) presenting to the ED for a medical injury or illness (except exclusions as noted below) adolescents ability to provide informed assent/consent depending on age access to a parent or guardian to provide informed consent Exclusion Criteria: adolescents who do not understand English prisoners adolescents classified by medical staff as "Level 1" trauma adolescents deemed unable to provide informed consent adolescents treated in the ED for suicide attempts adolescents triaged to the psychiatric ED

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    1

    2

    3

    Arm Description

    Therapist delivered adapted motivational enhancement therapy and skills training

    Computer delivered adapted motivational enhancement therapy and skills training

    3: Control brochure

    Outcomes

    Primary Outcome Measures

    Primary outcome variables include alcohol misuse and violent behaviors.

    Secondary Outcome Measures

    Secondary outcome measures include illicit drug use, unintentional injury, delinquency and weapon carriage.

    Full Information

    First Posted
    November 7, 2005
    Last Updated
    April 9, 2014
    Sponsor
    University of Michigan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00251212
    Brief Title
    Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER)
    Official Title
    Tailored Teen Alcohol and Violence Prevention in the ER
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to address both alcohol misuse and violence among adolescents ages 14-18 seeking care in an urban emergency department (ED). The study is a randomized controlled trial comparing the effectiveness of a combined Adapted Motivational Interviewing and Skills Training intervention, delivered either by a computer or by a counselor, and an informational handout control condition.
    Detailed Description
    This study will screen ~3000 adolescents in the ED (ages 14-18) over 30 months. Eligible adolescents will be asked to participate in the longitudinal study, stratified by age and gender and randomized to conditions (n=225/group): Computer Prevention Program, Counselor Prevention Program, or an informational handout control condition. Primary outcomes will be evaluated at 3, 6 and 12-months and include alcohol use/misuse, violent behaviors, illicit drug use, unintentional injury, delinquency, and weapon carriage. The proposed study integrates brief intervention strategies for alcohol misuse and violent behaviors using state-of-the-art technology to tailor the interventions to the specific risk factors of the adolescent. Tailored computerized programs use available technology to replace the need for clinical staff in the ED setting, where there is limited staff time to effect behavior change. This project will provide the critical first step toward the implementation of an integrated prevention program addressing overlapping risk factors that has the potential to be delivered to the millions of adolescents visiting urban Emergency Departments each year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Violence, Alcohol Abuse
    Keywords
    Alcohol, Violence, Alcohol consumption, Alcohol, drinking

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    3694 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Therapist delivered adapted motivational enhancement therapy and skills training
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Computer delivered adapted motivational enhancement therapy and skills training
    Arm Title
    3
    Arm Type
    No Intervention
    Arm Description
    3: Control brochure
    Intervention Type
    Behavioral
    Intervention Name(s)
    Adapted Motivational Interviewing & Skills Training
    Other Intervention Name(s)
    1: Therapist delivered brief intervention, 2: Computer delivered brief intervention, 3: Control condition
    Intervention Description
    Single session, 45 minute brief intervention during Emergency Department Visit
    Primary Outcome Measure Information:
    Title
    Primary outcome variables include alcohol misuse and violent behaviors.
    Time Frame
    12-months
    Secondary Outcome Measure Information:
    Title
    Secondary outcome measures include illicit drug use, unintentional injury, delinquency and weapon carriage.
    Time Frame
    12-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adolescents (ages 14-18) presenting to the ED for a medical injury or illness (except exclusions as noted below) adolescents ability to provide informed assent/consent depending on age access to a parent or guardian to provide informed consent Exclusion Criteria: adolescents who do not understand English prisoners adolescents classified by medical staff as "Level 1" trauma adolescents deemed unable to provide informed consent adolescents treated in the ED for suicide attempts adolescents triaged to the psychiatric ED
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maureen Walton, PhD, MPH
    Organizational Affiliation
    University of Michigan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19290695
    Citation
    Goldstein AL, Walton MA, Cunningham RM, Resko SM, Duan L. Correlates of gambling among youth in an inner-city emergency department. Psychol Addict Behav. 2009 Mar;23(1):113-21. doi: 10.1037/a0013912.
    Results Reference
    background
    PubMed Identifier
    19541253
    Citation
    Walton MA, Cunningham RM, Goldstein AL, Chermack ST, Zimmerman MA, Bingham CR, Shope JT, Stanley R, Blow FC. Rates and correlates of violent behaviors among adolescents treated in an urban emergency department. J Adolesc Health. 2009 Jul;45(1):77-83. doi: 10.1016/j.jadohealth.2008.12.005. Epub 2009 Feb 20.
    Results Reference
    background
    PubMed Identifier
    19508314
    Citation
    Whiteside LK, Walton MA, Stanley R, Resko SM, Chermack ST, Zimmerman MA, Cunningham RM. Dating aggression and risk behaviors among teenage girls seeking gynecologic care. Acad Emerg Med. 2009 Jul;16(7):632-8. doi: 10.1111/j.1553-2712.2009.00426.x. Epub 2009 Jun 9.
    Results Reference
    background
    PubMed Identifier
    20857328
    Citation
    Resko SM, Walton MA, Bingham CR, Shope JT, Zimmerman M, Chermack ST, Blow FC, Cunningham RM. Alcohol availability and violence among inner-city adolescents: A multi-level analysis of the role of alcohol outlet density. Am J Community Psychol. 2010 Dec;46(3-4):253-62. doi: 10.1007/s10464-010-9353-6.
    Results Reference
    background
    PubMed Identifier
    20370746
    Citation
    Cunningham RM, Resko SM, Harrison SR, Zimmerman M, Stanley R, Chermack ST, Walton MA. Screening adolescents in the emergency department for weapon carriage. Acad Emerg Med. 2010 Feb;17(2):168-76. doi: 10.1111/j.1553-2712.2009.00639.x.
    Results Reference
    background
    PubMed Identifier
    20159053
    Citation
    Loh K, Walton MA, Harrison SR, Zimmerman M, Stanley R, Chermack ST, Cunningham RM. Prevalence and correlates of handgun access among adolescents seeking care in an urban emergency department. Accid Anal Prev. 2010 Mar;42(2):347-53. doi: 10.1016/j.aap.2009.11.012. Epub 2010 Jan 19.
    Results Reference
    background
    PubMed Identifier
    21338903
    Citation
    Walton MA, Resko S, Whiteside L, Chermack ST, Zimmerman M, Cunningham RM. Sexual risk behaviors among teens at an urban emergency department: relationship with violent behaviors and substance use. J Adolesc Health. 2011 Mar;48(3):303-5. doi: 10.1016/j.jadohealth.2010.07.005.
    Results Reference
    background
    PubMed Identifier
    21996067
    Citation
    Ranney ML, Whiteside L, Walton MA, Chermack ST, Zimmerman MA, Cunningham RM. Sex differences in characteristics of adolescents presenting to the emergency department with acute assault-related injury. Acad Emerg Med. 2011 Oct;18(10):1027-35. doi: 10.1111/j.1553-2712.2011.01165.x.
    Results Reference
    background
    PubMed Identifier
    22119182
    Citation
    Resko SM, Walton MA, Chermack ST, Blow FC, Cunningham RM. Therapist competence and treatment adherence for a brief intervention addressing alcohol and violence among adolescents. J Subst Abuse Treat. 2012 Jun;42(4):429-37. doi: 10.1016/j.jsat.2011.09.006. Epub 2011 Nov 25.
    Results Reference
    background
    PubMed Identifier
    23200158
    Citation
    Whiteside LK, Ranney ML, Chermack ST, Zimmerman MA, Cunningham RM, Walton MA. The overlap of youth violence among aggressive adolescents with past-year alcohol use-A latent class analysis: aggression and victimization in peer and dating violence in an inner city emergency department sample. J Stud Alcohol Drugs. 2013 Jan;74(1):125-35. doi: 10.15288/jsad.2013.74.125.
    Results Reference
    background
    PubMed Identifier
    20053240
    Citation
    Cunningham RM, Walton MA, Goldstein A, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC. Three-month follow-up of brief computerized and therapist interventions for alcohol and violence among teens. Acad Emerg Med. 2009 Nov;16(11):1193-207. doi: 10.1111/j.1553-2712.2009.00513.x.
    Results Reference
    result
    PubMed Identifier
    20682932
    Citation
    Walton MA, Chermack ST, Shope JT, Bingham CR, Zimmerman MA, Blow FC, Cunningham RM. Effects of a brief intervention for reducing violence and alcohol misuse among adolescents: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):527-35. doi: 10.1001/jama.2010.1066.
    Results Reference
    result
    PubMed Identifier
    22614776
    Citation
    Cunningham RM, Chermack ST, Zimmerman MA, Shope JT, Bingham CR, Blow FC, Walton MA. Brief motivational interviewing intervention for peer violence and alcohol use in teens: one-year follow-up. Pediatrics. 2012 Jun;129(6):1083-90. doi: 10.1542/peds.2011-3419. Epub 2012 May 21.
    Results Reference
    result
    PubMed Identifier
    23758302
    Citation
    Cunningham RM, Whiteside LK, Chermack ST, Zimmerman MA, Shope JT, Bingham CR, Blow FC, Walton MA. Dating violence: outcomes following a brief motivational interviewing intervention among at-risk adolescents in an urban emergency department. Acad Emerg Med. 2013 Jun;20(6):562-9. doi: 10.1111/acem.12151.
    Results Reference
    result
    PubMed Identifier
    22744013
    Citation
    Stoddard SA, Whiteside L, Zimmerman MA, Cunningham RM, Chermack ST, Walton MA. The relationship between cumulative risk and promotive factors and violent behavior among urban adolescents. Am J Community Psychol. 2013 Mar;51(1-2):57-65. doi: 10.1007/s10464-012-9541-7.
    Results Reference
    derived

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    Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER)

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