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ViolenceNCT00251212

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

A study testing Adapted Motivational Interviewing & Skills Training in people with Violence and Alcohol Abuse, run by University of Michigan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 18 years
Conditions the study is for
Violence, Alcohol Abuse
What is being tested?
Adapted Motivational Interviewing & Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,694 participants
Where
No sites listed yet
Study dates
Sep 2006to Oct 2012
Phase
Interventional
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Tailored Teen Alcohol and Violence Prevention in the ER

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.

Read the 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.

Being tested
Adapted Motivational Interviewing & Skills Training
Keywords
Alcohol, Violence, Alcohol consumption, Alcohol, drinking
Medical subject headings
Alcoholism, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Motivational Interviewing & Skills TrainingBehavioural

    Also called 1: Therapist delivered brief intervention, 2: Computer delivered brief intervention, 3: Control condition

    Single session, 45 minute brief intervention during Emergency Department Visit

Study groups in NCT00251212
Study groupRoleWhat they receive
1Active comparatorTherapist delivered adapted motivational enhancement therapy and skills training
Receives: Behavioral: Adapted Motivational Interviewing & Skills Training
2Active comparatorComputer delivered adapted motivational enhancement therapy and skills training
Receives: Behavioral: Adapted Motivational Interviewing & Skills Training
3No intervention3: Control brochure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome variables include alcohol misuse and violent behaviors.

    Measured: 12-months

Secondary outcomes (1)

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

    Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2005 (estimated)
  2. Study startSep 2006
  3. Primary completionOct 2010
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,694 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251212
Sponsor's protocol ID
AA-014889-01A1
Status last verified
Apr 2014
First submitted
7 Nov 2005
Last updated
10 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19290695

  • 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.

    PubMed 19541253

  • 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.

    PubMed 19508314

  • 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.

    PubMed 20857328

  • 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.

    PubMed 20370746

  • 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.

    PubMed 20159053

  • 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.

    PubMed 21338903

  • 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.

    PubMed 21996067

  • 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.

    PubMed 22119182

  • 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.

    PubMed 23200158

  • 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.

    PubMed 20053240

  • 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.

    PubMed 20682932

  • 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.

    PubMed 22614776

  • 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.

    PubMed 23758302

  • 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.

    PubMed 22744013

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Motivational Interviewing & Skills Training in people with Violence and Alcohol Abuse, run by University of Michigan.

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 6 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Primary outcome variables include alcohol misuse and violent behaviors. (time frame: 12-months). 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 NCT00251212, which also lists 15 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 Apr 2014.

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