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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00251212
Other study ID # AA-014889-01A1
Secondary ID
Status Completed
Phase N/A
First received November 7, 2005
Last updated April 9, 2014
Start date September 2006
Est. completion date October 2012

Study information

Verified date April 2014
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 by a computer or by a counselor, and an informational handout control condition.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3694
Est. completion date October 2012
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Adapted Motivational Interviewing & Skills Training
Single session, 45 minute brief intervention during Emergency Department Visit

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

References & Publications (14)

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.2011-34 — View 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. — View 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: 1 — View 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 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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/jam — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Primary outcome variables include alcohol misuse and violent behaviors. 12-months Yes
Secondary Secondary outcome measures include illicit drug use, unintentional injury, delinquency and weapon carriage. 12-months Yes
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