NCT01051141

Brief Summary

The Emergency Department (ED) setting is a unique point of access for reaching underage drinkers (age 14-20). With the aid of computer technology, this study will screen underage drinkers in the ED and fully test promising ED-based brief intervention and 3-month follow-up brief treatment approaches for alcohol misuse. Developing methods to efficiently and effectively optimize these approaches has powerful public health implications for improving outcomes for underage drinkers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
870

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

3.5 years

First QC Date

January 15, 2010

Last Update Submit

April 20, 2015

Conditions

Alcohol Misuse

Keywords

alcohol usebrief interventionrisk behaviors

Outcome Measures

Primary Outcomes (1)

  • alcohol use, alcohol related consequences

    3 -12 month period

Secondary Outcomes (1)

  • health-related outcomes (injury, mental health, illicit and psychoactive prescription drug use/consequences, and other risk behaviors)

    3-12 month period

Study Arms (6)

CBI in ED with AMET at 3 months

ACTIVE COMPARATOR

computer brief intervention (CBI) at baseline with adapted motivational enhancement therapy-AMET at 3 months

Behavioral: Computer-delivered Brief Intervention (CBI)Behavioral: Adapted Motivational Enhancement Therapy (AMET)

CBI in ED with EUC at 3 months

ACTIVE COMPARATOR
Behavioral: Computer-delivered Brief Intervention (CBI)

IBI in ED with AMET at 3 months

ACTIVE COMPARATOR
Behavioral: Intervener-delivered Brief Intervention (IBI)Behavioral: Adapted Motivational Enhancement Therapy (AMET)

IBI in ED with EUC at 3 months

ACTIVE COMPARATOR
Behavioral: Intervener-delivered Brief Intervention (IBI)

EUC in ED with AMET at 3 months

ACTIVE COMPARATOR
Behavioral: Adapted Motivational Enhancement Therapy (AMET)

EUC in ED with EUC at 3 months

NO INTERVENTION

Interventions

Computer-delivered Brief Intervention (CBI)BEHAVIORAL

The multimedia, interactive CBI condition will be delivered using touch-screen tablet computers with audio delivered via headphones. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant.

CBI in ED with AMET at 3 monthsCBI in ED with EUC at 3 months
Intervener-delivered Brief Intervention (IBI)BEHAVIORAL

The IBI condition will be delivered by a master's-level clinician with the aid of graphics. The interventions are highly individualized and designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant.

IBI in ED with AMET at 3 monthsIBI in ED with EUC at 3 months
Adapted Motivational Enhancement Therapy (AMET)BEHAVIORAL

The AMET session will have a similar general outline (\~45 minutes) to the BI in the ED, including a review of participants' goals and values, alcohol use and consequences, decisional balance exercises, and change plan.

CBI in ED with AMET at 3 monthsEUC in ED with AMET at 3 monthsIBI in ED with AMET at 3 months

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (1) Patients age 14-20 years presenting to the UMMC ED for medical care
  • (2) ability to provide informed consent.

You may not qualify if:

  • (1) patients who do not understand English
  • (2) patients deemed unable to provide informed consent (e.g., mental incompetence, prisoners);
  • (3) adolescents ages 14-17 presenting without a parent/guardian; and
  • (4) patients treated in the ED for suicide attempts or sexual assault.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (12)

  • Bonar EE, Cunningham RM, Polshkova S, Chermack ST, Blow FC, Walton MA. Alcohol and energy drink use among adolescents seeking emergency department care. Addict Behav. 2015 Apr;43:11-7. doi: 10.1016/j.addbeh.2014.11.023. Epub 2014 Nov 26.

    PMID: 25528143RESULT

  • Whiteside LK, Cunningham RM, Bonar EE, Blow F, Ehrlich P, Walton MA. Nonmedical prescription stimulant use among youth in the emergency department: prevalence, severity and correlates. J Subst Abuse Treat. 2015 Jan;48(1):21-7. doi: 10.1016/j.jsat.2014.05.003. Epub 2014 Jun 10.

    PMID: 25012553RESULT

  • Singh V, Walton MA, Whiteside LK, Stoddard S, Epstein-Ngo Q, Chermack ST, Cunningham RM. Dating violence among male and female youth seeking emergency department care. Ann Emerg Med. 2014 Oct;64(4):405-412.e1. doi: 10.1016/j.annemergmed.2014.05.027. Epub 2014 Jun 30.

    PMID: 24993689RESULT

  • Bonar EE, Cunningham RM, Chermack ST, Blow FC, Barry KL, Booth BM, Walton MA. Prescription drug misuse and sexual risk behaviors among adolescents and emerging adults. J Stud Alcohol Drugs. 2014 Mar;75(2):259-68. doi: 10.15288/jsad.2014.75.259.

    PMID: 24650820RESULT

  • Dooley-Hash S, Lipson SK, Walton MA, Cunningham RM. Increased emergency department use by adolescents and young adults with eating disorders. Int J Eat Disord. 2013 May;46(4):308-15. doi: 10.1002/eat.22070. Epub 2012 Oct 9.

    PMID: 23044650RESULT

  • Dooley-Hash S, Banker JD, Walton MA, Ginsburg Y, Cunningham RM. The prevalence and correlates of eating disorders among emergency department patients aged 14-20 years. Int J Eat Disord. 2012 Nov;45(7):883-90. doi: 10.1002/eat.22026. Epub 2012 May 8.

    PMID: 22570093RESULT

  • Whiteside LK, Walton MA, Bohnert AS, Blow FC, Bonar EE, Ehrlich P, Cunningham RM. Nonmedical prescription opioid and sedative use among adolescents in the emergency department. Pediatrics. 2013 Nov;132(5):825-32. doi: 10.1542/peds.2013-0721. Epub 2013 Oct 28.

    PMID: 24167166RESULT

  • Walton MA, Chermack ST, Blow FC, Ehrlich PF, Barry KL, Booth BM, Cunningham RM. Components of Brief Alcohol Interventions for Youth in the Emergency Department. Subst Abus. 2015;36(3):339-49. doi: 10.1080/08897077.2014.958607. Epub 2014 Sep 15.

    PMID: 25222484RESULT

  • Ngo QM, Eisman AB, Walton MA, Kusunoki Y, Chermack ST, Singh V, Cunningham R. Emergency Department Alcohol Intervention: Effects on Dating Violence and Depression. Pediatrics. 2018 Jul;142(1):e20173525. doi: 10.1542/peds.2017-3525. Epub 2018 Jun 5.

    PMID: 29871891DERIVED

  • Ehrlich PF, Roche JS, Cunningham RM, Chermack ST, Carter PM, Booth BM, Blow F, Barry K, Walton MA. Underage drinking, brief interventions, and trauma patients: Are they really special? J Trauma Acute Care Surg. 2016 Jul;81(1):149-55. doi: 10.1097/TA.0000000000001093.

    PMID: 27120317DERIVED

  • Cunningham RM, Chermack ST, Ehrlich PF, Carter PM, Booth BM, Blow FC, Barry KL, Walton MA. Alcohol Interventions Among Underage Drinkers in the ED: A Randomized Controlled Trial. Pediatrics. 2015 Oct;136(4):e783-93. doi: 10.1542/peds.2015-1260. Epub 2015 Sep 7.

    PMID: 26347440DERIVED

  • Bonar EE, Walton MA, Caldwell MT, Whiteside LK, Barry KL, Cunningham RM. Sexually Transmitted Infection History among Adolescents Presenting to the Emergency Department. J Emerg Med. 2015 Nov;49(5):613-22. doi: 10.1016/j.jemermed.2015.02.017. Epub 2015 May 4.

    PMID: 25952707DERIVED

MeSH Terms

Conditions

Alcohol DrinkingRisk-Taking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Maureen Walton, PhD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

US(1)