CClinicalTrials.gg
CompletedNCT01051141Updated Apr 22, 2015

Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

An interventional study of Computer-delivered Brief Intervention (CBI) and Intervener-delivered Brief Intervention (IBI) in Alcohol Misuse, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 14 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by University of Michigan · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
870
Allocation
Randomized
Ages
14 Years to 20 Years
Sex
All
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Study 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.

Read the detailed description

The proposed study will use computerized screening using touchscreen computer tablets with audio (\~5,700 patients) and will test a developmentally appropriate, tailored intervention. Specifically, 900 patients aged 14-20 in the ED who screen positive for problematic alcohol use in the past 3 months will be randomized to the combinations of three ED-based conditions: 1) computer brief intervention-CBI; 2) therapist/intervener delivered brief intervention-IBI; or 3) enhanced usual care-EUC. All participants will be randomized to one of two follow-up conditions: 1) adapted motivational enhancement therapy-AMET; or 2) enhanced usual care-EUC that will take place 3 months post-ED. All participants will receive written information regarding community resources; individuals who meet alcohol use disorder criteria will additionally receive substance use treatment referrals.

Recognizing that brief interventions are important, but not necessarily sufficient, for change in all adolescents and young adults who misuse alcohol, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ED-based brief intervention conditions, 3-month follow-up brief treatment conditions, and combinations of conditions, for decreasing alcohol use and improving health-related outcomes (including injury, mental health, and other risk behaviors) at 6- and 12-months follow-up.

02

Conditions studied

  • Alcohol Misuse

Keywords

  • alcohol use
  • brief intervention
  • risk behaviors
03

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,476 studies on the registry; 197 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for screening:

  • (1) Patients age 14-20 years presenting to the UMMC ED for medical care
  • (2) ability to provide informed consent.
  • Additional inclusion criteria for intervention based on "alcohol misuse": Participants screening positive on the AUDIT for problematic alcohol use in the past 3 months will be eligible for the randomized control trial.

Exclusion Criteria:

  • (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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
870 participants (actual)

Study arms

  • Active comparator
    CBI in ED with AMET at 3 months

    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)

  • Active comparator
    CBI in ED with EUC at 3 months

    Behavioral: Computer-delivered Brief Intervention (CBI)

  • Active comparator
    IBI in ED with AMET at 3 months

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

  • Active comparator
    IBI in ED with EUC at 3 months

    Behavioral: Intervener-delivered Brief Intervention (IBI)

  • Active comparator
    EUC in ED with AMET at 3 months

    Behavioral: Adapted Motivational Enhancement Therapy (AMET)

  • No intervention
    EUC in ED with EUC at 3 months

Interventions

  • BehavioralComputer-delivered Brief Intervention (CBI)

    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.

  • BehavioralIntervener-delivered Brief Intervention (IBI)

    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.

  • BehavioralAdapted Motivational Enhancement Therapy (AMET)

    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.

06

What researchers measure

Primary outcomes

  1. alcohol use, alcohol related consequences

    Time frame: 3 -12 month period

Secondary outcomes

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

    Time frame: 3-12 month period

07

Study locations

1 site
  • University of Michigan Health System
    Ann Arbor, Michigan 48109, United States
08

References and documents

Publications

  • 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. PubMed 25528143 ↗
  • 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. PubMed 25012553 ↗
  • 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. PubMed 24993689 ↗
  • 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. PubMed 24650820 ↗
  • 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. PubMed 23044650 ↗
  • 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. PubMed 22570093 ↗
  • 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. PubMed 24167166 ↗
  • 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. PubMed 25222484 ↗
  • 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. PubMed 29871891 ↗
  • 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. PubMed 27120317 ↗
  • 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. PubMed 26347440 ↗
  • 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. PubMed 25952707 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01051141
Lead sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Maureen A Walton (Professor, University of Michigan) — Principal investigator
First posted
Jan 18, 2010
Start date
Sep 2010
Primary completion
Mar 2014
Completion
Jun 2014
Last update
Apr 22, 2015

Study contacts

Maureen Walton, PhD, MPH
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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