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

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ClinicalTrials.gov Identifier: NCT01051141
Recruitment Status : Completed
First Posted : January 18, 2010
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Maureen A Walton, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 15, 2010
First Posted Date  ICMJE January 18, 2010
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE September 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2011)
alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
alcohol use [ Time Frame: baseline, 3 months, 6 months, 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2011)
health-related outcomes (injury, mental health, illicit and psychoactive prescription drug use/consequences, and other risk behaviors) [ Time Frame: 3-12 month period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
health-related outcomes (injury, mental health, and other risk behaviors) [ Time Frame: baseline, 3 months, 6 months, 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
Official Title  ICMJE Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Alcohol Misuse
Intervention  ICMJE
  • Behavioral: Computer-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.
  • Behavioral: Intervener-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.
  • Behavioral: Adapted 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Behavioral: Computer-delivered Brief Intervention (CBI)
    • Behavioral: Adapted Motivational Enhancement Therapy (AMET)
  • Active Comparator: CBI in ED with EUC at 3 months
    Intervention: Behavioral: Computer-delivered Brief Intervention (CBI)
  • Active Comparator: IBI in ED with AMET at 3 months
    Interventions:
    • Behavioral: Intervener-delivered Brief Intervention (IBI)
    • Behavioral: Adapted Motivational Enhancement Therapy (AMET)
  • Active Comparator: IBI in ED with EUC at 3 months
    Intervention: Behavioral: Intervener-delivered Brief Intervention (IBI)
  • Active Comparator: EUC in ED with AMET at 3 months
    Intervention: Behavioral: Adapted Motivational Enhancement Therapy (AMET)
  • No Intervention: EUC in ED with EUC at 3 months
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
870
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2010)
900
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01051141
Other Study ID Numbers  ICMJE AA 018122 01
R01AA018122-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Maureen A Walton, University of Michigan
Original Responsible Party Maureen Walton, PhD, MPH, University of Michigan
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Maureen Walton, PhD, MPH University of Michigan
PRS Account University of Michigan
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP