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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maureen A Walton, University of Michigan
ClinicalTrials.gov Identifier:
NCT01051141
First received: January 15, 2010
Last updated: April 22, 2014
Last verified: April 2014

January 15, 2010
April 22, 2014
September 2010
March 2013   (final data collection date for primary outcome measure)
alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ] [ Designated as safety issue: Yes ]
alcohol use [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01051141 on ClinicalTrials.gov Archive Site
health-related outcomes (injury, mental health, illicit and psychoactive prescription drug use/consequences, and other risk behaviors) [ Time Frame: 3-12 month period ] [ Designated as safety issue: Yes ]
health-related outcomes (injury, mental health, and other risk behaviors) [ Time Frame: baseline, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Alcohol Misuse
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
June 2014
March 2013   (final data collection date for primary outcome measure)

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.
Both
14 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01051141
AA 018122 01, R01AA018122-01
No
Maureen A Walton, University of Michigan
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Maureen Walton, PhD, MPH University of Michigan
University of Michigan
April 2014

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