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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Misuse Behavioral: Computer-delivered Brief Intervention (CBI) Behavioral: Intervener-delivered Brief Intervention (IBI) Behavioral: Adapted Motivational Enhancement Therapy (AMET) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 870 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
Study Start Date : September 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014
Arms and Interventions
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Arm Intervention/treatment
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)
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: 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 EUC at 3 months 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.
Active Comparator: IBI in ED with AMET at 3 months 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: IBI in ED with EUC at 3 months 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.
Active Comparator: EUC in ED with AMET at 3 months 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.
No Intervention: EUC in ED with EUC at 3 months


Outcome Measures
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Primary Outcome Measures :
  1. alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ]

Secondary Outcome Measures :
  1. health-related outcomes (injury, mental health, illicit and psychoactive prescription drug use/consequences, and other risk behaviors) [ Time Frame: 3-12 month period ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051141


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Maureen Walton, PhD, MPH University of Michigan
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maureen A Walton, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01051141     History of Changes
Other Study ID Numbers: AA 018122 01
R01AA018122-01 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2010    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Maureen A Walton, University of Michigan:
alcohol use
brief intervention
risk behaviors
Additional relevant MeSH terms:
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Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs