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Completed

NCT Number: NCT01051141

Project U Connect - 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.

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Key information

Conditions

Alcohol Misuse Alcohol Drinking Behavior Drinking Behavior Risk-Taking

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2010
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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