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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01051141
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
870
1
6
45
19.3

Study Details

Study Description

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
  • Behavioral: Computer-delivered Brief Intervention (CBI)
  • Behavioral: Intervener-delivered Brief Intervention (IBI)
  • Behavioral: Adapted Motivational Enhancement Therapy (AMET)
N/A

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

Study Type:
Interventional
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 :
Sep 1, 2010
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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

Primary Outcome Measures

  1. alcohol use, alcohol related consequences [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) [3-12 month period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Maureen Walton, PhD, MPH, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maureen A Walton, Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT01051141
Other Study ID Numbers:
  • AA 018122 01
  • R01AA018122-01
First Posted:
Jan 18, 2010
Last Update Posted:
Apr 22, 2015
Last Verified:
Apr 1, 2015
Keywords provided by Maureen A Walton, Professor, University of Michigan

Study Results

No Results Posted as of Apr 22, 2015