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
  Purpose

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 Intervention
Alcohol Misuse
Behavioral: Computer-delivered Brief Intervention (CBI)
Behavioral: Intervener-delivered Brief Intervention (IBI)
Behavioral: Adapted Motivational Enhancement Therapy (AMET)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 900
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051141

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Maureen Walton, PhD, MPH University of Michigan
  More Information

No publications provided

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
Study First Received: January 15, 2010
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
alcohol use
brief intervention
risk behaviors

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014