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

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Ages Eligible for Study: | 14 Years to 20 Years (Child, Adult) |
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.

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
United States, Michigan | |
University of Michigan Health System | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Maureen Walton, PhD, MPH | University of Michigan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Maureen A Walton, Professor, University of Michigan |
ClinicalTrials.gov Identifier: | NCT01051141 |
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 |
alcohol use brief intervention risk behaviors |