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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Tracking Information | ||||
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First Submitted Date ICMJE | January 15, 2010 | |||
First Posted Date ICMJE | January 18, 2010 | |||
Last Update Posted Date | April 22, 2015 | |||
Study Start Date ICMJE | September 2010 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ] | |||
Original Primary Outcome Measures ICMJE |
alcohol use [ Time Frame: baseline, 3 months, 6 months, 12 months ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
health-related outcomes (injury, mental health, illicit and psychoactive prescription drug use/consequences, and other risk behaviors) [ Time Frame: 3-12 month period ] | |||
Original Secondary Outcome Measures ICMJE |
health-related outcomes (injury, mental health, and other risk behaviors) [ Time Frame: baseline, 3 months, 6 months, 12 months ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER | |||
Official Title ICMJE | Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER | |||
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. | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Alcohol Misuse | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
870 | |||
Original Estimated Enrollment ICMJE |
900 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion criteria for screening:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 14 Years to 20 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01051141 | |||
Other Study ID Numbers ICMJE | AA 018122 01 R01AA018122-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Maureen A Walton, University of Michigan | |||
Original Responsible Party | Maureen Walton, PhD, MPH, University of Michigan | |||
Current Study Sponsor ICMJE | University of Michigan | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | |||
Investigators ICMJE |
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PRS Account | University of Michigan | |||
Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |