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Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
This study has been completed.
Sponsor:
University of Michigan
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Maureen A Walton, University of Michigan
ClinicalTrials.gov Identifier:
NCT01051141
First received: January 15, 2010
Last updated: April 20, 2015
Last verified: April 2015
| Tracking Information | ||||
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| First Received Date ICMJE | January 15, 2010 | |||
| Last Updated Date | April 20, 2015 | |||
| Start Date ICMJE | September 2010 | |||
| 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 | Complete list of historical versions of study NCT01051141 on ClinicalTrials.gov Archive Site | |||
| 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 Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | 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 | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Alcohol Misuse | |||
| Intervention ICMJE |
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| Study Arms |
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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 | |||
| Enrollment ICMJE | 870 | |||
| Completion Date | June 2014 | |||
| 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 |
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| Ages | 14 Years to 20 Years (Child, Adult) | |||
| Accepts Healthy Volunteers | 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 ( US NIH Grant/Contract Award Number ) |
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| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Maureen A Walton, University of Michigan | |||
| Study Sponsor ICMJE | University of Michigan | |||
| 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 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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