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

Tracking Information
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; (submitted: August 12, 2011)	alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ]
Original Primary Outcome Measures ICMJE; (submitted: January 15, 2010)	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; (submitted: August 12, 2011)	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; (submitted: January 15, 2010)	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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	Alcohol Misuse
Intervention ICMJE	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: 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.
Study Arms	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 Interventions: Behavioral: Computer-delivered Brief Intervention (CBI) Behavioral: Adapted Motivational Enhancement Therapy (AMET); Active Comparator: CBI in ED with EUC at 3 months Intervention: Behavioral: Computer-delivered Brief Intervention (CBI); Active Comparator: IBI in ED with AMET at 3 months Interventions: Behavioral: Intervener-delivered Brief Intervention (IBI) Behavioral: Adapted Motivational Enhancement Therapy (AMET); Active Comparator: IBI in ED with EUC at 3 months Intervention: Behavioral: Intervener-delivered Brief Intervention (IBI); Active Comparator: EUC in ED with AMET at 3 months Intervention: Behavioral: Adapted Motivational Enhancement Therapy (AMET); No Intervention: EUC in ED with EUC at 3 months
Publications *	Bonar EE, Cunningham RM, Polshkova S, Chermack ST, Blow FC, Walton MA. Alcohol and energy drink use among adolescents seeking emergency department care. Addict Behav. 2015 Apr;43:11-7. doi: 10.1016/j.addbeh.2014.11.023. Epub 2014 Nov 26.; Whiteside LK, Cunningham RM, Bonar EE, Blow F, Ehrlich P, Walton MA. Nonmedical prescription stimulant use among youth in the emergency department: prevalence, severity and correlates. J Subst Abuse Treat. 2015 Jan;48(1):21-7. doi: 10.1016/j.jsat.2014.05.003. Epub 2014 Jun 10.; Singh V, Walton MA, Whiteside LK, Stoddard S, Epstein-Ngo Q, Chermack ST, Cunningham RM. Dating violence among male and female youth seeking emergency department care. Ann Emerg Med. 2014 Oct;64(4):405-412.e1. doi: 10.1016/j.annemergmed.2014.05.027. Epub 2014 Jun 30.; Bonar EE, Cunningham RM, Chermack ST, Blow FC, Barry KL, Booth BM, Walton MA. Prescription drug misuse and sexual risk behaviors among adolescents and emerging adults. J Stud Alcohol Drugs. 2014 Mar;75(2):259-68.; Dooley-Hash S, Lipson SK, Walton MA, Cunningham RM. Increased emergency department use by adolescents and young adults with eating disorders. Int J Eat Disord. 2013 May;46(4):308-15. doi: 10.1002/eat.22070. Epub 2012 Oct 9.; Dooley-Hash S, Banker JD, Walton MA, Ginsburg Y, Cunningham RM. The prevalence and correlates of eating disorders among emergency department patients aged 14-20 years. Int J Eat Disord. 2012 Nov;45(7):883-90. doi: 10.1002/eat.22026. Epub 2012 May 8.; Whiteside LK, Walton MA, Bohnert AS, Blow FC, Bonar EE, Ehrlich P, Cunningham RM. Nonmedical prescription opioid and sedative use among adolescents in the emergency department. Pediatrics. 2013 Nov;132(5):825-32. doi: 10.1542/peds.2013-0721. Epub 2013 Oct 28.; Walton MA, Chermack ST, Blow FC, Ehrlich PF, Barry KL, Booth BM, Cunningham RM. Components of Brief Alcohol Interventions for Youth in the Emergency Department. Subst Abus. 2015;36(3):339-49. doi: 10.1080/08897077.2014.958607. Epub 2014 Sep 15.; Ehrlich PF, Roche JS, Cunningham RM, Chermack ST, Carter PM, Booth BM, Blow F, Barry K, Walton MA. Underage drinking, brief interventions, and trauma patients: Are they really special? J Trauma Acute Care Surg. 2016 Jul;81(1):149-55. doi: 10.1097/TA.0000000000001093.; Cunningham RM, Chermack ST, Ehrlich PF, Carter PM, Booth BM, Blow FC, Barry KL, Walton MA. Alcohol Interventions Among Underage Drinkers in the ED: A Randomized Controlled Trial. Pediatrics. 2015 Oct;136(4):e783-93. doi: 10.1542/peds.2015-1260. Epub 2015 Sep 7.; Bonar EE, Walton MA, Caldwell MT, Whiteside LK, Barry KL, Cunningham RM. Sexually Transmitted Infection History among Adolescents Presenting to the Emergency Department. J Emerg Med. 2015 Nov;49(5):613-22. doi: 10.1016/j.jemermed.2015.02.017. Epub 2015 May 4.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 20, 2015)	870
Original Estimated Enrollment ICMJE; (submitted: January 15, 2010)	900
Actual Study Completion Date	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: (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.
Sex/Gender	Sexes Eligible for Study: All
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 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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	Principal Investigator: Maureen Walton, PhD, MPH University of Michigan
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