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

• ClinicalTrials.gov Identifier: NCT01051141
• Recruitment Status: Completed
• First Posted: January 18, 2010
• Last Update Posted: April 22, 2015
• Sponsor: University of Michigan
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Maureen A Walton, University of Michigan

Tracking Information

• First Submitted Date: January 15, 2010
• First Posted Date: January 18, 2010
• Last Update Posted Date: April 22, 2015
• Study Start Date: September 2010
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 12, 2011): alcohol use, alcohol related consequences [ Time Frame: 3 -12 month period ]
• Original Primary Outcome Measures (submitted: January 15, 2010): alcohol use [ Time Frame: baseline, 3 months, 6 months, 12 months ]
• Current Secondary Outcome Measures (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 (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Project U Connect - Optimizing Brief Alcohol Intervention for Underage Drinkers in the ER
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Alcohol Misuse

Intervention

• 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. doi: 10.15288/jsad.2014.75.259.
• 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.
• Ngo QM, Eisman AB, Walton MA, Kusunoki Y, Chermack ST, Singh V, Cunningham R. Emergency Department Alcohol Intervention: Effects on Dating Violence and Depression. Pediatrics. 2018 Jul;142(1):e20173525. doi: 10.1542/peds.2017-3525. Epub 2018 Jun 5.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2015): 870
• Original Estimated Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01051141
• Other Study ID Numbers: 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
• Current Responsible Party: Maureen A Walton, University of Michigan
• Original Responsible Party: Maureen Walton, PhD, MPH, University of Michigan
• Current Study Sponsor: University of Michigan
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Maureen Walton, PhD, MPH; University of Michigan

• PRS Account: University of Michigan
• Verification Date: April 2015