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Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event

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ClinicalTrials.gov Identifier: NCT00247221
Recruitment Status : Completed
First Posted : November 1, 2005
Last Update Posted : July 31, 2012
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Anthony Spirito, Brown University

Tracking Information
First Submitted Date  ICMJE October 28, 2005
First Posted Date  ICMJE November 1, 2005
Last Update Posted Date July 31, 2012
Study Start Date  ICMJE October 2002
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • Alcohol use [ Time Frame: 3 months ]
    Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
  • Alcohol use [ Time Frame: 6 months ]
    Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
  • Alcohol use [ Time Frame: 12 months ]
    Drinking frequency (days per month), quantity (drinks per occasion), and frequency of high-volume drinking (5 or more drinks per occasion) over the prior 3 months.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
  • Alcohol consumption
  • Alcohol-related consequences
  • Alcohol-related risky behaviors
  • Adolescent problem behaviors
  • Family management
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • marijuana use [ Time Frame: 3 months ]
    Days of use in prior 3 months
  • Marijuana use [ Time Frame: 6 months ]
    Days of use in prior 3 months
  • Marijuana use [ Time Frame: 12 months ]
    Days of use in prior 3 months
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
  • Parent influences on adolescent alcohol use and problems
  • Peer influences on adolescent alcohol use and problems
  • Impact of adolescent internalizing problems (depressed mood) on treatment
  • Impact of adolescent externalizing problems (behavior problems) on treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event
Official Title  ICMJE Family Motivational Interviews for ETOH+ Teens in the ER
Brief Summary The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.
Detailed Description

The long-term objectives of this research program are to develop effective interventions in health care settings for reducing problem drinking and associated problems among adolescents and to further enhance intervention approaches by identifying effective elements of treatment. The major purpose of this study is to compare a brief integrated individual and family intervention designed to reduce alcohol use and related problems to an enhanced standard care condition (standard care plus family assessment).

The targeted population is underage drinkers (13-17 years old) who have been treated in an Emergency Department following an alcohol-related event. It is important to intervene with this population because alcohol-involved adolescents may be at higher risk for having continuing alcohol problems (Fillmore, 1988; Zucker, in press). The intervention is conceptualized as using a "teachable moment" (i.e., shortly after a salient event) to increase family interest in reducing harmful drinking. The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent, based on our research group's prior work with this intervention, with a brief family intervention, the Family Check-Up (Dishion & Kavanagh, 2003).

The experimental condition will be compared to standard care plus family assessment. This design allows us to test the added benefit of the brief family intervention compared to the benefits often derived from assessment without added treatment. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome. The specific aims of this proposal are to test the effectiveness of the experimental intervention in reducing alcohol-related problems, alcohol consumption, and other behavior problems compared to the enhanced standard care condition. Second, we will examine whether depressed mood and behavior problems at baseline moderate the effects of the treatment conditions. We will also test whether individual factors (motivation to change behavior) and environmental factors (parent/family influence and peer influence) mediate the relation between the treatment condition and outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Abuse
Intervention  ICMJE
  • Behavioral: MI/Family Check-up
    The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention.
  • Behavioral: MI only
    An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.
Study Arms  ICMJE
  • Experimental: 1) MI/Family Check-Up
    Brief integrated individual and family intervention -- the experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up
    Intervention: Behavioral: MI/Family Check-up
  • Active Comparator: 2) MI only
    Intervention: Behavioral: MI only
Publications * Spirito A, Sindelar-Manning H, Colby SM, Barnett NP, Lewander W, Rohsenow DJ, Monti PM. Individual and family motivational interventions for alcohol-positive adolescents treated in an emergency department: results of a randomized clinical trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):269-74. doi: 10.1001/archpediatrics.2010.296.

*   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: September 26, 2008)
208
Original Enrollment  ICMJE
 (submitted: October 28, 2005)
252
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Child aged 13-17 years
  • Receiving treatment at the approved medical Emergency Department
  • Child living in a home with at least one parent or legal guardian

Exclusion Criteria:

  • Children who are suicidal, in police custody, not alert/oriented, non-English speaking, in severe pain, or who have sustained severe trauma
  • Children with a history of prior substance abuse treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
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 NCT00247221
Other Study ID Numbers  ICMJE NIAAASPI013385
R01AA013385 ( U.S. NIH Grant/Contract )
NIH grant R01 AA013385
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Spirito, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Study Director: Anthony Spirito, PhD Brown University
PRS Account Brown University
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP