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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT00247221
First received: October 28, 2005
Last updated: July 28, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Behavioral: MI/Family Check-up
Behavioral: MI only
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family Motivational Interviews for ETOH+ Teens in the ER

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Alcohol use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • marijuana use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Days of use in prior 3 months

  • Marijuana use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Days of use in prior 3 months

  • Marijuana use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Days of use in prior 3 months


Enrollment: 208
Study Start Date: October 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Active Comparator: 2) MI only 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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247221

Locations
United States, Rhode Island
Rhode Island Hospital/Lifespan Corporation and Brown University
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Investigators
Study Director: Anthony Spirito, PhD Brown University
  More Information

No publications provided by Brown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT00247221     History of Changes
Other Study ID Numbers: NIAAASPI013385, R01AA013385, NIH grant R01 AA013385
Study First Received: October 28, 2005
Last Updated: July 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
Alcohol
Substance abuse
Adolescent
Family functioning

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014