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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Abuse	Behavioral: MI/Family Check-up; Behavioral: MI only	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Family Motivational Interviews for ETOH+ Teens in the ER
• Study Start Date: October 2002
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. marijuana use [ Time Frame: 3 months ]
   Days of use in prior 3 months
2. Marijuana use [ Time Frame: 6 months ]
   Days of use in prior 3 months
3. Marijuana use [ Time Frame: 12 months ]
   Days of use in prior 3 months

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Rhode Island

Rhode Island Hospital/Lifespan Corporation and Brown University

Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Brown University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Study Director: Anthony Spirito, PhD; Brown University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Anthony Spirito, Professor, Brown University
• ClinicalTrials.gov Identifier: NCT00247221
• Other Study ID Numbers: NIAAASPI013385; R01AA013385 ( U.S. NIH Grant/Contract ); NIH grant R01 AA013385
• First Posted: November 1, 2005
• Last Update Posted: July 31, 2012
• Last Verified: July 2012

Keywords provided by Anthony Spirito, Brown University:

Alcohol; Substance abuse; Adolescent; Family functioning

Additional relevant MeSH terms:

Alcoholism; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders