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

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MI/Family Check-up
MI only
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Alcohol, Substance abuse, Adolescent, Family functioning

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rhode Island Hospital/Lifespan Corporation and Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1) MI/Family Check-Up

2) MI only

Arm Description

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

Outcomes

Primary Outcome Measures

Alcohol use
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
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
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
Days of use in prior 3 months
Marijuana use
Days of use in prior 3 months
Marijuana use
Days of use in prior 3 months

Full Information

First Posted
October 28, 2005
Last Updated
July 28, 2012
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00247221
Brief Title
Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event
Official Title
Family Motivational Interviews for ETOH+ Teens in the ER
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Alcohol, Substance abuse, Adolescent, Family functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1) MI/Family Check-Up
Arm Type
Experimental
Arm Description
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
Arm Title
2) MI only
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
MI/Family Check-up
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MI only
Intervention Description
An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.
Primary Outcome Measure Information:
Title
Alcohol use
Description
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.
Time Frame
3 months
Title
Alcohol use
Description
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.
Time Frame
6 months
Title
Alcohol use
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
marijuana use
Description
Days of use in prior 3 months
Time Frame
3 months
Title
Marijuana use
Description
Days of use in prior 3 months
Time Frame
6 months
Title
Marijuana use
Description
Days of use in prior 3 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Study Director
Facility Information:
Facility Name
Rhode Island Hospital/Lifespan Corporation and Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21383276
Citation
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.
Results Reference
derived

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

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