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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00247221
Other study ID # NIAAASPI013385
Secondary ID R01AA013385NIH g
Status Completed
Phase Phase 1
First received October 28, 2005
Last updated July 28, 2012
Start date October 2002
Est. completion date July 2008

Study information

Verified date July 2012
Source Brown University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
MI only
An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.

Locations

Country Name City State
United States Rhode Island Hospital/Lifespan Corporation and Brown University Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months No
Primary 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. 6 months No
Primary 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. 12 months No
Secondary marijuana use Days of use in prior 3 months 3 months No
Secondary Marijuana use Days of use in prior 3 months 6 months No
Secondary Marijuana use Days of use in prior 3 months 12 months No
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