NCT00247221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

5.8 years

First QC Date

October 28, 2005

Last Update Submit

July 28, 2012

Conditions

Alcohol Abuse

Keywords

AlcoholSubstance abuseAdolescentFamily functioning

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • marijuana use

    3 months

  • Marijuana use

    6 months

  • Marijuana use

    12 months

Study Arms (2)

1) MI/Family Check-Up

EXPERIMENTAL

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

2) MI only

ACTIVE COMPARATOR
Behavioral: MI only

Interventions

MI/Family Check-upBEHAVIORAL

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.

1) MI/Family Check-Up
MI onlyBEHAVIORAL

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

2) MI only

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital/Lifespan Corporation and Brown University

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • 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.

    PMID: 21383276DERIVED

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anthony Spirito, PhD

    Brown University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2005

First Posted

November 1, 2005

Study Start

October 1, 2002

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

US(1)