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Clinical Trials/NCT00229983
NCT00229983
Completed
Phase 2

Medical Office Intervention for Adolescent Drug Use

Boston Children's Hospital1 site in 1 country170 target enrollmentJune 2004

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Substance-Related Disorders
Sponsor
Boston Children's Hospital
Enrollment
170
Locations
1
Primary Endpoint
Quantity and days of substance use
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The goal of this study is to assess the efficacy of a new intervention based on motivational enhancement therapy among adolescents with a history of substance use.

Detailed Description

In many parts of the U.S. adolescent substance abuse treatment is scarce. Several studies have shown that brief interventions increase the likelihood of patients' completion of referrals to alcohol counseling or treatment. Other studies have shown a direct effect of brief interventions on patients' alcohol consumption. Although brief interventions have been widely recommended for adolescents, fewer studies have been conducted in this age group. If the current study confirms the effectiveness of the Motivational Enhancement Therapy approach, this will add another outpatient treatment option for adolescent patients with drug problems. The specific aims of the project are to: 1. Test the effect of the brief intervention on drug use. We hypothesize that, among 12-18 year old medical patients who use drugs, the experimental intervention (two 60-minute motivational interviewing sessions) administered by a trained clinician will be at least 25% more effective than "standard care" (assessment/referral only) in decreasing drug use as measured by a 90-day Timeline Followback (6) (TLFB) calendar. 2. Test the effect of the brief intervention in increasing engagement in substance abuse treatment. We hypothesize that, among 12-18 year old patients who are referred to drug counseling or other treatments, the experimental intervention administered by a trained clinician will result in at least 25% more patients entering treatment compared to standard care, as measured by the numbers of patients who complete referrals to treatment providers. 3. Test the effect of the intervention on other substance-related outcomes. We hypothesize that the intervention will result in similar reductions in alcohol use, as measured by the TLFB, and in driving/riding while impaired (DRWI) risks as measured by the score of a 4-item self-reported scale. Other outcomes of interest include readiness to change, school performance, and experience of other harmful consequences of substance use and associated risk behaviors. 4. Identify factors that moderate and/or mediate the effect of the experimental intervention on our outcomes of interest (drug use, engagement in treatment), and estimate their effect sizes. Identifying moderating variables will help us to identify subgroups of optimal responders to the brief intervention. Based on our previous experience, we theorize that girls may respond more strongly to the intervention than boys, and that those who participate in other treatments (outpatient counseling) and/or a laboratory drug testing program will also have greater response.

Registry
clinicaltrials.gov
Start Date
June 2004
End Date
May 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John R Knight, MD

Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • 12-21 years old
  • Use of alcohol, marijuana or other drugs 6 times in last 3 months
  • CRAFFT score of 1 or greater
  • Have completed evaluation at Adolescent Substance Abuse Program at Children's Hospital Boston

Exclusion Criteria

  • Can not read or understand English at a 6th grade reading level
  • Needs immediate hospitalization

Outcomes

Primary Outcomes

Quantity and days of substance use

Time Frame: Past 90 days

Secondary Outcomes

  • Amount of completed substance use treatment(Past 90 days)
  • DWI or RWID(Past 90 days)
  • Substance related risk behaviors(Past 90 days)

Study Sites (1)

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