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Medical Office Intervention for Adolescent Drug Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229983
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):
John R Knight, MD, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: Motivational Enhancement Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical Office Intervention for Adolescent Drug Use
Study Start Date : June 2004
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Experimental: Motivational Enhancement Therapy
Adolescents who are randomized to the experimental intervention will attend three 60-minute counseling sessions, delivered 2-4 weeks apart. The intervention will include a structured, developmentally appropriate, approach to identification of drug- and alcohol-related risks and problems, and establishment of goals for behavioral change.
Behavioral: Motivational Enhancement Therapy
Three 60 minute counseling sessions using a structured, developmentally appropriate approach to identification of drug- and alcohol- related risks and problems, and establishment of goals for behavioral change.
Other Name: MET

No Intervention: Enhanced Standard Care
Adolescents who are randomized to Enhanced Standard Care will receive the usual care at the outpatient adolescent substance abuse program. This will include an evaluation by pediatric and mental health staff and could include treatment in a group therapy program, urine drug testing, buprenorphine replacement therapy (for those dependent on opioids), and psychopharmacology evaluation and management.

Primary Outcome Measures :
  1. Quantity and days of substance use [ Time Frame: Past 90 days ]

Secondary Outcome Measures :
  1. DWI or RWID [ Time Frame: Past 90 days ]
    Driving while intoxicated or riding with an intoxicated

  2. Amount of completed substance use treatment [ Time Frame: Past 90 days ]
  3. Substance related risk behaviors [ Time Frame: Past 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00229983

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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02215-5737
Sponsors and Collaborators
Boston Children’s Hospital
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Principal Investigator: John R Knight, M.D. Boston Children’s Hospital

Additional Information:
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Responsible Party: 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 Identifier: NCT00229983    
Obsolete Identifiers: NCT00592787
Other Study ID Numbers: NIDA-R01DA014553
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John R Knight, MD, Boston Children’s Hospital:
Substance use disorders
Substance abuse
Alcohol abuse
Drug abuse
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders