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Medical Office Intervention for Adolescent Drug Use

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ClinicalTrials.gov Identifier: NCT00229983
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
John R Knight, MD, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE September 29, 2005
First Posted Date  ICMJE September 30, 2005
Last Update Posted Date October 7, 2016
Study Start Date  ICMJE June 2004
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
Quantity and days of substance use [ Time Frame: Past 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2005)
Drug and alcohol use
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
  • DWI or RWID [ Time Frame: Past 90 days ]
    Driving while intoxicated or riding with an intoxicated
  • Amount of completed substance use treatment [ Time Frame: Past 90 days ]
  • Substance related risk behaviors [ Time Frame: Past 90 days ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical Office Intervention for Adolescent Drug Use
Official Title  ICMJE Medical Office Intervention for Adolescent Drug Use
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Substance-Related Disorders
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Motivational Enhancement Therapy
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2011)
170
Original Enrollment  ICMJE
 (submitted: September 29, 2005)
150
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00229983
Other Study ID Numbers  ICMJE NIDA-R01DA014553
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John R Knight, MD, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John R Knight, M.D. Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP