Medical Office Intervention for Adolescent Drug Use

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00229983
First received: September 29, 2005
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Substance-Related Disorders
Behavioral: Motivational Enhancement Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medical Office Intervention for Adolescent Drug Use

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Quantity and days of substance use [ Time Frame: Past 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DWI or RWID [ Time Frame: Past 90 days ] [ Designated as safety issue: Yes ]
    Driving while intoxicated or riding with an intoxicated

  • Amount of completed substance use treatment [ Time Frame: Past 90 days ] [ Designated as safety issue: No ]
  • Substance related risk behaviors [ Time Frame: Past 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 170
Study Start Date: June 2004
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.      
  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229983

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

Additional Information:
Publications:
Responsible Party: John R. Knight, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00229983     History of Changes
Obsolete Identifiers: NCT00592787
Other Study ID Numbers: NIDA-R01DA014553
Study First Received: September 29, 2005
Last Updated: February 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Substance use disorders
Substance abuse
Alcohol abuse
Drug abuse

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014