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Medical Office Intervention for Adolescent Drug Use
This study is currently recruiting participants.
Verified by Children's Hospital Boston, February 2009
First Received: January 3, 2008   Last Updated: February 23, 2009   History of Changes
Sponsored by: Children's Hospital Boston
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00592787
  Purpose

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


Condition Intervention Phase
Substance-Related Disorders
Behavioral: Motivational enhancement therapy
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Medical Office Intervention for Adolescent Drug Use

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

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

Secondary Outcome Measures:
  • Driving while intoxicated or riding with an intoxicated driver [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Amount of completed substance use treatment [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Risk behaviors [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2004
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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 approach to identification of drug- and alcohol-related risks and problems, and establishing goals for behavioral change, which is suited to adolescents' emerging cognitive abilities.
Behavioral: 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 approach to identification of drug- and alcohol-related risks and problems, and establishing goals for behavioral change, which is suited to adolescents' emerging cognitive abilities.
2: No Intervention
Control arm participants will receive standard care.

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 this study 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 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 (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
  • CRAFFT score of 1 or more
  • Have used alcohol, cannabis or another substance 2 or more times in the past month or 6 or more times in the past 3 months
  • Can read and understand English

Exclusion Criteria:

  • Requires immediate hospitalization
  • Will not be available to complete the study visits over the next 9 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592787

Contacts
Contact: John R. Knight, MD 617-355-5433 john.knight@childrens.harvard.edu
Contact: Shari Van Hook, MPH 617-355-5433 shari.vanhook@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: John R Knight, MD     617-355-5433     john.knight@childrens.harvard.edu    
Contact: Shari Van Hook, MPH     617-355-5433     shari.vanhook@childrens.harvard.edu    
Principal Investigator: John R Knight, MD            
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: John R Knight, MD Children's Hospital Boston
  More Information

Additional Information:
Publications:
Responsible Party: Children's Hospital Boston ( John R. Knight, MD, Principal Investigator )
Study ID Numbers: 5 R01 DA014553, 5 R01 DA014553
Study First Received: January 3, 2008
Last Updated: February 23, 2009
ClinicalTrials.gov Identifier: NCT00592787     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Ethanol

Additional relevant MeSH terms:
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009