Medical Office Intervention for Adolescent Drug Use

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Behavioral: Motivational Enhancement Therapy

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: Interventional
• Enrollment (Actual): 170
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5737
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quantity and days of substance use	Past 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DWI or RWID	Driving while intoxicated or riding with an intoxicated	Past 90 days
Amount of completed substance use treatment		Past 90 days
Substance related risk behaviors		Past 90 days

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: John R Knight, M.D., Boston Children's Hospital

Publications and helpful links

General Publications

• Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.
• Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.

Helpful Links

• This is the web site of the Center for Adolescent Substance Abuse Research, the research center conducting the study "Medical Office Intervention for Adolescent Drug Use."

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: September 29, 2005
• First Submitted That Met QC Criteria: September 29, 2005
• First Posted (Estimate): September 30, 2005

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Alcohol abuse; Drug abuse; Substance use disorders; Substance abuse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: NIDA-R01DA014553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO