Medical Office Intervention for Adolescent Drug Use

Substance-Related Disorders Clinical Trial

Official title:

Medical Office Intervention for Adolescent Drug Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229983
• Other study ID #: NIDA-R01DA014553
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2005
• Last updated: October 6, 2016
• Start date: June 2004
• Est. completion date: May 2010

Study information

• Verified date: October 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00592787

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity and days of substance use		Past 90 days	No
Secondary	DWI or RWID	Driving while intoxicated or riding with an intoxicated	Past 90 days	Yes
Secondary	Amount of completed substance use treatment		Past 90 days	No
Secondary	Substance related risk behaviors		Past 90 days	Yes

External 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."