NCT00229983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

5.9 years

First QC Date

September 29, 2005

Last Update Submit

October 6, 2016

Conditions

Substance-Related Disorders

Keywords

Substance use disordersSubstance abuseAlcohol abuseDrug abuse

Outcome Measures

Primary Outcomes (1)

  • Quantity and days of substance use

    Past 90 days

Secondary Outcomes (3)

  • DWI or RWID

    Past 90 days

  • Amount of completed substance use treatment

    Past 90 days

  • Substance related risk behaviors

    Past 90 days

Study Arms (2)

Motivational Enhancement Therapy

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, developmentally appropriate, approach to identification of drug- and alcohol-related risks and problems, and establishment of goals for behavioral change.

Behavioral: Motivational Enhancement Therapy

Enhanced Standard Care

NO INTERVENTION

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.

Interventions

Motivational Enhancement TherapyBEHAVIORAL

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.

Also known as: MET
Motivational Enhancement Therapy

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Can not read or understand English at a 6th grade reading level
  • Needs immediate hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02215-5737, United States

Location

Related Publications (2)

  • 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.

    PMID: 10357299BACKGROUND

  • 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.

    PMID: 12038895BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • John R Knight, M.D.

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Study Record Dates

First Submitted

September 29, 2005

First Posted

September 30, 2005

Study Start

June 1, 2004

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)