search
Back to results

Mentored Clinical Career Award in Adolescent Substance Abuse

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomized Drug Testing Trial
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Substance-Related Disorders focused on measuring Alcohol abuse, Drug abuse

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adolescents ages 12-21
  • Participants must have use of alcohol, cannabis, or another substance on at least 2 occasions in the 30 days preceding their initial assessment or 6 or more times in the past 90 days
  • Participants must have health insurance or be willing to pay for the laboratory costs associated with drug testing.
  • Participants must provide informed assent and, for those under 18, parental consent.

Exclusion Criteria:

  • Participants who require immediate hospitalization or immediate referral to residential substance abuse treatment
  • Participants who cannot understand or read English at a 6th grade reading level
  • Participants who are enrolled in the ASAP buprenorphine program
  • Participants who report previous use of inhalants or any other substance that is not easily detected with urine drug testing

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Drug Testing

Control

Arm Description

Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).

Adolescents randomized to the control condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated) but will not be called for drug tests.

Outcomes

Primary Outcome Measures

Percentage days abstinent from any substance use during the past 90 days, as measured by self-report via a Time Line Follow Back calendar (TLFB).

Secondary Outcome Measures

Adolescent willingness to participate a in drug testing program.

Full Information

First Posted
February 11, 2008
Last Updated
June 19, 2017
Sponsor
Boston Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00622219
Brief Title
Mentored Clinical Career Award in Adolescent Substance Abuse
Official Title
Mentored Clinical Career Award in Adolescent Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 31, 2013 (Actual)
Study Completion Date
August 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this project is to determine the barriers to, and risks and benefits of random laboratory drug testing for adolescents with identified drug or alcohol problems.
Detailed Description
Use of drugs and alcohol is associated with a variety of health care problems, making settings where adolescents receive routine medical care ideal for implementation of routine screening and early intervention. However, little research has been conducted on the efficacy of interventions for adolescent primary care patients who are using drugs or alcohol. Urine drug testing can be used for a variety of indications, including school or work based population surveillance, verification of history, or monitoring of individuals who are in treatment for a drug-use disorder. This study will focus exclusively on the therapeutic use of urine drug testing. Drug testing can be a useful therapeutic adjuvant for patients with drug-use disorders in a variety of settings. This study will investigate the use of random laboratory drug testing as a therapeutic intervention for teens with drug problem use, abuse or dependence. We have 5 objectives: To develop a standardized protocol for random urine drug testing, produce a manual and training protocol, and refine the protocol in preparation for a future efficacy trial. To estimate the cost of a random drug-testing program. To determine the factors that are associated with willingness to be tested, and barriers to enrolling adolescents in laboratory drug testing programs. To perform an initial, small-scale experimental trial of the random drug testing protocol. The purpose of this trial is to estimate the effect size of the intervention and will be used in calculating the sample size for a future stage 1b trial. To determine the potential risks to adolescents who participate in a random drug testing program, including possible breach of confidentiality, greater conflict between the parent and child, more difficulty with communication between clinician and patient, increased use of drugs not detected by routine urine screens (i.e. inhalants), and increased use of strategies and products known to defeat drug tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Alcohol abuse, Drug abuse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Testing
Arm Type
Experimental
Arm Description
Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Adolescents randomized to the control condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated) but will not be called for drug tests.
Intervention Type
Other
Intervention Name(s)
Randomized Drug Testing Trial
Intervention Description
Adolescents in the experimental condition will receive all of the services offered by the Adolescent Substance Abuse Program (including individual meetings, parent and adolescent group meetings, psychopharmacology as indicated)and will be enrolled in a random drug testing program (with an average of 12 requests for testing over a 12 week period).
Primary Outcome Measure Information:
Title
Percentage days abstinent from any substance use during the past 90 days, as measured by self-report via a Time Line Follow Back calendar (TLFB).
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Adolescent willingness to participate a in drug testing program.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescents ages 12-21 Participants must have use of alcohol, cannabis, or another substance on at least 2 occasions in the 30 days preceding their initial assessment or 6 or more times in the past 90 days Participants must have health insurance or be willing to pay for the laboratory costs associated with drug testing. Participants must provide informed assent and, for those under 18, parental consent. Exclusion Criteria: Participants who require immediate hospitalization or immediate referral to residential substance abuse treatment Participants who cannot understand or read English at a 6th grade reading level Participants who are enrolled in the ASAP buprenorphine program Participants who report previous use of inhalants or any other substance that is not easily detected with urine drug testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Levy, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16461869
Citation
Levy S, Harris SK, Sherritt L, Angulo M, Knight JR. Drug testing of adolescents in ambulatory medicine: physician practices and knowledge. Arch Pediatr Adolesc Med. 2006 Feb;160(2):146-50. doi: 10.1001/archpedi.160.2.146.
Results Reference
background
PubMed Identifier
16549293
Citation
Levy S, Harris SK, Sherritt L, Angulo M, Knight JR. Drug testing of adolescents in general medical clinics, in school and at home: physician attitudes and practices. J Adolesc Health. 2006 Apr;38(4):336-42. doi: 10.1016/j.jadohealth.2005.11.023.
Results Reference
background
Links:
URL
http://www.ceasar.org
Description
web site of the Center for Adolescent Substance Abuse Research at Children's Hospital Boston

Learn more about this trial

Mentored Clinical Career Award in Adolescent Substance Abuse

We'll reach out to this number within 24 hrs