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Screening and Brief Advice to Reduce Teen Substance Use
This study is currently recruiting participants.
Verified by Children's Hospital Boston, January 2008
Sponsors and Collaborators: Children's Hospital Boston
Cambridge Health Alliance
Concord Hospital
Fallon Clinic
Tufts Medical Center
University of Vermont
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00592956
  Purpose

The major goal of this project is to assess the efficacy of a screening/brief provider advice intervention within a network of primary care practices.

We hypothesize that:

  1. Among 12-18 year old well care patients who screen positive for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing drug and alcohol use as measured by the Timeline Followback4 method;
  2. Among 12-18 year old well care patients who screen negative for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing initiation of drug and alcohol use as measured by self-reports of substance use;
  3. Among 12-18 year old well care patients who are at risk for driving/riding while impaired (DRWI), the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing DRWI risk behavior as measured by a standardized scale.

Condition Intervention Phase
Substance-Related Disorders
 Behavioral: Computerized CRAFFT screen and brief physician advice
 Phase II

MedlinePlus related topics: Alcohol Consumption
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title: Screening and Brief Advice to Reduce Teen Substance Use

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

Primary Outcome Measures:
  • Percent days abstinent from substance use [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cessation of substance use [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Initiation of substance use [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Driving under the influence of substances or riding with a driving who has been using substance [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: September 2004
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Control participants will receive "care as usual" from their provider.
2: Experimental
Participants who receive the intervention will complete the CRAFFT screen on the computer, and receive information and advice on the computer regarding health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Behavioral: Computerized CRAFFT screen and brief physician advice
Participants who receive the intervention will complete the CRAFFT screen on the computer, and receive information and advice on the computer regarding health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.

Detailed Description:

Primary medical care providers have a unique opportunity to screen adolescent patients for substance abuse, to provide early intervention for those who screen positive, and to provide positive reinforcement to those who screen negative. We have previously developed a brief substance abuse screening test, the CRAFFT, which is developmentally appropriate for adolescents, practical for use in busy primary care offices, and both valid and reliable among adolescent medical patients. We have also developed a computerized version of the CRAFFT screen, which delivers information about the health effects of substance use and advice to adolescents, and gives to providers the patient's CRAFFT score and suggested "talking points" about drug and alcohol use to discuss with the patient. We now plan to develop and test an intervention that can be widely applied by busy primary care providers, within the confines of the usual well care visit, to youth at all levels of substance involvement.

The goal of this project is to augment the screening/brief advice intervention with educational materials, and then to assess the efficacy of this approach within a network of primary care practices. The specific aims of the project are:

  1. To augment the existing computer screening program with adolescent and parent education materials.
  2. To produce a provider training protocol that is tailored to the needs of busy primary care clinicians.
  3. To test the effect of the comprehensive intervention (screening, brief physician advice, and adolescent/parent education) in a network of primary care settings.
  4. To assess the practicality, acceptability, and cost of the intervention.
  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients arriving for well care
  • All levels of substance use
  • Able to read and understand English

Exclusion Criteria:

  • Will not be available for the next 12 months to complete study assessments
  • Unstable medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592956

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
Cambridge Health Alliance Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Traci Brooks, MD     617-665-1264     tbrooks@challiance.org    
Principal Investigator: Traci Brooks, MD            
Fallon Clinic Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Robert Kossack, MD     508-852-0600     robert.kossack@fallon-clinic.com    
Principal Investigator: Robert Kossack, MD            
Tufts-New England Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: John Kulig, MD, MPH     617-636-4779     jkulig@tufts-nemc.org    
Principal Investigator: John Kulig, MD, MPH            
United States, New Hampshire
Capital Region Family Health Center Recruiting
Concord, New Hampshire, United States, 03301
Contact: Suzanne Boulter, MD     603-227-7000 ext 4787     sboulter@crhc.org    
Principal Investigator: Suzanne Boulter, MD            
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Peggy Carey, MD     802-847-4322     peggy.carey@vtmednet.org    
Principal Investigator: Peggy Carey, MD            
Sponsors and Collaborators
Children's Hospital Boston
Cambridge Health Alliance
Concord Hospital
Fallon Clinic
Tufts Medical Center
University of Vermont
Investigators
Principal Investigator: John R Knight, MD Children's Hospital Boston
  More Information

Web site of the Center for Adolescent Substance Abuse Research, the parent research group for the project.  This link exits the ClinicalTrials.gov site

Publications:
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.
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.
Van Hook S, Harris SK, Brooks T, Carey P, Kossack R, Kulig J, Knight JR; New England Partnership for Substance Abuse Research. The "Six T's": barriers to screening teens for substance abuse in primary care. J Adolesc Health. 2007 May;40(5):456-61. Epub 2007 Feb 15.
Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Prevalence of positive substance abuse screen results among adolescent primary care patients. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1035-41.
Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Adolescents' preference for substance abuse screening in primary care practice. Subst Abus. 2007;28(4):107-17.

Responsible Party: Children's Hospital Boston ( John R. Knight, MD )
Study ID Numbers: R01 DA018848, R01 DA018848
Study First Received: January 3, 2008
Last Updated: January 11, 2008
ClinicalTrials.gov Identifier: NCT00592956  
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on January 16, 2009



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