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Screening and Brief Advice to Reduce Teen Substance Use Czech Collaboration
This study is currently recruiting participants.
Verified by Children's Hospital Boston, January 2008
Sponsors and Collaborators: Children's Hospital Boston
The Centre for the Evaluation, Prevention, and Research of Substance Abuse
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00592878
  Purpose

The major goals of this project are to assess the validity of the CRAFFT screen in the Czech language and to assess the efficacy of a screening/brief provider advice intervention within a network of primary care practices in Prague, Czech Republic.


Condition Intervention Phase
Substance-Related Disorders
Behavioral: Computerized Screening and Physician Brief Advice
Phase II

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 International Collaboration

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

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

Secondary Outcome Measures:
  • Rate of cessations of substance use [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Rate of initiation of substance use [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Driving under the influence or riding with a driver under the influence [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: September 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Participants in the control condition receive "care as usual".
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 Screening and Physician Brief 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:

Since the restoration of democratic government in 1989, the Czech Republic has moved politically and economically closer to the West. Accompanying these profound social changes has been a sharp increase in rates of drug use by Czech teens, resulting in an urgent need to develop and test new prevention strategies.

The specific aims of the supplemental project are:

  1. To translate into Czech (and back-translate) the computerized CRAFFT screening program and all study measurements; to develop Czech versions of adolescent and parent educational materials, and to produce a Czech version of the provider training protocol;
  2. To conduct a controlled trial of the comprehensive screening and brief advice intervention, developed by CeASAR, in a group of pediatric offices in the greater Prague area. 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.
  3. To determine the criterion validity of the CRAFFT screen among Czech youth.
  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 visit
  • All levels of substance use
  • Able to read and understand Czech

Exclusion Criteria:

  • Unstable medical condition
  • Unavailable for 12 months to complete the study assessments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592878

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
Czech Republic
Centre for the Evaluation, Prevention and Research of Substance Abuse Recruiting
Prague, Czech Republic
Contact: Ladislav Csemy, PhD         csemy@pcp.lf3.cuni.cz    
Principal Investigator: Ladislav Csemy, PhD            
Sponsors and Collaborators
Children's Hospital Boston
The Centre for the Evaluation, Prevention, and Research of Substance Abuse
Investigators
Principal Investigator: John R Knight, MD Children's Hospital Boston
  More Information

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

Publications:
Responsible Party: Children's Hospital Boston ( John R. Knight, MD )
Study ID Numbers: R01 DA018848-03S1, R01 DA018848-03S1
Study First Received: January 3, 2008
Last Updated: January 3, 2008
ClinicalTrials.gov Identifier: NCT00592878  
Health Authority: United States: Institutional Review Board;   Czech Republic: Ethics Committee

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

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