Screening and Brief Advice to Reduce Teen Substance Use Czech Collaboration - Full Text View

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

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.

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:

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;
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.
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

Locations

Czech Republic
Centre for the Evaluation, Prevention and Research of Substance Abuse
Prague, Czech Republic

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

Additional Information:

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

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.

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:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00592878 History of Changes
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

Additional relevant MeSH terms:

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009