Screening and Brief Advice to Reduce Teen Substance Use

This study has been completed.
Sponsor:
Collaborators:
Cambridge Health Alliance
Concord Hospital
Fallon Clinic
Tufts Medical Center
University of Vermont
Center for the Evaluation, Prevention, and Research of Substance Abuse
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00227877
First received: September 27, 2005
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to test the effectiveness of a brief intervention for alcohol and drug use in adolescents that a primary care doctor can give in his/her office. The study will be conducted in nine primary care offices in three New England states, and in ten pediatric offices in Prague, Czech Republic (CZR).

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;
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Screening and Brief Advice to Reduce Teen Substance Use

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Cessation of substance use [ Time Frame: past 90 days ] [ Designated as safety issue: No ]
  • Initiation of substance use [ Time Frame: Past 90 days ] [ Designated as safety issue: No ]
  • DWI/RWID [ Time Frame: past 90 days ] [ Designated as safety issue: Yes ]
    DWI - driving under the influence of substances RWID - riding with a driver who has been using substances


Enrollment: 2145
Study Start Date: September 2004
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control participants will receive "care as usual" from their provider
Behavioral: Computerized CRAFFT screen and brief physician advice
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" 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.
Other Name: SBIRT
Experimental: Screening and Brief Advice
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the 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 are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" 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.
Other Name: SBIRT

Detailed Description:

We are trying to find out the best way for doctors to talk with their adolescent patients about alcohol and drug use. Adolescents 12-18 who are coming to their doctor's office for a routine well-care or follow-up visit will be invited to participate in the study. Participants do not have to have ever used alcohol or drugs. All participants will answer a computerized questionnaire about alcohol and drug use three times. The first one will be at the time of a doctor's visit. The second time will be three months later and the third time a year later. Adolescents who agree to be in the study during the first year will be in the 'control' group. Their doctor will talk to them about drugs and alcohol the same as he/she usually does for all his/her patients. Those who agree to be in the study during the second year will be in the 'intervention' group. Everyone in the 'intervention' group will receive some advice on the computer about their alcohol and drug use. Their doctor will also give them some specific advice about drug and alcohol use. The researchers have chosen what that advice will be, and all doctors involved in the study will give advice according to the study protocol. Participants and their parents will also be given educational information about alcohol and drugs. We will test the effectiveness of the intervention by comparing drug and alcohol use between those who are in the 'control' group, and those who are in the 'intervention' group.

We we will also validate the Czech version of the CRAFFT screen before conducting the effectiveness trial outlined above in the Czech Republic.

  Eligibility

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

Inclusion Criteria:

12-18 year old patients coming for well care or follow-up visits to one of the study sites, All levels of substance use, Able to read and understand English

Exclusion Criteria:

Will not be available for 12 month follow-up period, Medically unstable at the time of the visit

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227877

Locations
United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
Cambridge Pediatrics
Cambridge, Massachusetts, United States, 02139
Fallon Clinic
Worcester, Massachusetts, United States, 01605
United States, New Hampshire
Capital Region Family Health Center
Concord, New Hampshire, United States, 03301
United States, Vermont
Milton Family Practice
Milton, Vermont, United States, 05468
Czech Republic
Center for the Evaluation, Prevention, and Research of Substance Abuse
Prague, Czech Republic
Sponsors and Collaborators
Children's Hospital Boston
Cambridge Health Alliance
Concord Hospital
Fallon Clinic
Tufts Medical Center
University of Vermont
Center for the Evaluation, Prevention, and Research of Substance Abuse
Investigators
Principal Investigator: John R Knight, M.D. Children's Hospital Boston
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John R. Knight, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00227877     History of Changes
Obsolete Identifiers: NCT00592878, NCT00592956
Other Study ID Numbers: NIDA-R01DA0118848
Study First Received: September 27, 2005
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
alcohol abuse
substance abuse
substance related disorders

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014