Screening and Brief Advice to Reduce Teen Substance Use

August 1, 2019 updated by: John R Knight, MD, Boston Children's Hospital

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 riding with an impaired driver or driving while impaired, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing Riding/Driving risk behavior as measured by a standardized scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2695

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia
        • Center for the Evaluation, Prevention, and Research of Substance Abuse
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts-New England Medical Center
      • Cambridge, Massachusetts, United States, 02139
        • Cambridge Pediatrics
      • Worcester, Massachusetts, United States, 01605
        • Fallon Clinic
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • Capital Region Family Health Center
    • Vermont
      • Milton, Vermont, United States, 05468
        • Milton Family Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control - New England, USA
Control participants will receive "care as usual" from their provider
Experimental: cSBA - New England, USA
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: cSBA - New England, USA
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 Names:
  • SBIRT
No Intervention: Control - Prague, CZR
Control participants will receive "care as usual" from their provider
Experimental: cSBA - Prague, CZR
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: cSBA - Prague, CZR
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 Names:
  • SBIRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
Time Frame: Past-90-days at 3 months post-baseline
Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Past-90-days at 3 months post-baseline
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA
Time Frame: Past-90-days at 3 months post-baseline
Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Past-90-days at 3 months post-baseline
Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
Time Frame: Past-12-months at 12 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Past-12-months at 12 months post-baseline
Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
Time Frame: Past-12-months at 12 months post-baseline
Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Past-12-months at 12 months post-baseline
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR
Time Frame: Past-90-days at 3 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Past-90-days at 3 months post-baseline
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR
Time Frame: Past-90-days at 3 months post-baseline
Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Past-90-days at 3 months post-baseline
Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR
Time Frame: Past-12-months at 12 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Past-12-months at 12 months post-baseline
Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR
Time Frame: Past-12-months at 12 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Past-12-months at 12 months post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any Risky Riding or Driving at 3 Months - New England, USA
Time Frame: Past-90-days at 3 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England
Past-90-days at 3 months post-baseline
Any Risky Riding or Driving at 12 Months - New England, USA
Time Frame: Past-90-days at 12 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England
Past-90-days at 12 months post-baseline
Any Risky Riding or Driving at 3 Months - Prague, CZR
Time Frame: Past-90-days at 3 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic
Past-90-days at 3 months post-baseline
Any Risky Riding or Driving at 12 Months - Prague, CZR
Time Frame: Past-90-days at 12 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic
Past-90-days at 12 months post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

Tufts Medical Center
University of Vermont
Cambridge Health Alliance
Fallon Clinic
Concord Hospital

Investigators

  • Principal Investigator: John R Knight, M.D., Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-R01DA0118848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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