cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use

October 6, 2016 updated by: John R Knight, MD, Boston Children's Hospital
In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The goal of this project is to prepare for a large multi-site comparative effectiveness trial of a behavioral intervention, computer-facilitated Screening, Brief Intervention, and Referral to Treatment (cSBIRT) system that targets tobacco, alcohol, and drug use among adolescent dental patients. This enhanced computerized screening system includes: (1) screening, feedback, and provider talking points for tobacco and non-medical use of prescription drugs, (2) an interactive 2-part Motivational Enhancement Therapy module for adolescents at highest risk to complete from home, and (3) technological extenders (TEs), which are computer-generated messages that the provider sends to adolescents during the months following the clinic visit to reinforce the effect of the intervention over time.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

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 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12-21 years of age
  • arriving for routine care to dental office

Exclusion Criteria:

  • dentally, medically, or psychologically unstable at the time of the visit
  • cannot read or understand English at a 6th grade level
  • unavailable for 1-month post-visit assessment

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual Group 1
Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment
No Intervention: Treatment as Usual Group 2
Participants will receive treatment as usual and complete only the 1-month post-visit assessment
Experimental: Intervention Group 1
Computer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment
Behavioral: Computer Screening, Brief Intervention, Referral toTreatment
A computerized screening for tobacco, alcohol and drug use accompanied by 10-15 pages of health information regarding the risks of tobacco, alcohol and drug use. This is followed by a brief conversation with the primary care provider regarding the health risks of tobacco, alcohol and drug use and a referral to treatment for those at high risk of substance use problems.
Other Names:
  • Brief Advice
  • SBIRT
  • Screen and Brief Advice
Experimental: Intervention Group 2
Computer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment
Behavioral: Computer Screening, Brief Intervention, Referral toTreatment
A computerized screening for tobacco, alcohol and drug use accompanied by 10-15 pages of health information regarding the risks of tobacco, alcohol and drug use. This is followed by a brief conversation with the primary care provider regarding the health risks of tobacco, alcohol and drug use and a referral to treatment for those at high risk of substance use problems.
Other Names:
  • Brief Advice
  • SBIRT
  • Screen and Brief Advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent days abstinent of tobacco, alcohol and drugs
Time Frame: Past 90 days
Past 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of tobacco, alcohol and drug use
Time Frame: Past 90 days
Past 90 days

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Collaborators

Pearl Network

Investigators

  • Principal Investigator: John R. Knight, MD, 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

September 1, 2011

Primary Completion (Anticipated)

May 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFADEcSBIRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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