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cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use

This study has been withdrawn prior to enrollment.
(This project was not funded.)
Sponsor:
Collaborator:
Pearl Network
Information provided by (Responsible Party):
John R Knight, MD, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01275391
First received: January 11, 2011
Last updated: October 6, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Tobacco Abuse
Alcohol Abuse
Drug Abuse
Behavioral: Computer Screening, Brief Intervention, Referral toTreatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use

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

Primary Outcome Measures:
  • Percent days abstinent of tobacco, alcohol and drugs [ Time Frame: Past 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of tobacco, alcohol and drug use [ Time Frame: Past 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275391

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Pearl Network
Investigators
Principal Investigator: John R. Knight, MD Boston Children’s Hospital
  More Information

Additional Information:
Responsible Party: John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01275391     History of Changes
Other Study ID Numbers: RFADEcSBIRT 
Study First Received: January 11, 2011
Last Updated: October 6, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Boston Children’s Hospital:
Tobacco use
Alcohol abuse
Drug abuse
Substance use
Prevention
Brief intervention
Screening
Adolescents

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Tobacco Use Disorder
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016