Back to resultscSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
Primary Purpose
Tobacco Abuse, Alcohol Abuse, Drug Abuse
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer Screening, Brief Intervention, Referral toTreatment
Sponsored by
About this trial
This is an interventional prevention trial for Tobacco Abuse focused on measuring Tobacco use, Alcohol abuse, Drug abuse, Substance use, Prevention, Brief intervention, Screening, Adolescents
Eligibility 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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Experimental
Experimental
Arm Label
Treatment as Usual Group 1
Treatment as Usual Group 2
Intervention Group 1
Intervention Group 2
Arm Description
Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment
Participants will receive treatment as usual and complete only the 1-month post-visit assessment
Computer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment
Computer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment
Outcomes
Primary Outcome Measures
Percent days abstinent of tobacco, alcohol and drugs
Secondary Outcome Measures
Prevalence of tobacco, alcohol and drug use
Full Information
NCT ID
NCT01275391
First Posted
January 11, 2011
Last Updated
October 6, 2016
Sponsor
Boston Children's Hospital
Collaborators
Pearl Network
1. Study Identification
Unique Protocol Identification Number
NCT01275391
Brief Title
cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
Official Title
cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
This project was not funded.
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Pearl Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Abuse, Alcohol Abuse, Drug Abuse
Keywords
Tobacco use, Alcohol abuse, Drug abuse, Substance use, Prevention, Brief intervention, Screening, Adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual Group 1
Arm Type
No Intervention
Arm Description
Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment
Arm Title
Treatment as Usual Group 2
Arm Type
No Intervention
Arm Description
Participants will receive treatment as usual and complete only the 1-month post-visit assessment
Arm Title
Intervention Group 1
Arm Type
Experimental
Arm Description
Computer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment
Arm Title
Intervention Group 2
Arm Type
Experimental
Arm Description
Computer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment
Intervention Type
Behavioral
Intervention Name(s)
Computer Screening, Brief Intervention, Referral toTreatment
Other Intervention Name(s)
Brief Advice, SBIRT, Screen and Brief Advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent days abstinent of tobacco, alcohol and drugs
Time Frame
Past 90 days
Secondary Outcome Measure Information:
Title
Prevalence of tobacco, alcohol and drug use
Time Frame
Past 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Knight, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33605440
Citation
Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Results Reference
derived
Links:
URL
http://www.ceasar.org
Description
web site of the Center for Adolescent Substance Abuse Research at Children's Hospital Boston
Learn more about this trial
cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use
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