Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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.


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


Study is Available At:


Original ID:

RFADEcSBIRT


NCT ID:

NCT01275391


Secondary ID:


Study Acronym:


Brief Title:

cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use


Official Title:

cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use


Overall Status:

Withdrawn


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

12 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston Children’s Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

This project was not funded.


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Single


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:John R. Knight, MD
Principal Investigator
Boston Children’s Hospital

Study Dates

Start Date:September 2011
Completion Date:September 2013
Completion Type:Anticipated
Primary Completion Date:May 2013
Primary Completion Type:Anticipated
Verification Date:October 2016
Last Changed Date:October 6, 2016
First Received Date:January 11, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Prevalence of tobacco, alcohol and drug use
Time Frame:Past 90 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Percent days abstinent of tobacco, alcohol and drugs
Time Frame:Past 90 days
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Computer Screening, Brief Intervention, Referral t
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.
Arm Name:Intervention Group 1
Other Name:Brief Advice

Study Arms

Study Arm Type:No Intervention
Arm Name:Treatment as Usual Group 1
Description:Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment
Study Arm Type:No Intervention
Arm Name:Treatment as Usual Group 2
Description:Participants will receive treatment as usual and complete only the 1-month post-visit assessment
Study Arm Type:Experimental
Arm Name:Intervention Group 1
Description:Computer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment
Study Arm Type:Experimental
Arm Name:Intervention Group 2
Description:Computer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston Children’s Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:Pearl Network

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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