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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01275391
Other study ID # RFADEcSBIRT
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received January 11, 2011
Last updated October 6, 2016
Start date September 2011
Est. completion date September 2013

Study information

Verified date October 2016
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 21 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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.

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Children’s Hospital Pearl Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent days abstinent of tobacco, alcohol and drugs Past 90 days No
Secondary Prevalence of tobacco, alcohol and drug use Past 90 days No
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