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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00849589
Other study ID # PA-07-406
Secondary ID
Status Withdrawn
Phase N/A
First received February 23, 2009
Last updated October 6, 2016
Start date January 2010
Est. completion date December 2014

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

The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).


Description:

The specific aims of the proposed multisite RCT are:

1. To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;

2. To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;

3. To identify moderators, mediators, and optimal responders to the SBA/TE interventions;

4. To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 21 Years
Eligibility Inclusion Criteria:

- 12-21 years old

- patients arriving for routine medical care

- provide informed assent (for those <18) or informed consent (for those 18-21)

Exclusion Criteria:

- medically or psychologically unstable at time of visit

- receiving behavioral health services

- cannot read or understand English at a 6th grade reading level

- unavailable for follow-up assessments

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Behavioral:
Computerized screening and brief physician advice
Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors
Computerized SBA with technological extenders
Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors. In addition, the provider sends them a brief email or text message at 4 months and 9 months after study entry to reinforce the brief advice.

Locations

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

Sponsors (6)

Lead Sponsor Collaborator
Boston Children’s Hospital Cambridge Health Alliance, Dartmouth-Hitchcock Medical Center, Fallon Clinic, Tufts Medical Center, University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation of underage drinking Baseline, 3-months, 6-months, 12-months No
Secondary Cessation of underage drinking Baseline, 3-months, 6-months, 12-months No
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