- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01439334
Multiple Behavior Screening, Brief Intervention and Referral to Treatment (SBIRT) Model of Drug Abuse in Primary Care (SBIRT)
Multiple Behavior SBIRT Model of Drug Abuse in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief
- Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length
- Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control
Detailed Description
Emerging adults are defined as young adults ages 18-25. These young people have the highest levels of prescription, illicit and licit drug consumption of any age group in the nation (Johnston, O'Malley, Bachman, & Schulenberg, 2007). While previous SBIRT models have typically targeted single health risks, such as problem alcohol or cigarette use, the proposed novel multiple behavior SBIRT model uses social and future images and a positive fitness theme to link co-morbid health risk behaviors and problems, and is therefore likely to be viewed by both patients and medical practitioners as appealing and feasible within standard primary care routines.
Objectives
- Expanding and modifying existing social and future image screening and brief intervention content from our prior studies to include messages targeting prescription drug abuse and HIV/AIDS risk behaviors, as well as a referral to drug abuse assessment and treatment component;
- Translating the modified and expanded multiple behavior SBIRT model content into two versions of the community-friendly computer-based program, i.e., one targeting one health promoting and four risk behaviors vs. another targeting four health promoting and four risk behaviors;
- Conducting formative research on the modified content and format to ensure acceptability, quality, feasibility, accessibility, and potential effectiveness among target young adults and health care providers using expert panels, and target audience surveys; and
- Conducting a three-group randomized trial pilot test with 3-month follow-up.
A three-group randomized trial pilot test will be conducted, with participating young adult patients randomized to receive either: 1) computer-based MB-SBIRT targeting one health promoting and four risk behaviors, 2) computer based MB-SBIRT targeting four health promoting and four risk behaviors, or 3) primary care as usual. This trial will determine the acceptability, quality, feasibility, and short-term (3-month) effects of the proposed computer delivered MB-SBIRT model.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32256
- Addictive & Health Behaviors Research Institute, University of Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Understand English
- 18-25 Year old alcohol-drug using adults
- Attending the participating family care clinic
Exclusion Criteria:
- Can not understand English
- Not in age range
- Not attending participating clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
|
Control
Other Names:
|
|
Experimental: Online Program Brief
|
Online prevention program using positive images
Other Names:
|
|
Experimental: Online Program Extended Length
|
Online Program Extended Length
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in prescription drug misuse, alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Time Frame: Baseline to 3 months follow up
|
Baseline to 3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Time Frame: Baseline to 3 months follow up
|
Baseline to 3 months follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chudley E Werch, PhD, Addictive & Health Behaviors Research Institute, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-U-689
- R01DA026028 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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