Multiple Behavior Screening, Brief Intervention and Referral to Treatment (SBIRT) Model of Drug Abuse in Primary Care (SBIRT)
Primary Purpose
Drug Abuse
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control
Sponsored by
About this trial
This is an interventional prevention trial for Drug Abuse focused on measuring Brief, Online, Image, Interactive, Young Adult, Primary Care
Eligibility Criteria
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
Sites / Locations
- Addictive & Health Behaviors Research Institute, University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Online Program Brief
Online Program Extended Length
Control
Arm Description
Online Program Brief
Online Program Extended Length
Control
Outcomes
Primary Outcome Measures
Change in prescription drug misuse, alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up.
Secondary Outcome Measures
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Full Information
NCT ID
NCT01439334
First Posted
July 22, 2010
Last Updated
September 21, 2011
Sponsor
University of Florida
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01439334
Brief Title
Multiple Behavior Screening, Brief Intervention and Referral to Treatment (SBIRT) Model of Drug Abuse in Primary Care
Acronym
SBIRT
Official Title
Multiple Behavior SBIRT Model of Drug Abuse in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Withdrawn
Why Stopped
PI left UF
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this research is to develop and evaluate the short-term efficacy of an innovative multiple behavior screening, brief intervention and referral to treatment (MB-SBIRT) model using social images and future self-images to simultaneously link and reduce prescription and other co-occurring drug use behaviors among emerging adults in a primary care setting serving a racially and economically diverse community. The long term objective of this research is to cost-effectively reduce prescription and illicit drug abuse, along with alcohol and tobacco consumption, and improve health-related quality of life among high-risk emerging adults often ignored in intervention research and services.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
Brief, Online, Image, Interactive, Young Adult, Primary Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online Program Brief
Arm Type
Experimental
Arm Description
Online Program Brief
Arm Title
Online Program Extended Length
Arm Type
Experimental
Arm Description
Online Program Extended Length
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief
Other Intervention Name(s)
Online Program Brief
Intervention Description
Online prevention program using positive images
Intervention Type
Behavioral
Intervention Name(s)
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length
Other Intervention Name(s)
Online Program Extended Length
Intervention Description
Online Program Extended Length
Intervention Type
Behavioral
Intervention Name(s)
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control
Other Intervention Name(s)
Control
Intervention Description
Control
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in frequency of health promoting behaviors from baseline to 3 months follow up.
Time Frame
Baseline to 3 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chudley E Werch, PhD
Organizational Affiliation
Addictive & Health Behaviors Research Institute, University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addictive & Health Behaviors Research Institute, University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multiple Behavior Screening, Brief Intervention and Referral to Treatment (SBIRT) Model of Drug Abuse in Primary Care
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