Multiple Behavior Screening, Brief Intervention and Referral to Treatment (SBIRT) Model of Drug Abuse in Primary Care

This study has been withdrawn prior to enrollment.
(PI left UF)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01439334
First received: July 22, 2010
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Drug Abuse
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multiple Behavior SBIRT Model of Drug Abuse in Primary Care

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in frequency of health promoting behaviors from baseline to 3 months follow up. [ Time Frame: Baseline to 3 months follow up ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Online Program Brief
Online Program Brief
Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief
Online prevention program using positive images
Other Name: Online Program Brief
Experimental: Online Program Extended Length
Online Program Extended Length
Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length
Online Program Extended Length
Other Name: Online Program Extended Length
Active Comparator: Control
Control
Behavioral: MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control
Control
Other Name: 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

  1. 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;
  2. 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;
  3. 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
  4. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439334

Locations
United States, Florida
Addictive & Health Behaviors Research Institute, University of Florida
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Chudley E Werch, PhD Addictive & Health Behaviors Research Institute, University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01439334     History of Changes
Other Study ID Numbers: 2009-U-689, R01DA026028
Study First Received: July 22, 2010
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Brief
Online
Image
Interactive
Young Adult
Primary Care

ClinicalTrials.gov processed this record on September 16, 2014