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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01439334
Other study ID # 2009-U-689
Secondary ID R01DA026028
Status Withdrawn
Phase N/A
First received July 22, 2010
Last updated September 21, 2011
Start date December 2009
Est. completion date July 2011

Study information

Verified date September 2011
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief
Online prevention program using positive images
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length
Online Program Extended Length
MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control
Control

Locations

Country Name City State
United States Addictive & Health Behaviors Research Institute, University of Florida Jacksonville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in prescription drug misuse, alcohol, cigarette and marijuana use consumption from baseline to 3 months follow up. Baseline to 3 months follow up No
Secondary Change in frequency of health promoting behaviors from baseline to 3 months follow up. Baseline to 3 months follow up No
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