- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828370
DWI Offenders and Their Families App for Smartphones (B-SMART)
May 2, 2023 updated by: Klein Buendel, Inc.
Smartphone Help for DWI Offenders and Their Families: A B-SMART App
The smart phone application (B-SMART) to be developed in this research project for family members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid drunk driving once the IID is removed from their automobiles.
As such, the public health consequences of DWI, in terms of health, morbidity and mortality, and its economic and societal consequences, will be positively influenced by a highly accessible and diffusible intervention.
The proposed Phase II project will complete the development and programming of the B-SMART smartphone web app and test its impact in a randomized efficacy trial with first-time DWI offenders and their concerned family members.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Driving while intoxicated (DWI) remains a substantial and preventable source of morbidity and mortality in the United States.
A variety of sanctions and interventions have been attempted to reduce DWI in the U.S., including enhanced DWI enforcement efforts, stricter drunk driving laws, responsible alcohol beverage service training, and alcohol treatment.
The Ignition Interlock Device (IID), which requires a driver to blow into a breathalyzer unit installed in an automobile to establish sobriety, reduces drunk driving while installed.
The use of IIDs has become widespread: most states in the U.S. now require convicted drunk drivers to install an IID in their cars upon some form of conviction.
However, research has conclusively shown that once the IIDs are removed from DWI offenders' cars, DWI recidivism levels return to those comparable to offenders who did not have an IID.
Interventions are needed to increase the likelihood that the effectiveness of IIDs persists beyond the installation period.
The Brief Family-Involved Treatment (B-FIT) is a promising intervention to improve DWI recidivism by affecting the social environment of DWI offenders.
Proposed here is Phase II research, a continuation of the original Phase I project, that will complete the translation of B-FIT into the B-SMART mobile web app for smartphones.
The content of the intervention will be based on empirically-validated couples therapy for those with alcohol use disorders developed by Co-Investigator McCrady, translated to a smartphone platform.
Phase II of this project will involve the systematic completion of B-SMART, employing: 1) an Expert Advisory Board, and 2) iterative development, multimedia and usability focus groups, and interviews comprised of CFM and DWI offenders.
B-SMART will be fully produced for DWI offenders and their concerned family members (CFM) and then tested in a randomized controlled efficacy trial with first-time DWI offenders (n=150) and their CFMs (n=150) recruited from the Santa Fe County DWI Program.
Unique to this intervention are the involvement of family members in supporting the DWI offender to not drink and drive and the use of smartphone technology to make that support immediate, accessible, and diffusible.
B-SMART will involve the CFMs by providing coping skills, communication skills, and strategies to help avoid DWI.
The randomized efficacy trial of B-SMART will examine B-SMART's impact on a variety of alcohol-related dependent variables, including IID lockout events, alcohol use, and family functioning.
Should B-SMART be demonstrated to impact DWI offenders and their family members by reducing IID Lockout Events (which predict future DWI recidivism) and alcohol use, and improving family functioning, DWI offenders, their families, and their communities will have an important, effective, accessible tool to further reduce the social, health and economic consequences of DWI.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Golden, Colorado, United States, 80401
- Klein Buendel, Inc
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87107
- University of New Mexico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
DWI Offender
- male or female
- 21 years or older
- first-time DWI offender with IID installed in vehicle
- enrolled in Santa Fe County DWI Program
- have a smartphone, tablet computer, or personal computer with Internet access
- consent to participate
- able to read and speak English or Spanish
Concerned Family Member (CFM):
- male or female
- 21 years or older
- spouse, parent, or immediate family member of first-time DWI offender with IID installed in vehicle and enrolled in Santa Fe County DWI Program
- have a smartphone, tablet computer, or personal computer with Internet access
- consent to participate
- able to read and speak English or Spanish
Exclusion Criteria:
- other family members already enrolled in the project
- second or above DWI conviction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual & Customary Information Group
Study Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device |
Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on the IID installed in their vehicle and the manufacturer information provided about the IID in PDF format, in both English and Spanish.
This constitutes a UC group, as such pamphlets are widely available to DWI offenders who have IIDs installed in their vehicles.
Thus, providing this pamphlet represents a standard information provision for first-time DWI offenders and their CFMs.
|
Experimental: B-SMART Intervention Group
Study Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device |
The B-SMART mobile web app will contain four modules: 1) Supporting Abstinence, 2) Shared Positive Activities, 3) Common Challenges for Family Members with IID, and 4) Effective Communication.
Within each module there will be a series of learning activities, including presentation text, interactive engagement, and videos.
All app content will be available in both English and Spanish, based on user language preference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Primary Outcome Variable: IID Lockout Events.
Time Frame: 9 months
|
The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from the Santa Fe DWI program database for each first-time DWI offender participant.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measures of Secondary Outcome Variables and Mediators.
Time Frame: 9 months
|
Alcohol use by the DWI offender, a secondary outcome, will be assessed at baseline, 3-month follow-up, and 9-month follow-up with versions of the Form 9090,91 adapted for online assessment for the CFMs (Form 90-ACS) and first-time DWI offenders (Form 90-AF).
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2019
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
January 31, 2019
First Submitted That Met QC Criteria
January 31, 2019
First Posted (Actual)
February 4, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 0320
- 2R44AA022850-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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