Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03828370 |
Other study ID # |
0320 |
Secondary ID |
2R44AA022850-02 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 30, 2019 |
Est. completion date |
March 31, 2023 |
Study information
Verified date |
May 2023 |
Source |
Klein Buendel, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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.