Clinical trial NCT03828370: DWI Offenders and Their Families App for Smartphones
Official title: Smartphone Help for DWI Offenders and Their Families: A B-SMART App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coping Skills
Family Relations
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of New Mexico
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-02-04
Enrollment: 246
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The B-SMART mobile web app will be evaluated in a randomized pretest-posttest controlled design. First-time DWI offenders and their CFMs will be randomized together to the intervention (B-SMART) or a usual and customary (UC) IID information condition comparison group (n=150) following baseline assessment.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure of Primary Outcome Variable: IID Lockout Events.
timeFrame: 9 months
Secondary outcomes:
measure: Measures of Secondary Outcome Variables and Mediators.
timeFrame: 9 months
Other outcomes:
Locations:
city: Golden
country: United States
facility: Klein Buendel, Inc
state: Colorado
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: Klein Buendel, Inc.
name: Gill Woodall, PhD
role: PRINCIPAL_INVESTIGATOR
References: