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DWI Offenders and Their Families App for Smartphones

Smartphone Help for DWI Offenders and Their Families: A B-SMART App

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03828370
Acronym
B-SMART
Enrollment
246
Registered
2019-02-04
Start date
2019-03-30
Completion date
2023-03-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coping Skills, Family Relations

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.

Interventions

BEHAVIORALB-SMART Intervention Group

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.

BEHAVIORALUsual and Customary Information Group

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.

Sponsors

University of New Mexico
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Klein Buendel, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of Primary Outcome Variable: IID Lockout Events.9 monthsThe primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from Ignition Interlock providers for participants in the study design. Lockout events occur on an Ignition Interlock Device when a user repeatedly fails a breathalyzer test within a given time frame to allow the automobile to start. When a user repeatedly fails the IID test, the device locks out the automobile's ignition, thus a Lockout Event occurs. These events are significant in that they indicate an attempt by the user to drive while intoxicated. In prior research Lockout Events predict subsequent DWI recidvism.

Secondary

MeasureTime frameDescription
Measures of Secondary Outcome Variables and Mediators.9 monthsAlcohol 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual & Customary Information Group
Study Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device Usual and Customary Information Group: 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.
130
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 B-SMART Intervention Group: 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.
116
Total246

Withdrawals & dropouts

PeriodReasonFG000FG001
3 Month Follow-upLost to Follow-up412
9 Month Follow upLost to Follow-up1220

Baseline characteristics

CharacteristicB-SMART Intervention GroupTotalUsual & Customary Information Group
Age, Continuous38.09 years
STANDARD_DEVIATION 13.42
38.55 years
STANDARD_DEVIATION 13.38
38.96 years
STANDARD_DEVIATION 13.39
Ethnicity (NIH/OMB)
Hispanic or Latino
50 Participants120 Participants70 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants97 Participants49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
18 Participants29 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
19 Participants34 Participants15 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants8 Participants4 Participants
Race (NIH/OMB)
More than one race
2 Participants8 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants3 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
37 Participants72 Participants35 Participants
Race (NIH/OMB)
White
54 Participants121 Participants67 Participants
Sex: Female, Male
Female
62 Participants139 Participants77 Participants
Sex: Female, Male
Male
54 Participants107 Participants53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1300 / 116
other
Total, other adverse events
0 / 1300 / 116
serious
Total, serious adverse events
0 / 1300 / 116

Outcome results

Primary

Measure of Primary Outcome Variable: IID Lockout Events.

The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from Ignition Interlock providers for participants in the study design. Lockout events occur on an Ignition Interlock Device when a user repeatedly fails a breathalyzer test within a given time frame to allow the automobile to start. When a user repeatedly fails the IID test, the device locks out the automobile's ignition, thus a Lockout Event occurs. These events are significant in that they indicate an attempt by the user to drive while intoxicated. In prior research Lockout Events predict subsequent DWI recidvism.

Time frame: 9 months

ArmMeasureValue (MEAN)Dispersion
Usual & Customary Information GroupMeasure of Primary Outcome Variable: IID Lockout Events.10.13 Ignition Interlock Lockout EventsStandard Deviation 18.34
B-SMART Intervention GroupMeasure of Primary Outcome Variable: IID Lockout Events.2.78 Ignition Interlock Lockout EventsStandard Deviation 5.06
p-value: 0.04ANOVA
Secondary

Measures of Secondary Outcome Variables and Mediators.

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).

Time frame: 9 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual & Customary Information GroupMeasures of Secondary Outcome Variables and Mediators.20 Participants
B-SMART Intervention GroupMeasures of Secondary Outcome Variables and Mediators.7 Participants
p-value: 0.034Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026