Adults 21 to 85, any sex, with Coping Skills or Family Relations. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measure of Primary Outcome Variable: IID Lockout Events.Primary· 9 months
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 re
Group
Value
95% CI
Usual & Customary Information Group
10.13
± 18.34
B-SMART Intervention Group
2.78
± 5.06
Measures of Secondary Outcome Variables and Mediators.Secondary· 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).
Group
Value
95% CI
Usual & Customary Information Group
20
B-SMART Intervention Group
7
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Klein Buendel, Inc.
Last refreshed: 6 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03828370.