DWI Offenders and Their Families App for Smartphones

NCT03828370 | Completed Results

• 2 other identifiers: 03202R44AA022850-02
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 2

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.

Conditions

Coping Skills; Family Relations

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• Measures of Secondary Outcome Variables and Mediators.

  9 months

Study Arms (2)

Usual & Customary Information Group

ACTIVE COMPARATOR

Study Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test \& Interlock Ignition Device

Behavioral: Usual and Customary Information Group

B-SMART Intervention Group

EXPERIMENTAL

Study Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test \& Interlock Ignition Device

Behavioral: B-SMART Intervention Group

Interventions

B-SMART Intervention Group BEHAVIORAL

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.

B-SMART Intervention Group

Usual and Customary Information Group BEHAVIORAL

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.

Usual & Customary Information Group

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DWI Offender
• male or female
• 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
• 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

You may not qualify if:

• other family members already enrolled in the project
• second or above DWI conviction

Sponsors & Collaborators

• Klein Buendel, Inc.: lead
• University of New Mexico: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Klein Buendel, Inc

Golden, Colorado, 80401, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87107, United States

Location

Results Point of Contact

• Title: Dr. W. Gill Woodall, Ph. D.
• Organization: Klein Buendel Inc.-

gwoodall@kleinbuendel.com

5053829796

Study Officials

• Gill Woodall, PhD

  Klein Buendel, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: March 30, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-08

Locations

US (2)