Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

DWI Offenders and Their Families App for Smartphones (B-SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828370
Recruitment Status : Enrolling by invitation
First Posted : February 4, 2019
Last Update Posted : July 9, 2021
Sponsor:
Collaborators:
University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Klein Buendel, Inc.

Tracking Information
First Submitted Date  ICMJE January 31, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date July 9, 2021
Actual Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
Measure of Primary Outcome Variable: IID Lockout Events. [ Time Frame: 9 months ]
The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from the Santa Fe DWI program database for each first-time DWI offender participant.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
Measures of Secondary Outcome Variables and Mediators. [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DWI Offenders and Their Families App for Smartphones
Official Title  ICMJE Smartphone Help for DWI Offenders and Their Families: A B-SMART App
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Coping Skills
  • Family Relations
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Active Comparator: Usual & Customary Information Group

    Study Cohort Assessment:

    Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device

    Intervention: Behavioral: Usual and Customary Information Group
  • Experimental: 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

    Intervention: Behavioral: B-SMART Intervention Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03828370
Other Study ID Numbers  ICMJE 0320
2R44AA022850-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Klein Buendel, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Klein Buendel, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of New Mexico
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Gill Woodall, PhD Klein Buendel, Inc.
PRS Account Klein Buendel, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP