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
|Condition or disease||Intervention/treatment||Phase|
|Coping Skills Family Relations||Behavioral: B-SMART Intervention Group Behavioral: Usual and Customary Information Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
|Official Title:||Smartphone Help for DWI Offenders and Their Families: A B-SMART App|
|Actual Study Start Date :||March 30, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
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
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.
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
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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828370
|United States, Colorado|
|Klein Buendel, Inc|
|Golden, Colorado, United States, 80401|
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87107|
|Principal Investigator:||Gill Woodall, PhD||Klein Buendel, Inc.|