Smartphone Help for DWI Offenders and Their Families: A B-SMART App
Phase: NA
Conditions: Coping Skills, Family Relations
Sponsor: Klein Buendel, Inc.

 
 
 
 
 
Smartphone Help for DWI Offenders and Their Families:  
A B-SMART App 
 
AA022850 
 
Study Protocol and Statistical Analysis Plan 
 
December 7, 2018 

 
PI: WOODALL, W GILL
Title: Smartphone Help for DWI Offenders and Their Families: A B-SMART App
Received: 04/05/2018
FOA: PA18-573 
Clinical Trial:Required
Council: 08/2018
Competition ID: FORMS-E
FOA Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small
Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical
Trial Required)
2 R44 AA022850-02
Dual: DA
Accession Number: 4159205
IPF: 4368501
Organization: KLEIN BUENDEL, INC.
Former Number: 
Department: 
IRG/SRG: ZRG1 RPHB-Z (10)B
AIDS: N
Expedited: N
Subtotal Direct Costs
(excludes consortium F&A) 
Year 2:      466,158 
Year 3:      417,187
Animals: N 
Humans: Y 
Clinical Trial: Y 
Current HS Code: 30 
HESC: N
New Investigator: N 
Early Stage Investigator: N
 
Senior/Key Personnel: 
Organization: 
Role Category: 
W WOODALL Ph.D
Klein Buendel, Inc.
PD/PI
BARBARA MCCRADY Ph.D
University of New Mexico - CASAA
Co-Investigator
RANDALL STARLING Ph.D
University of New Mexico - CASAA
Co-Investigator
VERNER WESTERBERG Ph.D
University of New Mexico - CASAA
Co-Investigator
PAUL MARQUES Ph.D
Pacific Institute for Research and
Evaluation
Consultant
PAUL STASIEWICZ Ph.D
University at Buffalo
Consultant
Elizabeth Epstein Ph.D
University of Massachusetts Medical
School
Consultant
Reid Hester  
CHECKUP AND CHOICES, LLC
Consultant
Julia Berteletti  
Klein Buendel, Inc.
Co-Investigator
Gary Cutter Ph.D
Pythagoras, Inc.
Other (Specify)-Biostatistician
20182791
IRB Approved at the 
Protocol Level 
Dec 07, 2018
                   STUDY PROTOCOL

3. RESEARCH STRATEGY 
 
3A. SIGNIFICANCE 
 
Our objective is to maintain the cessation of intoxicated driving afforded by the Ignition Interlock Device 
(IID) by mobilizing the DWI offender’s social network, focusing on CFMs, and enhancing their involvement 
through the use of smartphone technology. This study will be the first to use smartphone technology to extend 
and make permanent the cessation of intoxicated driving, providing an intervention that uses easily-accessible 
and diffusible technology.  
 
 
3A.1. DWI Interventions and Outcomes  
 
Nochajski and Stasiewicz24 found that deterrence 
sanctions employed soon after the offense (e.g., fines, 
license suspension) may have a deterrent effect for repeat 
offense. IIDs have been shown to be effective while 
installed in offenders’ cars; however, once removed, re-
arrest rates rise to levels comparable to offenders who do 
not have IIDs installed.7,25-28 Evidence for the efficacy of 
therapeutic interventions for DWI offenders has improved 
over time.24 Cognitive-behavioral skills training29 and 
brief intervention modes30 have shown moderate effects 
for DWI offenders. Interventions that engage and retain 
the offender in treatment may produce beneficial 
results.24,31 Notably, family-based approaches which 
accomplish this are the basis of the planned smartphone 
app. 
 
3A.2. Family-Involved Treatment  
 
One limitation of DWI treatment interventions is the 
exclusive focus on the offender. Treatments that address 
the social environment should result in better maintenance of change by decreasing environmental cues for 
drinking and providing positive incentives for desirable behaviors.34 Research has found that family-involved 
treatment enhances positive AUD outcomes9,35,36 and family-based contingency management improves 
adherence to aftercare37 and medication.38 Efficacious treatments include interventions for family members 
alone;33 contingency management where family members learn to provide desirable outcomes contingent on 
treatment goals;37 12-20 session protocols of behavioral couple therapy (BCT);39 brief BCT of 1-6 sessions;40-42 
and single session applications of the BCT model to any 
CFM that motivates persons undergoing detoxification to 
continue treatment.41 Results across this literature 
suggest three core treatment elements: (a) increasing 
family support and reinforcement for behavior change, 
(b) increasing positive exchanges in the family, and (c) 
improving communication.16 The proposed B-SMART 
intervention incorporates these three major elements. 
 
3A.3. Smartphone Technology in Health 
Communication Interventions  
 
Smartphone applications (apps) are changing 
healthcare43 in a number of areas, including health 
education and clinical practice,44 data collection,45 sexual health education,46 weight management,47 
diabetes,48,49 smoking cessation,50-52 substance abuse,53 and sun protection.54 To date, there are few apps 
related to substance abuse available.55 Mobile apps on smartphones have not been tested extensively for 
disease prevention, but have for monitoring behavior.56,57 Cell phone use is widespread. Recent Pew Internet 
research indicates that 77% of adults in the United States are smartphone owners.58 Smartphones usually 
accompany users are usually turned on. Thus, mobile apps can deliver advice/reminders and content to the 
families of DWI offenders at all times. Little research has been conducted on use of smartphones for DWI 
offense issues in family settings. Some DWI-related smartphone apps are available: R-U-Buzzed estimates BAC 
and warns intoxicated users not to drive59; Stumble Safely plots safe walking routes home for intoxicated 
customers; SafeRide calls cabs for intoxicated bar customers. However, no empirical evaluations of these DWI-
related smartphone apps have been reported, and all are targeted to the offender only. Smartphone apps for 
DWI offenders or their family members have not been reported in the research literature or popular press. 
Preliminary Studies: DWI Research and 
Treatment. Drs. Woodall and Westerberg have 
extensive experience conducting DWI-related 
research, including randomized trials of the 
efficacy of MADD Victim Impact Panels on DWI 
Recidivism,12 an incarceration/ treatment 
program for first-time DWI offenders,13-19 and 
Responsible Beverage Service training.16,20-23 
They have developed extensive research 
experience with DWI offenders, including 
successful recruitment, assessment, tracking, 
and data analysis. Dr. McCrady directed an 
outpatient treatment program that served DWI 
offenders for 10 years and has clinical experience 
that complements the other investigators’ 
research experience. 
Preliminary Studies: Family-involved 
Research. Dr. McCrady, Co-Investigator, has 
conducted research on conjoint and family-
involved treatment for individuals for AUDs for 
more than 40 years. This research has found 
consistent support for the efficacy of couples 
approaches32 in reducing drinking and, in some 
studies, enhancing relationship stability and 
satisfaction.4,9,24,33 She currently is developing a 
brief family-involved treatment (B-FIT) based on 
these 3 principles.  
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 111

Smartphone apps may be useful, convenient, and easily diffusible tools that may extend and strengthen the 
impact of families on long-term outcomes for DWI offenders. 
 
3A.4. Interlock Ignition Device (IID) Research  
 
With the advent of the 
technology to support the 
development of IIDs in 1970, these 
devices have become more 
sophisticated technologically, 
allowing digital photography of the 
driver, WiFi connection to device 
providers and court systems that 
allow immediate data transmission 
of lockout events, and GPS 
monitoring of driving and breath-
testing events.68 They have also 
become more widespread in use, 
with estimates of 300,000 in use 
among DWI offenders.69 All 50 U.S. 
states have some type of IID law, 
with 25 U.S. states having 
mandatory IID laws for all DWI 
offenses.5 All 50 U.S. states have 
some type of Ignition Interlock law, 
with 25 U.S. states having 
mandatory Ignition Interlock laws 
for all DWI offenses.5 Research on 
the effectiveness of IIDs has shown: 
1) IID’s reduce the incidence of DWI 
recidivism while installed in the 
offender’s vehicle, but not once the IID is removed70 and 2) the frequency of a DWI offender being prevented 
from starting a vehicle because of a lockout event (the IID sensing the presence of alcohol and disallowing the 
vehicle to start) predicts DWI recidivism – the more frequent the lockout events, the more likely an offender 
will have a subsequent DWI arrest. These findings have led researchers to consider ways to extend the 
effectiveness of IIDs beyond their installation period, including implementing health promotion and treatment 
programs tied to IID use while in place in offenders’ vehicles.71,72 Most recently, Voas and colleagues73 have 
shown that requiring alcohol treatment of DWI offenders who have frequent IID lockout events resulted in a 
one-third reduction in DWI recidivism.68 has recommended increased attention to programs that integrate 
health promotion interventions while the offender has an IID installed in their vehicle. To date however, no 
research has examined the impact of family-based treatment on reducing IID lockout events and subsequent 
DWI recidivism or the provision of family-based treatment via smartphone apps to achieve lockout event 
reduction and subsequent DWI recidivism. The current investigation will examine this important possibility. 
 
3A.5. Summary of Significance  
 
DWI continues to be a major source of injuries and fatalities. To date, DWI interventions have focused 
almost exclusively on the DWI offender, with little regard for the offender’s social environment. Approaches 
that combine policy-level interventions such as the IID with interventions that target the DWI offender’s social 
environment (e.g., family-focused interventions) are likely to show strong efficacy. We will integrate an 
effective family-focused brief therapy (B-FIT) with the accessibility of the smartphone to extend the 
effectiveness of IID, as assessed by IID lockout events, after the device is removed from the vehicle. 
 
3B. INNOVATION  
 
3B.1. Innovation of the Proposed SBIR Research 
 
Innovation in the proposed Phase II SBIR research derives from the application of an existing conceptual 
model about maintaining behavior change to a new population and enhancing that application through 
smartphone technology: 
 
• Efforts to decrease repeat-DWI generally have used either external controls or therapeutic approaches. 
External controls in general, and the IID in particular, are incomplete approaches; controlled research 
Preliminary Studies: Web-based and Smartphone 
Interventions, and Adolescent Risk Behavior Research. Drs. 
Woodall, Starling, and colleagues have collaborated on the 
development and randomized trial testing of seven web-based 
interventions focusing on adolescent smoking,60 dietary change in 
multicultural rural adults,61 risky drinking among college students,62 
web-based responsible beverage service training,63 prevention of drug 
use and risky sexual behavior among adolescents,64,65 and HPV 
vaccine uptake among young adolescent girls.66 In mobile computing 
app development, Drs. Woodall and colleagues have developed and 
evaluated: 1) A web-based smoking cessation program for young 
adults, Real e Quit Mobile, that includes short counseling messages, a 
tool to list reasons and benefits of quitting and create plans for coping 
with craving and relapse, short informational documents, testimonials 
about quitting, and a screen for setting a quit date improved quitting 
behavior (27% of smokers reported 30-day point-prevalence 
abstinence and 24%, continuous abstinence at 12-weeks)52; and 2) a 
mobile app with sun protection advice for the adult population, called 
Solar Cell54 in a nationwide trial improved self-efficacy for sun 
protection (p=0.022), increased shade use (+7%, p=0.034), decreased 
reliance on sunscreen (-6%, p=0.48), and decreased participants’ time 
in the sun (+15%, p=010).67 The proposed project will leverage the 
research team’s extensive experience in developing and testing web 
and mobile applications in adolescent and family settings. 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 112

combining external controls with therapeutic approaches is lacking, making this research innovative. 
• Interventions have not considered the social context in which DWI offenders live. The proposed 
research will extend the reach of the IID and therapeutic intervention into the offender’s family 
environment, another unique aspect of the proposed research. 
• Smartphone apps are in the early stages of being tested as means to initiate and maintain changes in 
health behaviors; applications to the DWI offender population and their families are rare and untested.  
 
3B.2. Commercial Potential 
 
KB has a successful history of collaborating to commercialize a web-based alcohol responsible beverage 
service training program (i.e., WayToServe®).19 We envision taking a similar approach to market B-SMART 
mobile web app as we did with WayToServe®. A licensing partnership with Wedge Communications LLC, has 
resulted in over 60,000 purchases of the WayToServe® training in its seven years of commercialization. We 
anticipate that during Phase III commercialization, Wedge will market and distribute B-SMART to multiple 
target markets for bundling with devices and services including IID manufacturers, DWI schools, and car 
insurance companies. B-SMART will also be promoted to community social services agencies, mental health 
clinics, and government agencies responsible for implementing alcohol education and treatment programs for 
DWI offenders and families. For example, state alcohol beverage control agencies, state departments of 
transportation, and the National Highway Traffic Safety Administration are heavily involved in high-risk 
population alcohol prevention programs.74-77 In addition, there are nearly 8,100 substance abuse treatment 
services organizations in the U.S.73 B-SMART will be promoted directly to device users through social media 
advertising.78 Finally, IID providers may support the adoption of B-SMART as a way to extend the IID’s period 
of effectiveness, and we will reach out to IID providers (e.g., courts) for possible commercial collaboration. See 
the detailed Commercialization Plan. 
One of the most marketable characteristics of B-SMART is that through early intervention with first-time 
offenders, it has the potential of being an affordable option to reduce the economic and societal costs incurred 
by drunk driving. We anticipate that B-SMART will be an attractive tool to court systems and state agencies in 
all 50 states that have some IID law, the 25 states with mandatory IID laws, and the more than 30 states that 
mandate alcohol education and/or treatment following a DWI.79 B-SMART could enhance existing programs 
because it offers important skills training to CFM on a widely used platform. 
A recent review of current smartphone apps found sobriety testing and drink tracking apps80-82 and safe 
ride locator (e.g., to call a cab) apps but no apps providing skills training and communication guidelines to 
support interactions between family members and DWI offenders. To our knowledge, there are currently five 
apps in the Android Play Store and one app in the Apple Store for users of IID. These apps provide resources 
on state programs, overcoming reciprocity obstacles, and maintenance of the device. The information provided 
is more technical and targeted toward the offender than the information presented in B-SMART. B-SMART 
will be the first smartphone app designed to improve family members’ ability to support changes in drinking 
and driving and improve family relationships and communication as a way to reduce repeat DWI offenses. The 
innovation of the program, its potential impact on DWI re-arrest, and its strong commercial potential indicate 
that B-SMART would be an important and easily adoptable tool for families of DWI offenders. 
  
3C. APPROACH 
 
3C.1. Progress on SBIR Phase I Research 
 
All milestones and deliverables were achieved in the Phase I research funded in September of 2014 and 
completed with a no cost extension in September 2016. We completed focus groups and usability testing, 
developed an app prototype, convened the Expert Advisory Board, and created a specifications document. 
 
 
3C.1.1. Milestone 1: Expert Advisory Board. An Expert Advisory Board (EAB) included Dr. Paul 
Marques, an expert in DWI treatment interventions; Dr. Paul Stasiewicz, an expert in traffic safety, alcohol, 
and DWI epidemiology and policy in New Mexico; and Dr. Reid Hester, expert in development of alcohol-
related digital interventions. The EAB met on a quarterly basis during the Phase I project period to aid in the 
development of formative interview questions, review interview results, evaluate the B-SMART mobile web 
app beta version, and finally assess the results of the usability tests and determine feasibility for future 
development. The EAB provided key input at all phases of this investigation, found the B-SMART module 1 to 
be compelling and likely useful to target users (Concerned Family Members of DWI offenders and the 
offenders themselves), and strongly supported developing a full version of the B-SMART in this Phase II 
project. 
 
 
3C.1.2. Milestone 2: DWI Advisory Board. A DWI Advisory Board (DWI-AB) met quarterly during 
the project period to review 1) the translation of B-FIT to B-SMART content, 2) summaries of DWI offender 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 113

and CFM interviews, 3) the beta version of the first module of B-SMART mobile web app, 4) summaries of the 
DWI offender and CFM interviewees’ reactions to the beta B-SMART module, and 5) the specifications 
document for future production. The members of the DWI-AB were: Ms. Linda Atkinson, Director of the New 
Mexico DWI Resource Center, Ms. Carol Trotter, Director of the Albuquerque Metropolitan Counseling Intake 
program, Ms. Julie Walsh, Director of Walsh Counseling in Albuquerque, Mr. Tom Starke of Impact DWI in 
Santa Fe, NM, and Jill Ingraham, Director of rehabilitative services for Metropolitan Courts of Albuquerque. 
The DWI-AB was unanimous in its support for a Phase II project for full production and testing of the B-
SMART. 
 
 
3C.1.3. Milestone 3: Concerned Family Member and DWI Offender Development Interviews. 
Development interviews were conducted with CFM (n=6) and DWI offenders (n=6). Five participants were 
Anglo and 7 were Hispanic, with 6 males and 6 females comprising the sample. Participants were recruited on 
a voluntary and informed consent basis from local DWI counseling and court programs and were compensated 
for their time. Research staff posed a series of EAB-approved questions to each interviewee, and the interviews 
were audio recorded. The following consistent themes emerged from the interviews with DWI offenders. 1) 
They expressed frustration about the IID, including financial burden, embarrassment and social isolation, and 
heavy time investment; they were typically cautious about exposing their family to these challenges. 2) There 
was general distrust and perhaps misinformation about the interlock program and device. 3) All thought the 
proposed app was a good idea; they liked the idea of being linked with their family member via the app. 4) They 
expressed the importance of supportive behaviors (e.g., reminders about consequences; positive 
encouragement and affirmations; reflecting on goals/the future; discussing triggers; planning ways to avoid 
driving after drinking or not to drink at all; and shared activities such as walks/exercise) and unsupportive 
behaviors (e.g. family members engaging in heavy drinking themselves). 5) More specific ideas for app content 
included a BAC calculator/countdown; pop-up reminders about consequences, goals, and positive 
encouragement; and utilization of GPS services to connect easily to public transportation or their family 
member. Key takeaways from interviews with CFM included the following. 1) Overall, they had very good 
awareness about the DWI offenders’ challenges with the IID (as outlined above) and how those challenges 
affected the whole family. 2) All thought the app sounded promising and offered many specific ideas for 
content including a tip or fact of the day; inspirational anecdotes; incentives; check-in questions (e.g., “do you 
feel like drinking right now?”) with easy access for contacting social supports; information on local non-
alcoholic activities/events; reminders about consequences and progress; access to transportation services; and 
a social scheduling module. 3) They largely agreed with what the DWI offenders identified as supportive and 
unsupportive behaviors but noted that other family members are less insightful (a reason to potentially connect 
multiple people via the app). There 
appeared to be marked differences in 
responses between family members 
whose loved ones were now in 
control of their drinking compared to 
those who were still problem 
drinkers, with the former expressing 
more optimism and indicating that 
families have a range of perspectives 
and needs. As specified above, these 
themes were reviewed by both the 
EAB and DWI-AB and were used by 
research staff and web app 
production staff to structure and 
produce the first beta module of the 
B-SMART prototype.  
 
3C.1.4. Milestone 4: 
Prototype Creation. A prototype 
of the B-SMART mobile web app 
with one module was completed for 
Phase I (see Figure 1). In addition 
to the module titled Supporting 
Abstinence, the prototype also 
includes the following pages: login; 
module explorer; bookmarks; and 
information about the research 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 114

study. The programmed Supporting Abstinence module is highly interactive with six successive events, 
including a video as well as activities. The module begins with a video modeling a discussion between an 
offender and CFM. Supportive communication and behaviors (e.g., suggesting an alternative activity to do 
together) are demonstrated. The next activity, What is Support?, provides a series of statements and users have 
to swipe the statement to the right if they think it is supportive and to the left if they think it is unsupportive. 
Feedback is provided after each statement is swiped. The following event allows users to consider what 
behaviors are supportive in their relationship. There are two columns on this activity page. On the left, there is 
a description of ways to be supportive. On the right side, the user types in her/his own answers to ways she/he 
can be supportive. Categories of supportive actions are “Things you can say”, “Things you can do”, “Important 
words to use”, and “Important words to avoid”. The program saves this information in the user’s bookmarks 
and on-screen in the next activity. Finally, a page entitled Putting it All Together summarizes the lessons from 
the module and gives users the opportunity to edit their responses after seeing additional suggestions of 
supportive behavior. The module was built for users to experience linearly. They must view each page and 
activity in sequential order. Once they have completed it, they may navigate through the module. The prototype 
was built for CFM to access individually via a login, without their DWI offender. The B-SMART prototype was 
built on a full stack website using HTML/JavaScript as its main interface. Animations are performed using 
GreenSock Animation Platform, CSS3, and animated GIFs. Front-end JavaScript framework is Angular. Look 
and feel of the program was designed and developed using CSS 3.0 with HTML5. Login and network activity is 
managed by PHP, including creation of user calendar events. A backend tracking mechanism is utilized.  
 
3C.1.5. Milestone 5: Usability and Navigability Tests. Multimedia usability and navigability tests 
were conducted by having participants browse through the B-SMART beta mobile web app and provide 
feedback about the module while browsing (all comments were audio recorded). At the conclusion of browsing 
the module, participants 
rated their experience on 
the Bangor System 
Usability Scale (SUS).83 
CFMs of convicted DWI 
offenders (n= 32) in 
Bernalillo and Santa Fe 
counties in New Mexico 
were recruited for the 
usability tests and 
compensated for their 
time. Mean age was 37.2 
years (range = 20-63). 
Ethnicity of participants 
was 56% Hispanic/Latino, 38% non-Hispanic, while racial makeup of the sample was 76% Anglo/Hispanic, 6% 
Native American, 3% Asian, 3% multiple response, 9% no category applicable, and 3% prefer not to answer. 
The usability ratings reflected an average overall SUS rating of 44.2 (sd=4.78, scale range: 10-50) (Table 1), 
with 87% of participants rating the B-SMART module 40 or above, meeting the milestone set a priori in Phase 
I. Further, the results indicate that users found the B-SMART module easy to use, informative, and very 
positive. A summary of this developmental research for the B-SMART beta mobile web app was presented at 
the annual conference of the Research Society on Alcoholism.84  
 
 
 
3C.1.6. Importance of Phase I Findings. Results from Phase I demonstrate: 1) the potential impact of 
a smartphone app utilizing a therapeutic family-based approach to reduce DWI (i.e., B-FIT) is strong and 
extensive; 2) KB has the ability to create a prototype of the B-SMART mobile web app; and 3) focus group 
participants and usability testers approved of the B-SMART design and concept. The EAB advised the research 
team that the Phase I research results indicate it is feasible to develop a full-scale B-SMART mobile web app 
and that the team should conduct Phase II research to evaluate the effectiveness of B-SMART with DWI 
offenders and CFMs.  
 
3C.2. Overview of SBIR Phase II Research  
 
A two-phase project is proposed for the Phase II research. The overall goal of the proposed project is to 
systematically develop, produce, and test a smartphone application that will aid concerned family members 
(CFMs) of DWI offenders and the DWI offenders themselves in extending and reinforcing the drinking and 
driving abstinence introduced by the IID. The target population is first-time DWI offenders and their CFMs, 
defined as a spouse or close relative living with the DWI offender. In the development phase (Months 1-7), 
investigators and staff from Klein Buendel (KB) and U. of New Mexico (UNM), the consultants, and KB media 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 115

developers will iteratively design and 
program the B-SMART mobile web app. A 
web app functions similar to a mobile app 
on a smartphone or tablet computer. 
However, rather than a stand-alone 
program running on the local mobile 
device, a mobile web app runs through the 
phone’s/computer’s web browser, 
controlled by an external web server. 
Mobile web apps can be mobile device 
responsive and also run on personal 
laptop/desktop computers, ensuring cross-
platform compatibility. There are several 
advantages to this approach. 1) User 
experience of a mobile web app is similar 
to a stand-alone mobile app, but content 
can be updated more quickly than in stand-alone mobile apps that need to be downloaded to install updated 
versions. 2) Mobile web app programming avoids the need to program for multiple operating systems (e.g., iOS 
or Android for smartphones/tablet computers and iOS and Windows for personal computers), a more time and 
effort efficient approach. 3) Mobile web app use can be better tracked from the web server than a stand-alone 
mobile app, leading to superior tests of the relationship between app use and alcohol-related outcomes. This 
development phase also will include formative focus groups to finalize content and final usability testing 
sessions of B-SMART with DWI offenders and their CFM in both English and Spanish in New Mexico.  
The second phase of the project (Months 8-24) will involve implementation and evaluation of B-SMART in 
a randomized controlled efficacy trial, with baseline, 3-month, and 9-month posttest assessments. Participants 
will be recruited from the Santa Fe County 
DWI first-time offenders program, in 
cooperation with the Santa Fe Magistrate 
Court (see letter of support in Section 9G). 
See Figure 2 for the overall project 
timeline. 
 
3C.3. Target Population  
The project has two relevant, linked 
target populations: 1) CFM of DWI 
offenders and 2) the first-time DWI 
offenders themselves. The CFM is the 
primary user of the B-SMART mobile web 
app and content will be tailored toward 
them, with supporting information 
provided for the DWI offender. 
Participants in both the web app development phase (Months 1-7) and the randomized efficacy trial phase of 
the project (Months 7-24) will be recruited from the Santa Fe County DWI Program, the county-wide program 
that manages probation and sentencing programs and requirements for all DWI offenders in Santa Fe County, 
New Mexico. In New Mexico, Santa Fe County had the fourth-highest ranked number of first time DWI 
offenders (360) in 2015 and 313 first time convictions in 2016. Participants in the development phase will not 
be eligible for the randomized trial phase of the project. Figure 3 displays the inclusion and exclusion criteria 
for participation in either phase of the investigation.  
 
3C.4. Expert Advisory Board (EAB)  
 
Dr. McCrady, who developed the B-FIT program that is the basis of our smartphone app, will convene an 
EAB of DWI and Family Intervention experts, and Investigators. The EAB includes experts in DWI policy 
research, IID research, and traffic safety: Dr. Paul Marques of the Pacific Institute for Research and Evaluation 
(PIRE); an expert in DWI treatment interventions and IID research, Dr. Paul Stasiewicz of the Research 
Institute on Addictions, an expert on evidence-based approaches to alcohol treatment and drunk driving, Dr. 
Reid Hester, an expert in brief motivational interviewing, DWI intervention research, and digital intervention 
development and testing, Dr. Beth Epstein, a co-author with Dr. McCrady on brief interventions for couples in 
treatment, and Mr. Thomas Starke, an expert in traffic safety, alcohol and DWI epidemiology and IID policy in 
New Mexico. Similar to Phase I of this project, the EAB will meet bi-monthly during the project and review the 
translation of B-FIT to B-SMART content, review summaries of DWI offender and CFM focus groups, and 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 116

usability data for the final B-SMART mobile web app. The EAB will review and approve the final version of B-
SMART. The EAB will also review plans for, and monitor the progress of the randomized trial of the B-SMART 
mobile web app and review trial outcomes and advise the team the efficacy of B-SMART.  
 
3C.5. Iterative Final Production of B-SMART Mobile Web App (Specific Aims 1 & 3; Months 1-7)  
  
 
3C.5.1. The B-SMART Mobile Web App Intervention. Based on results of usability testing in Phase 
I, the research 
team, with the 
EAB’s input, 
proposed the 
flow (Figure 4) 
of the B-SMART 
mobile web app 
to be developed 
in Phase II. In 
the fully 
developed app, 
there will be four 
modules: 1) 
Supporting 
Abstinence 
(already 
developed in 
Phase I), 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. The 
content of the 
modules will be 
written primarily 
for CFMs in 
order to improve 
communication, 
provide 
resources on 
how to support their family member, and promote positive shared experiences to support the DWI offender’s 
abstinence. CFMs will be able to share content with the DWI offender. When appropriate, we will encourage 
the CFM to invite the DWI offender to participate in the activities together for shared learning. Working with 
KB’s instructional designer and utilizing the design of the Phase I prototype, the team will create a fully-
functional mobile web app with a learning-centric structure with content, activities, tools and exercises that are 
tailored for CFMs to maximize effective navigation for the user but allow a user to toggle settings to navigate all 
content. B-SMART will also be useful and functional for the first-time DWI offender and will be designed to be 
easily navigable and informative for both the CFM and offender. While our Phase I research developed these 
specifications, they will be validated in final form by the iterative development research for Phase II. Additional 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
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features to be programmed will be considered during the formative research, based on feedback from 
participants. All app content will be available in both English and Spanish, based on user language preference. 
The Spanish translation/back-translation verification process will be managed by Project Coordinator Ms. 
Jeannyfer Reither (KB), a native Spanish speaker, and assisted by Project Research Scientist Mr. Leonel Diaz 
(UNM), a native Spanish speaker. A professional translator will also be utilized for back-translation. 
 
 
 
3C.5.2. Iterative Development Approach. As with all effective digital designs, smartphone 
applications must be carefully and systematically designed, employing feedback and reviews from the intended 
target group (in this case, DWI offenders and their CFMs) in a series of repeated development cycles. We will 
employ a series of systematic app development steps used in prior smartphone application and website 
projects: 1) initial focus groups to review the proposed program flow and content (n=32); 2) usability testing 
sessions with CFM (n=16) and DWI offenders (n=16) of a beta version (near final) of B-SMART to ensure 
usability and navigability, and 3) review of the final version of B-SMART by EAB members. We project app 
development to occur in Months 1-7.  
 
3C.5.3. Final Content and Tailoring Focus Groups. Focus groups will be used to frame the content 
in the B-SMART mobile web app. Four focus groups (2 of DWI offenders, 1 each in English and in Spanish; 2 of 
CFM, 1 each in English and Spanish) will be conducted. Although the app will be designed for CFMs, input 
from DWI offenders will be crucial to learn what they believe would be helpful for them. Participants will be 
recruited from the Santa Fe County DWI program (see Letter of Support) in Month 2 of Phase I and paid $50 
for 2 hours of participation. Focus group discussions will be led by English and Spanish speaking research staff 
trained in focus group facilitation techniques who will follow a protocol to lead discussions about the use of B-
FIT content in the B-SMART smartphone app. Topics will include: how the CFM would share information with 
the DWI offender; what type of content the DWI offender would expect to see; examples of positive shared 
activities; obstacles to scheduling positive shared activities and how to overcome them; examples of how CFMs 
can be most supportive of the offender to reduce recidivism; typical difficulties in effective communication in 
couples in conflict; and examples of how to use specific skills to overcome these difficulties. Discussions will be 
audiotaped, transcribed, and analyzed using procedures developed in previous work by the research team. 
Analysis of all focus group discussions will be accomplished via InVivo NUDIST content and theme analysis 
software to identify consistent and recurrent content themes in response to focus group questions. These 
results will be summarized in focus group reports distributed to the research team, EAB, and KB media 
developers and used to make final decisions about app design, instructional design, and final content.  
 
3C.5.4. Mobile Web App Programming and Production Procedures. Production of the B-SMART 
mobile web app will be completed by KB’s media developers following well-established agile iterative 
production steps. Broad goals and specific instructional/behavioral objectives and content will be developed by 
investigators and staff. Messages and graphic design elements will be reviewed from Phase I research and 
previous digital programs and screen scripts created. Interface design ideas will be prepared in written form, 
combined with scripts into flowcharts/storyboards, and reviewed by investigators and EAB before authoring B-
SMART. An overall look and feel of the app and graphics and functions of components will be based on the 
Phase I development, and also this initial review and usability testing (see following section). Each component 
of the mobile web app will be thoroughly tested for platform stability and code errors prior to being exported to 
the Web server. Language, graphics, and video depictions that have "timeless" features will be used. KB’s 
production team includes a graphic designer, junior- and senior-level multimedia programmers, and an 
instructional designer. These production steps were implemented successfully in the production of the first 
module of B-SMART as a prototype in Phase I.  
 
3C.5.5. Hardware/Software Requirements and Region Connectivity. B-SMART will be served to 
smartphones, tablet computers, and personal laptop/desktop computers from KB’s state of the art web server 
(see description in KB’s Resources page). The content will be authored utilizing a Responsive Web Design 
approach that optimizes user experience across platforms and screen sizes, using HTML5, CSS, JavaScript, and 
Microsoft dotNet platform (using C# language). Microsoft SQL databases will track use. KB’s media developers 
will maintain the mobile web app, monitor app usage, manage the SQL database storing use data, and provide 
technical support to CFMs and DWI offenders (by email and toll-free phone number). B-SMART will be 
programmed to run on common web browsers on iOS and Android smartphones and tablet computers and on 
iOS devices and Windows personal computers. A recent review85 found that 91% of New Mexicans have access 
to wired Internet service and 99% of New Mexicans have access to mobile broadband service. While broadband 
speeds in New Mexico are not always optimal (75% of New Mexicans have broadband speeds of 25 megabits 
per second or greater), access to the Internet, particularly from mobile broadband service (the focus of this 
project) is widely available. As such, the connectivity requirements for the proposed project are in place in New 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 118

Mexico. 
 
3C.5.6. Iterative Usability Testing with Concerned Family Members (Specific Aim 2). Led by 
Ms. Berteletti, iterative usability testing will be conducted with CFMs (n=32), employing an established 
protocol to test the navigability and usability of the newly-programmed modules (i.e., those not programmed in 
Phase I: Shared Positive Activities; Common Challenges; and Effective Communication). During individual in-
person sessions with research staff, participants will be instructed to navigate through sections of B-SMART 
and provide their verbal reactions as they do so. Staff will prompt with questions, asking what the participants 
might change about activities and how they might use the app with their DWI offender. At the completion of 
each session, participants will complete the 10-item Bangor System Usability Scale (SUS).83 CFM ratings of the 
B-SMART beta module in Phase I on the SUS averaged 44.2 out of a possible 50 scale points, indicating good 
usability. The target score for indicating usability in Phase II will be 40 or above, as is suggested as being 
acceptable. In addition to the SUS measure, the Instructional Designer at KB will create a summary report 
listing usability problems experienced and their severity. The research team and KB media developers will 
make necessary changes to address these problems before launch in the randomized controlled trial (see 3C.6). 
All usability sessions will be video recorded and transcribed. Both qualitative and quantitative (SUS scale) 
summaries will be provided to Investigators and the EAB for review. All usability testing sessions will be held 
in New Mexico and will last approximately one hour. Spanish and English speakers will both be recruited. 
Participants will be compensated $50.00 for their time.  
 
 
3C.5.7. Summary of Development Phase. Our team will use its accumulated experience and expertise 
in developing technology interventions, including mobile technology, to design a highly functional and effective 
B-SMART mobile web app, continuing the production started in Phase I. Systematic, iterative development 
and testing will ensure that the app addresses the specific needs of CFMs and DWI offenders to provide 
therapeutic approaches, that are generally only provided to families during in-person sessions, to reduce 
recurrence of drunk driving.  
 
3C.6. Randomized Trial Evaluating B-SMART (Specific Aim 4; Months 8-24) 
 
3C.6.1. Experimental Design. The B-SMART mobile web app will be evaluated in a randomized 
pretest-posttest controlled design. In months 6-11, first time DWI offenders and CFMs will be recruited for 
participation in the trial. First-time DWI offenders and their CFMs will be randomized together to the 
intervention (B-SMART) 
(n=150) or a usual and 
customary (UC) IID 
information condition 
comparison group (n=150) 
following baseline 
assessment. Assessment via 
web-based surveys will be 
conducted with the DWI 
offenders and CFMs at 
baseline, 3-month follow-
up, and 9-month follow-up 
post randomization. Also, information on frequency of alcohol-positive IID tests (termed “lockout events) will 
be acquired by the project from the Santa Fe County and Municipal DWI Program at the 9-month assessment 
point (posttest only) for each DWI offender. Thus, the proposed efficacy trial (see Figure 5) will be a 2 (level of 
treatment – app intervention vs. UC information) x 3 (level of time – baseline vs. 3-month follow-up vs. 9-
month follow-up) mixed factorial design. Baseline and follow-up data collection will be conducted via online 
surveys and a customized web portal and include DWI offender and CFM alcohol frequency and use measures 
and measures of family communication and functioning (see 3C.7). Participants will fill out a locator form with 
contact information and collateral contact information to locate them for assessment at the 3-month and 9-
month follow-ups. We have employed these locator procedures in prior trials, keeping average loss across 9 
months at 15%-20%. Cumulative IID lockout event data will be collected for all DWI offenders from the Santa 
Fe County DWI Program at the 9-month assessment point. 
 
3C.6.2. Recruiting and Consenting Procedures. Potential participants will be contacted for 
recruitment and consenting at monthly Santa Fe County DWI Program meetings held for each DWI offender at 
the beginning of her/his probation period. CFMs of first-time DWI offenders will be contacted via email and a 
web recruitment portal designed exclusively for the project and followed up with a recruitment phone call. 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
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Participants will only be enrolled in the trial if both the DWI offender and CFM consent to participate. Our 
previous work in Phase I of the project found a strong willingness to participate in the project among both DWI 
offenders and CFMs based on their interest in better family functioning and the unique convenience of a B-
SMART mobile web app that could be beneficial to their experiences with the IID. 
 
 
3C.6.3. Implementation of B-SMART Mobile Web App. B-SMART will be implemented with first-
time DWI offenders and CFM randomized to the intervention in months 7-11. Following the baseline survey, a 
link will be presented to the participants where the B-SMART mobile web app can be accessed through their 
web browsers on their smartphones, tablet computers, or personal laptop/desktop computers. This link will 
also be sent to their email addresses and by text message to their mobile phones. A customized backend SQL 
database will track participants’ progress through the mobile web app. Unique identifying user codes will be 
assigned to all first-time DWI offenders and their CFM by the research staff; participants will select their own 
password under the user profile section of the web app. The User ID and password will be used to access B-
SMART and mark the usage data in the SQL database (see description of Server-side Process Measures in 
Section 3C.7.3). In case users forget their password, they will provide a unique answer to a standard personal 
question (e.g., what is your mother’s first name), and using this information, the mobile web app database will 
return the forgotten password. If users forget both their User ID and password, they can call or email a 
technical assistance hotline staffed by KB media developers.  
 
Orientation to B-SMART will be primarily self-explanatory, which we will confirm in usability testing (see 
3C.5.6). In our past research, nearly all adults were adept at using a web browser across devices, so we are 
confident that B-SMART and its use will take little explanation. To ensure use, we will: 1) design the mobile 
web app to be inherently interesting and enjoyable through our iterative development procedures 
incorporating user input (see C3.5.2); 2) make the user navigation simple and easy to browse so modules can 
be viewed quickly; 3) create a mobile web app that can be completed in no more than 120 minutes to avoid 
boredom that provokes drop out; 4) program the mobile web app so its interface is optimized on a variety of 
technology platforms (smartphone, tablet computer, or personal computer) to accommodate the preferences of 
any user; and 5) engineer low and high bandwidth versions of the mobile web app that automatically adjust to 
the user’s bandwidth access. While connectivity data in 3C.5.5 indicates sufficient broadband and cell coverage 
in New Mexico for the B-SMART mobile web app, this programming feature will allow the use of B-SMART 
even in limited connectivity situations. Reminders to use B-SMART (or read the IID Information pamphlet in 
UC group, see 3C.6.3) will be sent to participants every 5 days for two weeks after randomization. If the either 
the mobile web app (or the web pamphlet in the UC group) still is not accessed, research staff will contact 
participants by telephone and encourage them to use it. 
 
3C.6.4. Usual and Customary IID Information. 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 distributed 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.  
 
3C.6.5. Sample Size Determination. The sample size for the randomized trial in the Phase II research 
is designed to provide sufficient information for Phase III commercialization. The sample size assumes the 
counts of interlocks are Poisson distributed. We have assumed 4 interlocks over 9 months in the control arm or 
a rate of 0.44 per month for each DWI offender. In the B-SMART mobile web app group, we have assumed a 
reduction of 40% from 0.44, resulting in a rate of 0.27 per month. The null hypothesis is that the ratio of these 
two rates is 1.0 versus 0.6. Assuming a Type I error of 0.05 (2-sided), 90% power, sample size is only 27 DWI 
offenders per group. However, if the rate is higher up to 1 per month, the sample size required declines since 
the percent reductions yield wider absolute differences in the rates. We also are keen to know the reductions 
achievable with the B-SMART group, so we evaluated the sample size with regards to other effect sizes. A 
Cochrane meta-analysis7 reported the impact of IIDs to reduce risk by 64%, but with a confidence interval that 
ranged from 76% to 37%. In the proposed trial, we have two treatment groups and may see less impact than 
that in the meta-analysis. Thus, a sample size of 119 DWI offenders per group will allow for 90% power with a 
comparison of 0.44 to 0.36 or approximately a 20% reduction in interlocks. We will adjust for an expected 15% 
attrition and this sample size also has sufficient sample size to evaluate the impact in various gender and ethnic 
subgroups. Thus, we propose to randomize 150 DWI offenders and 150 CFMs to each arm of the trial. 
 
3C.7. Outcome Measures 
 
3C.7.1. Measure of Primary Outcome Variable: IID Lockout Events. The primary outcome 
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Research Strategy                                                                                             
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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. Marques, 
Voas and colleagues86-89 have demonstrated in a series of investigations that frequency of lockout events 
strongly predicts DWI recidivism over time, and as such, IID lockout events are an important and useful proxy 
measure for DWI recidivism. Given the length of time necessary to accumulate DWI recidivism data (average 
length of time varies across locales and can be between 2 and 8 years), IID lockout events provide a direct and 
accessible measure of DWI recidivism within the two-year project timeline. 
 
3C.7.2. 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). The Form 90 measures produce detailed quantity and frequency measure of alcohol 
use for the first-time offender that are validated by the CFM reports. Family functioning will be assessed at 
baseline, 3-month follow-up, and 9-month follow-up, as potential mediators of B-SMART effects, with DWI 
offenders and CFMs with three measures: (1) Family Environment Scale – Cohesion and Conflict subscales92 
assesses offender and CFM perceptions of positive and negative family functioning; the two subscales selected 
are strongly associated with treatment outcome; (2) Family Communication Scale from FACES-IV93 assesses 
perception of quality of communication in the family; (3) Pleasant Events Schedule (adapted)94 assesses shared 
positive activities within a family. These three measures are also being used in the B-FIT study, allowing for 
comparison of outcomes across the two studies.  
 
3C.7.3. Ancillary Measures. CASAA Demographics Form: This form collects participant identification 
data and demographic information (e.g., age, education, sex, and ethnicity) about DWI offenders and CFMs. 
Items will be added to describe the relationship between the offender and CFM and the frequency of contact 
between them. System Usability Scale:78,79 This scale consists of ten Likert strongly agree to disagree items 
(Cronbach’s alpha=.90) that asks the respondent to rate the technology product being reviewed (Example 
items: I think that I would like to use this product frequently; I found the product very awkward to use; I felt 
very confident using the product). Participants also provide a final overall rating of the product along a 7-point 
worst imaginable to best imaginable dimension.  
 
3C.7.4. Server-side Process Measures of Mobile Web App Performance and Use. KB’s 
programmers will create custom programs to track the implementation and use of the B-SMART mobile web 
app, as we have done for other technology-based and mobile interventions52,67,95). The mobile web app will be 
hosted on KB’s secure web server. Users will register and use a password to access the B-SMART mobile web 
app and this password will be used to track use, keeping data about users private. KB utilizes Microsoft SQL 
server for data collection of users; click-stream (pages visited), time on B-SMART, and number of individual 
visits.  
 
3C.8. Outcome Analysis Plan  
 
The trial is intended to evaluate the following hypotheses: 
 
H1: First-time DWI offenders in the intervention group (B-SMART mobile web app) will have significantly 
fewer IID lockout events than participants in the control group (UC information condition). 
H2: Lower rates of IID lockout events will be mediated by improvements in Family Functioning, Family 
Communication, and Shared Positive Family Events in the intervention (B-SMART mobile web app) 
condition compared to the UC information condition. 
 
We will also analyze moderation of the effect of B-SMART by demographics and mediation of IID lockout 
events by B-SMART use in the intervention group.  
 
Three levels of analysis are planned: (1) hypothesis testing using Poisson regression testing the differences 
in lockout events between the two intervention groups, (2) analysis of possible covariates (e.g., sex, ethnicity, 
and age of DWI offenders and CFMs), added to the Poisson regression and (3) other exploratory analyses.  
 
 
3C.8.1. Preliminary Analysis of Baseline Data. Descriptive data at baseline, with comparisons by 
treatment group, will be examined to check distributional characteristics and assess any concerns for 
imbalances that might be considered as covariates in analyses. The potential meaning of non-normality will be 
examined, i.e., excessive skewness potentially identifying key subgroups. These analyses will be at the level of 
the individual DWI offenders and CFMs responses and be conducted within 3 months of completion of 
recruitment. If there is excessive skewness on the IID lockout rates, negative binomial regression will be used. 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 121

 
 
3C.8.2. Planned Analysis for Hypothesis 1. The second major analysis will focus on impact of the B-
SMART mobile web app on primary (IID lockout events) and secondary (DWI offender’s alcohol consumption) 
outcomes, and be completed within 1 month of the end of the posttest data collection in Year 2. The effect of B-
SMART on IID lockout events in Hypothesis 1 will be tested primarily using PROC GENMOD with a Poisson 
link via SAS Version 9.4, which includes capabilities to test these Poisson models with missing data, account 
for the temporal design, and include information by participant. Participants will be treated as a random effect 
and treatment as a fixed effect, at p=0.05 (2-sided). Analyses of primary outcomes will not be released before 
completion of the intervention. Since CFM and DWI offender can be clustered within the same family, 
hierarchical models with participants nested within families will be considered.  
 
The secondary outcome of quantity and frequency of alcohol consumption by DWI offenders will be 
compared in several ways. Quantity and frequency will be evaluated using Poisson models, as well as a 
composite variable based on total alcohol consumption (the product of the two variables), using negative 
binomial regression models, unless a Poisson model is sufficient.  
 
Since date of IID lockout events will collected and alcohol consumption is measured at all three 
assessments, we will examine the time by treatment interaction in the analyses of Hypothesis 1 to assess the 
question of the durability of the effects of B-SMART over time. For example, we will evaluate time to first 
lockout using a Kaplan Meier approach and the times to subsequent lockouts.  
 
 
3C.8.3. Mediation Analysis for Hypothesis 2. To address the predicted mediation effects of family 
function on improving the effect of the B-SMART mobile web app in Hypothesis 2, we will assess a formal 
effect on predicting fewer IID lockout events. Mediation will be tested by applying regression techniques from 
Judd and Kenny96 and elaborated by MacKinnon,97 with significance of mediation determined via interval 
estimation using bootstrapping.98,99 Ratio of indirect to total effects will estimate the proportion of the effect 
mediated. The primary mediational analysis will rely on temporal order of assessments by examining the effect 
of B-SMART on change in the mediators from baseline to 3-month follow-up and in turn their association with 
changes in the IID lockout events from baseline to the 9-month follow-up and from 3- to 9-month follow-up.  
 
 
3C.8.4. Ancillary Analysis of Moderators. Potential moderators (see 3C.7.3) will be tested at p=.05 
(2-tailed) unadjusted for multiple tests. For Hypothesis 1, they will be added as interactions by condition in a 
manner similar to regression testing for effect modification. Gender is included to probe differences by sex of 
DWI offenders and CFMs. For Hypothesis 2, we will explore if improvements in IID lockout events produced 
by increases in family function by different participant groups (sex, ethnicity, age, etc.), using moderated 
mediational analyses.98 Moderation effects must be large to be detected, so these are ancillary tests.  
 
 
 
3C.8.5. Ancillary Analysis of the B-SMART Mobile Web App Exposure. The same mediational 
analysis techniques described in 3C.8.4 will be used to explore the relationship of exposure to the B-SMART 
mobile web app and pre-post changes in IID lockout events. Summed scores on exposure will be calculated 
from the SQL database (e.g., time on app, number of visits to the app, etc.) to assess intervention exposure. 
 
3C.9. Strengths and Limitations to Approach 
 
The research has several strengths. A scientifically-rigorous pretest-posttest randomized controlled design 
is used. Randomization will equalize participants across conditions. Established recruitment protocols and 
measures will be used and IID lockout events will be measured from court records, an objective assessment. 
The B-SMART mobile web app is built on our B-FIT theory- and evidence-based family intervention. Data 
collection will be automated (i.e., court records and online survey) so project staff are blind to condition. We 
minimized potential problems. Participation will be confidential to minimize selection bias. Valid, easy-to-
administer, and low-cost self-report measures of mediators will be used to control social desirability biases and 
any bias is equalized by randomization. 
 
Contact PD/PI: WOODALL, W GILL
Research Strategy                                                                                             
Page 122

PHS Human Subjects and Clinical Trials Information
OMB Number: 0925-0001 and 0925-0002
Expiration Date: 03/31/2020
Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Are Human Subjects Involved
●Yes
❍No
Is the Project Exempt from Federal regulations?
❍Yes
●No
Exemption Number
❏1
❏2
❏3
❏4
❏5
❏6
❏7
❏8
Other Requested Information
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 123

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Human Subject Studies
Study#
Study Title
Clinical Trial?
1
B-SMART: A randomized trial of a smartphone app for DWI Offenders and their Families
Yes
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 124

OMB Number: 0925-0001 and 0925-0002
Expiration Date: 03/31/2020
Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Section 1 - Basic Information (Study 1)
1.1. Study Title *
B-SMART: A randomized trial of a smartphone app for DWI Offenders and their Families
1.2. Is this study exempt from Federal
Regulations *
❍Yes
●No
1.3. Exemption Number
❏1
❏2
❏3
❏4
❏5
❏6
❏7
❏8
1.4. Clinical Trial Questionnaire *
1.4.a. Does the study involve human participants?
●Yes
❍No
1.4.b. Are the participants prospectively assigned to an intervention?
●Yes
❍No
1.4.c. Is the study designed to evaluate the effect of the intervention on the
participants?
●Yes
❍No
1.4.d. Is the effect that will be evaluated a health-related biomedical or
behavioral outcome?
●Yes
❍No
1.5. Provide the ClinicalTrials.gov Identifier (e.g.
NCT87654321) for this trial, if applicable
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 125

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Section 2 - Study Population Characteristics (Study 1)
2.1. Conditions or Focus of Study
❍
Secondary Prevention
❍
Driving Under the Influence
❍
Accident Prevention
❍
Alcoholic Intoxication
❍
Alcohol Drinking
2.2. Eligibility Criteria
The project has two relevant, linked target populations: 1) concerned family members (CFM) of  driving while intoxicated (DWI)
 offenders and 2) the first-time DWI offenders themselves. The inclusion/exclusion criteria for these populations are as follows.
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
2.3. Age Limits
Min Age:
21 Years
Max Age:
85 Years
2.4. Inclusion of Women, Minorities, and Children
2.4_BSMART.pdf
2.5. Recruitment and Retention Plan
2.5_BSMART.pdf
2.6. Recruitment Status
Not yet recruiting
2.7. Study Timeline
2.7_BSMART.pdf
2.8. Enrollment of First Subject
06/01/2019
Anticipated
Contact PD/PI: WOODALL, W GILL
                                                                                                             
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2.4. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN 
 
Inclusion of Women and Minorities  
Potential participants will not be excluded based on ethnic group or race.  We will attempt to recruit 
participants at similar rates to the 2014 New Mexico DWI Offender Characteristics and Recidivism 
Report.  According to the Report, the race/ethnicity of the DWI offender population in New Mexico from 2003 
through 2013 were as follows: 49% Hispanic, 28% White, 20% American Indian/Alaska Natives, and 3% 
African American. The gender of the DWI offender population was 72% male and 28% female. The Targeted 
Enrollment Table represents a composite of these numbers. 
During the recruitment process, the UNM project coordinator will screen for participants using IRB-
approved protocols for screening based on gender, race, and ethnicity. If the project coordinator finds that we 
are over-recruiting a particular gender or racial or ethnic group, we will place them on a waiting list until we 
have recruited an adequate number of targeted participants 
 
Inclusion of Children 
Children under 18 will be ineligible for participation.  Children under 18 will not be enrolled in the 
proposed project because this app is aimed at adults. We are limiting age to no younger then 21 years old 
because DWI offenders under age 21 fall under a different set of laws and court programs than offender 21 or 
older. To keep things simple, we will also limit the age of CFMs to 21 years or older. Age will be self-reported by 
the participants.   
 
Contact PD/PI: WOODALL, W GILL
Inclusion of Women, Minorities, and Children                                                                  
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Human Subjects oversight will be conducted by the Western Institutional Review Board (WIRB; DHHS IRB 
Reg. No. 00000533). The IRBs will approve all consenting procedures (including recruitment advertisements, 
posters, recruitment letters and consent forms), intervention protocols, survey instruments and data collection 
protocols, and data management procedures prior to study implementation and prior to the recruitment of any 
participants.  
The investigative team has extensive experience from previous community-based trials and as a result 
already have a rich inventory of recruiting materials and protocols to be used for this study, including materials 
and protocol used to recruit DWI offenders and CFMs to the Phase I research. We will recruit 300 eligible DWI 
offenders and 300 eligible CFMs to complete the baseline assessment and be randomized. That way, at least 
255 DWI offenders and 255 CFMs will complete the 9-month follow-up (85% retention).  
Potential participants will be contacted for recruitment and consenting at monthly Santa Fe County DWI 
program meetings held for each DWI offender at the beginning of her/his probation period. CFMs of first-time 
DWI offenders will be contacted via email and a web recruitment portal designed exclusively for the project 
and followed up with a recruitment phone call.  Participants will only be enrolled in the trial if both the DWI 
offender and CFM consent to participate. Our previous work in Phase I of the project found a strong 
willingness to participate in the project among both DWI offenders and CFM based on their interest in better 
family functioning and the unique convenience of a B-SMART mobile web app that could be beneficial to their 
experiences with the IID. In New Mexico, Santa Fe County had the fourth-highest ranked number of first time 
DWI offenders (360) in 2015 and 313 first time convictions in 2016. 
The Project Coordinator will track participants and report on progress in recruiting women and 
ethnic/racial minorities. The study data team will provide detailed reports describing overall recruitment, as 
well as with strategies for recruiting women and ethnic/racial minorities. To retain participants, participants 
will fill out a locator form with contact information (name, address, telephone numbers [landline and cell], and 
email address) and collateral contact information (i.e., a person close to them who can reach them if they do 
not respond to follow-up communication from the study) to locate them for assessment at the 3-month and 9-
month follow-ups. Prior to the posttests, study staff will text and email the participants to remind them of the 
upcoming posttest survey. Once invitations are issued for the follow-up surveys, reminders to complete the 
follow-up survey will be sent by email and text at 5-day intervals for two weeks. To reach persistent non-
responders, staff will send printed/PDF copies of posttests by mail (with a stamped return envelope) and email. 
Although participants can withdraw at any time, steps will be used to minimize dropouts to ensure high 
internal validity. Participant progression will be tracked. Staff will use behavioral reinforcement strategies 
known to be effective in the behavior change literature and be trained to develop rapport with participants by 
communicating expectations for participants and staff. We will compare dropouts to those retained to 
determine if there is any potential bias. We have employed these retention procedures in prior trials, keeping 
average loss across 9 months at 15%-20%. 
 
Contact PD/PI: WOODALL, W GILL
Recruitment and Retention Plan                                                                                
Page 128

 
Contact PD/PI: WOODALL, W GILL
Study Timeline                                                                                                
Page 129

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Inclusion Enrollment Reports
Entry#
Enrollment Location Type
Enrollment Location
Study 1, IER 1
Domestic
New Mexico
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 130

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Inclusion Enrollment Report 1
Using an Existing Dataset or Resource* :
❍Yes
●No
Enrollment Location Type* :
●Domestic
❍Foreign
Enrollment Country(ies):
USA: UNITED STATES
Enrollment Location(s):
New Mexico
Comments:
32/Focus Group; 32/Usability testing; 600/Randomized Control Trial
Planned
Racial Categories
Ethnic Categories
 
 
Not Hispanic or Latino
Female
Male
 
Hispanic or Latino
Female
Male
Total
American Indian/
Alaska Native
37
96
0
0
133
Asian
0
0
0
0
0
Native Hawaiian or
Other Pacific Islander
0
0
0
0
0
Black or African
American
6
14
0
0
20
White
52
134
91
234
511
More than One Race
0
0
0
0
0
Total
95
244
91
234
664
Cumulative (Actual)
Racial Categories
Ethnic Categories
 
 
Not Hispanic or Latino
Female
Male
Unknown/
Not
Reported
 
Hispanic or Latino
Female
Male
Unknown/
Not
Reported
Unknown/Not
Reported Ethnicity
Female
Male
Unknown/
Not
Reported
Total
American Indian/
Alaska Native
0
0
0
0
0
0
0
0
0
0
Asian
0
0
0
0
0
0
0
0
0
0
Native Hawaiian or
Other Pacific Islander
0
0
0
0
0
0
0
0
0
0
Black or African
American
0
0
0
0
0
0
0
0
0
0
White
0
0
0
0
0
0
0
0
0
0
More than One Race
0
0
0
0
0
0
0
0
0
0
Unknown or
Not Reported
0
0
0
0
0
0
0
0
0
0
Total
0
0
0
0
0
0
0
0
0
0
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 131

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Section 3 - Protection and Monitoring Plans (Study 1)
3.1. Protection of Human Subjects
3.1._Protection_of_Human_Subjects20180401.pdf
3.2. Is this a multi-site study that will use the same protocol to
conduct non-exempt human subjects research at more than one
domestic site?
❍
Yes
●
No
❍
N/A
If yes, describe the single IRB plan
3.3. Data and Safety Monitoring Plan
3.3._Data_and_Safety_Monitoring_Plan_draft_20180401.pdf
3.4. Will a Data and Safety Monitoring Board be appointed for
this study?
❍Yes
●
No
3.5. Overall structure of the study team
3.5_structure.pdf
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 132

3. PROTECTION OF HUMAN SUBJECTS 
3.1. RISKS TO HUMAN SUBJECTS 
 
3.1.A. Human Subjects Involvement, Characteristics, and Design.  This proposed Phase II SBIR 
project will develop a full-scale, fully programmed B-SMART mobile web app that aims to enhance the 
maintenance of behavior change among DWI offenders by mobilizing the DWI offender’s social network and 
enhancing that involvement via smartphone technology. We will complete the development of the B-SMART 
mobile web app, test its usability, translate the complete app to Spanish, and test the impact of the app on 
alcohol-related outcomes and family function outcomes. 
   
The two target populations consist of first-time DWI offenders and their concerned family members (CFM - 
defined as a spouse or close relative living with the DWI offender). All participants will be recruited from the 
Santa Fe County DWI Program, a county-wide program that manages probation and sentencing programs and 
requirements for all DWI offenders in Santa Fe County, New Mexico. 
 
Inclusion criteria for DWI offenders are: (a) over 21 years of age; (b) first-time offender with an Ignition 
Interlock Device (IID) installed in their vehicle, (c) have a smartphone, tablet computer, or personal computer 
with internet access, (d) able to read and speak in English or Spanish, and (e) consent to participate.  Inclusion 
criteria for CFMs are: (a) over 21 years of age; (b) parent, spouse, or immediate family member of a 
participating DWI offender, (c) have a smartphone, tablet computer, or personal computer with internet 
access, (d) able to read and speak in English or Spanish, and (e) consent to participate. Participants in the 
development phase will not be eligible for the randomized trial phase of the project. 
 
The collaborating site is the University of New Mexico (FWA No. 00003255). 
 
3.1.B. Study Procedures, Materials, and Potential Risks.    
Study Procedures:  
 
Focus Groups Participants (n=32).  Four focus groups will be conducted. Two focus groups will be held 
with DWI offenders (one in English and one in Spanish). In addition, two focus groups with CFMs will be held 
(one ins English and one in Spanish). Although the app is designed for CFMs, input from DWI offenders will be 
crucial to learn what they believe would be helpful for them. Focus group discussions will be led by English and 
Spanish speaking research staff trained in focus group facilitation techniques who will follow a protocol to lead 
discussions about the use of B-FIT content in smartphone applications. Topics include: how the CFM would 
share information with the DWI offender; what type of content the DWI offender would expect to see; 
examples of positive shared activities; and examples of how CFMs can be most supportive of the offender to 
reduce reoffending. 
Discussions will be audio taped, transcribed and analyzed using procedures developed in previous work by 
the research team. Analysis of all focus group discussions will be accomplished via InVivo NUDIST content and 
theme analysis software to identify consistent and recurrent content themes in response to focus group 
questions. These results will be summarized in focus group results reports distributed to research team 
members and the EAB. These results will be used to make final decisions about smartphone application design, 
structure, navigability, and approach.  
 
Usability Testing Participants (n=32).  One round of iterative usability testing will be conducted with CFMs 
on an individual basis to validate the design approach and identify usability problems. During individual in-
person sessions with research staff, participants will be instructed to navigate through sections of the app and 
provide their verbal reactions as they do so. Staff will prompt with questions, asking what the participants 
might change about activities and how they might use the app with their DWI offender. At the completion of 
the usability session, participants will complete the Bangor System Usability Scale (SUS). In addition to the 
SUS measure, the Instructional Designer at KB will create a summary report listing usability problems 
experienced and their severity. The research team and KB media developers will make necessary changes to 
address these problems before launch in the RCT. All usability sessions will be video recorded and transcribed. 
Both qualitative and quantitative (Bangor scale) summaries will be provided to Investigators and the EAB for 
review. All usability testing sessions will be held in New Mexico and will last approximately one hour. Spanish 
and English speakers will both be recruited. 
 
Randomized Controlled Trial Participants (n=300).  First-time DWI offenders and their CFM will be 
randomized to the intervention (B-SMART mobile web app) (n=150) or a usual and customary (UC) IID 
Information condition comparison group (n=150) following the baseline assessment. Assessments, conducted 
via web-based surveys, will be conducted with first-time the DWI offenders and CFMs at baseline, 3-month 
follow-up, and 9-month follow-up post randomization. Also, information on frequency of alcohol-positive IID 
tests (termed “lockout events) will be acquired by the project from the Santa Fe County and Municipal DWI 
Program at the 9-month assessment point (posttest only) for each DWI offender. Baseline and follow-up data 
collection will be conducted via online surveys and a customized web portal and include DWI offender and 
CFM alcohol frequency and use measures, and measures of family communication and functioning. 
Participants will fill out a locator form with contact information and collateral contact information to locate 
them for assessment at the 3-month and 9-month follow-ups.  
Contact PD/PI: WOODALL, W GILL
Protection of Human Subjects                                                                                  
Page 133

 
Study Materials: Data from the focus groups, usability testing, surveys, and randomized trial will be 
collected in the form of handwritten notes, audio tapes, computer files, transcriptions, and questionnaires. 
Discussions will be recorded, transcribed, and analyzed using Atlas.ti© software. Data will be gathered from 
surveys used in the randomized trial.  Data will be obtained specifically for research purposes and will be kept 
confidential with access limited to the Investigators and specific project staff. All data will be kept in locked 
files. 
     Potential Risks:  Potential risks are minimal, mainly social or psychological.  Focus group participants 
may be hesitant or uncomfortable responding to questions about the challenges of having an IID, concerns 
about family members’ feelings about the IID, and ways that family members could be helpful in supporting 
the DWI offender to not drink and drive.  Usability test participants may not feel comfortable responding to 
questions about their opinions on appeal, ease of understanding, navigation, and functionality of the B-SMART 
mobile app.  There are no anticipated risks from completing the self-report questionnaires.  If signs of minor 
stress or fatigue are apparent, participants will be given time to take a break from completing the 
questionnaires. For the randomized trial, surveys will be completed online, at the participants own pace. 
Participants’ responses will not be shared with anyone except project staff.  Responses to survey 
questions will be coded to protect confidentiality. All participants will be allowed to withdraw at any time if 
they are uncomfortable with the discussions. Although half of the potential participants are involved with the 
criminal justice system as a result of having a DWI, that involvement is overseen by other entities and is not a 
part of the research project.  
 
3.2.  ADEQUACY OF PROTECTION AGAINST RISKS  
3.2.A. Informed Consent and Assent.  
Human Subjects oversight will be conducted by the Western Institutional Review Board (WIRB; DHHS IRB 
Reg. No. IRB0000053; FWA No. 00003715) and the University of New Mexico’s Institutional Review Board 
DHHS IRB Reg. No. IRB0000431; FWA No. 00004690). All consenting procedures will be IRB-approved.  The 
IRB(s) will review and approve subject materials (including recruitment letters, consent forms, survey 
instruments) and data management procedures prior to study implementation. Potential participants will be 
informed of the study purposes and procedures, given opportunities to ask questions and have them answered, 
and provide informed consent according to IRB-approved guidelines.  
Focus group and usability test participants will be consented in-person and will sign an IRB-approved 
consent form.  For the randomized trial, DWI offenders recruited to the study will be consented in-person and 
will be administered by a UNM Project Coordinator.  Project staff will provide participants with copies of their 
signed IRB-approved consent forms.  For the randomized trial, CFMs will be consented online and will have an 
option to save or print the IRB-approved consent.  Participants will only be enrolled in the trial if both the DWI 
offender and CFM consent to participate.  Consent forms will be either Spanish or English, dependent on the 
participants’ language. 
The IRB-approved consent forms will describe the purpose of the project, risks and benefits, and selection 
criteria. Participation will be voluntary, with the right to stop participating at any time. No clinical data will be 
captured. All data coding, data entry, analysis, and reporting activities will be conducted by KB. Participants 
will be informed that they have a right to withdraw from the study at any time. No additional data will be 
collected from participants who decide to withdraw; however, the information collected prior to withdrawal 
will remain in the study. IRB-approved surveys and discussions will be carried out under the supervision of 
senior project staff. 
 
3.2.B. Protection Against Risk.     
Although we are working with participants who have been convicted of DWI and mandated to treatment, 
their participation in this research study has absolutely no bearing on the requirements they need to fulfill 
obligations with the court.  To minimize the risk of coercion to participate, we will make it clear both verbally 
and in the consent form that participation in the study will not help nor hinder their standing with the courts. 
Although participants in this study are not prisoners, they are involved in the criminal justice system insofar as 
they have been convicted for DWI.  We will make it very plain that data collected as part of the research study 
will not be available to the courts and will have no bearing on their DWI status with the courts.  Because they 
are not prisoners they will not require special protections, but we still need to be mindful that simply being 
involved in the criminal justice system makes them more vulnerable than a group not involved in the criminal 
justice system.   
 
To minimize potential psychological risk, all focus group and usability testing facilitators will establish 
ground rules for discussion that includes an open, non-evaluative exchange of comments and ideas.  All surveys 
and data collection forms will be approved by an IRB and employed under the supervision of senior project 
staff. Participants will be told that they do not have to answer any questions which make them uncomfortable 
and can terminate their participation at any time they wish.   
 
Notes, surveys, audiotapes, and data will be accessible only by research personnel.  No clinical data will be 
Contact PD/PI: WOODALL, W GILL
Protection of Human Subjects                                                                                  
Page 134

captured.  The data collected on this project will be obtained with the "use of educational tests, survey 
questions, [and] interview procedures." 
 
Data forms will be labeled only with participant identification number.  Participant names and study 
identification numbers will be recorded and stored separately from the research data files. Focus group 
participants will be asked to use first names only during focus groups. Data will be de-identified before being 
submitted for analysis. All notes and printed data collection forms and questionnaires will be stored in locked 
cabinets; all electronic data files will be stored on UNM’s and/or KB’s secure network servers behind computer 
firewalls, with routine backup. All identifiers will be stored in secure files and behind computer firewalls and 
results will be shared in aggregate form only. All human subjects participating in this project will be adults who 
are 18 years and older.   
 
All focus group and usability testing research data collected by research staff (e.g., focus groups scales, 
demographic and locator forms, etc.) will be logged in and taken back to the CASAA research offices in a 
briefcase or similar closed storage medium for transport - loose papers or papers in open folders will not be 
allowed.  After returning to the research office, all hard copy materials (consent forms, demographic and 
locator forms, usability scales) will be logged in and stored in a locked file cabinet, within a locked office, in a 
locked suite. Once information from the focus groups is transcribed, the transcriptions will also be placed 
within the locked file cabinet. There is a risk that data could be accessed by someone other than project staff. 
While hard copies of materials will be placed within a locked filing cabinet, inside a locked office, digital audio 
recordings will be uploaded to a secure server located within UNM-CASAA and transcribed. The UNM-CASAA 
server is located in a locked room, on the second floor of the CASAA building, which is burglar alarmed. Access 
to the server in the locked room is gained through the IT Manager's office.   Only four staff members (having a 
need to have access to the server) have keys to that locked room. Electronic access to files and data are 
provided by the IT Manager on a need to know basis, meaning staff can only access that part of the server on 
which their project-specific files and data reside.  The server is protected by IT protocols and a firewall from 
outside access and attacks. The only outside access is through a secure virtual private network (VPN). The VPN 
requires a shared key that is known only by the IT manager. The original focus group digital audio recordings 
will be deleted from the recording device once the recording is uploaded to the previously mentioned server.   
To minimize the risk to participant data privacy and protection through the internet in the randomized 
trial, KB programmers will monitor and maintain all programs and databases and use an established protocol 
for participant cyber safety and security. KB is HIPAA complaint and maintains vigorous technical safeguards 
which are built into KB’s IT system to protect information and to control access to it.  All participant 
information will be protected using 128-bit SSL encryption. All Internet information must travel through KB’s 
CISCO ASA 5505 firewall using ASA software version 9.0(2) encrypted 3DES-AES. Traffic then moves to KB’s 
web server. This server is a Dell Power Edge T-310 with 32 GB of RAM, 1.5 TB available disk space on a RAID 5 
redundant drive system using Windows Hyper-V Operating System. The virtual web server uses Windows 
2008 IIS Web server software. User click stream data is collected using Webtrends and is saved to our SQL 
server. Enrollment data is transferred to our SQL server (Windows Server 2008) which uses MS SQL server 
2008 R2 database software. This machine is also a Dell Power Edge T-310 with 32 GB of RAM, 1.5 TB available 
disk space on a RAID 5 redundant drive system using Windows Hyper-V OS and has no access to the Internet. 
When a participant is directed to take a survey, their computer is linked to a third server in our system which is 
also a Dell Power Edge T-310 with 32 GB of RAM, 1.5 TB available disk space on a RAID 5 redundant drive 
system using Windows Hyper-V OS. This server runs Question Pro Survey software. Data from each survey is 
collected and saved to the SQL server mentioned above. All network traffic is sent from the CISCO firewall to a 
Syslog server using Manage Engine Firewall Analyzer 7 software. Login and network activity is required and 
monitored by Windows servers to an event viewer. Servers are kept in a locked room on site. All files are 
secured locally using MS NTFS. All traffic between servers and PCs on the LAN are digitally signed 
communications. Each local machine has a built-in operating system firewall. Data from the Question Pro 
surveys are exported for data analysis by local machines which are also behind KB’s firewall. Access to this 
exported data by outside sources is done using File Transfer Protocol (FTP) protected by Secure Socket Layer 
(SSL). SQL databases are protected by the built-in security of MS Active Directory. Data is backed up using a 
Quantum SuperLoader 3 tape library using LT04 tapes that contain 800 GB/1.6 TB of info (depending on 
compression used). The device holds 16 tapes. The backup software used by KB is Symantec Back-up Exec. 
2012. Daily backups are incremental and tapes are recycled weekly. Weekly backups are done every Friday and 
are recycled every 6 weeks. Monthly backups are done on the last Friday of each month and are full backups of 
all data. These monthly tapes are stored in a secure offsite facility and are never recycled. 
 
With regards to app security on personal devices, Apple (e.g., iOS programmed apps) completes a full 
security review of any app installed on a phone including beta/testing apps through their App Transport 
Security (ATS).  KB App programming will include all key developer-related features to ensure ATS security.  
Google Play (Android programming) does not conduct a similar security check; however, KB has extensive 
experience with developing and marketing both iOS and Android programmed apps using an established 
Contact PD/PI: WOODALL, W GILL
Protection of Human Subjects                                                                                  
Page 135

protocol (SSL/TLS: Secure Sockets Layer/Transport Security Layer) and has never experienced a data breach. 
All usability testers will be informed that information being sent to and from their device will remain encrypted 
and password protected, and at any time they are allowed to opt-out and uninstall the app.  
 
3.3.  POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO PARTICIPANTS AND  
OTHERS 
 
Potential benefits for all participants will be the knowledge that one has helped in development of an 
innovative method of maintaining the cessation of intoxicated driving. Participants may benefit by knowing 
that they are instrumental in developing the content that will help others.  
 
A description of this study will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This 
website will not include information that can identify the participant. At most, the website will include a 
summary of the results. This website can be searched at any time. 
  
3.4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED   
 
We are proposing two innovations with potential to enhance maintenance of changes in drinking that 
begin with the DWI conviction and installation of the IID by extending the reach of treatment into the 
offender’s world through family-involved treatment and smartphone technology to reinforce treatment 
interventions. We believe these interventions have the potential to provide efficient means to decrease an 
important public health consequence of risky drinking and will add substantial original knowledge to the DWI 
field. 
 
This study will be the first to use smartphone technology to extend and make permanent the cessation of 
intoxicated driving, providing an intervention that uses easily-accessible and diffusible technology.  
 
 
Contact PD/PI: WOODALL, W GILL
Protection of Human Subjects                                                                                  
Page 136

3.3. DATA AND SAFETY MONITORING PLAN  
A data safety and monitoring plan will be implemented for this project, following well-established 
procedures within KB and UNM. We will not set up an independent Data Safety and Monitoring Board because 
this trial is very low risk; does not include use of therapeutics; and physical risks are not anticipated. The 
progress of the research will be monitored monthly by the PI, Co-Investigators, Project Coordinator, and 
Project Biostatistician, who will meet bi-weekly to discuss the activities in the project, participant recruitment, 
and data collection. Any issues that the research scientist has identified will also be discussed at that time. 
 
The study investigators have extensive experience in clinical trials organization and management, including 
data safety monitoring for single site and multisite trials. Relevant study staff will also be trained in monitoring 
and documenting adverse events.  
 
Critical events will be reviewed by the investigators to ensure that project methods have not been intrusive 
or disruptive. Annual reports on data safety and monitoring are submitted to the IRBs. Compliance with data 
collection protocols will be monitored throughout data collection by the Investigators and Project Coordinator. 
The data management staff at KB will examine the quality of data input throughout the data collection period 
following standard quality control and assurance procedures (e.g., double entry of hard-copy coded data; 
detection and estimates of keystroke errors, identification of systematic mistakes in coding or responses; range 
checks). Analyses of the data will be performed by Dr. Cutter and Ms. Liu at the conclusion of the data 
collection period to assess distributional assumptions and the success of randomization. By having the Project 
Coordinator, Project Biostatistician and data management staff monitor the data, the PI’s conflict of interest is 
reduced. The PI and Project Coordinator are responsible for reporting all adverse events to the IRBs. Only 
Grade 1 events are expected on this trial. Thus, adverse events will be reported annually, as required by DHHS. 
This report will be reviewed by the IRBs. Any action taken by the IRB or project investigators resulting in a 
temporary or permanent suspension of the trial will be communicated immediately by the PI to the NIH 
program officer. 
 
All study staff will be required to report serious adverse events within 24 hours of their occurrence, 
regardless of their relevance to the study. The PI will be required to provide a report of all serious adverse 
events to the IRB within 24 hours of the reporting.  
 
An annual report will be submitted to the IRB. This report will include all progress report categories. 
 
Contact PD/PI: WOODALL, W GILL
Data and Safety Monitoring Plan                                                                               
Page 137

 The governance structure for the research team is designed to take advantage of the expertise of each 
investigator, consultant, and staff person, while minimizing overlap. The PI, Dr. Gill Woodall, is responsible for 
governance of the overall study and he will chair a Steering Committee comprised of the Co-Investigators (Drs. 
McCrady, Starling, and Westerberg and Ms. Berteletti), Biostatistical Advisor (Dr. Cutter), and Project 
Coordinator. The Steering Committee will communicate with NIH and IRBs. This Committee will meet weekly 
to make design and administration decisions, plan activities, track progress across sites, trouble-shoot 
problems, maintain consistency in actions, and implement quality controls. Major decisions concerning the 
project will be made within the Steering Committee with the ultimate decision-making responsibility residing 
with Dr. Woodall.  
 
Four subcommittees will supervise important parts of the project. Dr. Woodall will chair the Recruitment 
Committee that will recruit the participating DWI Offenders and CFMs. Dr. Starling will be on this committee. 
Drs. Woodall and McCrady will co-chair the Intervention Development Committee and will be assisted by Dr. 
Westerberg, Ms. Berteletti, and the KB media developers. Drs. Starling and Woodall will Co-Chair the Data 
Collection Committee and survey the DWI Offenders and CFMs and obtain the cumulative IID lockout event 
data for the DWI offenders from the Santa Fe County DWI Program at the 9-month assessment point. Dr. 
Cutter, Project Biostatistician, will assist in the development of the procedures for the surveys and lockout 
event collection.  This committee will work to ensure that all data collection procedures have detailed protocols. 
The Analysis Subcommittee, co-chaired by Dr. Cutter and Dr. Woodall with Drs. McCrady, Starling, and 
Westerberg and Ms. Berteletti as members, will plan and conduct all data management and analysis 
procedures. This subcommittee will develop a detailed data analysis plan and supervise work by KB’s 
Biostatistical Manager to prepare all databases for analysis. The subcommittees will meet on a weekly, biweekly 
or monthly basis as needed depending on the project tasks and activities. Ad hoc committees will be formed to 
address specialized tasks as necessary. Dr. Woodall will supervise project activities at KB; Dr. Starling will 
supervise project activities at UNM; and Dr. Cutter will supervise project activities at Pythagoras, Inc.  
 
The Project Coordinator at KB, Ms. Jeannyfer Reither, will assist Dr. Woodall with all aspects of the project. 
Ms. Reither will coordinate the relationships among the investigators and project staff, sit on the Steering 
Committee, and oversee the conduct of the study protocols. Ms. Liu (Biostatistical Manager) and Mr. Kramer 
(Data Assistant) will perform data management and Ms. Liu will assist Dr. Cutter with day-to-day data analysis 
tasks. Ms. Liu and Mr. Kramer will create data entry programs for printed forms. Dr. Woodall and Ms. Reither 
will work with the IRBs to obtain approval of all forms and procedures. Dr. Cutter, Ms. Liu, and Mr. Kramer 
will work together to ensure successful transfer of database files and performance of all analyses.  
 
With investigators collaborating from two organizations, high quality communication among project staff 
and investigators will be maintained by using telephone, fax, email, web-assisted conference call technology, 
and Wrike, KB’s new, robust, real-time, cloud-based work management software. We successfully conducted 
the Phase I research on the B-SMART mobile web app with investigators from these same institutions and Dr. 
Woodall has successfully conducted other multi-institution trials using these same communication methods. 
Regular meetings of the Steering Committee and subcommittees will take place using telephone and web 
conferencing technology. All investigators and staff will meet in person at KB three times each project year. 
Telephone and email will be used for day-to-day communication, as needed. With Wrike, the team is able to 
organize the important components of a project and break large deliverables into manageable pieces, attach 
files, communicate quickly, and assign tasks with due dates. It allows for live editing and file management to 
facilitate efficient collaboration amongst users. KB staff are equipped with full licenses to use all features of 
Wrike and investigators outside of KB will be provided with a collaborator license. Having project-related files, 
deliverables, and tasks in a centralized location greatly improves communication among investigators and 
research staff. Wrike practices industry-standard network protection procedures, including network 
segregation, firewall and router technologies, intrusion detection systems, log aggression and alert 
mechanisms. TLS technology protects information accessed in Wrike using both server authentication and data 
encryption. This is equivalent to network security methods used in banking and leading e-commerce sites. KB’s 
IT manager oversees Wrike security and activity. 
 
Conflicts will be handled through frank discussions within the Steering Committee and subcommittees. All 
sides of an issue or sources of the conflict will be discussed and a final decision will be rendered through group 
consensus when possible. Conflict arising from differences in interpersonal style will be handled by the PI, 
respecting the privacy of those involved. If conflict cannot be resolved within the research team, Dr. Valerie 
Myers, a Senior Scientist at KB who is a clinical psychologist and not a member of the research team, will serve 
as an outside mediator, meeting with both sides in the dispute and recommending ways to resolve it. If the 
conflict still cannot be resolved, a mediator from Mountain States Employer Council will be hired to mediate 
the dispute. This Council provides business advice and services to small businesses. KB has been a member of 
this Council for 11 years and regularly uses its business services. At that point, the research team will agree to 
make the mediator’s decision binding. We have used these same management procedures to conduct 
successfully community-based research in previous multi-institutional projects. 
Contact PD/PI: WOODALL, W GILL
Overall Structure of the Study Team                                                                           
Page 138

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Behavioral (e.g.,
Psychotherapy,
Lifestyle
Counseling)
B-SMART Mobile Web App
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 (e.g.,
Psychotherapy,
Lifestyle
Counseling)
Usual and Customary Ignition
Interlock Device Information
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.
4.2.d. Study Phase
Phase 3
Is this an NIH-defined Phase III Clinical Trial?
●
Yes
❍
No
4.2.e. Intervention Model
Parallel
4.2.f. Masking
❍
Yes
●
No
❏Participant
❏Care Provider
❏Investigator
❏Outcomes Assessor
4.2.g. Allocation
Randomized
4.3. Outcome Measures
Type
Name
Time Frame
Brief Description
Primary
Ignition Interlock Device
Lockout Events
9-month follow-up posttest
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.
Secondary
Alcohol Use
Baseline, 3-month follow-up
posttest, and 9-month follow-
up posttest
Alcohol use by the DWI offender will be assessed
 with versions of the Form 90 adapted for online
 assessment for the CFMs (Form 90-ACS) and
 first-time DWI offenders (Form 90-AF). The Form
 90 measures produce detailed quantity and
 frequency measure of alcohol use for the first-time
 offender.
Other
Family Functioning Scales
Baseline, 3-month follow-up
posttest, and 9-month follow-
up posttest
Family functioning will be assessed as a
 potential mediator of B-SMART effects, with
 DWI offenders and CFMs with three scales:
 (1) Family Environment Scale - Cohesion and
 Conflict subscales assesses offender and CFM
 perceptions of positive and negative family
 functioning; the two subscales selected are
 strongly associated with treatment outcome; (2)
 Family Communication Scale from FACES-IV
 assesses perception of quality of communication
 in the family; (3) Pleasant Events Schedule
 (adapted) assesses shared positive activities
 within a family.
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 141

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Other
System Usability Scale
3-month follow-up posttest and
9-month follow-up posttest
The System Usability Scale consists of ten Likert
 strongly agree to disagree items that asks the
 respondent to rate the technology product being
 reviewed (Example items: I think that I would like
 to use this product frequently; I found the product
 very awkward to use; I felt very confident using
 the product). Participants also provide a final
 overall rating of the product along a 7-point worst
 imaginable to best imaginable dimension. This
 measure will be assessed with DWI offenders and
 CFMs in the intervention group.
Other
B-Smart Mobile Web App Use
3-month follow-up posttest and
9-month follow-up posttest
A custom program on the KB web server will track
 use of the B-SMART mobile web app. Users will
 register and use a password to access B-SMART
 and this password will be used to track use,
 keeping data about users private. Click-stream
 (pages visited), time spent on the B-SMART
 mobile web app, and number of individual visits to
 the mobile web app will be recorded.
Other
Demographic Characteristics
Baseline
The CASAA demographics form will collect
 information on participants' age, education, sex,
 and ethnicity.
4.4. Statistical Design and Power
4.4_bsmart.pdf
4.5. Subject Participation Duration
9 months
4.6. Will the study use an FDA-regulated intervention?
❍
Yes
●
No
4.6.a. If yes, describe the availability of Investigational
Product (IP) and Investigational New Drug (IND)/
Investigational Device Exemption (IDE) status
4.7. Dissemination Plan
4.7_bsmart.pdf
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 142

Sample Size Determination  
The sample size for the randomized trial in the Phase II research is designed to provide sufficient 
information for Phase III commercialization. The sample size assumes the counts of interlocks are Poisson 
distributed. We have assumed 4 interlocks over 9 months in the control arm or a rate of 0.44 per month for 
each DWI offender. In the B-SMART mobile web app group, we have assumed a reduction of 40% from 0.44, 
resulting in a rate of 0.27 per month. The null hypothesis is that the ratio of these two rates is 1.0 versus 0.6. 
Assuming a Type I error of 0.05 (2-sided), 90% power, sample size is only 27 DWI offenders per group. 
However, if the rate is higher up to 1 per month, the sample size required declines since the percent reductions 
yield wider absolute differences in the rates. We also are keen to know the reductions achievable with the B-
SMART group, so we evaluated the sample size with regards to other effect sizes. In a Cochrane meta-analysis 
reported the impact of IIDs to reduce risk by 64%, but with a confidence interval that ranged from 76% to 37%. 
In the proposed trial, we have two treatment groups and may see less impact than that in the meta-analysis. 
Thus, a sample size of 119 DWI offenders per group will allow for 90% power with a comparison of 0.44 to 0.36 
or approximately a 20% reduction in interlocks. We will adjust for an expected 15% attrition and this sample 
size also has sufficient sample size to evaluate the impact in various gender and ethnic subgroups. Thus, we 
propose to randomize 150 DWI offenders and 150 CFMs to each arm of the trial. 
 
Outcome Analysis Plan  
The trial is intended to evaluate the following hypotheses: 
 
H1: First-time DWI offenders in the intervention group (B-SMART mobile web app) will have significantly 
fewer IID lockout events than participants in the control group (UC information condition). 
H2: Lower rates of IID lockout events will be mediated by improvements in Family Functioning, Family 
Communication, and Shared Positive Family Events in the intervention (B-SMART mobile web app) 
condition compared to the UC information condition. 
 
We will also analyze moderation of the effect of B-SMART by demographics and mediation of IID lockout 
events by B-SMART use in the intervention group.  
 
Three levels of analysis are planned: (1) hypothesis testing using Poisson regression testing the differences 
in lockout events between the two intervention groups, (2) analysis of possible covariates (e.g., sex, ethnicity, 
and age of DWI offenders and CFMs), added to the Poisson regression and (3) other exploratory analyses.  
 
Preliminary Analysis of Baseline Data. Descriptive data at baseline, with comparisons by treatment 
group, will be examined to check distributional characteristics and assess any concerns for imbalances that 
might be considered as covariates in analyses. The potential meaning of non-normality will be examined, i.e., 
excessive skewness potentially identifying key subgroups. These analyses will be at the level of the individual 
DWI offenders and CFMs responses and be conducted within 3 months of completion of recruitment. If there is 
excessive skewness on the IID lockout rates, negative binomial regression will be used. 
 
Planned Analysis for Hypothesis 1. The second major analysis will focus on impact of the B-SMART 
mobile web app on primary (IID lockout events) and secondary (DWI offender’s alcohol consumption) 
outcomes, and be completed within 1 month of the end of the posttest data collection in Year 2. The effect of B-
SMART on IID lockout events in Hypothesis 1 will be tested primarily using PROC GENMOD with a Poisson 
link via SAS Version 9.4, which includes capabilities to test these Poisson models with missing data, account 
for the temporal design, and include information by participant. Participants will be treated as a random effect 
and treatment as a fixed effect, at p=0.05 (2-sided). Analyses of primary outcomes will not be released before 
completion of the intervention. Since CFM and DWI offender can be clustered within the same family, 
hierarchical models with participants nested within families will be considered.  
 
The secondary outcome of quantity and frequency of alcohol consumption by DWI offenders will be 
compared in several ways. Quantity and frequency will be evaluated using Poisson models, as well as a 
Contact PD/PI: WOODALL, W GILL
Statistical Design and Power                                                                                  
Page 143

composite variable based on total alcohol consumption (the product of the two variables), using negative 
binomial regression models, unless a Poisson model is sufficient.  
 
Since date of IID lockout events will collected and alcohol consumption is measured at all three 
assessments, we will examine the time by treatment interaction in the analyses of Hypothesis 1 to assess the 
question of the durability of the effects of B-SMART over time. For example, we will evaluate time to first 
lockout using a Kaplan Meier approach and the times to subsequent lockouts.  
 
Mediation Analysis for Hypothesis 2. To address the predicted mediation effects of family function on 
improving the effect of the B-SMART mobile web app in Hypothesis 2, we will assess a formal effect on 
predicting fewer IID lockout events. Mediation will be tested by applying regression techniques from Judd and 
Kenny and elaborated by MacKinnon, with significance of mediation determined via interval estimation using 
bootstrapping. Ratio of indirect to total effects will estimate the proportion of the effect mediated. The primary 
mediational analysis will rely on temporal order of the posttests by examining the effect of B-SMART on 
change in the mediators from baseline to 3-month follow-up and in turn their association with changes in the 
IID lockout events from baseline to the 9-month follow-up and from 3- to 9-month follow-up.  
 
Ancillary Analysis of Moderators. Potential moderators (see 3C.7.3) will be tested at p=.05 (2-tailed) 
unadjusted for multiple tests. For Hypothesis 1, they will be added as interactions by condition in a manner 
similar to regression testing for effect modification. Gender is included to probe differences by sex of student 
and employee. For Hypothesis 2, we will explore if improvements in IID lockout events produced by increases 
in family function by different participant groups (gender, ethnicity, etc.), using moderated mediational 
analyses. Moderation effects must be large to be detected, so these are ancillary tests.  
 
Ancillary Analysis of the B-SMART Mobile Web App Exposure. The same mediational analysis 
techniques described in 3C.8.4 will be used to explore the relationship of exposure to the B-SMART mobile 
web app and pre-post changes in IID lockout events. Summed scores on exposure will be calculated from the 
SQL database (e.g., time on app, number of visits to the app, etc.) to assess intervention exposure. 
 
Contact PD/PI: WOODALL, W GILL
Statistical Design and Power                                                                                  
Page 144

A description of this study will be made available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify participants. At most, the website will include a 
summary of the results. This website can be searched at any time. The PI will ensure that the project is 
registered and results are submitted to ClinicalTrials.gov according to specific timelines as outlined in the Final 
Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). All informed 
consent documents will include a specific statement relating to posting of clinical trial information at 
ClinicalTrials.gov as outlined in the policy. 
To ensure compliance, the PI and Project Coordinators will review the Final Rule Webinar Series and 
Protocol Registration and Results System (PRS User’s Guide) and confirm understanding of knowledge and 
procedures with the Klein Buendel, Inc. (KB) Compliance Officer. KB (applicant organization) has a Quality 
Control procedure in place for registering all required data into ClinicalTrials.gov. The PI will be the 
responsible party for ensuring all documents are uploaded based on Final Rule policy. The KB Compliance 
Officer will independently monitor the timeliness of the uploads and will provide direct communication with 
the Multiple PIs if a procedure is out of compliance. A formal internal policy is in place to ensure that clinical 
trials registration and results reporting occur in compliance with policy requirements.    
The B-SMART mobile web app will be disseminated commercially as described in the Commercialization 
Plan.  The Commercialization Plan addresses five different potential markets for commercialization of B-
SMART: 1) DWI Offenders with Court-mandated Ignition Interlock Devices, an estimated 300,000 users; 2) 
Ignition Interlock Device Manufacturing Companies, eight different companies currently in the market; 3) 
DWI Schools – almost 3700 schools typically working under the auspices of court systems currently exist in the 
U.S.; 4) Magistrate and DWI Courts – which oversee and supervise the remediary and probation activities of 
offenders and sentence offenders to Ignition Interlock Device use; and 5) Automobile Insurance Associations, 
Companies, Agents and Brokers – whose business practices and policies are greatly affected by DWI 
convictions.  These five separate markets hold great potential for the commercialization of B-SMART. 
 
Contact PD/PI: WOODALL, W GILL
Dissemination Plan                                                                                            
Page 145

Tracking Number: GRANT12604543
Funding Opportunity Number: PA-18-573 Received Date:
2018-04-05T17:31:31.000-04:00
Delayed Onset Studies
Delayed
Onset
Study#
Study Title
Anticipated Clinical
Trial?
Justification
The form does not have any delayed onset studies
Contact PD/PI: WOODALL, W GILL
                                                                                                             
Page 146

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STATISTICAL ANALYSIS PLAN 
Sample Size Determination  
The sample size for the randomized trial in the Phase II research is designed to provide sufficient 
information for Phase III commercialization. The sample size assumes the counts of interlocks are Poisson 
distributed. We have assumed 4 interlocks over 9 months in the control arm or a rate of 0.44 per month for 
each DWI offender. In the B-SMART mobile web app group, we have assumed a reduction of 40% from 0.44, 
resulting in a rate of 0.27 per month. The null hypothesis is that the ratio of these two rates is 1.0 versus 0.6. 
Assuming a Type I error of 0.05 (2-sided), 90% power, sample size is only 27 DWI offenders per group. 
However, if the rate is higher up to 1 per month, the sample size required declines since the percent reductions 
yield wider absolute differences in the rates. We also are keen to know the reductions achievable with the B-
SMART group, so we evaluated the sample size with regards to other effect sizes. In a Cochrane meta-analysis 
reported the impact of IIDs to reduce risk by 64%, but with a confidence interval that ranged from 76% to 37%. 
In the proposed trial, we have two treatment groups and may see less impact than that in the meta-analysis. 
Thus, a sample size of 119 DWI offenders per group will allow for 90% power with a comparison of 0.44 to 0.36 
or approximately a 20% reduction in interlocks. We will adjust for an expected 15% attrition and this sample 
size also has sufficient sample size to evaluate the impact in various gender and ethnic subgroups. Thus, we 
propose to randomize 150 DWI offenders and 150 CFMs to each arm of the trial. 
Outcome Analysis Plan  
The trial is intended to evaluate the following hypotheses: 
H1: First-time DWI offenders in the intervention group (B-SMART mobile web app) will have significantly 
fewer IID lockout events than participants in the control group (UC information condition). 
H2: Lower rates of IID lockout events will be mediated by improvements in Family Functioning, Family 
Communication, and Shared Positive Family Events in the intervention (B-SMART mobile web app) 
condition compared to the UC information condition. 
We will also analyze the moderation of the effect of B-SMART by demographics and mediation of IID lockout 
events by B-SMART use in the intervention group.  
 
Three levels of analysis are planned: (1) hypothesis testing using Poisson regression testing the differences 
in lockout events between the two intervention groups, (2) analysis of possible covariates (e.g., sex, ethnicity, 
and age of DWI offenders and CFMs), added to the Poisson regression and (3) other exploratory analyses.  
 
Preliminary Analysis of Baseline Data. Descriptive data at baseline, with comparisons by treatment 
group, will be examined to check distributional characteristics and assess any concerns for imbalances that 
might be considered as covariates in analyses. The potential meaning of non-normality will be examined, i.e., 
excessive skewness potentially identifying key subgroups. These analyses will be at the level of the individual 
DWI offenders and CFMs responses and be conducted within 3 months of completion of recruitment. If there is 
excessive skewness on the IID lockout rates, negative binomial regression will be used. 
 
Planned Analysis for Hypothesis 1. The second major analysis will focus on impact of the B-SMART 
mobile web app on primary (IID lockout events) and secondary (DWI offender’s alcohol consumption) 
outcomes and be completed within 1 month of the end of the posttest data collection in Year 2. The effect of B-
SMART on IID lockout events in Hypothesis 1 will be tested primarily using PROC GENMOD with a Poisson 
link via SAS Version 9.4, which includes capabilities to test these Poisson models with missing data, account 
for the temporal design, and include information by participant. Participants will be treated as a random effect 
and treatment as a fixed effect, at p=0.05 (2-sided). Analyses of primary outcomes will not be released before 
completion of the intervention. Since CFM and DWI offender can be clustered within the same family, 
hierarchical models with participants nested within families will be considered.  
 
The secondary outcome of quantity and frequency of alcohol consumption by DWI offenders will be 
compared in several ways. Quantity and frequency will be evaluated using Poisson models, as well as a 
composite variable based on total alcohol consumption (the product of the two variables), using negative 
binomial regression models, unless a Poisson model is sufficient.  
 
Since date of IID lockout events will collected and alcohol consumption is measured at all three 
assessments, we will examine the time by treatment interaction in the analyses of Hypothesis 1 to assess the 

question of the durability of the effects of B-SMART over time. For example, we will evaluate time to first 
lockout using a Kaplan Meier approach and the times to subsequent lockouts.  
 
Mediation Analysis for Hypothesis 2. To address the predicted mediation effects of family function on 
improving the effect of the B-SMART mobile web app in Hypothesis 2, we will assess a formal effect on 
predicting fewer IID lockout events. Mediation will be tested by applying regression techniques from Judd and 
Kenny and elaborated by MacKinnon, with significance of mediation determined via interval estimation using 
bootstrapping. Ratio of indirect to total effects will estimate the proportion of the effect mediated. The primary 
mediational analysis will rely on temporal order of the posttests by examining the effect of B-SMART on 
change in the mediators from baseline to 3-month follow-up and in turn their association with changes in the 
IID lockout events from baseline to the 9-month follow-up and from 3- to 9-month follow-up.  
 
Ancillary Analysis of Moderators. Potential moderators (see 3C.7.3) will be tested at p=.05 (2-tailed) 
unadjusted for multiple tests. For Hypothesis 1, they will be added as interactions by condition in a manner 
similar to regression testing for effect modification. Gender is included to probe differences by sex of student 
and employee. For Hypothesis 2, we will explore if improvements in IID lockout events produced by increases 
in family function by different participant groups (gender, ethnicity, etc.), using moderated mediational 
analyses. Moderation effects must be large to be detected, so these are ancillary tests.  
 
 
Ancillary Analysis of the B-SMART Mobile Web App Exposure. The same mediational analysis 
techniques described in 3C.8.4 will be used to explore the relationship of exposure to the B-SMART mobile 
web app and pre-post changes in IID lockout events. Summed scores on exposure will be calculated from the 
SQL database (e.g., time on app, number of visits to the app, etc.) to assess intervention exposure.