Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
Phase: NA
Conditions: Risk Reduction
Sponsor: University of Pittsburgh

 
SaVE Trial Protocol v.1.0 
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June 01, 2019 
 
 
Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young 
Adults – 3 Parallel Randomized Controlled Trials 
 
Acronym: Safe Vehicle Engament (SaVE) Trials 
 
CLINICAL TRIAL PROTOCOL 
 
             Version 1.0 
 
 
Clinical Trials.Gov Identifier: NCT03833713 
 
Principal investigator: 
Brian Suffoletto, MD MS 
Assistant Professor of Medicine, University of Pittsburgh 
Attending Physician in Emergency Medicine, UPMC Mercy Hospital 
 
Co-Investigators: 
Catherine McDonald, Ph.D. 
Kit Delgado, MD 
University of Pennsylvannia, Department of Emergency Medicine 
 
Contact Address: 
Iroquois Building, Suite 400A 
3600 Forbes Ave 
Pittsburgh, PA 15261 
 
Phone: 412-901-6892 
Fax: 617-647-6999 
Email: suffbp@upmc.edu 
 
Funded By: 
National Highway Traffic Safety Administration (NHTSA) 
 
 
 
 
 
 

 
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SYNOPSIS ......................................................................................................................................................... 5 
TRIAL OVERVIEW ............................................................................................................................................ 6 
Feasibility .................................................................................................................................................... 7 
Acceptability ............................................................................................................................................... 7 
Effectiveness .............................................................................................................................................. 7 
STEERING COMMITTEE ................................................................................................................................ 8 
TRIAL SITES ...................................................................................................................................................... 9 
1. BACKGROUND AND SIGNIFICANCE.................................................................................................... 10 
1.1 Scope of the Problem ........................................................................................................................... 10 
1.2 
Existing Vehicle Safety Interventions ........................................................................................... 10 
1.4 Existing Interventions Targeting Cognitive and Motivational Factors of Vehicle Safety............ 10 
1.4 
Rationale for SMS Behavioral Interventions ............................................................................... 11 
2 
TRIAL DESIGN ........................................................................................................................................ 12 
2.1 Overview ................................................................................................................................................ 12 
2.2 Setting ..................................................................................................................................................... 12 
2.3 Inclusion criteria .................................................................................................................................... 12 
2.4  Participant Identification...................................................................................................................... 12 
2.5. Consent procedures ............................................................................................................................ 13 
2.6 Contact Information .............................................................................................................................. 13 
2.7 Baseline Questionnaire ........................................................................................................................ 13 
2.8 
Allocation to Cohorts ....................................................................................................................... 13 
2.9 SMS & App Onboarding ...................................................................................................................... 13 
2.10 SMS Run-in ......................................................................................................................................... 14 
2.12 SMS Interventions .............................................................................................................................. 14 
2.14 Outcome Assessments & Blinding ................................................................................................... 14 
2.15 Compensation ..................................................................................................................................... 14 
2.16 
Regulatory Issues ............................................................................................................................ 15 
2.17 Contingencies and Participant Withdrawal ................................................................................. 15 

 
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2.18 
Study flow diagram .......................................................................................................................... 15 
3. OUTCOMES ................................................................................................................................................ 15 
3.1 Definitions .............................................................................................................................................. 15 
3.1.1 Primary Outcome ........................................................................................................................... 15 
3.1.2 Secondary Outcomes: Feasibility ............................................................................................... 15 
3.1.3 Secondary Outcomes: Acceptability ........................................................................................... 15 
3.1.4 Secondary Outcomes: Effectiveness ......................................................................................... 15 
3.2 Rationale for Primary Outcomes ........................................................................................................ 16 
3.3 Safety ...................................................................................................................................................... 16 
3.3.1 Overview ......................................................................................................................................... 16 
3.3.2 Specific adverse event data collection ....................................................................................... 16 
3.3.3 Adverse Event Reporting ............................................................................................................. 17 
4. SAMPLE SIZE CALCULATION AND STATISTICAL ANALYSIS PLAN ............................................ 17 
4.1 Sample size calculation ....................................................................................................................... 17 
4.2 Statistical analysis plan ........................................................................................................................ 17 
4.2.1 General considerations ................................................................................................................. 17 
4.2.2 Primary Analyses ........................................................................................................................... 17 
4.2.4 Subgroup analyses........................................................................................................................ 18 
6.2.6 Statistical stopping criteria ........................................................................................................... 18 
5. DATA COLLECTION AND MANAGEMENT ........................................................................................... 18 
5.1 Data collection process ........................................................................................................................ 18 
5.2 Variables ................................................................................................................................................ 18 
5.3 Data quality and validity ....................................................................................................................... 18 
5.4 Data storage and security.................................................................................................................... 18 
6.1 RISKS TO HUMAN SUBJECTS ............................................................................................................. 19 
7. MONITORING ............................................................................................................................................. 20 
7.1 Institutional Review Board (IRB) ........................................................................................................ 20 
7.2 Data Safety and Monitoring ................................................................................................................. 20 
8. TIMELINE AND ENROLLMENT ............................................................................................................... 21 
8.1 Timeline .................................................................................................................................................. 21 
8.2 Screening & Enrollment ....................................................................................................................... 21 
9. FUNDING ..................................................................................................................................................... 22 
10. PUBLICATIONS ........................................................................................................................................ 22 
11. DATA SHARING ....................................................................................................................................... 22 

 
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12. INTELLECTUAL PROPERTY ................................................................................................................. 22 
13. TASKS AND RESPONSIBILITIES ......................................................................................................... 22 
Appendices ....................................................................................................................................................... 23 
Appendix 1: Abbreviations ......................................................................................................................... 23 
Appendix 2: Screening Questions ............................................................................................................ 23 
Appendix 3: Baseline Questions ............................................................................................................... 25 
Appendix 4: SMS Run-In ............................................................................................................................ 28 
 

 
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SYNOPSIS 
 
The “Safe Vehicle Engagement (SaVE)” trials are 3 parallel randomized clinical trials that aim to 
determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly SMS vehicle 
safety self-monitoring alone on seat belt use, distracted driving and drink driving among young 
adults identified in the emergency department with risky vehicle behaviors.  
 
 

 
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TRIAL OVERVIEW 
 
Title 
Utilizing Text Messaging to Improve Vehicle Safety 
Behavior Among At-Risk Young Adults – 3 Parallel 
Randomized Controlled Trials (The SaVE Trials) 
Clinical Trials Number 
NCT 
Sources of monetary or 
material support 
NHTSA  
Study Sites 
2-sites in the United States (Pittsburgh & Philadelphia) 
Conditions studied 
Seat belt use, distracted driving, drink driving 
Interventions 
Text messaging (SMS) intervention: vehicle safety self-
monitoring with performance feedback and goal support 
Comparator  
SMS vehicle safety self-monitoring 
Inclusion criteria 
Young adult (age 18-25 years) 
• Cohort 1: Any vehicle trip in past 2 weeks where 
individual reports not using a seat belt 
• Cohort 2: Any vehicle trip in past 2 weeks where 
individual reports phone was used to type while driving 
and car was moving  
• Cohort 3: Any vehicle trip in past 2 weeks where 
individual reports driving a vehicle within 3 hours after 
consuming 3 or more drinks  
 
Exclusion criteria 
• Member of a protected population (prisoner) 
• Unable to provide informed consent 
• No plan to drive and/or ride in a vehicle in the next month 
• Non-English speaking 
• No personal mobile phone or planning on changing 
phone in next 3 months 
 
Study type 
Interventional 
Assessment-only run-in (2-week) 
Allocation to trial cohort: Computerized algorithm to 
preferentially allocate to seat beltcohort 
Allocation to treatment: Randomized (1:1) 
Intervention model: Parallel group 
Masking: Assessor-blinded 
Target sample size 
500 Participants  
• 
Cohort 1: N=300 
• 
Cohort 2: N=100 
• 
Cohort 3: N=100 
Primary outcome (week 8) 
a. Cohort 1: Any vehicle trip in past 2 weeks where 
individual reports not using a seat belt 
b. Cohort 2: Any vehicle trip in past 2 weeks where 
individual reports phone was used to type while 
driving and car was moving  

 
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c. Cohort 3: Any vehicle trip in past 2 weeks where 
individual reports driving a vehicle within 3 hours after 
consuming 3 or more drinks  
 
Key secondary outcomes 
Effectiveness 
-Primary outcomes at week 14 (durability) 
Feasibility 
-Percentage of ED patients who screen positive and 
agree to enroll. 
-Percentage of ED patients who enroll who meet run-in 
criteria. 
Acceptability 
-Percentage of ED patients enrolled in the Intervention 
arm who complete at least 50% of the SMS assessments 
during the intervention period.  
-Percentage of ED patients enrolled in the Intervention 
arm who found the program helpful. 
 

 
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STEERING COMMITTEE 
 
Brian Suffoletto, M.D.  
Assistant Professor of Emergency Medicine 
University of Pittsburgh School of Medicine 
Catherine McDonald, Ph.D. 
Assistant Professor of Nursing 
University of Pennsylvania School of 
Medicine 
Kit Delgado, M.D. 
Assistant Professor of Emergency Medicine 
University of Pennsylvania School of Medicine 
Jean Shope , Ph.D. 
Professor 
University of Michigan 
Jana Nelson  
American College of Emergency Physicians  
Emergency Medicine Foundation 
Cynthia Singh 
Director of Grant Development   
American College of Emergency Physicians  
Emergency Medicine Foundation  
 
Conflicts of interest 
The members of the steering committee have no financial conflicts of interest related to the current 
trial.  

 
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TRIAL SITES 
 
Coordinating Center 
University of Pittsburgh 
Department of Emergency Medicine 
Site Investigator: Brian Suffoletto, MD 
 
Enrolling Sites* 
 
Hospital Name 
Location 
Site Principal Investigator 
UPMC Mercy Hospital 
Pittsburgh, PA 
Brian Suffoletto, MD 
UPMC Passavant Hospital 
McCandless, PA 
Brian Suffoletto, MD 
Hospital of the University of Penn 
Philadelphia, PA 
Catherine McDonald, PhD 
Penn Presbyerian Hospital 
Philadelphia, PA 
Catherine McDonald, PhD 
 
*Depending on study progress, sites may be added or removed in the future. 
 
 
 

 
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1. BACKGROUND AND SIGNIFICANCE 
1.1 Scope of the Problem  
There were around 25,0000 people killed inside vehicles on U.S. roadways during 2016 (NHTSA, 
2016) and over 2 million injured in motor vehicle crashes (MVC) (CDC, 2016). A few key behaviors 
contribute to increased risk of either MVCs or MVC-related injuries: lack of seat belt use, impaired 
driving (due to drugs and/or alcohol), and distracted driving (due to either other passengers or 
electronic devices).  Among the deaths from MVCs in 2016, 42% were unrestrained passengers 
(NHTSA, 2016).  These behaviors are especially prevalent in young adults. Over 35% of lifetime 
medical costs for crash injuries (US$6.5 billion of US$18 billion) are attributed to young drivers aged 
15 to 29 (CDC, 2014).  
 
1.2 Existing Vehicle Safety Interventions 
To date, most primary prevention interventions for young adult vehicle safety have been through 
multimedia campaigns (Whittam KP et al., 2006),  driver training programmes (Lenne LG et al., 
2011; Unni P et al., 2017), or public policies such as surveillance with fines for speeding and seat 
beltuse (Wilson C et al., 2011). Secondary prevention approaches include mandated interventions 
for offenders such as alcohol Ignition Interlocks (McGinty EE et al., 2017).  Recently, improved 
knowledge of the behavioral drivers of vehicle safety allow for updated interventions incorporating 
psychological theories and behavior change techniques (Fernandez et al., 2010).  
 
1.3 Behavioral Drivers of Vehicle Safety 
Two psychological theories useful in understanding vehicle safety behaviors are the Theory of 
Planned Behaviour (TPB) and the Health Belief Model (HBM). In the TPB, intentions are influenced 
by a person’s attitude, perceived norms and self-efficacy. The TPB has been shown to explain up to 
53% of variance in intention to speed and 40% of variance in speeding behavior (Stead M et al., 
2005). In the HBM,the perceived risks/threats of personal injury and the perceived benefits of 
performing a safety behavior influence the likelihood of performing them. These HBM factors have 
been shown to be important in sealt belt use  (Chaudhary, Solomon, & Cosgrove, 2004; Helweg-
Larsen & Sheppard, 2001).  
 
1.4 Existing Interventions Targeting Cognitive and Motivational Factors of Vehicle Safety 
Among the few studies have been published testing behavioral interventions for vehicle safety, 
several have shown that these cognitive and motivational factors of vehicle safety behaviors can be 
potentially modified. One study showed that an intervention targeting TPB factors resulted in small 
immediate improvements in vehicle safety (Poulter DR et al., 2010) but effects were not durable 
over time. Another study by McDonald et al (2018) reported on the development of a digital 
intervention targeting TPB factors, finding feasible and initial evidence of effects.  
 

 
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1.5 Rationale for SMS Behavioral Interventions 
In the US, mobile phones are near ubiquitous, and by the year 2020, 70% of the world's population 
will use a smartphone (Ericsson, 2015). Text messaging (SMS) is a commonly used digital 
communication modality that has particular usefulness in reaching individuals to support behavior 
change (Suffoletto et al.,2017). SMS interventions are ideally suited to deliver microinterventions– 
interventions that can be completed in a few moments, typically as a repeated administration, 
tailored to some immediate assessed need or trigger.  These microinterventions are more closely in 
line with the expectations of consumers of digital information, who may routinely interact with fast-
paced, user-driven, interactive content. Systematic reviews have found SMS interventions to be 
effective in short-term behavioral outcomes (Fjedsoe et al., 2009) and supporting preventive health 
for adolescents specifically (Badway & Kuns, 2017). Our group has shown that SMS interventions 
incorporating behavior change strategies of self-monitoring with performance feedback and goal 
support produces reductions in alcohol use in at-risk young adults (Suffoletto et al., 2017). 
 
1.6 SMS Interventions to Reduce Risky Vehicle Behaviors 
In this proposal, we plan to design and test three unique SMS interventions each targeting a 
different vehicle risk behaviors (seat belt use, distracted driving, and impaired driving). They will all 
use psychological theory and state of the art human-interaction design to optimize engagement and 
effects. Specifically, the SMS interventions will incorporate periodic (weekly) check-ins to promote 
self-monitoring of recent risks, goal commitment prompts tailored to past performance to maximize 
willingness and support gradual behavioral shaping, and performance feedback. Feedback and 
features will focus on modifying cognitive and motivational factors found in the TPB amnd HBM.   

 
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2. TRIAL DESIGN 
2.1 Overview 
We propose to conduct 3 related randomized, controlled, parallel group, assessor-blind, superiority 
trials of 6-week text message interventions vs. SMS vehicle safety self-monitoring in young adult 
participants with risky vehicle behaviors. A total of 500 adult participants will be enrolled: 300 into 
Cohort 1 (seat belt); 100 into Cohort 2 (distracted driving); 100 into Cohort 3 (drink driving). Each 
SMS intervention will be desgined to target a single risk behavior. The study is powered to show a 
difference of 15% in the percentage of subjects reporting seat belt use at week 8. Other cohort trials 
(i.e. distracted driving, drink driving) and outcomes will be exploratory. 
 
2.2 Setting 
The trial will be conducted at 4 hospital emergency departments in Pennsylvania. Additional sites 
might be recruited if needed.  
 
2.3 Inclusion criteria 
Inclusion criteria:  
1) Adult participant (age ≥ 18 years & ≤25 years) 
a. Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat 
belt 
b. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used 
to type while driving and car was moving  
c. Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle 
within 3 hours after consuming 3 or more drinks  
Exclusion criteria:  
1) Member of a protected population (prisoner) 
2) Unable to provide informed consent 
3) No plan to drive and/or ride in a vehicle in the next month 
4) Non-English speaking 
5) No personal mobile phone or planning on changing phone in next 3 months 
 
Justification of Inclusion and Exclusion Criteria: The inclusion criteria were chosen to isolate three 
different vehicle risk behaviors in a population with high risk of injuries due to these risks. We chose 
to be more inclusive than restrictive in these criteria to ensure me meet enrollment goals in the 
allotted time of funding. The exclusion criteria were chosen to minimize the risk of potential harm to 
vulnerable populations. 
 
2.4  Participant Identification  
In the ED a research associate (RA) will conduct confidential screening of ED patients during 
breaks in patient medical care. The RA will review ED admissions data form the EMR to identify 
potential subjects, identifying adult patients 18-25 years of age who receive medical care in the ED. 
The RA will then ask a clinician (physicians, nurses, or physician extenders) caring for a potential 
participant to ask the patient if they are interested in speaking with a researcher about a research 
study. ED clinicians are instructed to refer only patients who are able to provide informed consent 
(i.e., oriented, able to concentrate, not intoxicated and can understand/remember requirements of 
the study). We ask clinicians to document in their medical record about the patient’s assent to talk 
with the RA.  
The RA will then discuss the screening and study details with these patients who agree to be 
approached. Those who wish to see if they are eligible will be asked to complete limited 
demographics (age, sex, race, and current education), a 13-question screening test to determine 
presence of vehicle risks  using a secure password-protected website. The demographics will be 

 
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used to determine how those who screen and/or enroll in our study differ from the general ED 
population of young adults. See Appendix for Screen Questions.  
All participants who are screen positive will be provided an information sheet on vehicle risk 
reduction. See Appendix for draft of Discharge Instructions.  We will request a waiver of informed 
consent to view the electronic medical record to identify potential participants by age and a waiver 
of written consent to ask limited screening questions. Detailed screening logs, with reason(s) for 
exclusion will be stored in a password-protected database. 
 
2.5. Consent procedures 
After it is determined that they meet all inclusion criteria and no exclusion criteria, the participant  
will be approached for written informed consent by a RA. The RA will provide the 
participant/representative information regarding the background and significance of the study, 
eligibility criteria, and a description of the protocol. The consent process may need to be modified 
based on site-specific IRB recommendations. The name of the study investigator obtaining consent 
will be clearly documented, and this person will sign the informed consent document and provide 
the date and time of their signature. Signed copies of the consent form will be given to the 
participant/surrogate, and the original consent document will be stored in the secure study file. In 
obtaining and documenting informed consent, each investigator will comply with the applicable 
regulatory requirements and adhere to the ethical and Good Clinical Practice principles that have 
their origin in the Declaration of Helsinki.  
 
2.6 Contact Information 
Participants will be asked to provide us with their contact information (name, phone number, email). 
We will also ask them to provide a social security number, as it is required for participant payment. 
 
2.7 Allocation to Cohorts 
We will use the risks reported in the screening survey to allocate the participant to their cohort. The 
overall goal is to meet recruitment goals for all three cohorts simultaneously, but to preferentially 
allocate individuals to the seat belt group (Cohort 1). Individuals who report only one risk behavior 
will be allocated to that study cohort. Individuals who report more than one risk factor will be 
allocated probabilistically. Individuals who screen positive for seat belt risk + one other risk will have 
a 75% chance of being allocated to Cohort 1.  Individuals who screen positive for seat belt risk + 
two other risks will be allocate as 60% Cohort 1, 20% Cohort 2, 20% Cohort 3. Individuals who 
screen positive for both other (non-seat belt) risks will be allocated in a 1:1 ratio.  
 
2.8 Baseline Assessment 
We will ask participants to complete a questionnaire collecting detailed demographics, vehicle-
related risks, and impulsivity traits. This survey takes about 5 minutes to complete See Appendix for 
Survey Questions. We will also ask participants to complete the 5-Trial Adjusting Delay Discounting 
Task (Kaffaurnus & Bickel, 2014) to assess monetary impulsivity trait. All cohorts will complete 
identical baseline assessments. 
 
2.9 SMS Onboarding 
We will then ask participants to text in a keyword to our program phone number. Only phone 
numbers that match the phone numbers entered by the RA in the enrollment process wil receive 
texts.  Once this match is recognized, participants will receive several texts welcoming them to the 
study and describing the 2-week run-in. Each chohort will receive similar yet unique welcome 
messages tailored to their risk behavior.  
  

 
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2.10 SMS Run-in 
All participants will complete a 2-week run-in period where they complete weekly SMS assessments 
related to their target risk behavior without receiving any feedback or goal support. The primary 
purpose of the run-in is to exclude noncompliant subjects. Only participants who respond to at least 
50% of the SMS queries in week 1 & 2 will be eligible to continue in the study. The secondary 
purpose is to identify the post-enrollment/ pre-intervention vehicle risk behaviors that may occur as 
a result of assessment reactivity. We expect that simply the act of enrolling in a study about vehicle 
risk and completing weekly SMS assessments of risk may result in reduced risk behaviors.  
 
2.11 Allocation to Treatment 
Participants in each cohort who meet run-in criteria will be randomized in a 1:1 ratio to either the 
SMS intervention or SMS self-monitoring in blocks of 4. The randomization will be stratified 
according to site (i.e. ED). An independent statistician will create the randomization list using a 
random number generator. The randomization list will be stored in an electronic database to be 
unblinded once trial enrollment and follow-up periods have been completed.  
 
2.12 SMS Interventions 
All three SMS interventions work iteratively primarily through once-weekly dialogue sessions or 
micro-interventions and use behavior change techniques (BCTs) including self-monitoring with 
performance feedback and goal support. Each SMS intervention will differ in the content of queries 
and feedback, which is tailored to the target risk behavior. SMS queries and subject responses are 
stored and time-stamped in a database. Branching logic is used to tailor SMS feedback and 
queries. At the completion of 6-weeks, all SMS intervention participants will be asked to complete 
another 6 weeks of SMS assessments without receiving any feedback or goal support. This is to 
serve as a washout period so that durability can be assessed at week 14. All queries, feedback 
libraries and branching logic will be written prior to trial enrollment. See Appendix for SMS 
Intervention Material. 
 
2.13 SMS vehicle safety self-monitoring (i.e. assessment control) 
Participants allocated to the control arm will simply continue to receive weekly SMS assessments 
related to their target risk behavior without receiving any feedback or goal support for 12 more 
weeks.  
 
2.14 Outcome Assessments & Blinding  
The primary outcomes will be the percentage of participants in each treatment arm who report 
vehicle risks at week 8 (immediate effects) and week 14 (durable effects). Questions are the same 
as those used in screening. Participants will receive a text prompting them to log in to the secure 
web site to complete the 21-question survey which should take them no more than 10 minutes to 
complete.  Research associates and investigators will be blinded to the allocation until outcome 
evaluation.  It is not possible to blind subjects given the nature of the intervention.  We do not 
expect any scenarios where emergency unblinding will be necessary.  
 
2.15 Compensation 
Participants will be compensated $15 for completing enrollment procedures. We will add $15 if they 
meet run-in criteria at the end of week 2 and complete the 8-week follow-up assessment. We will 
add a final $15 if they complete the 14-week assessment.  
 

 
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2.16 Regulatory Issues 
We will submit an IRB protocol both for the trial and coordinating center at the University of 
Pittsburgh. We will also submit an IRB protocol at the Univeristy of Pennsylvania. We expect the 
trial to be minimial risk to participants, given that the only possible risk will be from potential breach 
of confidentiality. We will minimize these risks through various strategies. 
The trial will be registerted on ClinicalTrials.gov. 
 
2.17 Contingencies and Participant Withdrawal  
• In the unlikely event that a participant is discharged from the ED prior to completing enrollment 
procedures, we will make every attempt to assist the participant in completing them in the 
following 48 hours. Those participants who still do not complete in this time period will be 
withdrawn from the study. 
• If a participant withdraws from the study, further communication will be stopped. Data collected 
prior to withdrawal will be maintained but additional data will not be collected.   
  
2.18 Study flow diagram 
 
 
 
3. OUTCOMES 
3.1 Definitions 
3.1.1 Primary Outcome 
 -Percentage of participants who report a vehicle risk at week 8.  
d. Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt 
e. Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type while 
driving and car was moving  
f. 
Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 3 
hours after consuming 3 or more drinks  
 
3.1.2 Secondary Outcomes: Feasibility 
-Percentage of ED patients who screen positive and agree to enroll 
-Percentage of ED patients who enroll who meet run-in criteria. 
 
3.1.3 Secondary Outcomes: Acceptability 
-Percentage of ED patients enrolled in the Intervention arm who complete at least 50% of the SMS 
assessments during the intervention period.  
-Percentage of ED patients enrolled in the Intervention arm who found the program helpful. 
 
3.1.4 Secondary Outcomes: Effectiveness 
-Percentage with Vehicle Risks at Week 14 – We are interested to see if there is any signal of 
effectiveness once the intervention is “turned-off”. This measure of durability is especially critical to 
understand potential public health benefits.  

 
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-Slopes of change over time – We will also examine the average slopes of change over time, 
specifically examining the slopes of change in the pre-enrollment, run-in (2-weeks), active 
intervention (6-weeks), and post-intervention (6-weeks) periods.  
 
3.2 Rationale for Primary Outcomes  
3.2.1 Overview 
We chose to measure self-reported outcomes because objective data on vehicle safety behaviors is 
difficult to collect, costly, and obtrusive. For example, seat belt use would require in-vehicle 
equipment or camera monitoring. Alcohol use would require an individual to provide semi-
continuous breath alcohol measurements. We chose to assess outcomes over a 2-week timeframe 
to minimize recall biases associated with longer recall periods but to allow an adequate sampling 
period where an individual had enough vehicle trips to be considered representative of behaviors. 
For list of outcome assessment questions, see Appendix. 
 
3.2.2 Cohort 1: Any vehicle trip in past 2 weeks where individual reports not using a seat belt.  
Not wearing a seat belt is associated with higher odds of death or serious injury related to a motor 
vehicle crash. The SMS intervention aims to encourage consistent use of a seat belt. We will 
explore whether differences exist between front and rear-seat passenger trips or driver versus 
passenger trips.  
 
3.2.3 Cohort 2: Any vehicle trip in past 2 weeks where individual reports phone was used to type 
while driving and car was moving.  Typing while driving (TWD) has been shown to increase collision 
or near-collision event risk by two-fold (Fitch et al., 2013), and studies among younger drivers have 
found that TWD is associated with 35% slower reaction times (Reed and Robbins, 2008) and a four-
fold increase in time spent looking away from the road compared to those driving undistracted 
(Hosking et al., 2006). We chose to asses not just typing text messages, but any typing on a phone, 
as there are a number of platforms for communication outside of texting that are commonly used 
(e.g. Google searches, social media messaging, location-based services).  
 
3.2.4 Cohort 3: Any vehicle trip in past 2 weeks where individual reports driving a vehicle within 3 
hours of consuming 3 or more drinks.  The risk of a motor vehicle crash increases exponentially with 
elevated blood alcohol content (NHTSA). We chose as an outcome driving a vehicle within 3 hours 
of consuming 3 or more drinks as this would indicate a high likelihood of a peak BAC of at least 0.05 
mg/dl, which would inidicate some psychomotor impairment and elevated risk taking (Van Dyke & 
Filmore, 2017).    
 
3.3 Safety 
3.3.1 Overview 
We do not expect, based on the nature of the SMS intervention, to have any serious adverse 
events. The only forseeable rare adverse event would be to cause a vehicle crash by texting with 
someone when they are driving. We will minimize this risk by informing all participants to refrain 
from texting us while driving.  
 
3.3.2 Specific adverse event data collection 
To assess specific amd potentially serious adverse events that may be related to the interventions, 
we will collect data on the following:  
 

 
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3.3.3 Adverse Event Reporting 
Any unexpected adverse events will be recorded and reported directly to the appropriate IRB 
shortly following the event per local protocol.  
 
 
4. SAMPLE SIZE CALCULATION AND STATISTICAL ANALYSIS PLAN  
4.1 Sample size calculation 
The study has been powered to have at least 80% power for the primary outcome for Cohort 1 (seat 
belt use). Based on Sommers et al., 2013, we can likely expect the intervention to increase the 
percentage of subjects reporting seat belt use by15% on top of self-monioting alone. Using a 2-
sample test of proportions, estimating 25% of the intervention participants and 10% of the control 
(SMS self-monitoring) report always seat beltuse, we would need around 100 subjects per group to 
show a significant difference between arms.  Expecting 10% drop-out in the SMS 2-week run-in and 
80% completing 8-week assessments, 300 enrolled in the ED should provide an analyzed sample of 
216 (108 per arm). 
 
4.2 Statistical analysis plan 
4.2.1 General considerations 
The statistical analyses and reporting will adhere to the CONSORT guidelines. All tests will be two-
sided, a p-value < 0.05 will be considered significant, and all confidence intervals will have 95% 
coverage. All analyses will be conducted on a modified intention-to-treat basis only including 
participants responding to at least one week of SMS assessments during the intervention period. 
The two groups will be compared in relation to baseline characteristics using descriptive statistics. 
The persons conducting the statistical analysis will be blinded to the randomized allocation. Groups 
will be designated as “A” and “B” until all pre-specified analyses are performed and shared with all 
authors. 
 
4.2.2 Primary Analysis 
At baseline, all participants (based on screening criteria) all had the risk factor. At subsequent time 
points, participants are analyzed as having/not having the same risk factor by randomized group. 
For our primary analysis, we will examine the proportion of participants in each group (SMS 
intervention; assessment control) who report the risk behavior using a chi-squared test of 
proportions. We will then perform a logistical regression, entering any baseline attribute that has 
univariate association with the outcome in the final model. We will report the difference in 
percentage with primary outcomes as well as odds ratios (from logistical regressions) with 95% 
confidence intervals The α level is set at .05 for all statistical tests. 
 
4.2.3 Secondary Analyses 
The percentage of ED patients who screen positive and agree to enroll, the percentage of ED 
patients who enroll who meet run-in criteria, the percentage of ED patients enrolled in the 
Intervention arm who complete at least 50% of the SMS assessments during the intervention 
period, and the percentage of ED patients enrolled in the Intervention arm who found the program 
helpful will be calculated and presented with 95% confidence intervals. We will explore whether 
individual factors (e.g. sex, race, education) are associated with enrolling, meeting run-in criteria, 
completing SMS assessments or finding the program helpful using multi-level modeling. We will 
examine whether perceived norms, perceived control, or perceived risk differed between treatment 
arms. We will explore the slope of change over time in SMS risk reports using generized estimating 
equations (GEE) with log link function, examining time, treatment and time*treatment effects. Any 
individual factors signifianctly associated with SMS assessment completion will be included as 

 
SaVE Trial Protocol v.1.0 
Page 18 of 36 
covariates.GEE is the recommended technique to handle non-parametric residuals and 
missingness associated with repeated-measured data. We will use robust estimates and account for 
clustering of outcome data within individuals. Results will be presented as odds ratios with 95% 
confidence intervals.   
 
Handling Missing Outcome Data: If a participant is missing outcome assessment time points (week 8 
or week 14), vehicle risk behavior will be imputed based on a pre-defined plan as follows. If a 
participant has reported that risk via SMS weekly reports, we will use those values for missing weeks. 
If either of the prior 2 weeks is missing on both web-based recall report or SMS reports,  we will impute 
the missing week based on the worst performance recorded in the weeks either before or after the 
missing one using SMS values. We believe that this will provide the most conservative estimate of 
the missing value.  Sensitivity analyses will be performed using various other imputation techniques, 
including multiple chained imputations using baseleine and prior SMS reports. 
 
4.2.4 Subgroup analyses  
The analysis will include three pre-defined subgroup analyses for the primary and key secondary 
outcomes according to 1) participants with high baseline impulsivity (based on delay discount task 
or self-report (S-UPPS); 2) participants with low perceived danger (defined as those who report No 
danger associated with target vehicle risk); and 3) participants with low perceived control (i.e. 
disagree with being able to control behavior)  . These cut-off were chosen to represent a population 
with the highest predicted likelihood of injury due to vehicle risks.  The trial is not powered to detect 
subgroup differences and these will be considered exploratory and hypothesis generating.    
 
4.2.5 Statistical stopping criteria  
There will be no formal stopping criteria for efficacy. There will be no predefined stopping criteria for 
futility since enrollment of the full cohort might allow for detection of efficacy in subgroups or in other 
outcomes even if the primary outcome is negative.  
 
5. DATA COLLECTION AND MANAGEMENT  
5.1 Data collection process  
Data collection will be the responsibility of the individual site investigators with oversite from the trial 
coordinating center. All baseline and outcome variables (i.e. demographics, vehicle risk behaviors) 
will be obtained prospectively from electronic surveys. Data will be entered directly into the online 
database software (see below).  
 
5.2 Variables 
Measure library is included in the Appendix. 
 
5.3 Data quality and validity  
Data quality and validity will be optimized by using a detailed data dictionary which will be 
distributed to all sites. Data quality will be monitored both centrally by the coordinating site and 
locally by each site principal investigator.  
 
5.4 Data storage and security  
All data will be stored and secured by Jack Doman, the Director of the Office of Academic 
Computing (OAC) at Western Psychiatric Institute and Clinic (WPIC). Baseline data will be entered 
into Web Data Xpress,  a web-based data entry system that enables users to add and edit records 
in a database.  By using Secure Sockets Layer (SSL) and user authentication, users can be 
assured that data transmitted over the internet is safe and secure.  The system to send, receive and 
process text messages, was developed on the OAC SQL Server 2005 system with permissions 
granted to specific EM faculty and staff to access the data for a given project through a Microsoft 

 
SaVE Trial Protocol v.1.0 
Page 19 of 36 
Access front-end. Through these mechanisms, as well as relevant training for all involved parties, 
participant confidentiality will be safeguarded.  
 
The consent form and other trial documents for each participant will initially be stored in a secure, 
locked place at the individual sites. Participating sites will be responsible for maintaining their own 
trial documents and study materials. Trial documents generated at the Coordinating Center will be 
maintained the Coordinating Center. Following completion of the trial, documents will be maintained 
for a period of at least 7-years at each site (or longer depending on local IRB guidelines). 
 
6.1 RISKS TO HUMAN SUBJECTS 
Information obtained at the time of screening and assessment may pose psychological risks and some of 
the questions may be considered sensitive in nature and may cause emotional distress. We will be 
collecting information that if disclosed could have adverse consequences for subjects or damage their 
financial standing, employability, insurability, or reputation. Additionally, we are enrolling underage 
individuals, which risk disclosure of illegal activity associated with alcohol and/or drug use. Participants 
face some risk of loss of confidentiality due to the nature of data acquisition through the internet and cell 
phone SMS. First, participants may have information on their mobile phone that is seen by someone else. 
As well, there may be the rare risk that someone not associated with this research sees their medical 
record or data as a result of their participation in this research. Overall, the likelihood of any of these risks 
causing a subject any serious discomfort or inconvenience is very low.  Confidentiality of information will 
be maximized in accordance with HIPPA regulations.   
 
6.2 ADEQUANCY OF PROTECTION AGAINST RISK 
6.2.1 Recruitment and Informed Consent: Eligible patients will be identified by a Research Associate 
with clinical appointments at enrolling hospitals. The RA will conduct confidential screening of ED patients 
during breaks in patient medical care. All responses to screening questions will be recorded on a secure 
web site. The Primary Investigator will audit screenings and will be available to the RA during screening.  
The RA will approach all permission-granting, potentially eligible patients to obtain informed consent for 
study screening. To ensure privacy, family or other individuals accompanying the patient will be asked to 
leave the area prior to the screening procedures and patients will be reminded that other people may be 
able to overhear the conversation. The RA will provide tablet computer for participants to complete 
screening questionnaire immediately after informed consent.  Screening will include review of 
inclusion/exclusion criteria and basic demographic information to determine how those who screen 
positive differ from those who screen negative.  Interested and eligible individuals will be asked to 
complete written informed consent. The computer shows the RA whether the participant is eligible or not, 
and whether the risks were present or not. The RA will then read a standard script based on eligibility and 
offer eligible patients study participation, obtaining written informed consent. The RA will present an oral 
and written description of the study as part of informed consent, including a description of the project 
procedures, potential risks and benefits, and confidentiality. The RA will review any questions the patient 
may have during the consent process. Patients will be informed that they will be compensated for their 
time during the research assessments.  
 
6.2.2 Protection Against Risk: In order to protect study participants form potential risks related to the 
loss of confidentiality and due to any discomfort that they may experience in answering any questions, the 
following steps will be taken: 1) Patients will be told that they can withdraw from the study at any time by 
contacting us. 2) All information provided by the patient will be referenced to a subject ID# and will be 
kept in locked file cabinets. The patient’s ID# can be connected to the subject’s name only through a 
single master file, accessible only by the Primary Investigator. All data and files will be entered on 
computers protected by passwords and stored in a locked office. 3) All research staff will be trained in the 
importance of maintaining confidentiality and will undergo annual mandatory training of human subjects 
research. 4) All patient data will be presented in aggregate and no individuals will be identified 
individually.  Additionally, we will make every effort to ensure that subject information is protected so only 

 
SaVE Trial Protocol v.1.0 
Page 20 of 36 
authorized persons can see their information. All messages sent from subjects to our phone number will 
be catalogued and encrypted, stored per UPMC security standards. All participants will be advised to set 
up password protection on their cell phones and to erase messages after responding to minimize the 
chance of loss of private information. We state explicitly in the consent that we will not be able to respond 
in real-time to any concern a patient has that is outside the expected responses that is sent to our phone 
number, nor any text message outside the scope of the question we ask. Immediate or emergency text-
messages that are received and outside the scope of the questions we sent will all receive a standardized 
text message, stating "We appreciate your participation. If you have an emergency, please call 911." As 
well, all messages are archived in our database and will be reviewed at least every 2 days by the 
investigators. At the end of this study, the data key will be destroyed.  
 
6.2.3 Certificte of Confidentiality: Because we are collecting data that is sensitive, we will seek a 
Certificate of Confidentiality from the NIH.  
 
6.2.4 Potential Benefits to Individual Participants: All participants (and those who screen positive) 
will be offered an informational sheet on vehicle risks. Particiapnts in both treatment arms will also be 
prompted to self-monitor their vehicle risks over a period of 14 weeks, which also will likely result in 
reduced risks thorugh assessment reactivity and awareness. Assuming our hypothesis is correct, 
individual participants enrolled in our study and randomized to the treatment arm will also benefit in 
learning improved vehicle safety behaviors.  
 
6.2.4 Potential Benefits to Society: Risky vehicle behaivors are associated with increased 
probability of serious injury due to motor vehicle crashes. No current existing behavioral support tool 
exists to reduce these risky behviors. Our study, assuming our hypothesis is confirmed, will provide 
strong support for the widespread adoption of an SMS program for young adults with these risks. This, 
in turn, could significantly reduce the global burden of injury-related morbidity and mortality.  
  
 
7. MONITORING 
7.1 Institutional Review Board (IRB) 
The study will be reviewed and approved by the IRB at each participating site.  
 
7.2 Data Safety and Monitoring 
The proposed study will be monitored to enhance the safety of study participants. Although minimal 
risks are expected for participants in the study, all data and research enrollment processing will be 
audited at least monthly by the Departmental Clinical Research Meeting (DCRM) of the Department 
of Emergency Medicine. This DCRM includes senior researchers in the Department of Emergency 
Medicine and is responsible for continual review of all non-exempt studies involving patients. At 
least one investigator of this study will attend these meetings. All members of the DCRM have 
considerable research and clinical experience to evaluate the study’s recruitment and retention 
procedures, to monitor any potential significant benefits or risks that may occur so as to warrant the 
early termination of the study and to monitor study progress. Additionally, bi-weekly meetings will be 
held with primary investigators and research assistants to review research process. Any significant 
issues or variations from protocol related to this study will be reported to Department of Emergency 
Medicine DCRM and to the University of Pittsburgh Institutional Review Board in a timely fashion. 
Upon study renewal, a monitoring report will be provided to the IRB. 
 
 

 
SaVE Trial Protocol v.1.0 
Page 21 of 36 
8. TIMELINE AND ENROLLMENT  
8.1 Timeline  
 
Pre-
trial 
Months 0-6 
Months 7-12 
Months 12-18 
 
Months 19-24 
Funding 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol development  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Creation of data dictionary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinicaltrials.gov registration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethical approval 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Creation of randomization list 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site start-up (Pitt) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Site start-up (Penn)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 1 Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 1 Follow-ups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 2 Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 2 Follow-ups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 3 Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cohort 3 Follow-ups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DSMB monitoring 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cleaning and closing of the 
database 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Unblinding & Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Main manuscript writing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publication and presentation 
of results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2 Screening & Enrollment  
Enrollment at each site will be continuously monitored by the site investigator and the principal 
investigator. Each site will maintain a screening log including all participants who meet all eligibility 
criteria at that site. A standardized screening log will be kept using WebDataXpress, thus allowing 
for continuous updating of the screening log and will allow capture of all screening failures.    
 
Enrollment will be competitive (i.e. without specific enrollment caps). Number of enrollments at each 
site will be shared with all sites on a monthly basis. Sites will be expected to complete all elements 
of the online screening and enrollment forms for each subject.  In the case that a site continuously 
underperforms despite troubleshooting and feedback, the Investigators will evaluate whether 
enrollment will continue at that site. 
 

 
SaVE Trial Protocol v.1.0 
Page 22 of 36 
9. FUNDING 
Funding for the present trial is provided by NHTSA in partnership with EMF. The funding agencies  
have no role in the design and conduct of the study, collection, management, analysis, and 
interpretation of the data, preparation, review, or approval of the manuscript, or the decision to 
submit the manuscript for publication.  
 
10. PUBLICATIONS 
We plan to write 3 separate main manuscripts describing findings related to Cogorts 1,2, &3. The 
manuscripts will adhere to the CONSORT guidelines. The principal investigator will be responsible 
for assigning authorship position and will follow authorship guidelines from the International 
Committee of Medical Journal Editors. At a minimum, all members of the Investigator Team will be 
included in the primary author list. The main results will be presented at an international conference. 
The trial results will be shared with participating sites and via press releases but not directly with the 
participants. 
 
11. DATA SHARING 
Six months after the publication of the last results, all de-identified individual participant data will be 
made available for data sharing. Procedures, including re-coding of key variables, will be put in 
place to allow for complete de-identification of the data. All relevant trial-related documents, 
including the protocol, data dictionary, and the main statistical code, will be shared along with the 
data. There will be no predetermined end date for the data sharing. Data will be available for any 
research purpose to all interested parties who have approval from an independent ethics review 
committee and who have a methodological sound proposal as determined by the steering 
committee of the current trial. Interested parties will be able to request the data by contacting the 
principal investigator. Authorship of publications emerging from the shared data will follow standard 
authorship guidelines from the International Committee of Medical Journal Editors and might or 
might not include authors from the steering committee depending on the nature of their involvement.  
 
12. INTELLECTUAL PROPERTY 
We will submit a disclosure of intellectual proprerty to the University of Pittsburgh between primary 
analyses and publication submission. Inventors to be listed include Brian Suffoletto, Catherine 
McDonald and Kit Delgado.  
 
13. TASKS AND RESPONSIBILITIES  
Principal investigator: Overall responsibility for protocol development, intervention development, 
budget overview, data dictionary development, ethical approval, trial registration, daily 
management, trial oversight and collection of adverse events, and the data and safety monitoring 
board, assessment of overall recruitments, potential recruitment of additional sites, data analysis, 
and dissemination and presentation of results.  
 
Co-Investigators: Site-specific enrollment, education of personnel at participating sites, reporting of 
site-specific issues or challenges to the principal investigator, participant consent for data collection, 
collecting and reporting data regarding adverse events. Also protocol development, data dictionary 
development, trial oversight, dissemination of results. 
 
Steering committee: Protocol development, data dictionary development, trial oversight, 
dissemination of results. 
 

 
SaVE Trial Protocol v.1.0 
Page 23 of 36 
 
 
Appendix: Screening Questions 
  
Question 
How old are you? 
18 years 
old  
19 
years 
old 
20 
years 
old 
21 
years 
old 
Code 
age 
0 
1 
2 
3 
Question 
What is your sex? 
Female 
Male 
Code 
sex 
0 
1 
Question 
Are you Hispanic or Latino? 
No 
Yes 
Code 
hisp 
0 
1 
Question 
What is your race? (Select one or more responses.) 
Black or 
African 
American 
White 
Asian 
Other 
Code 
brace, wrace, asian, rother 
0/1 
0/1 
0/1 
0/1 
Question 
Are you currently enrolled in school? 
No 
Yes, 
High 
School 
Yes, 
College 
Code 
school 
0 
1 
2 
  
  
  
  
  
  
 
The following questions ask you to recall times you have been in a car over the past 2 
weeks. 
 
 
 
 
Question 
How often have you driven a car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
driver 
0 
1 
2 
3 
Question 
How often did you wear a seat belt when you drove a car? 
Never 
A few 
times 
Most of 
the 
time 
Always 
Code 
drive_seatbelt 
0 
1 
2 
3 
Question 
How often have you been a passenger in the front seat of a car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
pass_front 
0 
1 
2 
3 
Question 
How often did you wear a seat belt when you were a passenger in the front seat? 
Never 
A few 
times 
Most of 
the 
time 
Always 
Code 
pass_seatbelt1 
0 
1 
2 
3 
 
How often have you been a passenger in the back seat of a car? 
Never 
A few 
times 
Most 
days 
Every 
day 
 
pass_back 
0 
1 
2 
3 
 
How often did you wear a seat belt when you were a passenger in the back seat? 
Never 
A few 
times 
Most of 
the 
time 
Always 
 
pass_seatbelt2 
0 
1 
2 
3 
Question 
How often did you type on your phone while you were driving and when the car was 
moving?  
Never 
A few 
times 
Most of 
the 
time 
Always 
Code 
distract 
0 
1 
2 
3 
Question 
Have you driven a vehicle within 3 hours after consuming 3 or more alcoholic drinks? 
No 
Yes 
Code 
drinks 
0 
1 
 
Thanks! Please hand the iPAD back to the Researcher. 
 
  
  
  
  
  
  
 
RA enters code: SAVE 
 
 
 
 
Program displays which risks+  
Script 
RA tells pt they are potentially eligible for study or thanks them for their time.  
 
 
If eligible pt interested, RA asks the following: 
 
 

 
SaVE Trial Protocol v.1.0 
Page 24 of 36 
Question 
Do you have a personal cell phone with text messaging ? 
No 
Yes 
Code 
sms 
0 
1 
Question 
Do you plan to drive and/or ride in a vehicle in the next month? 
No 
Yes 
Code 
future 
0 
1 
Question 
Do you plan to change phone numbers in the next 3 months? 
No 
Yes 
Code 
phone 
0 
1 
 
 
Logic 
If sms=0 or future=0 or phone=1, they are excluded.  
 
 
 
RA either thanks them for their time or starts informed consent. 
 
 
RA goes to WebDataXpress site 
 
 
  
 

 
SaVE Trial Protocol v.1.0 
Page 25 of 36 
Appendix: Baseline Questions 
  
Quest
ion Who do you live with? 
I live alone 
Friend(s), 
same sex 
Friend(
s), 
other 
sex 
Parents 
or 
family 
Code livew 
0 
1 
2 
3 
Quest
ion Are you currently employed? 
No 
Yes, part-
time 
Yes, 
full 
time 
 
 
Code emply 
0 
1 
2 
Quest
ion Check off all the reasons you have not used a seat belt 
Uncomfortab
le 
Forgot 
Don't 
think 
they 
help 
Like 
freedo
m 
Other 
I always 
wear 
my seat 
belt 
Code seatbelt_reasons 
0 
1 
2 
3 
4 
5 
Quest
ion If other, state reasons 
 
 
 
 
 
 
Code seatbelt_other 
 
 
 
 
 
 
Quest
ion How often do your friends use their seat belt? 
Never 
Rarely 
Most of 
the 
time 
Always 
 
 
Code 
 
0 
1 
2 
3 
 
 
Quest
ion How dangerous is it to not wear a seat belt? 
Not at all 
Somewhat 
Very 
Comple
tely 
 
 
Code danger_seatbelt 
0 
1 
2 
3 
 
 
Quest
ion 
How much do you agree: I have complete control over whether I wear a 
seat belt. 
Strongly 
Disagree 
Disagree 
Somew
hat 
Agree 
Mostly 
agree 
Strongly 
Agree 
 
Code control_sb 
0 
1 
2 
3 
4 
 
Quest
ion Check off all the reasons you have typed on your phone while driving? 
I could not 
wait 
I don’t think 
it affects my 
driving 
It was 
an 
emerge
ncy 
It is fun I get bored 
driving 
I do not 
use my 
phone 
while 
driving 
Code twd_reasons 
0 
1 
2 
3 
4 
5 
Quest
ion How often do your friends type on their phones while driving? 
Never 
Rarely 
Most of 
the 
time 
Always 
 
 
Code 
 
0 
1 
2 
3 
 
 
Quest
ion How dangerous is it to type on your phone while driving? 
Not at all 
Somewhat 
Very 
Comple
tely 
 
 
Code danger_twd 
0 
1 
2 
3 
 
 
Quest
ion 
How much do you agree: I have complete control over whether I type on 
my phone while driving. 
Strongly 
Disagree 
Disagree 
Somew
hat 
Agree 
Mostly 
agree 
Strongly 
Agree 
 
Code control_twd 
0 
1 
2 
3 
4 
 
Quest
ion Check off all the reasons you have driven a car after drinking alcohol? 
I had no 
other opiton 
I don’t think 
it affects my 
driving 
It's not 
a big 
deal 
I am 
careful 
It is fun 
I do not 
drive 
after 
dirnking 
alcohol 
Code dd_reasons 
0 
1 
2 
3 
4 
5 
Quest
ion How often do your friends drive after drinking alcohol? 
Never 
Rarely 
Most of 
the 
time 
Always 
 
 
Code friends_dd 
0 
1 
2 
3 
 
 
Quest
ion 
How dangerous is it to drive soon after drinking more 3 or more alcoholic 
drinks? 
Not at all 
Somewhat 
Very  Comple
tely 
 
 
Code danger_dd 
0 
1 
2 
3 
 
 

 
SaVE Trial Protocol v.1.0 
Page 26 of 36 
Quest
ion 
How much do you agree: I have complete control over whether I type on 
my phone while driving. 
Strongly 
Disagree 
Disagree 
Somew
hat 
Agree 
Mostly 
agree 
Strongly 
Agree 
 
Code control_dd 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
  
  
Quest
ion Answer the following questions about yourself. 
Strongly 
Disagree 
Disagree 
Somew
hat 
Agree 
Mostly 
agree 
Strongly 
Agree 
cat 
code S-UPPS 
0 
1 
2 
3 
4 
Questi
on 
When I feel bad, I will often do things I later regret in order to make myself 
feel better now. 
Questi
on 
Sometimes when I feel bad, I can’t seem to stop what I am doing even 
though it is making me feel worse. 
Questi
on 
When I am upset I often act without thinking. 
Questi
on 
When I feel rejected, I will often say things that I later regret. 
Questi
on 
I generally like to see things through to the end.  
Questi
on 
Unfinished tasks really bother me.  
Questi
on 
Once I get going on something I hate to stop.  
Questi
on 
I finish what I start. 
Questi
on 
My thinking is usually careful and purposeful. 
Questi
on 
I like to stop and think things over before I do them.  
Questi
on 
I tend to value and follow a rational, "sensible" approach to things.  
Questi
on 
I usually think carefully before doing anything.  
Questi
on 
I quite enjoy taking risks. 
Questi
on 
I welcome new and exciting experiences and sensations, even if they are 
a little frightening and unconventional. 
Questi
on 
I would like to learn to fly an airplane. 
Questi
on 
I would enjoy the sensation of skiing very fast down a high mountain 
slope. 
Questi
on 
When I am in great mood, I tend to get into situations that could cause me 
problems. 
Questi
on 
I tend to lose control when I am in a great mood. 
Questi
on 
Others are shocked or worried about the things I do when I am feeling 
very excited. 
Questi
on 
I tend to act without thinking when I am really excited. 
  
  
  
  
  
  
  
  
Questi
on 
How long have you been driving a car?  
Less than 6 
months 
6 months to 
1 year 
1-2 
years 
2-5 
years 
More than 5 
years 
never 
driven 
Code long_dr 
0 
1 
2 
3 
4 
5 
Questi
on 
How many times in the last 12 months have you received a traffic ticket? 
(Not including parking tickets) 
Code tix 
# 
Questi
on 
As a driver of a car, have you been in a crash in the past 12 months? 
Code crash 
# 
  
  
  
  
  
  
  
  
Questi
on 
How many days over the last month have you drank more than (3 drinks 
for women/ 4 drinks for men)? 
 
Code lmbinge 
# 

 
SaVE Trial Protocol v.1.0 
Page 27 of 36 
Questi
on 
How many days over the last month have you used cannabis (marijuana, 
pot, has, grass, etc)? 
 
Code lmbinge 
# 
Thanks, This ends your baseline survey. Please hand me back to the 
Researcher. 
  
 

 
SaVE Trial Protocol v.1.0 
Page 28 of 36 
Appendix: SMS Run-In: Seat belt 
 
Day & Time 
Incoming  
Outgoing 
Enrollment 
Hi [_NAME_]. Welcome to to the SaVE  Study 
For the next 2 weeks, each Sunday, we will ask you about your seat belt use in the past week 
If you complete at least 50% of the text queries, you will be eligible for the rest of the study 
Any 
response 
If at any time you wish to stop receiving texts, just text us "stop" 
  
  
  
Sunday, 4pm 
Hi [_NAME_], it's theSaVE Team checking in 
How often have you been a passenger or driver in a car the past week? 0=never; 1=a few times; 
2=most days; 3=every day 
2 hours 
[Missing] 
x1 
We missed your response.  Text us how often you have been a passenger or driver in a car the past 
week 
2 hours 
[Missing] 
x2 
You must be busy. We will check in next week 
 
[Nonsense
] 
We don't understand. Please text us a response option:  0=never; 1=a few times; 2=most days; 3=every 
day 
0 
OK 
1,2,3 
How often did you wear a seat belt? 0=never; 1=a few times; 2=most of the time; 3=every time 
1 hour 
[Missing] 
x1 
We missed your response.  Text us how often you wore a seatbelt 
1 hour 
[Missing] 
x2 
You must be busy. We will check in next week 
[Nonsense
] 
We don't understand. Please text us a response option:   0=never; 1=a few times; 2=most of the time; 
3=every time 
0,1,2,3 
Thanks 
  
  
  
Day 15 
(Monday) 
Due to your low response rate, you will be withdrawn from the SaVE Study 
For further information about seat belt safety, go to www.NHTSA.gov 
 
 
Appendix: SMS Run-In: Typing While Driving (TWD) 
 
 
Day & 
Time 
Incomin
g  
Outgoing 
Enrollment 
Hi [_NAME_]. Welcome to to the SaVE  Study 
For the next 2 weeks, each Sunday, we will ask you about your seatbelt use in the past week 
If you complete at least 50% of the text queries, you will be eligible for the rest of the study 
Any 
respons
e 
If at any time you wish to stop receiving texts, just text us "stop" 
  
  
  
Sunday, 
4pm 
Hi [_NAME_], it's theSaVE Team checking in 
How often have you driven a car the past week? 0=never; 1=a few times; 2=most days; 
3=every day 
2 hours 
[Missing
] x1 
We missed your response.  Text us how often you have been a passenger or driver in a car 
the past week? 
2 hours 
[Missing
] x2 
You must be busy. We will check in next week 
[Nonsen
se] 
We don't understand. Please text us a response option:  0=never; 1=a few times; 2=most 
days; 3=every day 
0 
OK.  

 
SaVE Trial Protocol v.1.0 
Page 29 of 36 
1,2,3 
When driving, how often did you type on your phone when the car was moving? 
0=never; 1=a few times; 2=most of the time; 3=every time 
1 hour 
[Missing
] x1 
We missed your response.  Text us how often you  typed on your phone when the car was 
moving 
1 hour 
[Missing
] x2 
You must be busy. We will check in next week 
[Nonsen
se] 
We don't understand. Please text us a response option:   0=never; 1=a few times; 2=most of 
the time; 3=every time 
0,1,2,3 
Thanks 
  
  
  
Day 15 
(Monday) 
Due to your low response rate, you will be withdrawn from the SaVE Study 
For further information about safe vehicle use, go to www.NHTSA.gov 
 
Appendix: SMS Run-In: Drink Driving 
 
Day & Time 
Incoming  
Outgoing 
Enrollment 
Hi [_NAME_]. Welcome to to the SaVE  Study 
For the next 2 weeks, each Sunday, we will ask you about your seatbelt use in the past 
week 
If you complete at least 50% of the text queries, you will be eligible for the rest of the 
study 
Any 
response 
If at any time you wish to stop receiving texts, just text us "stop" 
  
  
  
Sunday, 4pm 
Hi [_NAME_], it's theSaVE Team checking in 
How often have you driven a car the past week? 0=never; 1=a few times; 2=most 
days; 3=every day 
2 hours 
[Missing] 
x1 
We missed your response.  Text us how often you have been a passenger or driver in a 
car the past week? 
2 hours 
[Missing] 
x2 
You must be busy. We will check in next week 
[Nonsense
] 
We don't understand. Please text us a response option:  0=never; 1=a few times; 
2=most days; 3=every day 
0 
OK 
1,2,3 
Have you driven a vehicle within 3 hours after consuming 3 or more alcoholic 
drinks? 
1 hour 
[Missing] 
x1 
We missed your response.  Text us Yes or No. 
1 hour 
[Missing] 
x2 
You must be busy. We will check in next week 
[Nonsense
] 
We don't understand. Please text us either Yes or No 
No 
Thanks 
  
  
  
Day 15 
(Monday) 
Due to your low response rate, you will be withdrawn from the SaVE Study 
For further information about safe vehcile use, go to www.NHTSA.gov 
 
 

 
SaVE Trial Protocol v.1.0 
Page 30 of 36 
  
 
Appendix: SMS Interventions: Seat belt Safety 
Day & Time 
Incomin
g  
Outgoing 
Qualified Week 3, 
Monday, 5pm 
  
  
Qualified  
Congratulations [Name]! You have qualified to continue the SaVE Study 
 
For the next 6 weeks, we will help you set goals and provide you personalized feedback on 
your seat belt use 
 
We will check in next Sunday. Until then, take care 
Week 3-8: Sunday, 
3pm 
  
  
Hi [_NAME_], it's the SaVE Study Team checking in 
How often have you been a passenger or driver in a car the past week? 0=never; 1=a 
few times; 2=most days; 3=every day 
2 hours 
[Missing] 
x1 
We missed your response.  Text us how often you have been a passenger or driver in a car 
the past week? 
2 hours 
[Missing] 
x2 
You must be busy. We will check in next week 
[Nonsen
se] 
We don't understand. Please text us a response option:  0=never; 1=a few times; 2=most 
days; 3=every day 
0 
OK 
1,2,3 
When in the car, how often did you wear a seat belt? 0=never; 1=a few times; 2=most of 
the time; 3=every time 
1 hour 
[Missing] 
x1 
We missed your response.  Text us how often you wore a seat belt 
1 hour 
[Missing] 
x2 
You must be busy. We will check in next week 
[Nonsen
se] 
We don't understand. Please text us a response option:   0=never; 1=a few times; 2=most of 
the time; 3=every time 
If Goal Not Set 
3 
[Posiitve Reinforcement Message] 
  
0,1,2 
[Social Norms Message] 
If Goal Set 
Goal met 
[Goal Met Message] 
  
Goal not 
met 
[Goal Not Met Message] 
Would you be willing to commit to a goal to wear a seat belt every time this week? 
1 hour 
[Missing] 
x1 
We missed your response.  Text us whether you'd be willing to set a goal? 
1 hour 
[Missing] 
x2 
You must be busy. We will check in next week 
[Nonsen
se] 
We don't understand. Please text us either yes or no 
No Goal  
No 
[No Goal Roll Library Message] 
Goal + 
Yes 
[Goal Reinforcement  Message] 
Random 2 days per 
week, 4pm 
  
  
If goal - 
[Seat belt Safety Info Message] 
If goal + 
[Goal Reminder Message] 
 
 
 
 
 
 

 
SaVE Trial Protocol v.1.0 
Page 31 of 36 
Appendix: SMS Interventions: TWD Safety 
 
 
Day & Time 
Incomi
ng  
Outgoing 
Qualified Week 3, Monday, 
5pm 
  
  
Qualified [At least 1 Sunday 
Assessment complete] 
Congratulations [Name]! You have qualified to continue the SaVE Study 
 
For the next 6 weeks, we will help you set goals and provide you personalized feedback 
on your driving safety 
 
We will check in next Sunday. Until then, take care. 
Week 3-8: Sunday, 3pm 
  
  
Hi [_NAME_], it's the SaVE Study Team checking in. 
How often have you driven a car the past week? 0=never; 1=a few times; 2=most 
days; 3=every day 
2 hours 
[Missin
g] x1 
We missed your response.  Text us how often you have been a passenger or driver in a 
car the past week? 
2 hours 
[Missin
g] x2 
You must be busy. We will check in tomorrow. 
[Nonse
nse] 
We don't understand. Please text us a response option:  0=never; 1=a few times; 2=most 
days; 3=every day 
0 
OK.  
1,2,3 
When driving, how often did you type on your phone when the car was moving? 
0=never; 1=a few times; 2=most of the time; 3=every time 
1 hour 
[Missin
g] x1 
We missed your response.  Text us how often did you type on your phone while the car 
was moving 
1 hour 
[Missin
g] x2 
You must be busy. We will check in tomorrow. 
[Nonse
nse] 
We don't understand. Please text us a response option:   0=never; 1=a few times; 2=most 
of the time; 3=every time 
If Goal Not Set 
0 
[Posiitve Reinforcement Message] 
  
1,2,3 
[Social Norms Message] 
If Goal Set 
Goal 
met 
[Goal Met Message] 
  
Goal 
not met 
[Goal Not Met Message] 
Would you be willing to commit to a goal to refrain from typing on your phone 
while driving this week? 
1 hour 
[Missin
g] x1 
We missed your response.  Text us whether you'd be willing to set a goal? 
1 hour 
[Missin
g] x2 
You must be busy. We will check in later. 
[Nonse
nse] 
We don't understand. Please text us either yes or no 
No Goal  
No 
[No Goal Roll Library Message] 
Goal + 
Yes 
[Goal Reinforcement  Message] 
Random 2 days per week, 
4pm 
  
  
If goal - 
[Distracted Driving Info Message] 
If goal + 
[Goal Reminder Message] 
 
 
 

 
SaVE Trial Protocol v.1.0 
Page 32 of 36 
Appendix: SMS Interventions: Drink Driving Safety 
Incoming  
Outgoing 
  
  
Congratulations [Name]! You have qualified to continue the SaVE Study 
For the next 6 weeks, we will help you set goals and provide you personalized feedback on your driving safety 
We will check in next Sunday. Until then, take care 
  
  
Hi [_NAME_], it's the SaVE Study Team checking in 
How often have you driven a car the past week? 0=never; 1=a few times; 2=most days; 3=every day 
[Missing] x1 
We missed your response.  Text us how often you driven a car the past week? 
[Missing] x2 
You must be busy. We will check in tomorrow 
[Nonsense] 
We don't understand. Please text us a response option:  0=never; 1=a few times; 2=most days; 3=every day 
0 
OK 
1,2,3 
Have you driven a vehicle within 3 hours after consuming 3 or more alcoholic drinks? 
[Missing] x1 
We missed your response.  Text us whether you have driven within 3 hours of drinking 3 or more alcoholic beverages. 
[Missing] x2 
You must be busy. We will check in next week 
[Nonsense] 
We don't understand. Please text us Yes or No. 
No 
[Posiitve Reinforcement Message] 
Yes 
[Social Norms Message] 
Goal met 
[Goal Met Message] 
Goal not met 
[Goal Not Met Message] 
Would you be willing to commit to a goal to not drive after drinking this week? 
[Missing] x1 
We missed your response.  Text us whether you'd be willing to set a goal? 
[Missing] x2 
You must be busy. We will check in next week 
[Nonsense] 
We don't understand. Please text us either yes or no 
No 
[No Goal Roll Library Message] 
Yes 
[Goal Reinforcement  Message] 
  
  
[Drink Driving Info Message] 
[Goal Reminder Message] 
 
 

 
SaVE Trial Protocol v.1.0 
Page 33 of 36 
 
Appendix: 8-Week Assessment 
 
 
The following questions ask you to recall times you have 
been in a car over the past 2 weeks. 
 
 
 
 
  
  
  
Questi
on 
How often have you driven a car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
driver 
0 
1 
2 
3 
Questi
on 
How often did you wear a seat belt when you drove a car? 
Never 
A few 
times 
Most of 
the time 
Always 
Code 
drive_seatbelt 
0 
1 
2 
3 
Questi
on 
How often have you been a passenger in the front seat of a 
car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
pass_front 
0 
1 
2 
3 
Questi
on 
How often did you wear a seat belt when you were a 
passenger in the front seat? 
Never 
A few 
times 
Most of 
the time 
Always 
Code 
pass_seatbelt1 
0 
1 
2 
3 
Questi
on 
How often have you been a passenger in the back seat of a 
car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
pass_back 
0 
1 
2 
3 
Questi
on 
How often did you wear a seat belt when you were a 
passenger in the back seat? 
Never 
A few 
times 
Most of 
the time 
Always 
Code 
pass_seatbelt2 
0 
1 
2 
3 
Questi
on 
How often did you type on your phone while you were 
driving and when the car was moving?  
Never 
A few 
times 
Most of 
the time 
Always 
Code 
distract 
0 
1 
2 
3 
Questi
on 
What's the most number of alcoholic drinks you've had 
prior to driving on any occasion? 
# 
Code 
drinks 
# 
  
  
  
  
  
  
  
Questi
on 
Check off all the reasons you have not used a seat belt 
Uncomfort
able 
Forgot 
Don't 
think 
they 
help 
Like 
freedom 
Other 
I 
alway
s 
wear 
my 
seat 
belt 
 
Code 
seatbelt_reasons 
0 
1 
2 
3 
4 
5 
 
Questi
on 
If other, state reasons 
 
 
 
 
 
 
 
Code 
seatbelt_other 
 
 
 
 
 
 
 
Questi
on 
How often do your friends use their seat belt? 
Never 
Rarely 
Most of 
the time 
Always 
 
 
 
Code 
 
0 
1 
2 
3 
 
 
 
Questi
on 
How dangerous is it to not wear a seat belt? 
Not at all 
Somew
hat 
Very 
Comple
tely 
 
 
 
Code 
danger_seatbelt 
0 
1 
2 
3 
 
 
 
Questi
on 
How much do you agree: I have complete control over 
whether I wear a seat belt. 
Strongly 
Disagree 
Disagre
e 
Somew
hat 
Agree 
Mostly 
agree 
Stron
gly 
Agree 
 
 
Code 
control_sb 
0 
1 
2 
3 
4 
 
 
Questi
on 
Check off all the reasons you have typed on your phone 
while driving? 
I could not 
wait 
I don’t 
think it 
affects 
my 
driving 
It was 
an 
emerge
ncy 
It is fun 
I get 
bored 
drivin
g 
I do 
not 
use 
my 
phon
e 
while 
drivin
g 
I 
do 
not 
dri
ve 
Code 
twd_reasons 
0 
1 
2 
3 
4 
5 
6 
Questi
on 
How often do your friends type on their phones while 
driving? 
Never 
Rarely 
Most of 
the time 
Always 
 
 
 
Code 
 
0 
1 
2 
3 
 
 
 

 
SaVE Trial Protocol v.1.0 
Page 34 of 36 
Questi
on 
How dangerous is it to type on your phone while driving? 
Not at all 
Somew
hat 
Very 
Comple
tely 
 
 
 
Code 
danger_twd 
0 
1 
2 
3 
 
 
 
Questi
on 
How much do you agree: I have complete control over 
whether I type on my phone while driving. 
Strongly 
Disagree 
Disagre
e 
Somew
hat 
Agree 
Mostly 
agree 
Stron
gly 
Agree 
 
 
Code 
control_twd 
0 
1 
2 
3 
4 
 
 
Questi
on 
Check off all the reasons you have driven a car after 
drinking alcohol? 
I had no 
other 
opiton 
I don’t 
think it 
affects 
my 
driving 
It's not 
a big 
deal 
I am 
careful 
It is 
fun 
I do 
not 
drive 
after 
dirnki
ng 
alcoh
ol 
I 
do 
not 
dri
ve 
Code 
dd_reasons 
0 
1 
2 
3 
4 
5 
6 
Questi
on 
How often do your friends drive after drinking alcohol? 
Never 
Rarely 
Most of 
the time 
Always 
 
 
 
Code 
friends_dd 
0 
1 
2 
3 
 
 
 
Questi
on 
How dangerous is it to drive soon after drinking more 3 or 
more alcoholic drinks? 
Not at all 
Somew
hat 
Very  
Comple
tely 
 
 
 
Code 
danger_dd 
0 
1 
2 
3 
 
 
 
Questi
on 
How much do you agree: I have complete control over 
whether I type on my phone while driving. 
Strongly 
Disagree 
Disagre
e 
Somew
hat 
Agree 
Mostly 
agree 
Stron
gly 
Agree 
 
 
Code 
control_dd 
0 
1 
2 
3 
4 
 
 
  
  
  
  
  
  
  
 
 
 
Questi
on 
Did you find the text message  program helpful?  
Not at all 
Somew
hat 
Very 
much 
 
Code 
helpful 
0 
1 
2 
 
Questi
on 
Would you recommend the program to others?  
No  
Yes 
Code 
recom 
0 
1 
Questi
on 
Any other comments you'd like to provide that could help 
us make the text message program better? 
Code 
comments 
 
 
Appendix: 14-Week Assessment 
 
 
The following questions ask you to recall times you have 
been in a car over the past 2 weeks. 
 
 
 
 
  
  
  
Questi
on 
How often have you driven a car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
driver 
0 
1 
2 
3 
Questi
on 
How often did you wear a seat belt when you drove a car? 
Never 
A few 
times 
Most of 
the time 
Always 
Code 
drive_seatbelt 
0 
1 
2 
3 
Questi
on 
How often have you been a passenger in the front seat of a 
car? 
Never 
A few 
times 
Most 
days 
Every 
day 
Code 
pass_front 
0 
1 
2 
3 
Questi
on 
How often did you wear a seat belt when you were a 
passenger in the front seat? 
Never 
A few 
times 
Most of 
the time 
Always 
Code 
pass_seatbelt1 
0 
1 
2 
3 
 
How often have you been a passenger in the back seat of a 
car? 
Never 
A few 
times 
Most 
days 
Every 
day 
 
pass_back 
0 
1 
2 
3 
 
 
 
 
How often did you wear a seat belt when you were a 
passenger in the back seat? 
Never 
A few 
times 
Most of 
the time 
Always 
 
pass_seatbelt2 
0 
1 
2 
3 

 
SaVE Trial Protocol v.1.0 
Page 35 of 36 
Questi
on 
How often did you type on your phone while you were 
driving and when the car was moving?  
Never 
A few 
times 
Most of 
the time 
Always 
Code 
distract 
0 
1 
2 
3 
Questi
on 
What's the most number of alcoholic drinks you've had 
prior to driving on any occasion? 
# 
Code 
drinks 
# 
  
  
  
  
  
  
  
Questi
on 
Check off all the reasons you have not used a seat belt 
Uncomfort
able 
Forgot 
Don't 
think 
they 
help 
Like 
freedom 
Other 
I 
alway
s 
wear 
my 
seat 
belt 
 
Code 
seatbelt_reasons 
0 
1 
2 
3 
4 
5 
 
Questi
on 
If other, state reasons 
 
 
 
 
 
 
 
Code 
seatbelt_other 
 
 
 
 
 
 
 
Questi
on 
How often do your friends use their seat belt? 
Never 
Rarely 
Most of 
the time 
Always 
 
 
 
Code 
 
0 
1 
2 
3 
 
 
 
Questi
on 
How dangerous is it to not wear a seat belt? 
Not at all 
Somew
hat 
Very 
Comple
tely 
 
 
 
Code 
danger_seatbelt 
0 
1 
2 
3 
 
 
 
Questi
on 
How much do you agree: I have complete control over 
whether I wear a seat belt. 
Strongly 
Disagree 
Disagre
e 
Somew
hat 
Agree 
Mostly 
agree 
Stron
gly 
Agree 
 
 
Code 
control_sb 
0 
1 
2 
3 
4 
 
 
Questi
on 
Check off all the reasons you have typed on your phone 
while driving? 
I could not 
wait 
I don’t 
think it 
affects 
my 
driving 
It was 
an 
emerge
ncy 
It is fun 
I get 
bored 
drivin
g 
I do 
not 
use 
my 
phon
e 
while 
drivin
g 
I 
do 
not 
dri
ve 
Code 
twd_reasons 
0 
1 
2 
3 
4 
5 
6 
Questi
on 
How often do your friends type on their phones while 
driving? 
Never 
Rarely 
Most of 
the time 
Always 
 
 
 
Code 
 
0 
1 
2 
3 
 
 
 
Questi
on 
How dangerous is it to type on your phone while driving? 
Not at all 
Somew
hat 
Very 
Comple
tely 
 
 
 
Code 
danger_twd 
0 
1 
2 
3 
 
 
 
Questi
on 
How much do you agree: I have complete control over 
whether I type on my phone while driving. 
Strongly 
Disagree 
Disagre
e 
Somew
hat 
Agree 
Mostly 
agree 
Stron
gly 
Agree 
 
 
Code 
control_twd 
0 
1 
2 
3 
4 
 
 
Questi
on 
Check off all the reasons you have driven a car after 
drinking alcohol? 
I had no 
other 
opiton 
I don’t 
think it 
affects 
my 
driving 
It's not 
a big 
deal 
I am 
careful 
It is 
fun 
I do 
not 
drive 
after 
dirnki
ng 
alcoh
ol 
I 
do 
not 
dri
ve 
Code 
dd_reasons 
0 
1 
2 
3 
4 
5 
6 
Questi
on 
How often do your friends drive after drinking alcohol? 
Never 
Rarely 
Most of 
the time 
Always 
 
 
 
Code 
friends_dd 
0 
1 
2 
3 
 
 
 
Questi
on 
How dangerous is it to drive soon after drinking more 3 or 
more alcoholic drinks? 
Not at all 
Somew
hat 
Very  
Comple
tely 
 
 
 
Code 
danger_dd 
0 
1 
2 
3 
 
 
 
Questi
on 
How much do you agree: I have complete control over 
whether I type on my phone while driving. 
Strongly 
Disagree 
Disagre
e 
Somew
hat 
Agree 
Mostly 
agree 
Stron
gly 
Agree 
 
 
Code 
control_dd 
0 
1 
2 
3 
4 
 
 

 
SaVE Trial Protocol v.1.0 
Page 36 of 36