Clinical trial NCT03538431
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder ASD Anxiety
Sponsor: Massachusetts General Hospital
Start date: 2018-10-31; Completion date: 2019-12-16
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD).

The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two Driving Simulation visits that will take place at Massachusetts Institute of Technology (MIT). Subjects will be given buspirone and asked to take the medication for the two days preceding the Driving Simulation Visit.

Detailed description:

Arms: arm 1: These subjects will receive buspirone prior to engaging in the driving simulation. arm 2: These subjects will take no medication prior to engaging in the driving simulation
Interventions: intervention 1: Buspirone
Intervention descriptions: intervention 1: Buspirone is an atypical anxiolytic medication.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
 
 
 
 
 
 
 
 
 
Improving Driving in Adults with Autism Spectrum Disorders 
NCT03538431 
5/3/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Improving Driving in Adults with Autism Spectrum Disorders  
PI: Joseph Biederman, MD  
 
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I. 
BACKGROUND AND SIGNIFICANCE  
 
Autism Spectrum Disorder (ASD) is a common, childhood-onset, lifelong neurodevelopmental 
disorder characterized by persistent deficits in social communication and social interaction as 
well as restricted interests and activities (American Psychiatric Association, DSM 5)1. 
Individuals with ASD frequently struggle with cognitive inflexibility and non-verbal learning 
disability (NVLD), which can compound the clinical picture. It is estimated that up to 1% of 
children are affected with ASD and more than half of them have adequate cognitive and 
language abilities (hence “high functioning” [HF]) Such HF-ASD individuals can more 
successfully participate in educational programs and achieve adequate educational skills that 
could facilitate them joining the workforce and attain independence 2. Although a key factor 
towards attaining independence is the ability to drive 3, recent estimates indicate that only one-
third of individuals with HF-ASD drive 4, a much lower rate that non-affected youth. This 
finding suggests that driving may pose unique challenges to individuals with HF-ASD. 
 
Although the reasons for driving challenges in individuals with HF-ASD remain unclear, 
findings from a recent pilot driving simulation study 5 in HF-ASD drivers suggested that anxiety 
could be an important contributor. In that study, during the driving simulation, drivers with HF-
ASD manifested significantly abnormalities in gaze directionality relative to controls as well as 
elevated heart rates and abnormal skin conductance relative to controls. Because these 
physiological correlates are well-known proxies for hyperarousal and anxiety, these findings 
raise the possibility that driving induces hyperarousal and anxiety in this population that could 
lead to the abnormalities in atypical eye tracking behaviors observed. These findings raise the 
possibility that if driving induced anxiety could be mitigated, it could improve driving 
performance of HF–ASD individuals. 
 
One such intervention is the atypical anxiolytic medicine busporine. Unlike other anxiolytics, 
the pharmacology of buspirone is not related to that of benzodiazepines, barbituates or 
carbamates (it is not a GABA receptor agonist) and so buspirone does not carry abuse potential 
risk for which other anxiolytics are known. As such, buspirone is not considered to be a drug-of-
abuse and is unscheduled. Buspirone is rapidly acting and non-sedating. It is also a very safe 
medicine with a benign adverse effect profile, no meaningful drug-drug interactions, and lacks 
withdrawal reactions. Because of its short duration of action, it can be used on as needed basis 
making it an ideal and safe compound to target driving-induced anxiety in HF-ASD individuals. 
The main aim of the current study is to test the hypothesis that pharmacological pre-treatment (2 
days before and during the simulation) of adult drivers with HF-ASD with low doses of 
buspirone (5.0 mg BID) will be associated with reduction in hyperarousal as measured by 
elevated heart rates and abnormal skin conductance, and improvement in driving performance in 
a simulator as measured by eye tracking deviations. To this end, we propose to conduct a 
randomized cross-over trial of treatment with buspirone for 2 days before and during the 
simulation in 24 HF-ASD subjects using an AB-BA design. 
. 
 
II. 
SPECIFIC AIMS  


Improving Driving in Adults with Autism Spectrum Disorders  
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Main Aim: To examine the effects of treatment with the anti-anxiety medicine buspirone on 
driving performance (eye tracking) in individuals with HF-ASD.  
 
Hypothesis: We hypothesize that, compared to the untreated performance, treatment with 
buspirone will improve 1) physiologically measured hyperarousal (through heart rate and skin 
conductance) and 2) driving performance (eye tracking deviations) while performing a simulated 
driving task in a driving simulator. 
 
 
III. 
SUBJECT ENROLLMENT  
 
We propose to enroll 24 adult drivers with HF-ASD. Subjects will be males and females, ages 
18-45, with a diagnosis of DSM-V Autism Spectrum Disorder. Potential subjects will be 
recruited from advertising in the local media (newspapers, radio, etc.), MBTA advertisements, 
flyers posted in the local community and on college campuses, and through the MGH 
recruitment website, Rally. Potential subjects may also be recruited from local associations that 
provide programming for individuals with HF-Autism Spectrum Disorder (e.g. AANE, Aspire) 
or through outpatient clinics at MGH that service individuals with HF-ASD. If a potential subject 
expresses interest to participate in the study via email, the coordinator will reply and instruct the 
subject to review the Partner’s required language surrounding encrypted and unencrypted emails 
and will verify their preference prior to proceeding with email communication. 
 
A brief phone screen will be completed with subjects who are interested in participating in the 
study by a member of study staff. The phone screen asks some questions regarding medical and 
psychiatric history. If the subject is eligible after the screen, a member of study staff will 
schedule a time for them to come into the office.    
 
Informed consent will be obtained by a licensed physician investigator prior to the performance 
of any study procedures. The informed consent will be used to explain, in simple terms, the risks 
and benefits of study participation to the subject. The subjects may take as much time as they 
feel necessary to consider their participation in the study, as well as consult with their family 
members or a physician.  
 
Inclusion Criteria:  
• Males and females, ages 18-45, with a diagnosis of DSM-V Autism Spectrum Disorder  
• Has a valid Driver’s License or a current state-issued driving permit who are actively 
driving, as deemed appropriate by the investigator 
 
Exclusion Criteria:  
• Major sensorimotor handicaps (e.g. deafness, blindness) 
• Individuals who have never held a valid driver’s license or a current state-issued driving 
permit 
• Intellectual Deficiency (Verbal Comprehension Index < 80) 
• Inadequate command of the English language 


Improving Driving in Adults with Autism Spectrum Disorders  
PI: Joseph Biederman, MD  
 
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• Subjects with any clinically meaningful medical or psychiatric condition as determined 
by the investigator 
• Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any 
reason 
• Pregnant  
 
 
IV. 
STUDY PROCEDURES  
 
Completion of this study will be dependent on the availability of the participant and includes a 
clinical assessment visit at Massachusetts General Hospital and two driving simulation visits 
(approximately 1.5 hours each) at Massachusetts Institute of Technology.  
 
Assessment Visit  
 
Before any study procedures are initiated, subjects will provide informed consent. The informed 
consent documents will be used to explain in simple terms the risks and benefits of study 
participation. The nature of the study will be fully explained to the subject by a board-certified 
physician who is either the primary investigator or a co-investigator. The subject will be 
encouraged to ask questions pertaining to their participation in the study, and the subject may 
take as much time as they feel necessary to consider their participation in the study. Participation 
in this study is voluntary, and the subject may withdraw at any time for any reason. The IRB-
approved informed consent documents will be signed and dated by the subject and the physician 
obtaining consent.  
 
After providing informed consent, if a subject has been previously diagnosed with a DSM 
Autism Spectrum Disorder by a licensed psychiatrist and documentation of that diagnosis is 
available then the K-SADS direct and indirect interviews will be bypassed. Otherwise, all 
subjects will be interviewed by a licensed physician or psychologist to confirm the DSM-V 
diagnosis of Autism Spectrum Disorder. The interview will use the questions and probes from 
the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-PL) model on ASD. 
Because the K-SADS-PL was designed for use in clinical and epidemiological research to obtain 
past and current history of psychiatric disorders in children and adolescents aged 6 to 17, it will 
be adapted to be used as a direct interview with adults with suspected ASD. Whenever the direct 
assessment for the diagnosis of ASD with the subject is unclear, if possible and feasible, an 
additional indirect interview will be conducted with a parent as informant. The subject must 
grant permission for the research team to contact a parent for the indirect interview. If they agree, 
the parent will be contacted via telephone. Interviews can be done in person, via telephone, or 
via telemedicine through the MGH secure site based on subject preference. The subject’s 
responses will be recorded on paper and entered in RedCap by the clinician or a member of study 
staff. If both a direct and indirect interview are completed for a participant the we will combine 
data by considering a diagnostic criterion positive if it was endorsed in either interview. 
 
Subjects will also be asked to complete the Adult Self Report (ASR), a 126-item self-report 
questionnaire that assesses aspects of adaptive functioning and problems, and asks individuals to 
rate items on a 3-point scale (0-Not True, 1-Somewhat or Sometimes True, 2-Very True or Often 


Improving Driving in Adults with Autism Spectrum Disorders  
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True). Subjects will have a choice to complete this instruments remotely through a RedCap 
secured link or in person. RedCap is a platform for electronic data capture that streamlines data 
collection and management, and ensures data integrity, resulting in improved data quality. If 
RedCap is unavailable for use, the subject will complete the ASR on paper and it will later be 
entered into RedCap by a member of study staff.  
 
In addition, we may ask a parent, guardian, or third-party informant to complete the Adult 
Behavior Checklist (ABCL). The ABCL is an informant version of the ASR that assesses similar 
aspects of adaptive functioning and problems, and asks informants to rate items on a 3-point 
scale (0- Not True, 1- Somewhat or Sometimes True, 2- Very True or Often True). If this is the 
case, the subject must grant permission for the research team to contact a parent, guardian, or 
third-party informant for the completion of this questionnaire. If the participant agrees, this 
instrument will be provided to the informant through a Redcap secured link or in person. If 
RedCap is unavailable for use, the informant will complete the ABCL on paper and the data will 
be entered into RedCap by a member of the study staff.  This questionnaire will either be used 
instead of the ASR or to supplement the provided answers on the ASR. 
 
Each subject will be compensated $90.00 in the form of a check for completing the MGH 
Assessment Visit.  
 
Driving Simulation Visits  
 
Previous work between MGH and MIT utilized the simulator that will be used in this study 6,7. 
After completion of the Assessment Visit, the subject will schedule the two driving simulation 
visits at Massachusetts Institute of Technology during this time they will be given or emailed an 
information sheet regarding what the MIT driving simulation visit will entail. Each driving 
simulation visit will be approximately 1.5 hours long. At the first driving simulation visit, 
subjects will be asked to review and sign the MIT consent form before proceeding. 
 
Half of eligible and consenting subjects (A-B group) will be tested on the driving first on 
medication while the other half (B-A group) will be tested first unmedicated based on a 
randomization list. The subjects will be instructed to take 5.0 mg of buspirone with breakfast and 
5.0mg of buspirone with dinner for 2 days before their driving simulation. On the day of the 
simulation, they will be instructed to take the dose 1 hour before the simulation. A member of 
study staff will remind the subjects via phone call and/or email to take their medication on the 
two days preceding their driving simulation, and remind them of the specific times at which they 
should take the medication.  
 
If a subject is assigned to the A-B group per the randomization list, they will receive the 
buspirone at the completion of their assessment visit at MGH. A member of study staff will 
remind the subject that they should not take the medication until 2 days before the driving 
simulation. Written instructions will also be provided explaining the dates and times when the 
medication should be taken. If the individual is currently taking buspirone they will be instructed 
to take the busiprone, as prescribed, prior to their first simulation visit. However, prior to their 
second simulation visit with MIT they will be asked to withhold their medication starting 24 
hours prior to their second visit.  


Improving Driving in Adults with Autism Spectrum Disorders  
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The other half of the eligible and consenting subjects (B-A group), per the randomization list, 
will take the buspirone the two days preceding their second driving simulation, and on the day of 
their second driving simulation at MIT. On the day of their first scheduled driving simulation 
visit at MIT, a member of study staff from MGH will meet the subject at MIT. After the first 
driving simulation is complete, the member of study staff will provide the subject with the 
buspirone, and instruct the subject that he/she should take the medication for two days preceding 
their second scheduled driving visit, and the day of their second scheduled driving visit. The 
member of study staff will also provide the subject with written instructions of the dates and 
times when the medication should be taken, and send a reminder to the subject via phone call or 
email. If the individual is currently taking buspirone, they will be instructed to withhold their 
medication starting 24 hours prior to their first visit and then take the buspirone, as prescribed, 
prior to their second visit. If the member of study staff from MGH is unable to attend the 
subject’s first driving simulation visit at MIT, the prescription of buspirone will be picked up 
from the Clinical Trials Pharmacy, and the research coordinator will package the medication. 
The medication will be shipped to the subject using UPS. The subject will be notified on which 
day they should expect to receive the medication, and that they will need to sign for the delivery. 
The package will include dosing instructions for the medication and will indicate which dates the 
medication should be taken based on when their driving simulation visit at MIT is scheduled. 
 
MIT AgeLab driving simulation experiments are conducted in a high fidelity driving simulator 
designed and fabricated by RTI (Realtime Technologies Inc., Ann Arbor, MI), running the 
SimCreator and SimVista software packages. The simulator consists of the full cab of a 
2001Volkswagen New Beetle. Three exterior screens provide a 180-degree simulated forward 
and partial side field of view of a virtual roadway and associated environment. A rear projector 
screen behind the car displays the rear roadway, which is viewable using the vehicle’s standard 
rearview mirror. Two LCD displays placed in the cab’s side mirrors present images of the rear 
roadway in a perspective corresponding to what actual side mirrors provide. Images of the 
roadway are displayed at 60 frames per second. The steering wheel, accelerator, and brake pedals 
all provide force feedback to the subjects. Internal and external speakers produce simulated 
vehicle and environmental sound during the experiment. The cab is instrumented with three 
cameras and one microphone to record the environment in the cab. One camera is focused on the 
driver’s face to capture head and eye movements, one is positioned to recorded hand movements 
and interactions with steering wheel and center stack, and the final camera is positioned to record 
the forward screen to validate video and simulator data synchronization. The simulator is also 
instrumented with the capacity to record from a wide variety of physiological sensors using 
medical grade instrumentation (FDA 510(k) reviewed class II) (NeuroDyne Medical Corp., 
model MEDAC System/3) to monitor changes in a subject’s internal state (sensors to be used are 
detailed below) associated with the environmental stimulation of the virtual roadway and the 
driving task. 
 
Upon reporting to the driving simulation lab, subjects will be asked to complete questionnaires. 
Sensors for monitoring heart rate (via ECG) and skin conductance will then be attached. For the 
ECG sensors, the skin will be cleaned with isopropyl alcohol and disposable electrodes (Vermed 
A10005) applied in a modified lead II configuration with the negative lead immediately under 
the right clavicle, the common immediately under the left clavicle, and the positive lead over the 


Improving Driving in Adults with Autism Spectrum Disorders  
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lowest left rib. This placement has been found minimize movement artifact induced by 
fundamental vehicle control (i.e. steering) while also involving minimal intrusiveness during 
placement. Skin conductance is measured using a constant current configuration and non-
polarizing, low-impedance gold-plated electrodes. The skin conductance electrodes will be 
placed on the underside of outer segments of the ring and middle finger of the left hand. Data 
sampling is carried out at a rate of 250 Hz to provide sufficient resolution for detecting the ECG 
R-wave to calculate heart rate. Where appropriate, statistical computations for physiological data 
will be completed based upon transforms designed to control for individual variability. Eye 
glance behavior will be coded from the in-cab video recordings and reduced to numeric values 
prior to further analysis. Source data will be labeled with subject identification numbers and 
maintained on password access controlled computers. 
 
At each of the driving simulation visits, subjects will complete some questionnaires. The pre -
experiment questionnaire includes the Beck Anxiety Inventory (BAI), which is a 21-item self-
report inventory that is used for measuring the severity of anxiety in children and adults. Each 
question on the BAI is scored on a scale value of 0 (not at all) to 3 (severely), and higher total 
scores indicate more severe anxiety symptoms. Also included in the pre-experiment 
questionnaire is a standard MIT short questionnaire that includes basic demographics, driving 
history information, a state anxiety checklist, and a sleep-awake scale.  
 
For the actual driving simulation, subjects will be seated in the driving simulator and introduced 
to interacting with the simulation environment through a brief adaptation drive of approximately 
10 minutes. This training drive will begin under low speed and with no oncoming traffic. The 
speed limit will be gradually increased along with increased visual complexity of the roadway 
and density of on-coming traffic. This gradual increase in visual complexity follows guidelines 
designed to reduce the likelihood of simulator sickness. This period is also intended to allow 
subjects the opportunity to become accustomed to the mechanisms of the simulator and to reduce 
the novelty of driving the simulator8. 
 
Following the adaptation period, subjects will be asked to “stop” the vehicle. A staff member 
will check with the subject to see if they are comfortable to proceed with the study. Upon accent 
to continue, the general characteristics of the primary drive will be explained and any questions 
that the subject has will be answered. The driving protocol will include periods of both high and 
low task stimulation. If the subject follows typical travel behavior based upon posted speed 
limits and surrounding traffic flow, the duration of the primary drive should run for 
approximately 45 minutes. As described previously, the primary dependent measures collected 
during the simulated drive will focus on driving performance related eye glance / scanning 
behavior and physiological measures indicative of relative arousal levels (heart rate and skin 
conductance). Other driving performance metrics related to variables such as speed control and 
lane discipline maintenance will be collected as secondary measures. 
 
After the simulation, subjects will complete the post-experiment questionnaire, which includes 
the short state anxiety scale and questions about the subject’s experience in the simulator. 
Subjects will also complete the Kennedy Simulator Sickness Questionnaire9, which is a 16-item 
questionnaire to assess the extent to which simulator sickness may have been experienced. Each 
experience is rated on a scale of 1 (None) to 4 (Severe).  


Improving Driving in Adults with Autism Spectrum Disorders  
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Subjects will be compensated by MIT $60 at the completion of each of the two driving 
simulation visits ($120 total) for the MIT portion of the study. 
 
During study participation, if an individual expresses spontaneous suicidality or endorses 
suicidality through any study questionnaires or procedures, the principal investigator of the study 
will be contacted immediately via phone or page to assess the risk of the current situation and 
recommend a suggested plan of action to assist the current participant. The participant may be 
referred to the emergency department for immediate evaluation upon recommendation of the 
principal investigator. 
 
The Institutional Review Board at Massachusetts Institute of Technology will review the driving 
simulation protocol. No study procedures will be performed until IRB approval is granted from 
both institutions, and the MIT IRB approval letter is submitted the PHRC for approval.  
 
 
V. 
BIOSTATISTICAL ANALYSIS  
 
Our tests of hypotheses will rely heavily on random regression models (RRM) [also known as 
the hierarchical linear model and random (or mixed) effects model]. This approach has several 
advantages over traditional methods such as repeated measures ANOVA or MANOVA. We will 
estimate our RRMs using the generalized estimating equation (GEE) framework. Canonical links 
will be used to correctly model the distribution of dependent variables. For binary outcomes, 
logistic regression models will be fit with the binomial family and the logit link. For count data, 
Poisson regression models will be fit with the Poisson family and the log link, and for normally 
distributed data, linear regression models will be fit with the Gaussian distribution and identity 
link. Working covariance structures will be specified with Huber-White robust estimators of 
variance to account for repeated measures of each subject. 
 
 
VI. 
RISKS AND DISCOMFORTS  
 
Participants will be told that they can stop study participation at any time for any reason. Study 
information and all other personal and identifying information will be kept on a password-
protected computer within the secure Partners firewall. All research-related records initiated as a 
result of a subject’s participation in this study that reveal the subject’s identity will remain 
confidential except as may be required by law. Data obtained from this study will not identify the 
subjects individually. Subjects will be assigned ID numbers, and data obtained may be published, 
but published data will not identify individual participants.  
 
Risks of taking buspirone 
Buspirone can cause one or more of the side effects listed below:  
Common side effects (experienced by 2 to 12 out of every 100 subjects in previous  
studies):  
• nausea and vomiting  
• headache 


Improving Driving in Adults with Autism Spectrum Disorders  
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• dizziness  
• drowsiness  
• fatigue  
• weakness  
• numbness  
• difficulty sleeping 
• depression  
• excitement 
 
Less common side effects (experienced by 1 out of 100 subjects):  
• Skin rash  
• itching  
• fast or irregular heartbeat  
• blurred vision 
• unusual movements of the head or neck muscles 
 
Pregnancy  
The effects of buspirone to an embryo or fetus are unknown and may be harmful. Therefore, 
individuals who are pregnant cannot take part in the study. The research coordinator will 
complete the pregnancy screening form with women of childbearing age. During the assessment 
visit, if the subject is a menstruating female, the pregnancy screening form will be completed by 
a member of study staff. She will be asked if she is pregnant or if there is any possibility that she 
may be pregnant, if she is experiencing a late menstrual period, the date of her last menstrual 
period, and about any contraceptive use. If she confirms that she is not pregnant and there is no 
possibility that she may be pregnant during screening, we will proceed. If there is a possibility 
that she is pregnant, a urine pregnancy test will be performed. If the test is negative, we will 
proceed.   
 
Some subjects may feel uncomfortable when asked to answer detailed questions. Subjects may 
refuse to answer any of these questions. During the driving simulation, there is a chance that 
subjects may experience simulator sickness that is similar to motion sickness. Subjects may 
choose to stop their participation at any time.   
 
The Principal Investigator will be available 24 hours per day via pager to respond to all reports 
of adverse events, including those that emerge outside of regularly scheduled visits. Adverse 
events and unanticipated problems will be reported to the PHRC according to current guidelines. 
We will follow and adhere to all guidelines as defined and outlined on the Partners Human 
Research Committee website: http://healthcare.partners.org/phsirb/adverse_events.htm. 
 
 
VII. 
POTENTIAL BENEFITS 
 
There may be no direct benefit to subjects participating in this study. Potential benefits to the 
participants include education about ASD, a trial of medication that could be continued after the 
study, and the opportunity to contribute to medical science and thus help others with ASD. 
 


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VIII. MONITORING AND QUALITY ASSURANCE  
 
The principal investigator will be responsible for monitoring and ensuring the integrity of the 
data and adherence to the IRB-approved protocol. He will review any questions or concerns 
regarding data collected. Each staff member will undergo focused training on each task for 
which they are responsible and will perform quality control for others similarly engaged.  
 
The study clinicians, research coordinator, and Principal Investigator will monitor study progress 
including enrollment, adherence to inclusion/exclusion criteria and study protocol, as well as any 
adverse events. The Principal Investigator will be responsible for ensuring that adverse events 
are reported to the Partners Human Research Committee in compliance with requirements. Any 
changes to the protocol will be made in accordance with local IRB policies. 
 
Any paper material, including the names of subjects or other identifying information (e.g., 
consent forms and check requests) will be locked up and will be accessible only by study staff. 
Digital material including the names of subjects or other identifying information (e.g., subject 
tracking logs) will be kept in password-protected files on protected servers accessible only to 
departmental staff. All study materials, such as rating scales and neuroimaging data, will be 
labeled with ID numbers only and will not include identifying information. 
 
Data for all scales collected at the MGH will be entered in RedCap, a platform for electronic data 
capture that streamlines data collection and management, and ensures data integrity, resulting in 
improved data quality.  
 
 
IX. 
REFERENCES   
 
1. 
Association AP. DSM-5: The Future of Psychiatric Diagnosis. 2010; 
http://www.dsm5.org/Pages/Default.aspx. 
2. 
Carpenter LA, Soorya L, Halpern D. Asperger's syndrome and high-functioning autism. 
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3. 
Tantam D. The challenge of adolescents and adults with Asperger syndrome. Child 
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4. 
Curry AE, Yerys BE, Huang P, Metzger KB. Longitudinal study of driver licensing rates 
among adolescents and young adults with autism spectrum disorder. Autism. 
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5. 
Reimer B, Fried R, Mehler B, et al. Brief Report: Examining Driving Behavior in Young 
Adults with High Functioning Autism Spectrum Disorders: A Pilot Study Using a 
Driving Simulation Paradigm. J Autism Dev Disord. 2013. 
6. 
Biederman J, Fried R, Monuteaux MC, et al. A laboratory driving simulation for 
assessment of driving behavior in adults with ADHD: a controlled study. Ann Gen 
Psychiatry. 2007;6:4. 
7. 
Biederman J, Fried R, Hammerness P, et al. The effects of lisdexamfetamine dimesylate 
on the driving performance of young adults with ADHD: A randomized, double-blind, 


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placebo-controlled study using a validated driving simulator paradigm. J Psychiatr Res. 
2012;46(4):484-491. 
8.  
Stoner, H. A., Fisher, D. L., & Mollenhauer, M. A. (2011). Simulator and Scenario 
 
Factors Influencing Simulator Sickness. In D. L. Fisher, J. Caird, & J. D. Lee (Eds.), 
 
Handbook of driving simulation for engineering, medicine, and psychology (pp. 14.11–
 
14.20). Boca Raton, FL: CRC Press. 
9.  
Kennedy, R.S., A simulator sickness questionnaire (SSQ): A new method for quantifying 
 
simulator sickness. International Journal of Aviation Psychology, 1993. 3(3): p. 203-220.