Autism Spectrum DisorderNCT01263756
Autism Spectrum Disorders (ASD) Driving Study
An observational study of Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.
Who may be able to join
- Male and female patients, aged 16-50 years
- Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD
Who cannot join
- Major sensorimotor handicaps (e.g. deafness, blindness)
- Inadequate command of the English language
- Individuals who have never held a valid driver's license
- Mental retardation (IQ < 80)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: A Study of the Driving Performance of Individuals With Autism Spectrum Disorders
The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.
- Conditions
- Autism Spectrum Disorder
- Keywords
- Driving, Autism Spectrum Disorders, ASD, Attention Deficits, Adults, Adolescents, Pervasive Developmental Disorders
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD group | Adolescents and adults with Autism Spectrum Disorders (ASDs). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated driving performance of adolescents and adults with ASDs.
Data will be obtained on velocity, collision risk, and visual attention of subjects with ASDs who drive in the driving simulator at the Massachusetts Institute of Technology (MIT).
Measured: one-time observation (3 hour assessment)
Secondary outcomes (1)
Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.
Subjects with ASD will complete two questionnaires, the Driver Behavior Questionnaire and the Driving History Questionnaire, to provide data on the frequency of violations, errors, accidents, and other aspects of driving history and behavior.
Measured: one-time assessment (2-6 hour screening visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Joseph Biederman, MD, Massachusetts General Hospital
- Investigators
- Joseph Biederman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263756
- Sponsor's protocol ID
- 2010-P-000173
- Status last verified
- Dec 2011
- First submitted
- 29 Nov 2010
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Driving Performance of Individuals With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01263756
- Acronym / sponsor ID
- 2010-P-000173
- Conditions
- Autism Spectrum Disorder
- Keywords
- Driving, Autism Spectrum Disorders, ASD, Attention Deficits, Adults, Adolescents, Pervasive Developmental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed pilot study will begin to assess whether driving impairments are included in the functional deficits associated with Autism Spectrum Disorders (ASDs). This will be completed by obtaining data on velocity, collision risk, and visual attention of subjects with ASDs who drive in a simulator. The study includes 2-3 visits for the screening period (approximately 6 hours of assessments) and one driving simulation visit (approximately 2.5 hours). The investigators expect to enroll 20 adolescents and adults (ages 16-50, inclusive) who have been identified as having an ASD from a prior diagnosis or participation in community conferences for individuals with ASDs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | –Adolescents and adults with Autism Spectrum Disorders (ASDs). |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.
Key inclusion criteria (2 listed)
- Male and female patients, aged 16-50 years
- Identification as having ASD from a prior diagnosis or participation in community conferences for individuals with ASD
Key exclusion criteria (4 listed)
- Major sensorimotor handicaps (e.g. deafness, blindness)
- Inadequate command of the English language
- Individuals who have never held a valid driver's license
- Mental retardation (IQ < 80)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Simulated driving performance of adolescents and adults with ASDs.
Time frame: one-time observation (3 hour assessment)
Data will be obtained on velocity, collision risk, and visual attention of subjects with ASDs who drive in the driving simulator at the Massachusetts Institute of Technology (MIT).
1 secondary outcome
Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.
Time frame: one-time assessment (2-6 hour screening visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Biederman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulated driving performance of adolescents and adults with ASDs. (time frame: one-time observation (3 hour assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.