NCT01263756

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

December 8, 2011

Status Verified

December 1, 2011

Enrollment Period

1 year

First QC Date

November 29, 2010

Last Update Submit

December 6, 2011

Conditions

Keywords

DrivingAutism Spectrum DisordersASDAttention DeficitsAdultsAdolescentsPervasive Developmental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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).

    one-time observation (3 hour assessment)

Secondary Outcomes (1)

  • Questionnaire measures of driving history and behavior of adolescents and adults with ASDs.

    one-time assessment (2-6 hour screening visit)

Study Arms (1)

ASD group

Adolescents and adults with Autism Spectrum Disorders (ASDs).

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents and adults, ages 16-50, with Autism Spectrum Disorders.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAttention Deficit Disorder with HyperactivityChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Study Officials

  • Joseph Biederman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 21, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 8, 2011

Record last verified: 2011-12

Locations