Trial · NCT03538431
Improving Driving in Young People With Autism Spectrum Disorders
NCT03538431, Phase 4, Completed, Massachusetts General Hospital; results first posted 2021-03-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Driving in Young People With Autism Spectrum Disorders. Trials, record NCT03538431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03538431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Driving in Young People With Autism Spectrum Disorders
- NCT number
- NCT03538431
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 26 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Autism Spectrum Disorder
- Interventions
- Buspirone
- First posted
- 2018-05-29
- Last updated
- 2021-03-18
- Results first posted
- 2021-03-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Driving Performance - Measured by Mean Off-Road Glance Duration | Up to 6 weeks | Driving performance will be analyzed using eye tracking in individuals with Autism Spectrum Disorder while on the anti-anxiety medication buspirone and while not on buspirone. Eye movement behavior (measured by glance duration) during the driving simulation was manually coded on a frame-by-frame basis from recorded video by trained coders for all cases where usable video recordings were available for both the medicated and non-medicated driving simulation sessions per participant. |
| Primary | Heart Rate | Up to 6 weeks | Hyperarousal will be measured by heart rate during participants' time in the driving simulation. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Driving Performance - Measured by Mean Off-Road Glance Duration | Up to 6 weeks | Seconds | MEAN | |
| PRIMARY | Heart Rate | Up to 6 weeks | Beats Per Minute | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Driving Performance - Measured by Mean Off-Road Glance Duration | Buspirone | 0.85 | Standard Deviation 0.17 | Seconds | |
| Driving Performance - Measured by Mean Off-Road Glance Duration | Unmedicated | 0.90 | Standard Deviation 0.27 | Seconds | |
| Heart Rate | Buspirone | 81.78 | Standard Deviation 10.67 | Beats Per Minute | |
| Heart Rate | Unmedicated | 82.74 | Standard Deviation 11.70 | Beats Per Minute |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2 | 13 | |
| Overall Study | STARTED | No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2 | 13 | |
| Overall Study | COMPLETED | Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2 | 12 | |
| Overall Study | COMPLETED | No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2 | 12 | |
| Overall Study | NOT COMPLETED | Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2 | 1 | |
| Overall Study | NOT COMPLETED | No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2 | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild allergic reaction to medication prescribed not related to the study | Immune system disorders | Buspirone | 1 | 26 | 1 |
| other | Mild allergic reaction to medication prescribed not related to the study | Immune system disorders | Unmedicated | 0 | 26 | 0 |
| other | Concussion | Musculoskeletal and connective tissue disorders | Buspirone | 1 | 26 | 1 |
| other | Concussion | Musculoskeletal and connective tissue disorders | Unmedicated | 0 | 26 | 0 |
| other | Chest Tightness, mild excitement, and nausea | Cardiac disorders | Buspirone | 1 | 26 | 1 |
| other | Chest Tightness, mild excitement, and nausea | Cardiac disorders | Unmedicated | 0 | 26 | 0 |
| other | Mild nausea | Gastrointestinal disorders | Buspirone | 1 | 26 | 1 |
| other | Mild nausea | Gastrointestinal disorders | Unmedicated | 0 | 26 | 0 |
| other | Head Cold | Infections and infestations | Buspirone | 1 | 26 | 1 |
| other | Head Cold | Infections and infestations | Unmedicated | 0 | 26 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buspirone | 0 | 26 |
| Total, all-cause mortality | Unmedicated | 0 | 26 |
| Total, other adverse events | Buspirone | 5 | 26 |
| Total, other adverse events | Unmedicated | 0 | 26 |
| Total, serious adverse events | Buspirone | 0 | 26 |
| Total, serious adverse events | Unmedicated | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buspirone vs Unmedicated: deaths from any cause | Trial comparisons |
| Buspirone vs Unmedicated: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03538431
GET https://conductscience.org/api/trials/v1/NCT03538431/registered