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Trial record 4 of 4 for:    19948568 [PUBMED-IDS]

Evaluating the Validity of an Eye Gaze Paradigm in Predicting Autism Spectrum Disorder (EYE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02573428
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas W. Frazier, Ph.D, The Cleveland Clinic

Brief Summary:

The primary purpose of the present study is to evaluate the diagnostic validity of eye tracking measurements acquired during viewing of socially-relevant stimuli in predicting ASD diagnosis. The secondary purpose was to explore the potential prognostic value of eye tracking measures through cross-sectional associations with non-verbal cognitive ability.

Deficits in eye gaze are a hallmark sign of autism. A large and growing body of research supports the ability of eye-tracking based measurements to sensitively discriminate individuals with ASD and healthy participants. These investigations have identified that the core deficit in autism as disruption of social attention, reflecting an inability to appropriately engage and track socially- and emotionally-relevant aspects of the visual world. Thus, eye gaze tracking, acquired during viewing of socially-relevant stimuli, may be a useful approach to identifying objective markers of ASD. Eye tracking also carries the advantages of being less intrusive and expensive than MRI and genetic testing and specifically focuses on the core neurobehavioral characteristics of ASD - abnormalities in social attention.

After diagnosis of ASD, key clinical tasks in young children involve determining an accurate prognosis and tracking the progress of early interventions. Currently, the only prognostic indicators are clinical observations (subjective and expensive) and non-verbal cognitive ability testing (difficult to acquire, time-consuming, unavailable in many settings). Recently, eye gaze tracking was found to predict functional outcomes. Thus, in addition to being an objective marker for ASD, eye tracking measurements have potential to be useful for predicting cognitive and functional outcomes. Similarly, the only available methods for tracking treatment progress are parental reports (highly subjective), clinical observations (subjective and expensive), and cognitive measurements (expensive and unavailable in many settings. This study will evaluate, using cross-section data, the potential for eye tracking data to serve as a proxy for non-verbal cognitive ability scores in determining prognosis for ASD-affected children. Additionally, this study will evaluate the test re-test reliability of eye tracking parameters that can potentially be used to track treatment progress.


Condition or disease
Autism Spectrum Disorders

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 389 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluating the Validity of an Eye Gaze Tracking Assessment Tool in Identifying Autism Spectrum Disorder
Study Start Date : June 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Autism Spectrum Disorder
Individuals who receive a clinical diagnosis of Autism Spectrum Disorder
Developmental/Psychiatric Controls
Individuals who receive a clinical diagnosis of another developmental or psychiatric disorder
Healthy Controls
Individuals who have no specific developmental or psychiatric diagnosis



Primary Outcome Measures :
  1. Percentage of correctly discriminated ASD and non-ASD cases using the autism risk index. [ Time Frame: 1 year from study start ]
    In the development phase, all of the eye gaze measurements acquired from the social attention paradigm will be included as predictor variables in a random forest analysis. This analysis permits evaluation of the discriminative ability of a large number of variables in data sets with a modest number of cases. The variables with highest importance scores, indicating good diagnostic discrimination, will be entered into a logistic regression analysis with ASD diagnostic status (ASD vs. non-ASD) as the dichotomous dependent variable. Significant predictors will be retained and coefficients from the retained predictors will serve as the diagnostic autism risk index.


Secondary Outcome Measures :
  1. Area under the ROC curve of the prognostic algorithm in discriminating non-verbal cognitive disability. [ Time Frame: 21 months from study start ]
    All the available eye tracking measurements as predictors and non-verbal cognitive ability scores (dichotomized at <70 and 70 and above) as the dependent variable in random forest analyses.

  2. Number of regions of interest with significant dwell time differences between ASD-affected and non-ASD participants. [ Time Frame: 3 months from study start ]
    Effect size between ASD and non-ASD participants for dwell time relative to social targets presented in the social attention paradigm.

  3. Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Upper Face Region of Interest (ROI) from 0.5-24 seconds [ Time Frame: 6 months from study start ]
  4. Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Desk picture and Cup/Phone Regions of Interest (ROI) from 0.5-24 seconds [ Time Frame: 6 months from study start ]
  5. Natural Interaction, Joke 1 Stimulus - Dwell time in the Upper and Lower Face ROIs from 0.5-5.5 seconds [ Time Frame: 6 months from study start ]
  6. Natural Interaction, Joke 1 Stimulus - Dwell time in Body and Toys ROIs from 0.5-6.88 seconds [ Time Frame: 6 months from study start ]
  7. Natural Interaction, Joke 2 Stimulus - Dwell time in Upper Face ROI and Lower Face ROI from 0.5-8.0 seconds [ Time Frame: 6 months from study start ]
  8. Natural Interaction, Joke 2 Stimulus - Dwell time in Upper Face ROI from 4.3-5.0 seconds [ Time Frame: 6 months from study start ]
  9. Natural Interaction, Joke 2 Stimulus - Dwell time in Distractor 1, Distractor 2, Distractor 3 and Body ROIs from 0.2-10.34 seconds [ Time Frame: 6 months from study start ]
  10. Joint Attention, Gaze Middle Stimulus - Dwell time in Face ROI from 0.3-1.1 seconds [ Time Frame: 6 months from study start ]
  11. Joint Attention, Gaze Middle Stimulus - Dwell time in Target Toy, Distractor Right and Distractor Left ROIs from 1.0-2.3 seconds [ Time Frame: 6 months from study start ]
  12. Joint Attention, Gaze Right Stimulus - Dwell time in Face A and Face B ROIs from 3.3-3.7 seconds [ Time Frame: 6 months from study start ]
  13. Joint Attention, Gaze Right Stimulus - Dwell time in Target Toy and Distractor Toy ROIs from 1.0-2.3 seconds [ Time Frame: 6 months from study start ]
  14. Joint Attention, Gaze Right 2 Stimulus - Dwell time in Face ROI from 2.0-3.0 [ Time Frame: 6 months from study start ]
  15. Joint Attention, Gaze Right 2 Stimulus - Dwell time in Left Distractor, Middle Distractor and Right Target from 0.9-1.6 seconds [ Time Frame: 6 months from study start ]
  16. Joint Attention, Gesture Middle 1 Stimulus - Left Distractor, Right Distractor and Middle Target from 1.5-3.5 seconds [ Time Frame: 6 months from study start ]
  17. Joint Attention, Gesture Right 1 Stimulus - Target Toy, Distractor Middle and Distractor Left ROIs from 0.8-3.5 seconds [ Time Frame: 6 months from study start ]
  18. Joint Attention, Gesture Right 2 Stimulus - Target Toy and Distractor Toy ROIs from 1.3-2.4 seconds [ Time Frame: 6 months from study start ]
  19. Joint Attention, Gesture Left 1 Stimulus - Target Toy, Distractor Middle and Distractor Right ROIs from 1.4-3.4 seconds [ Time Frame: 6 months from study start ]
  20. Joint Attention, Gesture Left 2 Stimulus - Target Toy and Distractor Right ROIs from 1.2-2.7 seconds [ Time Frame: 6 months from study start ]
  21. Joint Attention - Gesture Left 3 Stimulus - Left Target, Middle Distractor and Right Distractor ROIs from 0.7-2.3 seconds [ Time Frame: 6 months from study start ]

Other Outcome Measures:
  1. Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Face Region of Interest (ROI) from 0.5-8.0 seconds. [ Time Frame: 6 months from study start ]
  2. Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Cup/Phone, Desk Picture, Wall Picture and Light Switch ROIs from 0.2-24.0 seconds [ Time Frame: 6 months from study start ]
  3. Side by Side Faces, Male Sad Target Stimulus - Dwell time in Target Upper Face ROI from 0.3-0.5 seconds [ Time Frame: 6 months from study start ]
  4. Side by Side Faces, Male Sad Target Stimulus - Dwell time in Distracter Face ROI from 0.7-1.1 seconds [ Time Frame: 6 months from study start ]
  5. Side by Side Faces, Male Sad Target Stimulus - Dwell time in Target Upper Face ROI from 1.5-5.0 seconds [ Time Frame: 6 months from study start ]
  6. Side by Side Faces, Male Sad Target Stimulus - Dwell time in Distrater Face, Target Body, and Distracter Body ROI from 1.5-5.0 seconds [ Time Frame: 6 months from study start ]
  7. Side by Side Faces, Female Scared Target Stimulus - Dwell time Target Upper Face ROI from 0.5-0.8 seconds [ Time Frame: 6 months from study start ]
  8. Side by Side Faces, Female Scared Target Stimulus - Dwell time Target Upper Face ROI from 1.9-5.0 seconds [ Time Frame: 6 months from study start ]
  9. Side by Side Faces, Female Scared Target Stimulus - Dwell time Distracter Face, Target Body, and Distracter Body ROI from 1.9-5.0 seconds [ Time Frame: 6 months from study start ]
  10. Side by Side Faces, Female Surpised Target Stimulus - Dwell time Target Upper Face ROI from 1.8-5.0 seconds [ Time Frame: 6 months from study start ]
  11. Side by Side Faces, Female Surpised Target Stimulus - Dwell time Distracter Face, Target Body, and Distracter Body ROI from 1.8-5.0 seconds [ Time Frame: 6 months from study start ]
  12. Side by Side Faces, Female Sad Target Stimulus - Dwell time Target Upper Face ROI from 1.3-5.0 seconds [ Time Frame: 6 months from study start ]
  13. Side by Side Faces, Female Sad Target Stimulus - Dwell time Distracter Face, Target Body,and Distracter Body ROI from 1.3-5.0 seconds [ Time Frame: 6 months from study start ]
  14. Side by Side Faces, Male Happy Target Stimulus - Dwell time Target Upper Face ROI from 2.0-5.0 seconds [ Time Frame: 6 months from study start ]
  15. Side by Side Faces, Male Happy Target Stimulus - Dwell time Distracter Face, Target Body, and Distracter Face ROI from 2.0-5.0 seconds [ Time Frame: 6 months from study start ]
  16. Side by Side Faces, Male Angry Target Stimulus - Dwell time Target Upper Face ROI from 1.7-5.0 seconds [ Time Frame: 6 months from study start ]
  17. Side by Side Faces, Male Angry Target Stimulus - Dwell time Target Lower Face ROI from 1.7-5.0 seconds [ Time Frame: 6 months from study start ]
  18. Side by Side Faces, Male Angry Target Stimulus - Dwell time Distracter Face, Target Body, and Distracter Body ROI from 1.7-5.0 seconds [ Time Frame: 6 months from study start ]
  19. Face vs. Abstract Design 1 Stimulus - Dwell time Upper Face ROI from 0.5-10.0 seconds [ Time Frame: 6 months from study start ]
  20. Face vs. Abstract Design 1 Stimulus - Dwell time Abstract ROI from 0.5-10.0 seconds [ Time Frame: 6 months from study start ]
  21. Biological vs. Non-Biological Motion, Scramble vs. Give Me Stimulus - Dwell time Predictive Action ROI from 1.1 to 1.5 seconds [ Time Frame: 6 months from study start ]
  22. Biological vs. Non-Biological Motion, Scramble vs. Give Me Stimulus - Dwell time Predictive Action ROI from 3.4 to 4.3 seconds [ Time Frame: 6 months from study start ]
  23. Joint Attention, Gaze Middle 1 Stimulus - Dwell time Face ROI from 0.4 to 1.0 seconds [ Time Frame: 6 months from study start ]
  24. Joint Attention, Gaze Middle 1 Stimulus - Dwell time Target Toy ROI from 1.0 to 2.3 seconds [ Time Frame: 6 months from study start ]
  25. Joint Attention, Gaze Middle 1 Stimulus - Dwell time Distracter Right, and Distracter Left ROI from 1.0 to 2.3 seconds [ Time Frame: 6 months from study start ]
  26. Joint Attention, Gaze Middle 1 Stimulus - Dwell time Face ROI from 2.4 to 3.0 seconds [ Time Frame: 6 months from study start ]
  27. Joint Attention, Gesture Right 1 Stimulus - Dwell time Face ROI from 2.0 to 3.5 seconds [ Time Frame: 6 months from study start ]
  28. Joint Attention, Gesture Right 1 Stimulus - Dwell time Gesture ROI from 0.6 to 3.3 seconds [ Time Frame: 6 months from study start ]
  29. Joint Attention, Gesture Right 1 Stimulus - Dwell time Target Toy ROI from 0.8 to 2.8 seconds [ Time Frame: 6 months from study start ]
  30. Joint Attention, Gesture Right 1 Stimulus - Dwell time Distracter Middle, and Distracter Left ROI from 0.8 to 2.8 seconds [ Time Frame: 6 months from study start ]
  31. Joint Attention, Gesture Left 1 Stimulus - Dwell time Face ROI from 0.3 to 1.0 seconds [ Time Frame: 6 months from study start ]
  32. Joint Attention, Gesture Left 1 Stimulus - Dwell time Gesture ROI from 1.1 to 3.2 seconds [ Time Frame: 6 months from study start ]
  33. Joint Attention, Gesture Left 1 Stimulus - Dwell time Target Toy ROI from 1.4 to 3.4 seconds [ Time Frame: 6 months from study start ]
  34. Joint Attention, Gesture Left 1 Stimulus - Dwell time Distracter Right, and Distracter Middle ROI from 1.4 to 3.4 seconds [ Time Frame: 6 months from study start ]
  35. Face vs. Abstract Design 2 Stimulus - Dwell time Upper Face ROI from 0.7 to 10.0 seconds [ Time Frame: 6 months from study start ]
  36. Face vs. Abstract Design 2 Stimulus - Dwell time Abstract ROI from 0.7 to 10.0 seconds [ Time Frame: 6 months from study start ]
  37. Biological vs. Non-Biological Motion, Scramble vs. Which One Stimulus - Dwell time Predictive Action ROI from 1.3 to 5.0 seconds [ Time Frame: 6 months from study start ]
  38. Biological vs. Non-Biological Motion, Scramble vs. Help Self Stimulus - Dwell time Predictive Action ROI from 4.9 to 5.5 seconds [ Time Frame: 6 months from study start ]
  39. Natural Interaction, Gesture Stop Stimulus - Dwell time Female Face ROI from 0.5 to 18.28 seconds [ Time Frame: 6 months from study start ]
  40. Natural Interaction, Gesture Stop Stimulus - Dwell time Male Face ROI from 0.5 to 18.28 seconds [ Time Frame: 6 months from study start ]
  41. Natural Interaction, Gesture Stop Stimulus - Dwell time Bubble Wrap ROI from 4.1 to 5.4 seconds [ Time Frame: 6 months from study start ]
  42. Natural Interaction, Gesture Stop Stimulus - Dwell time Bubble Wrap ROI from 10.0 to 11.5 seconds [ Time Frame: 6 months from study start ]
  43. Natural Interaction, Gesture Stop Stimulus - Dwell time Monitor, Laptop, Desk Picture, and Pencil Cup ROI from 0.2 to 18.28 seconds [ Time Frame: 6 months from study start ]
  44. Natural Interaction, Reciprocal Conversation Stimulus - Dwell time Female Face ROI from 0.5 to 16.34 seconds [ Time Frame: 6 months from study start ]
  45. Natural Interaction, Reciprocal Conversation Stimulus - Dwell time Male Face ROI from 0.5 to 16.34 seconds [ Time Frame: 6 months from study start ]
  46. Natural Interaction, Reciprocal Conversation Stimulus - Dwell time Hats ROI from 1.5 to 3.5 seconds [ Time Frame: 6 months from study start ]
  47. Natural Interaction, Reciprocal Conversation Stimulus - Dwell time Hats ROI from 9.5 to 16.34 seconds [ Time Frame: 6 months from study start ]
  48. Natural Interaction, Drink Spill Stimulus - Dwell time Face 1 ROI from 2.4 to 2.9 seconds [ Time Frame: 6 months from study start ]
  49. Natural Interaction, Drink Spill Stimulus - Dwell time Face 2 ROI from 3.2 to 3.7 seconds [ Time Frame: 6 months from study start ]
  50. Natural Interaction, Drink Spill Stimulus - Dwell time Pitcher/Glass Spill ROI from 4.3 to 8.6 seconds [ Time Frame: 6 months from study start ]
  51. Natural Interaction, Drink Spill Stimulus - Dwell time Face 1 Expression ROI from 9.0 to 11.88 seconds [ Time Frame: 6 months from study start ]
  52. Natural Interaction, Drink Spill Stimulus - Dwell time Face 2 ROI from 10.0 to 11.88 seconds [ Time Frame: 6 months from study start ]
  53. Natural Interaction, Joke 1 Stimulus - Dwell time Upper Face ROI from 0.5 to 6.88 seconds [ Time Frame: 6 months from study start ]
  54. Natural Interaction, Joke 1 Stimulus - Dwell time Body, and Toys ROI from 0.5 to 6.88 seconds [ Time Frame: 6 months from study start ]
  55. Natural Interaction, Tap Shoulder Stimulus - Dwell time Male Face ROI from 0.3 to 12.29 seconds [ Time Frame: 6 months from study start ]
  56. Natural Interaction, Tap Shoulder Stimulus - Dwell time Female Face ROI from 2.2 to 12.29 seconds [ Time Frame: 6 months from study start ]
  57. Natural Interaction, Tap Shoulder Stimulus - Dwell time Tap ROI from 6.4 to 7.1 seconds [ Time Frame: 6 months from study start ]
  58. Natural Interaction, Tap Shoulder Stimulus - Dwell time Paper ROI from 0.2 to 12.29 seconds [ Time Frame: 6 months from study start ]
  59. Natural Interaction, Offer to Share Stimulus - Dwell time Face A ROI from 0.6 to 3.2 seconds [ Time Frame: 6 months from study start ]
  60. Natural Interaction, Offer to Share Stimulus - Dwell time Face B and Gesture/Shrug ROI from 3.8 to 6.7 seconds [ Time Frame: 6 months from study start ]
  61. Natural Interaction, Offer to Share Stimulus - Dwell time Face A ROI from 7.2 to 9.1 seconds [ Time Frame: 6 months from study start ]
  62. Natural Interaction, Offer to Share Stimulus - Dwell time Orange/Hands ROI from 9.4 to 11.3 seconds [ Time Frame: 6 months from study start ]
  63. Dynamic Facial Expression, Happy Stimulus - Dwell time Upper Face ROI from 0.2 to 4.0 seconds [ Time Frame: 6 months from study start ]
  64. Dynamic Facial Expression, Angry Stimulus - Dwell time Upper Face ROI from 0.2 to 0.8 seconds [ Time Frame: 6 months from study start ]
  65. Dynamic Facial Expression, Angry Stimulus - Dwell time Lower Face ROI from 0.9 to 1.2 seconds [ Time Frame: 6 months from study start ]
  66. Dynamic Facial Expression, Angry Stimulus - Dwell time Upper Face ROI from 1.3 to 2.2 seconds [ Time Frame: 6 months from study start ]
  67. Dynamic Facial Expression, Sad Stimulus - Dwell time Upper Face ROI from 0.6 to 4.0 seconds [ Time Frame: 6 months from study start ]
  68. Dynamic Facial Expression, Surprise Stimulus - Dwell time Upper Face ROI from 0.5 to 1.6 seconds [ Time Frame: 6 months from study start ]
  69. Joint Attention, Gesture Left 2 Stimulus - Dwell time Face B ROI from 0.7 to 1.1 seconds [ Time Frame: 6 months from study start ]
  70. Joint Attention, Gesture Left 2 Stimulus - Dwell time Target ROI from 1.2 to 2.7 seconds [ Time Frame: 6 months from study start ]
  71. Joint Attention, Gesture Left 2 Stimulus - Dwell time Distracter Right ROI from 1.2 to 2.7 seconds [ Time Frame: 6 months from study start ]
  72. Joint Attention, Gesture Left 2 Stimulus - Dwell time Face A ROI from 1.4 to 3.2 seconds [ Time Frame: 6 months from study start ]
  73. Joint Attention, Gaze Right Stimulus - Dwell time Face B-male ROI from 0.7 to 2.5 seconds [ Time Frame: 6 months from study start ]
  74. Joint Attention, Gaze Right Stimulus - Dwell time Face B-male ROI from 3.1 to 3.7 seconds [ Time Frame: 6 months from study start ]
  75. Joint Attention, Gesture Right 2 Stimulus - Dwell time Face B ROI from 0.8 to 1.1 seconds [ Time Frame: 6 months from study start ]
  76. Joint Attention, Gesture Right 2 Stimulus - Dwell time Face B ROI from 2.6 to 3.2 seconds [ Time Frame: 6 months from study start ]
  77. Joint Attention, Gesture Right 2 Stimulus - Dwell time Target & Gesture ROI from 1.0 to 2.0 seconds [ Time Frame: 6 months from study start ]
  78. Joint Attention, Gesture Right 2 Stimulus - Dwell time Distracter ROI from 1.0 to 2.0 seconds [ Time Frame: 6 months from study start ]
  79. Dynamic Facial Expressions, Surprise 2 Stimulus - Dwell time Upper Face ROI from 0.4 to 1.3 seconds [ Time Frame: 6 months from study start ]
  80. Dynamic Facial Expressions, Surprise 2 Stimulus - Dwell time Lower Face ROI from 1.5 to 1.7 seconds [ Time Frame: 6 months from study start ]
  81. Dynamic Facial Expressions, Surprise 2 Stimulus - Dwell time Upper Face ROI from 1.8 to 4.0 seconds [ Time Frame: 6 months from study start ]
  82. Dynamic Facial Expressions, Angry 2 Stimulus - Dwell time Upper Face ROI from 0.3 to 1.8 seconds [ Time Frame: 6 months from study start ]
  83. Dynamic Facial Expressions, Angry 2 Stimulus - Dwell time Upper Face ROI from 2.5 to 4.0 seconds [ Time Frame: 6 months from study start ]
  84. Dynamic Facial Expressions, Happy 2 Stimulus - Dwell time Upper Face ROI from 2.5 to 4.0 seconds [ Time Frame: 6 months from study start ]
  85. Dynamic Facial Expressions, Scared Stimulus - Dwell time Upper Face ROI from 3.5 to 3.8 seconds [ Time Frame: 6 months from study start ]
  86. Natural Interaction, Joke 2 Stimulus - Dwell time Upper Face ROI from 2.0 to 8.0 seconds [ Time Frame: 6 months from study start ]
  87. Natural Interaction, Joke 2 Stimulus - Dwell time Distracter 1, Distracter 2, Distracter 3, and Microphone ROI from 0.2 to 10.34 seconds [ Time Frame: 6 months from study start ]
  88. Joint Attention, Gaze Right 2 Stimulus - Dwell time Face ROI from 0.5 to 0.8 seconds [ Time Frame: 6 months from study start ]
  89. Joint Attention, Gaze Right 2 Stimulus - Dwell time Left Distracter, and Middle Distracter ROI from 0.9 to 1.6 seconds [ Time Frame: 6 months from study start ]
  90. Joint Attention, Gaze Right 2 Stimulus - Dwell time Right Target ROI from 0.9 to 1.6 seconds [ Time Frame: 6 months from study start ]
  91. Joint Attention, Gesture Middle Stimulus - Dwell time Face ROI from 0.4 to 0.6 seconds [ Time Frame: 6 months from study start ]
  92. Joint Attention, Gesture Middle Stimulus - Dwell time Left Distracter, and Right Distracter ROI from 1.5 to 3.0 seconds [ Time Frame: 6 months from study start ]
  93. Joint Attention, Gesture Middle Stimulus - Dwell time Gesture and Middle Target ROI from 1.5 to 3.0 seconds [ Time Frame: 6 months from study start ]
  94. Joint Attention, Gesture Middle Stimulus - Dwell time Face ROI from 3.4 to 4.0 seconds [ Time Frame: 6 months from study start ]
  95. Joint Attention, Gesture Left 3 Stimulus - Dwell time Face ROI from 0.3 to 0.5 seconds [ Time Frame: 6 months from study start ]
  96. Joint Attention, Gesture Left 3 Stimulus - Dwell time Left Target, Middle Distracter, and Right Distracter ROI from 0.7 to 2.3 seconds [ Time Frame: 6 months from study start ]
  97. Joint Attention, Gesture Left 3 Stimulus - Dwell time Gesture ROI from 0.8 to 1.8 seconds [ Time Frame: 6 months from study start ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ASD and Non-ASD participants will be recruited following their evaluations in the Center for Autism diagnostic clinics as well as from the Social Practice and Instruction Enhances Socialization (SPIES) program both of which are part of the Cleveland Clinic Center for Autism.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Autism Spectrum Disorder (299.0) following evaluation in Cleveland Clinic Center for Autism Diagnostic Clinic, or a clinical diagnosis of another developmental or psychiatric disorder, or have no specific developmental or psychiatric diagnosis.
  • Age 1.5 to 18 years at time of consent.

Exclusion Criteria:

  • Individuals whom, with corrective lenses are still legally blind.
  • Individuals whom, it is determined at the discretion of hte Primary Investigator, after consultation with the evaluating psychologist in the Center for Autism Diagnostic Clinic, are not able to sufficiently attend to the stimulus presentation or have substantial challenging behaviors that would prohibit participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573428


Locations
United States, Ohio
Cleveland Clinic Center for Autism
Cleveland, Ohio, United States, 44104
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Thomas Frazier, Ph.D. The Cleveland Clinic

Publications:
Ganz ML. The costs of autism. In: Moldin SO, Rubenstein JLR, eds. Understanding autism: From basic neuroscience to treatment: CRC Press; 2006.
Lord, RM, DiLavore PC, et al. Autism Diagnostic Observation Schedule: WPS (ADOS-WPS). Los Angeles, CA: Western Psychological Services. 1999.

Responsible Party: Thomas W. Frazier, Ph.D, Director, Center for Autism, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02573428     History of Changes
Other Study ID Numbers: 14-620
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Thomas W. Frazier, Ph.D, The Cleveland Clinic:
Autism Spectrum Disorder
Eye Gaze
Remote Eye Gaze Tracking
Autism

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders