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

NCT02573428 | Completed DMC

• 1 other identifier: 14-620
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum Disorder; Eye Gaze; Remote Eye Gaze Tracking; Autism

Outcome Measures

Primary Outcomes (1)

• Percentage of correctly discriminated ASD and non-ASD cases using the autism risk index.

  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.

  1 year from study start

Secondary Outcomes (21)

• Area under the ROC curve of the prognostic algorithm in discriminating non-verbal cognitive disability.

  21 months from study start

• Number of regions of interest with significant dwell time differences between ASD-affected and non-ASD participants.

  3 months from study start

• Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Upper Face Region of Interest (ROI) from 0.5-24 seconds

  6 months from study start

• Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Desk picture and Cup/Phone Regions of Interest (ROI) from 0.5-24 seconds

  6 months from study start

• Natural Interaction, Joke 1 Stimulus - Dwell time in the Upper and Lower Face ROIs from 0.5-5.5 seconds

  6 months from study start

Other Outcomes (97)

• Natural Interaction, Monologue with Directed Attention Stimulus - Dwell time in Face Region of Interest (ROI) from 0.5-8.0 seconds.

  6 months from study start

• 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

  6 months from study start

• Side by Side Faces, Male Sad Target Stimulus - Dwell time in Target Upper Face ROI from 0.3-0.5 seconds

  6 months from study start

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Center for Autism

Cleveland, Ohio, 44104, United States

Location

Related Publications (21)

• Ritvo ER, Freeman BJ, Pingree C, Mason-Brothers A, Jorde L, Jenson WR, McMahon WM, Petersen PB, Mo A, Ritvo A. The UCLA-University of Utah epidemiologic survey of autism: prevalence. Am J Psychiatry. 1989 Feb;146(2):194-9. doi: 10.1176/ajp.146.2.194.

  PMID: 2783539 BACKGROUND

• Fombonne E. Epidemiology of autistic disorder and other pervasive developmental disorders. J Clin Psychiatry. 2005;66 Suppl 10:3-8.

  PMID: 16401144 BACKGROUND

• Developmental Disabilities Monitoring Network Surveillance Year 2010 Principal Investigators; Centers for Disease Control and Prevention (CDC). Prevalence of autism spectrum disorder among children aged 8 years - autism and developmental disabilities monitoring network, 11 sites, United States, 2010. MMWR Surveill Summ. 2014 Mar 28;63(2):1-21.

  PMID: 24670961 BACKGROUND

• Ganz ML. The costs of autism. In: Moldin SO, Rubenstein JLR, eds. Understanding autism: From basic neuroscience to treatment: CRC Press; 2006.

  BACKGROUND

• Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343.

  PMID: 17404130 BACKGROUND

• Pierce K, Carter C, Weinfeld M, Desmond J, Hazin R, Bjork R, Gallagher N. Detecting, studying, and treating autism early: the one-year well-baby check-up approach. J Pediatr. 2011 Sep;159(3):458-465.e1-6. doi: 10.1016/j.jpeds.2011.02.036. Epub 2011 Apr 27.

  PMID: 21524759 BACKGROUND

• Ozonoff S, Iosif AM, Baguio F, Cook IC, Hill MM, Hutman T, Rogers SJ, Rozga A, Sangha S, Sigman M, Steinfeld MB, Young GS. A prospective study of the emergence of early behavioral signs of autism. J Am Acad Child Adolesc Psychiatry. 2010 Mar;49(3):256-66.e1-2.

  PMID: 20410715 BACKGROUND

• Grice SJ, Halit H, Farroni T, Baron-Cohen S, Bolton P, Johnson MH. Neural correlates of eye-gaze detection in young children with autism. Cortex. 2005 Jun;41(3):342-53. doi: 10.1016/s0010-9452(08)70271-5.

  PMID: 15871599 BACKGROUND

• Lord, RM, DiLavore PC, et al. Autism Diagnostic Observation Schedule: WPS (ADOS-WPS). Los Angeles, CA: Western Psychological Services. 1999.

  BACKGROUND

• Volkmar FR, Lord C, Bailey A, Schultz RT, Klin A. Autism and pervasive developmental disorders. J Child Psychol Psychiatry. 2004 Jan;45(1):135-70. doi: 10.1046/j.0021-9630.2003.00317.x.

  PMID: 14959806 BACKGROUND

• Bolton PF, Golding J, Emond A, Steer CD. Autism spectrum disorder and autistic traits in the Avon Longitudinal Study of Parents and Children: precursors and early signs. J Am Acad Child Adolesc Psychiatry. 2012 Mar;51(3):249-260.e25. doi: 10.1016/j.jaac.2011.12.009. Epub 2012 Feb 3.

  PMID: 22365461 BACKGROUND

• Kozlowski AM, Matson JL, Horovitz M, Worley JA, Neal D. Parents' first concerns of their child's development in toddlers with autism spectrum disorders. Dev Neurorehabil. 2011;14(2):72-8. doi: 10.3109/17518423.2010.539193.

  PMID: 21410398 BACKGROUND

• Jones W, Klin A. Attention to eyes is present but in decline in 2-6-month-old infants later diagnosed with autism. Nature. 2013 Dec 19;504(7480):427-31. doi: 10.1038/nature12715. Epub 2013 Nov 6.

  PMID: 24196715 BACKGROUND

• Chawarska K, Macari S, Shic F. Decreased spontaneous attention to social scenes in 6-month-old infants later diagnosed with autism spectrum disorders. Biol Psychiatry. 2013 Aug 1;74(3):195-203. doi: 10.1016/j.biopsych.2012.11.022. Epub 2013 Jan 11.

  PMID: 23313640 BACKGROUND

• Wolff JJ, Gu H, Gerig G, Elison JT, Styner M, Gouttard S, Botteron KN, Dager SR, Dawson G, Estes AM, Evans AC, Hazlett HC, Kostopoulos P, McKinstry RC, Paterson SJ, Schultz RT, Zwaigenbaum L, Piven J; IBIS Network. Differences in white matter fiber tract development present from 6 to 24 months in infants with autism. Am J Psychiatry. 2012 Jun;169(6):589-600. doi: 10.1176/appi.ajp.2011.11091447.

  PMID: 22362397 BACKGROUND

• Chawarska K, Campbell D, Chen L, Shic F, Klin A, Chang J. Early generalized overgrowth in boys with autism. Arch Gen Psychiatry. 2011 Oct;68(10):1021-31. doi: 10.1001/archgenpsychiatry.2011.106.

  PMID: 21969460 BACKGROUND

• Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.

  PMID: 19948568 BACKGROUND

• Campbell DJ, Shic F, Macari S, Chawarska K. Gaze response to dyadic bids at 2 years related to outcomes at 3 years in autism spectrum disorders: a subtyping analysis. J Autism Dev Disord. 2014 Feb;44(2):431-42. doi: 10.1007/s10803-013-1885-9.

  PMID: 23877749 BACKGROUND

• Farroni T, Csibra G, Simion F, Johnson MH. Eye contact detection in humans from birth. Proc Natl Acad Sci U S A. 2002 Jul 9;99(14):9602-5. doi: 10.1073/pnas.152159999. Epub 2002 Jun 24.

  PMID: 12082186 BACKGROUND

• Kisilevsky BS, Hains SM, Brown CA, Lee CT, Cowperthwaite B, Stutzman SS, Swansburg ML, Lee K, Xie X, Huang H, Ye HH, Zhang K, Wang Z. Fetal sensitivity to properties of maternal speech and language. Infant Behav Dev. 2009 Jan;32(1):59-71. doi: 10.1016/j.infbeh.2008.10.002. Epub 2008 Dec 5.

  PMID: 19058856 BACKGROUND

• Vouloumanos A, Hauser MD, Werker JF, Martin A. The tuning of human neonates' preference for speech. Child Dev. 2010 Mar-Apr;81(2):517-27. doi: 10.1111/j.1467-8624.2009.01412.x.

  PMID: 20438457 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Thomas Frazier, Ph.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Autism

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 9, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)