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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02118649
Other study ID # 14-10788
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date April 2026

Study information

Verified date April 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants will play a computer game that is controlled by their gaze patterns and designed to direct attention their attention to specific on-screen targets. Visual attention to targets will be rewarded. Both visual behavior and brain response will be recorded during game play. It is hypothesized that that, over the course of the game, relative to baseline, participants will show (a) increased looking to targets, (b) decreased response time to targets, and (c) enhanced, more efficient neural response to visual cues. It is hypothesized that clinical variability will associate with visual attention and brain response.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Able to participate in an eye-tracking experiment - Able to participate in an EEG experiment Exclusion Criteria: - Sensory or physical impairment that would preclude completion of protocol - Participants taking prescription medications that may affect cognitive processes - Participants reporting significant head trauma or history of seizures

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Game


Locations

Country Name City State
United States Yale Child Study Center New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (15)

Charlop-Christy MH, Le L, Freeman KA. A comparison of video modeling with in vivo modeling for teaching children with autism. J Autism Dev Disord. 2000 Dec;30(6):537-52. doi: 10.1023/a:1005635326276. — View Citation

Constantino, J. N., & Gruber, C. P. (2012). The Social Responsiveness Scale, Second Edition. Los Angeles, CA: Western Psychological Services.

Elliott C. Differential Ability Scales: Second Edition (DAS-II). San Antonio, TX: Psychological Corporation. 2007.

Gena A, Couloura S, Kymissis E. Modifying the affective behavior of preschoolers with autism using in-vivo or video modeling and reinforcement contingencies. J Autism Dev Disord. 2005 Oct;35(5):545-56. doi: 10.1007/s10803-005-0014-9. — View Citation

Hutt C, Ounsted C. The biological significance of gaze aversion with particular reference to the syndrome of infantile autism. Behav Sci. 1966 Sep;11(5):346-56. doi: 10.1002/bs.3830110504. No abstract available. — View Citation

Klin A, Jones W, Schultz R, Volkmar F, Cohen D. Defining and quantifying the social phenotype in autism. Am J Psychiatry. 2002 Jun;159(6):895-908. doi: 10.1176/appi.ajp.159.6.895. — View Citation

La Greca AM, Lopez N. Social anxiety among adolescents: linkages with peer relations and friendships. J Abnorm Child Psychol. 1998 Apr;26(2):83-94. doi: 10.1023/a:1022684520514. — View Citation

Landa RJ, Holman KC, O'Neill AH, Stuart EA. Intervention targeting development of socially synchronous engagement in toddlers with autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2011 Jan;52(1):13-21. doi: 10.1111/j.1469-7610.2010.02288.x. Epub 2010 Dec 3. — View Citation

Lord, C., Rutter, M., DiLavore, P. C., & Risi, S. (1999). Autism Diagnostic Observation Schedule - WPS (ADOS-WPS), Los Angeles, CA: Western Psychological Services.

Senju A, Tojo Y, Yaguchi K, Hasegawa T. Deviant gaze processing in children with autism: an ERP study. Neuropsychologia. 2005;43(9):1297-306. doi: 10.1016/j.neuropsychologia.2004.12.002. Epub 2005 Jan 24. — View Citation

Senju A, Yaguchi K, Tojo Y, Hasegawa T. Eye contact does not facilitate detection in children with autism. Cognition. 2003 Aug;89(1):B43-51. doi: 10.1016/s0010-0277(03)00081-7. — View Citation

Sparrow, S. S., Balla, D., Cicchetti, D. (1984). Vineland Adaptive Behavior Scales. Circle Pines, MN, American Guidance Service.

Tanaka JW, Wolf JM, Klaiman C, Koenig K, Cockburn J, Herlihy L, Brown C, Stahl S, Kaiser MD, Schultz RT. Using computerized games to teach face recognition skills to children with autism spectrum disorder: the Let's Face It! program. J Child Psychol Psychiatry. 2010 Aug;51(8):944-52. doi: 10.1111/j.1469-7610.2010.02258.x. — View Citation

Tanaka JW, Wolf JM, Klaiman C, Koenig K, Cockburn J, Herlihy L, Brown C, Stahl SS, South M, McPartland JC, Kaiser MD, Schultz RT. The perception and identification of facial emotions in individuals with autism spectrum disorders using the Let's Face It! Emotion Skills Battery. J Child Psychol Psychiatry. 2012 Dec;53(12):1259-67. doi: 10.1111/j.1469-7610.2012.02571.x. Epub 2012 Jul 11. — View Citation

Wilson KP. Teaching social-communication skills to preschoolers with autism: efficacy of video versus in vivo modeling in the classroom. J Autism Dev Disord. 2013 Aug;43(8):1819-31. doi: 10.1007/s10803-012-1731-5. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary EEG brain response to targets Measures will be recorded for the duration of their visit, an expected average of 3 hours.
Secondary Visual attention to targets as measured by eye-tracking Measures will be recorded for the duration of their visit, an expected average of 3 hours.
Secondary Social Responsiveness Scale, Second Edition Measures will be collected during visit, an expected average of 3 hours.
Secondary Autism Diagnostic Observation Schedule Measures will be collected during visit, an expected average of 3 hours.
Secondary Differential Abilities Scale Measures will be collected during visit, an expected average of 3 hours.
Secondary Vineland Adaptive Behavior Scales, Second Edition Measures will be collected during visit, an expected average of 3 hours.
Secondary Social Anxiety Scale for Children, Revised Measures will be collected during visit, an expected average of 3 hours.
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