NCT02118649

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

12 years

First QC Date

April 5, 2014

Last Update Submit

May 7, 2025

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

  • EEG brain response to targets

    Measures will be recorded for the duration of their visit, an expected average of 3 hours.

Secondary Outcomes (6)

  • 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.

  • Social Responsiveness Scale, Second Edition

    Measures will be collected during visit, an expected average of 3 hours.

  • Autism Diagnostic Observation Schedule

    Measures will be collected during visit, an expected average of 3 hours.

  • Differential Abilities Scale

    Measures will be collected during visit, an expected average of 3 hours.

  • Vineland Adaptive Behavior Scales, Second Edition

    Measures will be collected during visit, an expected average of 3 hours.

  • +1 more secondary outcomes

Study Arms (1)

Game

EXPERIMENTAL

Participants will play a video game directing their gaze to on-screen targets.

Behavioral: Game

Interventions

GameBEHAVIORAL
Game

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Able to participate in an eye-tracking experiment
  • Able to participate in an EEG experiment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (15)

  • 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.

    PMID: 5970485BACKGROUND

  • 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.

    PMID: 15949514BACKGROUND

  • 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.

    PMID: 12893128BACKGROUND

  • 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.

    PMID: 20646129BACKGROUND

  • 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.

    PMID: 22780332BACKGROUND

  • 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.

    PMID: 11261466BACKGROUND

  • 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.

    PMID: 16163569BACKGROUND

  • 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.

    PMID: 23224593BACKGROUND

  • 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.

    PMID: 12042174BACKGROUND

  • 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.

    PMID: 21126245BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 9634131BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2014

First Posted

April 21, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

US(1)