Clinical trial NCT02488226: Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder
Official title: Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project seeks to understand how the gaze behavior of infants and children with or at high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic social and non-social scenes. The study explores not only the methods which may be most effective in aligning and teaching normative patterns of scene exploration, but also seeks to establish what behavioral characteristics may be most predictive of atypical scanning and atypical learning.

Detailed description: This study initiates a highly novel line of research which uses adaptive, gaze-contingent, eye-tracking technology to help infants and children with or at high risk for ASD learn to direct their attention to people and their actions in a more typical fashion. This study will begin with a Normative Collection phase, and will conclude with a Gaze-Shaping phase. In the Normative Collection phase, the investigators will examine the gaze behavior of a group of typically developing infants and children with typical development (TD), in order to establish a normative gaze pattern. In the Gaze-Shaping phase, within the same videos shown in the Normative Collection phase, the investigators will highlight selectively targeted people, objects, and activities, in an attempt to shape participants' viewing patterns to match the normative gaze pattern.

Manual coding of live-action interaction probes will provide an additional evaluative measure, allowing the investigators to track real-world (live-action) correlates alongside video-eye-tracking behaviors. In addition, live-action probes may allow the investigators to check for generalization to live interaction with another person (as opposed to gaze behavior when watching videos). In live-action probes, one or two clinical research staff member(s) will interact with each participant (or with each other in front of the participant), in a manner analogous to the actions performed in the training videos.

Please note: The original estimated enrollment as specified to and funded by NIH was 98 participants, but was incorrectly listed on ClinicalTrials.gov as 220 participants reflecting maximal recruitment in this and other ongoing studies.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 60 months
* Fulfill criteria for autistic disorder or PDD-NOS (Pervasive Developmental Disorder- Not Otherwise Specified) on the Autism Diagnostic Observation Schedule - Module 1
* A diagnosis of autism or PDD-NOS by experienced clinicians

Exclusion Criteria:

* Gestational age below 32 weeks
* Suspected or diagnosed hearing loss or visual impairment
* History of head trauma with loss of consciousness
* Non-febrile seizure disorders
* Diagnosed neurological abnormality significantly impacting on visual or auditory acuity.

Primary outcomes:
measure: Gaze behavior during eye tracking tasks measured by standard eye-tracking analysis protocols
timeFrame: 1-7 days
Secondary outcomes:
measure: Behavior during real-world interactions measured by coding of video recordings
timeFrame: 1-7 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Frederick Shic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: