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Novel Measure of Social Deficits in Children (OATS)

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ClinicalTrials.gov Identifier: NCT02035176
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Garet Lahvis, Oregon Health and Science University

Brief Summary:

Autism Spectrum Disorders (ASD) feature impairments in social interaction and communication. Drug and behavioral treatments for ASD are undergoing rapid development, yet our diagnostic tools are not suitable for efficacy assessment. The Autism-Diagnosis Observational Schedule (ADOS) is a clinical interview with the child and the gold standard for diagnosis. However, this test is subjective, course grained and costly, precluding repeated tests of the same child to assess treatment efficacy and large-scale control assessments of typically developing (TD) children. For these reasons, the ADOS can impede imaging and genetic research.

In light of these concerns, the Oregon Animation Test for Social Reciprocity (OATS) will be developed to evaluate distinct autistic behavioral phenotypes, including joint attention, empathy, imitation, and lack of narrative coherence. The main idea of OATS is that animated characters and social scenarios are presented on a computer screen while the responses of the child are recorded by video camera, microphone, and eye-tracking equipment. Animations are used to test each behavioral phenotype of autism. The long-term vision for OATS is to evaluate behavioral and physiological responses of autistic children, including heart rate variability, pupil dilation, and EEG. Our first objective is to use existing animations to build an OATS "Prototype" that discriminates autistic from normal children (Aim 1). From these results, and use of a defined library of still frame posed images, we will design our own animation platform to assess differences between autistic and normal children (Aim 2).


Condition or disease
Autism Spectrum Disorders ADHD

Detailed Description:
Please see the brief summary above.

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Oregon Animation Test for Social Reciprocity (OATS)
Study Start Date : February 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Autistic children ages 6-11
Autistic children ages 6-11
ADHD children ages 6-11
ADHD children ages 6-11
Typical children ages 6-11
Typical children ages 6-11



Primary Outcome Measures :
  1. Eye gaze in response to animated social situations [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Facial expressions in response to animated social situations [ Time Frame: 60 minutes ]
    A child is shown an animation and facial expressions are coded for various emotions.


Other Outcome Measures:
  1. Ability to recount a story shown via animation [ Time Frame: 10 minutes ]
    A child is shown an animation and is asked to recount the story.

  2. Ability to imitate an action shown via animation [ Time Frame: 10 minutes ]
    A child is shown an animation and is asked to imitate a character's action .



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children 6-11 years of age with autism, ADHD, or typical, with and IQ exceeding 70.
Criteria

Inclusion Criteria:

  • 6-11 years of age with autism,
  • ADHD, or typical

Exclusion Criteria:

  • IQ below 70.

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): NCT02035176


Locations
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United States, Oregon
OHSU
Portland, Oregon, United States, 97239
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Garet P Lahvis, PhD Oregon Health and Science University
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Responsible Party: Garet Lahvis, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02035176    
Other Study ID Numbers: eIRB 9747
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Garet Lahvis, Oregon Health and Science University:
autism
ADHD
attention deficit hyperactivity disorder
behavioral assessment
behavior
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders