Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Novel Measure of Social Deficits in Children (OATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 6, 2013
First Posted Date January 14, 2014
Last Update Posted Date August 28, 2019
Study Start Date February 2014
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2014)
Eye gaze in response to animated social situations [ Time Frame: 60 minutes ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 13, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 13, 2014)
  • 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.
  • 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 .
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Novel Measure of Social Deficits in Children
Official Title Oregon Animation Test for Social Reciprocity (OATS)
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).

Detailed Description Please see the brief summary above.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Children 6-11 years of age with autism, ADHD, or typical, with and IQ exceeding 70.
Condition
  • Autism Spectrum Disorders
  • ADHD
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 26, 2019)
92
Original Estimated Enrollment
 (submitted: January 13, 2014)
120
Actual Study Completion Date December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • IQ below 70.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02035176
Other Study ID Numbers eIRB 9747
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Garet Lahvis, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Not Provided
Investigators
Principal Investigator: Garet P Lahvis, PhD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date August 2019