Novel Measure of Social Deficits in Children

ADHD Clinical Trial

— OATS  

Official title:

Oregon Animation Test for Social Reciprocity (OATS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035176
• Other study ID #: eIRB 9747
• Status: Completed
• Start date: February 2014
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Please see the brief summary above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• 6-11 years of age with autism,

• ADHD, or typical

Exclusion Criteria:

• IQ below 70.

Related Conditions & MeSH terms

• ADHD
• Autism Spectrum Disorder
• Autism Spectrum Disorders

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ability to recount a story shown via animation	A child is shown an animation and is asked to recount the story.	10 minutes
Other	Ability to imitate an action shown via animation	A child is shown an animation and is asked to imitate a character's action .	10 minutes
Primary	Eye gaze in response to animated social situations		60 minutes
Secondary	Facial expressions in response to animated social situations	A child is shown an animation and facial expressions are coded for various emotions.	60 minutes