Novel Measure of Social Deficits in Children

Completed

• Conditions: ADHD; Autism Spectrum Disorders

• Registration Number: NCT02035176
• Lead Sponsor: 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).

Detailed Description

Please see the brief summary above.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Study Start: 2014-02
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

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

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Exclusion Criteria

• IQ below 70.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eye gaze in response to animated social situations	60 minutes

Secondary Outcome Measures

Name	Time	Method
Facial expressions in response to animated social situations	60 minutes	A child is shown an animation and facial expressions are coded for various emotions.

Trial Locations

Locations (2)

OHSU; 🇺🇸 Portland, Oregon, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States