Clinical trial NCT02035176: Novel Measure of Social Deficits in Children
Official title: Oregon Animation Test for Social Reciprocity (OATS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorders
ADHD
Keywords: autism
ADHD
attention deficit hyperactivity disorder
behavioral assessment
behavior
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 92
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children 6-11 years of age with autism, ADHD, or typical, with and IQ exceeding 70.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* IQ below 70.

Primary outcomes:
measure: Eye gaze in response to animated social situations
timeFrame: 60 minutes
Secondary outcomes:
measure: Facial expressions in response to animated social situations
timeFrame: 60 minutes
Other outcomes:
measure: Ability to recount a story shown via animation
timeFrame: 10 minutes
measure: Ability to imitate an action shown via animation
timeFrame: 10 minutes
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Garet P Lahvis, PhD
role: PRINCIPAL_INVESTIGATOR
References: