Novel Measure of Social Deficits in Children (OATS)

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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 .

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Garet P Lahvis, PhD; Oregon Health and Science University

More Information

• 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
• 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:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders