Trial record 24 of 136 for:    ADHD | Open Studies | United States | Child, Adult

Novel Measure of Social Deficits in Children (OATS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Garet Lahvis, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT02035176
First received: November 6, 2013
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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
Autism Spectrum Disorders
ADHD

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oregon Animation Test for Social Reciprocity (OATS)

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Eye gaze in response to animated social situations [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Facial expressions in response to animated social situations [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    A child is shown an animation and facial expressions are coded for various emotions.


Other Outcome Measures:
  • Ability to recount a story shown via animation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A child is shown an animation and is asked to imitate a character's action .


Estimated Enrollment: 120
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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

Detailed Description:
Please see the brief summary above.
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035176

Contacts
Contact: Garet P Lahvis, PhD 503 346 0820 lahvisg@ohsu.edu

Locations
United States, Oregon
OHSU Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Garet P Lahvis, PhD    503-346-0820    lahvisg@ohsu.edu   
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Monet Meyer, B.S.    503-890-3042    meyemo@ohsu.eu   
Contact: Garet P Lahvis, PhD    503 346 0820    lahvisg@ohsu.edu   
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     History of Changes
Other Study ID Numbers: eIRB 9747 
Study First Received: November 6, 2013
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 24, 2016