Autism Spectrum DisordersOATSNCT02035176
Novel Measure of Social Deficits in Children
An observational study of Autism Spectrum Disorders and ADHD, run by Oregon Health and Science University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders, ADHD
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 6-11 years of age with autism, ADHD, or typical, with and IQ exceeding 70.
Who may be able to join
- 6-11 years of age with autism,
- ADHD, or typical
Who cannot join
- IQ below 70.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OHSU
Portland, Oregon, 97239
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Oregon Animation Test for Social Reciprocity (OATS)
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).
Read the detailed description
Please see the brief summary above.
- Conditions
- Autism Spectrum Disorders, ADHD
- Keywords
- autism, ADHD, attention deficit hyperactivity disorder, behavioral assessment, behavior
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye gaze in response to animated social situations
Measured: 60 minutes
Secondary outcomes (1)
Facial expressions in response to animated social situations
A child is shown an animation and facial expressions are coded for various emotions.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garet Lahvis, Oregon Health and Science University
- Investigators
- Garet P Lahvis, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035176
- Sponsor's protocol ID
- eIRB 9747
- Acronym
- OATS
- Status last verified
- Aug 2019
- First submitted
- 6 Nov 2013
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oregon Animation Test for Social Reciprocity (OATS)
- ClinicalTrials.gov ID
- NCT02035176
- Acronym / sponsor ID
- OATS / eIRB 9747
- Conditions
- Autism Spectrum Disorders, ADHD
- Keywords
- autism, ADHD, attention deficit hyperactivity disorder, behavioral assessment, behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 6-11 years of age with autism, ADHD, or typical, with and IQ exceeding 70.
Key inclusion criteria (2 listed)
- 6-11 years of age with autism,
- ADHD, or typical
Key exclusion criteria (1 listed)
- IQ below 70.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eye gaze in response to animated social situations
Time frame: 60 minutes
1 secondary outcome
Facial expressions in response to animated social situations
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garet P Lahvis, PhD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders and ADHD, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye gaze in response to animated social situations (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.