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NDAR provides a single access to de-identified autism research data. For permission to download data, you will need an NDAR account with approved access to NDAR or a connected repository (AGRE, IAN, or the ATP). For NDAR access, you need to be a research investigator sponsored by an NIH recognized institution with federal wide assurance. See Request Access for more information.

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The filters you have selected from various query interfaces will be stored here, in the 'Filter Cart'. The database will be queried using filters added to your 'Filter Cart', when multiple filters are defined, each will be executed using 'AND' logic, so with each filter that is applied the result set gets smaller.

From the 'Filter Cart' you can inspect each of the filters that have been defined, and you also have the option to remove filters. The 'Filter Cart' itself will display the number of filters applied along with the number of subjects that are identified by the combination of those filters. For example a GUID filter with two subjects, followed by a GUID filter for just one of those subjects would return only data for the subject that is in both GUID filters.

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1 Numbers reported are subjects by age
New Trial
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Format should be in the following format: Activity Code, Institute Abbreviation, and Serial Number. Grant Type, Support Year, and Suffix should be excluded. For example, grant 1R01MH123456-01A1 should be entered R01MH123456

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New Documentation

Please enter the name of the data structure to search or if your definition does not exist, please upload that definition so that it can be appropriately defined for submission. Multiple data structures may be associated with a single Data Expected entry. Please add only one data structure per assessment.

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Data Expected Item Original Sharing Date New Sharing Date

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Shared

Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

General

Title, investigators, and Collection Description may be edited along with the Collection Phase. For Collection Phase, the options Pre-enrollment, Enrollment, and Completed can be chosen allowing the Collection Owner to indicate the stage of data collection.

Funding Source

The ability to associate the funding source for the project is provided. For NIH funded grants, linkage to Project Reporter information (e.g. R01MH123456) is supported. Projects funded by others, including the URL of the project, are listed. Non NIH funded projects will become available here to link that data with the appropriate funding agency.

Supporting Documentation

Any documents related to the project may be uploaded clarifying the data or acquisition methods used may be uploaded and made available here. The default is to share these documents to the general public. An option to share only to qualified Researchers is also an option.

Clinical Trials

For clinical trials, the option to link to the clinical trial in clinicaltrials.gov is optionally provided.

Collection Summary Collection Charts
Collection Title Collection Investigators Collection Description
Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B)
Linmarie Sikich 
This application proposes creation of the ACE SOARS Network and a pivotal clinical trial of sustained oxytocin treatment in children with ASD known as SOARS-B (Study of Oxytocin in ASD to improve Reciprocal Social Behaviors). The ACE SOARS Network consists of five Treatment Sites across the country headed by Chris McDougle (MA), Alex Kolevzon (NY), Bryan King (WA), Lin Sikich (NC) and Jeremy Veenstra-Vander Weele(TN), a Genetic Center run by Simon Gregory (Duke); a Data Center directed by Robert Hamer (UNC); and a Coordinating Center. The mission of the ACE SOARS Network is to develop safe treatments that meaningfully improve functioning and reduce disability for people of all ability levels with autism spectrum disorders (ASD)and to determine factors that predict who will respond to what treatment. The ACE SOARS Network has built on exciting new findings that oxytocin enhances social behavior in people with typical development and ASD and findings from pilot studies of sustained oxytocin treatment in ASD to develop an optimized intranasal form of oxytocin that we expect will be well tolerated. We hypothesize that oxytocin will increase social orienting and the value of social rewards in children with ASD, thus leading to enhanced social motivation and improvement in ASD's core social and communication symptoms. The ACE SOARS Network will rigorously test this hypothesis by conducting SOARS-B, a large (n=300), randomized double-blind, placebo-controlled trial of sustained (6 month), flexibly-dosed intranasal oxytocin treatment for improving reciprocal social behaviors in children 3-17 years old with ASD. We will enroll at least 142 participants who are low-functioning (significant language impairment and intellectual disability with nonverbal IQ < 70) and at least 142 who are high functioning(fluent phrase speech and nonverbal IQ > 70). After completing double-blind treatment, every participant will be treated with open-label oxytocin for six months to more fully assess safety and functional benefits that may emerge with longer treatment. We will identify clinical characteristics (such as age or verbal fluency) and biological factors (such as level of methylation of the oxytocin receptor gene OXTR) that preferentially influence oxytocin response. We also will describe changes in OXTR methylation and mRNA expression of genes relevant to oxytocin signaling in ASD that occur in response to oxytocin or placebo treatment to facilitate future development of novel treatments. In sum, SOARS-B will definitively test oxytocin,an extremely promising biological treatment for ASD's core social symptoms.
NDAR
Enrolling
Shared
$11,764,242.00
255
576
229
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NIH - Extramural None


U01HD073984-01 Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B) 09/04/2012 05/31/2017 576 229 DUKE UNIVERSITY $11,764,242.00

Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

Experiments

To create a new Omics, eye tracking, fMRI, or EEG experiment, press the "+ New Experiment" button. Once an experiment is created, then raw files for these types of experiments should be provided, associating the experiment – through Experiment_ID – with the metadata defined in the experiments interface.

IDNameCreated DateStatusType
No records found.

Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

Shared Data

Data structures with the number of subjects submitted and shared are provided.

ACE Subject Medical History Clinical Assessments 250
ACE Subject Physical Exam Clinical Assessments 250
Autism Diagnostic Interview, Revised (ADI-R) Clinical Assessments 114
Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) - Module 1 Clinical Assessments 72
Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) - Module 2 Clinical Assessments 65
Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) - Module 3 Clinical Assessments 93
Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) - Module 4 Clinical Assessments 29
Mullen Scales of Early Learning Clinical Assessments 55
Research Subject Clinical Assessments 250
Stanford-Binet Intelligence Scales, Fifth Edition (SB5) Clinical Assessments 200
Vital Signs Clinical Assessments 251

Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

Publications

Publications relevant to NDAR data are listed below. Most displayed publications have been associated with the grant within Pubmed. Use the "+ New Publication" button to add new publications. Publications relevant/not relevant to data expected are categorized. Relevant publications are then linked to the underlying data by selecting the Create Study link. Study provides the ability to define cohorts, assign subjects, define outcome measures and lists the study type, data analysis and results. Analyzed data and results are expected in this way.

PubMed IDStudyTitleJournalAuthorsDateStatus
25182180Create StudyIntervention in the context of development: pathways toward new treatments.Neuropsychopharmacology : official publication of the American College of NeuropsychopharmacologyVeenstra-VanderWeele, Jeremy; Warren, ZacharyJanuary 2015Not Relevant
help.tab.dataexpected

Relevant Publications
PubMed IDStudyTitleJournalAuthorsDate
No records found.
help.tab.dataexpected.addnew
Data Expected
Data ExpectedTargeted EnrollmentInitial SubmissionSubjects SharedStatus
Research Subject and Pedigree info iconApproved
Stanford Binet info iconApproved
Social Responsiveness Scale (SRS) info iconApproved
ADI-R info iconApproved
Vital Signs Assessment info iconApproved
ABC Community info iconApproved
ADOS info iconApproved
Caregiver Strain Questionnaire info iconApproved
Child and Adolescent Symptom Inventory (CASI) info iconApproved
Medical History info iconApproved
Medication List info iconApproved
Mullen Scales of Early Learning info iconApproved
PDD Behavior Inventory (PDDBI) info iconApproved
Physical Exam info iconApproved
Vineland (Parent and Caregiver) info iconApproved
Clinical Global Impression (CGI) info iconApproved
Reading the Mind in the Eyes info iconApproved
Adverse Event (AE) and Serious Adverse Event (SAE) info iconApproved
genomics/omics info iconApproved
Structure not yet defined

Collection Owners and those with Collection Administrator permission, may edit a collection. The following is currently available for Edit on this page:

Associated Studies

Studies that have been defined using data from a Collection are important criteria to determine the value of data shared. The number of subjects column displays the counts from this Collection that are included in a Study, out of the total number of subjects in that study. The Data Use column represents whether or not the study is a primary analysis of the data or a secondary analysis. State indicates whether the study is private or shared with the research community.

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