NIMH Data Archive - Data

Genomics

Neuroimaging

Phenotype¹

New Trial
Clinical Trial

¹ Numbers reported are subjects by age

New Project
Grant/Project Number

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

Collection - Use Existing Experiment

To associate an experiment to the current collection, just select an axperiment from the table below then click the associate experiment button to persist your changes (saving the collection is not required). Note that once an experiment has been associated to two or more collections, the experiment will not longer be editable.

The table search feature is case insensitive and targets the experiment id, experiment name and experiment type columns. The experiment id is searched only when the search term entered is a number, and filtered using a startsWith comparison. When the search term is not numeric the experiment name is used to filter the results.

Select	Experiment Id	Experiment Name	Experiment Type	Created On

24	HI-NGS_R1	Omics	02/16/2011
475	MB1-10 (CHOP)	Omics	06/07/2016
490	Illumina Infinium PsychArray BeadChip Assay	Omics	07/07/2016
501	PharmacoBOLD Resting State	fMRI	07/27/2016
506	PVPREF	Omics	08/05/2016
509	ABC-CT Resting v2	EEG	08/18/2016
13	Comparison of FI expression in Autistic and Neurotypical Homo Sapiens	Omics	12/28/2010
18	AGRE/Broad Affymetrix 5.0 Genotype Experiment	Omics	01/06/2011
22	Stitching PCR Sequencing	Omics	02/14/2011
26	ASD_Methylation	Omics	03/01/2011
29	Microarray family 03 (father, mother, sibling)	Omics	03/24/2011
37	Standard paired-end sequencing of BCRs	Omics	04/19/2011
38	Illumina Mate-Pair BCR sequencing	Omics	04/19/2011
39	Custom Jumping Libraries	Omics	04/19/2011
40	Custom CapBP	Omics	04/19/2011
41	Immunofluorescence	Omics	05/11/2011
43	Autism brain sample genotyping, Illumina	Omics	05/16/2011
47	ARRA Autism Sequencing Collaboration at Baylor. SOLiD 4 System	Omics	08/01/2011
53	AGRE Omni1-quad	Omics	10/11/2011
59	AGP genotyping	Omics	04/03/2012
60	Ultradeep 454 sequencing of synaptic genes from postmortem cerebella of individuals with ASD and neurotypical controls	Omics	06/23/2012
63	Microemulsion PCR and Targeted Resequencing for Variant Detection in ASD	Omics	07/20/2012
76	Whole Genome Sequencing in Autism Families	Omics	01/03/2013
519	Resting	fMRI	11/08/2016
90	Genotyped IAN Samples	Omics	07/09/2013
91	NJLAGS Axiom Genotyping Array	Omics	07/16/2013
93	AGP genotyping (CNV)	Omics	09/06/2013
106	Longitudinal Sleep Study. H20 200. Channel set 2	EEG	11/07/2013
107	Longitudinal Sleep Study. H20 200. Channel set 3	EEG	11/07/2013
108	Longitudinal Sleep Study. AURA 200	EEG	11/07/2013
105	Longitudinal Sleep Study. H20 200. Channel set 1	EEG	11/07/2013
109	Longitudinal Sleep Study. AURA 400	EEG	11/07/2013
116	Gene Expression Analysis WG-6	Omics	01/07/2014
131	Jeste Lab UCLA ACEii: Charlie Brown and Sesame Street - Project 1	Eye Tracking	02/27/2014
132	Jeste Lab UCLA ACEii: Animacy - Project 1	Eye Tracking	02/27/2014
133	Jeste Lab UCLA ACEii: Mom Stranger - Project 2	Eye Tracking	02/27/2014
134	Jeste Lab UCLA ACEii: Face Emotion - Project 3	Eye Tracking	02/27/2014
145	AGRE/FMR1_Illumina.JHU	Omics	04/14/2014
146	AGRE/MECP2_Sanger.JHU	Omics	04/14/2014
147	AGRE/MECP2_Junior.JHU	Omics	04/14/2014
151	Candidate Gene Identification in familial Autism	Omics	06/09/2014
152	NJLAGS Whole Genome Sequencing	Omics	07/01/2014
154	Math Autism Study - Vinod Menon	fMRI	07/15/2014
155	Resting	fMRI	07/25/2014
156	Speech	fMRI	07/25/2014
159	Emotion	fMRI	07/25/2014
160	syllable contrast	EEG	07/29/2014
167	School-age naturalistic stimuli	Eye Tracking	09/19/2014
44	AGRE/Broad Affymetrix 5.0 Genotype Experiment	Omics	06/27/2011
45	Exome Sequencing of 20 Sporadic Cases of Autism Spectrum Disorder	Omics	07/15/2011

Collection - Add Experiment

Add Supporting Documentation

Funding Source:
URL:

To add an existing Data Structure, enter its title in the search bar. If you need to request changes, select the indicator "No, it requires changes to meet research needs" after selecting the Structure, and upload the file with the request changes specific to the selected Data Structure. Your file should follow the Request Changes Procedure. If the Data Structure does not exist, select "Request New Data Structure" and upload the appropriate zip file.

Use/Modify Existing Data Structure

Request New Data Structure

Targeted Enrollment:

Initial Submission Date:

Initial Share Date:

Data Structure Search:

Data Structures:

Submit

Request Submission Exemption

Not Eligible

The Data Expected list for this Collection shows some raw data as missing. Contact the NDA Help Desk with any questions.

Please confirm that you will not be enrolling any more subjects and that all raw data has been collected and submitted.

Collection Updated

Your Collection is now in Data Analysis phase and exempt from biannual submissions. Analyzed data is still expected prior to publication or no later than the project end date.

[CMS] Error

[CMS]

Unable to change collection phase where targeted enrollment is less than 90%

You have requested to move the sharing dates for the following assessments:

Data Expected Item	Original Sharing Date	New Sharing Date

Please provide a reason for this change, which will be sent to the Program Officers listed within this collection:

Explanation must be between 20 and 200 characters in length.

Please press Save or Cancel

Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program #2249

General
Experiments (0)
Shared Data
Publications (0)
Data Expected (21)
Associated Studies (7)

Collection Title	Collection Investigators	Collection Description
Collection Title:	Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Collection Investigators:	John Kane
Collection Description:	Schizophrenia is a major mental illness characterized by psychosis, negative symptoms (e.g., apathy, social withdrawal, anhedonia), and cognitive impairment. Depression and substance abuse commonly co-occur. These individuals have impaired functioning in the areas of work, school, parenting, self-care, independent living, interpersonal relationships, and leisure time. Among adult psychiatric disorders, schizophrenia is the most disabling, and its treatment accounts for a disproportionate share of mental health services. This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Early Treatment Program (ETP), is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. ETP is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services. The ETP study aimed to compare two early treatment interventions for adolescents and adults experiencing a first episode of psychosis. The clinical centers were randomly allocated to offer one of the two treatment programs. Both treatment interventions were designed to provide a person with treatment soon after he or she experienced the early signs of schizophrenia. Participants were offered mental health services such as medication and psychosocial therapy. These strategies were all aimed at promoting symptom reduction and improving life functioning. Participation in this study lasted between 2 and 3 years. All participants first underwent an initial video conference interview to confirm a diagnosis of schizophrenia, schizoaffective disorder, psychosis NOS, brief psychotic disorder, or schizophreniform disorder. Eligible participants were then offered mental health services. In addition to the mental health services, participants participated in a series of research interviews. Participants were interviewed every 3 months for the first 6 months and then every 6 months for up to 3 years. At the research visit, participants completed an interview about their symptoms and general quality of life, complete questions about experiences with their illness, their vital signs will be measured, and a blood draw will be collected. At the initial, 12 and 24 month visits, participants will also complete a brief test that assessed skills such as memory, attention and problem solving. Participants also had monthly telephone interviews about their illness and services that they have received.
Data Repository:	NIMH Data Archive
Permission Group:
Collection Creation Date:	01/06/2015
NIH Research Initiative:	NIMH Repository & Genomics Resource (NRGR)
Collection Phase:	Funding Completed
Collection Sub-Phase:	Close Out
Blinded Clinical Trial:	No
Subjects Shared:	404

{"values":[]}

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Funding Sources:

Funding Source Name	Funding Source URL
NIH - Contract	None

Supporting Documentation:

File Name	File Type	Description	Audience
Intent_to_Attend.xlsx	Background	Intent to Attend	Qualified Researchers
RAISE_ETP_Item_Level_Database_Documentation.pdf	Methods	Trial Overview	Qualified Researchers
ETP_Datasets_Summary_Assessments_NDCT.xlsx	Other	Assessments mapping	Qualified Researchers
NDA Note to Authorized Users on Data Variable Naming.docx	Methods	NDA Note to Authorized Users on Data Variable Naming	Qualified Researchers

Grant Information:

Clinical Trials:

Brief Summary	Status	Clinical Trial ID	Study ID	Principal Investigator	Start Date	End Date
The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.	Completed	NCT01321177	HHSN271200900019C	John Kane, MD	July 2010	July 2017

helpcenter.collection.general-tab

Collection - General Tab

Fields available for edit on the top portion of the page include:

Collection Title
Investigators
Collection Description
Collection Phase
Funding Source
Clinical Trials

Collection Phase: The current status of a research project submitting data to an NDA Collection, based on the timing of the award and/or the data that have been submitted.

Pre-Enrollment: The default entry made when the NDA Collection is created.
Enrolling: Data have been submitted to the NDA Collection or the NDA Data Expected initial submission date has been reached for at least one data structure category in the NDA Collection.
Data Analysis: Subject level data collection for the research project is completed and has been submitted to the NDA Collection. The NDA Collection owner or the NDA Help Desk may set this phase when they’ve confirmed data submission is complete and submitted subject counts match at least 90% of the target enrollment numbers in the NDA Data Expected. Data submission reminders will be turned off for the NDA Collection.
Funding Completed: The NIH grant award (or awards) associated with the NDA Collection has reached its end date. NDA Collections in Funding Completed phase are assigned a subphase to indicate the status of data submission.
- The Data Expected Subphase indicates that NDA expects more data will be submitted
- The Closeout Subphase indicates the data submission is complete.
- The Sharing Not Met Subphase indicates that data submission was not completed as expected.

Blinded Clinical Trial Status:

This status is set by a Collection Owner and indicates the research project is a double blinded clinical trial. When selected, the public view of Data Expected will show the Data Expected items and the Submission Dates, but the targeted enrollment and subjects submitted counts will not be displayed.
Targeted enrollment and subjects submitted counts are visible only to NDA Administrators and to the NDA Collection or as the NDA Collection Owner.
When an NDA Collection that is flagged Blinded Clinical Trial reaches the maximum data sharing date for that Data Repository (see https://nda.nih.gov/nda/sharing-regimen.html), the embargo on Data Expected information is released.

Funding Source

The organization(s) responsible for providing the funding is listed here.

Supporting Documentation

Users with Submission privileges, as well as Collection Owners, Program Officers, and those with Administrator privileges, may upload and attach supporting documentation. By default, supporting documentation is shared to the general public, however, the option is also available to limit this information to qualified researchers only.

Grant Information

Identifiable details are displayed about the Project of which the Collection was derived from. You may click in the Project Number to view a full report of the Project captured by the NIH.

Clinical Trials

Any data that is collected to support or further the research of clinical studies will be available here. Collection Owners and those with Administrator privileges may add new clinical trials.

Frequently Asked Questions

How does the NIMH Data Archive (NDA) determine which Permission Group data are submitted into?

During Collection creation, NDA staff determine the appropriate Permission Group based on the type of data to be submitted, the type of access that will be available to data access users, and the information provided by the Program Officer during grant award.
How do I know when a NDA Collection has been created?

When a Collection is created by NDA staff, an email notification will automatically be sent to the PI(s) of the grant(s) associated with the Collection to notify them.
Is a single grant number ever associated with more than one Collection?

The NDA system does not allow for a single grant to be associated with more than one Collection; therefore, a single grant will not be listed in the Grant Information section of a Collection for more than one Collection.
Why is there sometimes more than one grant included in a Collection?

In general, each Collection is associated with only one grant; however, multiple grants may be associated if the grant has multiple competing segments for the same grant number or if multiple different grants are all working on the same project and it makes sense to hold the data in one Collection (e.g., Cooperative Agreements).

Glossary

Administrator Privilege

A privilege provided to a user associated with an NDA Collection or NDA Study whereby that user can perform a full range of actions including providing privileges to other users.
Collection Owner

Generally, the Collection Owner is the contact PI listed on a grant. Only one NDA user is listed as the Collection owner. Most automated emails are primarily sent to the Collection Owner.
Collection Phase
The Collection Phase provides information on data submission as opposed to grant/project completion so while the Collection phase and grant/project phase may be closely related they are often different. Collection users with Administrative Privileges are encouraged to edit the Collection Phase. The Program Officer as listed in eRA (for NIH funded grants) may also edit this field. Changes must be saved by clicking the Save button at the bottom of the page. This field is sortable alphabetically in ascending or descending order. Collection Phase options include:
- Pre-Enrollment: A grant/project has started, but has not yet enrolled subjects.
- Enrolling: A grant/project has begun enrolling subjects. Data submission is likely ongoing at this point.
- Data Analysis: A grant/project has completed enrolling subjects and has completed all data submissions.
- Funding Completed: A grant/project has reached the project end date.
Collection Title

An editable field with the title of the Collection, which is often the title of the grant associated with the Collection.
Grant

Provides the grant number(s) for the grant(s) associated with the Collection. The field is a hyperlink so clicking on the Grant number will direct the user to the grant information in the NIH Research Portfolio Online Reporting Tools (RePORT) page.
Supporting Documentation

Various documents and materials to enable efficient use of the data by investigators unfamiliar with the project and may include the research protocol, questionnaires, and study manuals.
NIH Research Initiative

NDA Collections may be organized by scientific similarity into NIH Research Initiatives, to facilitate query tool user experience. NIH Research Initiatives map to one or multiple Funding Opportunity Announcements.
Permission Group

Access to shared record-level data in NDA is provisioned at the level of a Permission Group. NDA Permission Groups consist of one or multiple NDA Collections that contain data with the same subject consents.
Planned Enrollment

Number of human subject participants to be enrolled in an NIH-funded clinical research study. The data is provided in competing applications and annual progress reports.
Actual Enrollment

Number of human subjects enrolled in an NIH-funded clinical research study. The data is provided in annual progress reports.
NDA Collection

A virtual container and organization structure for data and associated documentation from one grant or one large project/consortium. It contains tools for tracking data submission and allows investigators to define a wide array of other elements that provide context for the data, including all general information regarding the data and source project, experimental parameters used to collect any event-based data contained in the Collection, methods, and other supporting documentation. They also allow investigators to link underlying data to an NDA Study, defining populations and subpopulations specific to research aims.
Data Use Limitations

Data Use Limitations (DULs) describe the appropriate secondary use of a dataset and are based on the original informed consent of a research participant. NDA only accepts consent-based data use limitations defined by the NIH Office of Science Policy.
Total Subjects Shared

The total number of unique subjects for whom data have been shared and are available for users with permission to access data.

Contact NDA Help Desk

ID	Name	Created Date	Status	Type
No records found.

helpcenter.collection.experiments-tab

Collection - Experiments

The number of Experiments included is displayed in parentheses next to the tab name. You may download all experiments associated with the Collection via the Download button. You may view individual experiments by clicking the Experiment Name and add them to the Filter Cart via the Add to Cart button.

Collection Owners, Program Officers, and users with Submission or Administrative Privileges for the Collection may create or edit an Experiment.

Please note: The creation of an NDA Experiment does not necessarily mean that data collected, according to the defined Experiment, has been submitted or shared.

Frequently Asked Questions

Can an Experiment be associated with more than one Collection?
Yes -see the “Copy” button in the bottom left when viewing an experiment. There are two actions that can be performed via this button:
1. Copy the experiment with intent for modifications.
2. Associate the experiment to the collection. No modifications can be made to the experiment.

Glossary

Experiment Status

An Experiment must be Approved before data using the associated Experiment_ID may be uploaded.
Experiment ID

The ID number automatically generated by NDA which must be included in the appropriate file when uploading data to link the Experiment Definition to the subject record.

Contact NDA Help Desk

Shared Data:

Title	Type	Number of Subjects
Abnormal Involuntary Movement Scale	Clinical Assessments	370
Autonomy Support Scale	Clinical Assessments	403
Beliefs about Medications and Psychotherapy	Clinical Assessments	399
Brief Assessment of Cognition	Clinical Assessments	402
COINS Medical History	Clinical Assessments	403
Calgary Depression Rating Scale	Clinical Assessments	404
Clinical Global Impression of Severity	Clinical Assessments	404
Clinical Lab Tests	Clinical Assessments	363
Fagerstrom Test for Nicotine Dependence	Clinical Assessments	404
Family Assessment Scale	Clinical Assessments	294
Medical Outcomes Survey SF-12	Clinical Assessments	404
Medications Adherence Form	Clinical Assessments	404
Medications Documentation Form	Clinical Assessments	404
Mental Health Recovery Measure	Clinical Assessments	404
Patient Chart Form	Clinical Assessments	404
Patient-Rated Inventory of Side Effects	Clinical Assessments	404
Psychological Well-Being Questionnaire	Clinical Assessments	404
Quality of Life	Clinical Assessments	404
Recovery Outcomes Assessment	Clinical Assessments	272
Self Rating Stigma Scale	Clinical Assessments	404
Service Utilization and Resources Monthly Form for Schizophrenia	Clinical Assessments	404
Service Utilization and Resources Quarterly Form for Schizophrenia	Clinical Assessments	404
Structured Clinical Interview for the Positive and Negative Syndrome Scale	Clinical Assessments	404
Substance Use Monthly Form	Clinical Assessments	404
Vital Signs	Clinical Assessments	402

helpcenter.collection.shared-data-tab

Collection - Shared Data

This tab provides a quick overview of the Data Structure title, Data Type, and Number of Subjects that are currently Shared for the Collection. The information presented in this tab is automatically generated by NDA and cannot be edited. If no information is visible on this tab, this would indicate the Collection does not have shared data or the data is private.

The shared data is available to other researchers who have permission to access data in the Collection's designated Permission Group(s). Use the Download button to get all shared data from the Collection to the Filter Cart.

Frequently Asked Questions

How will I know if another researcher uses data that I shared through the NIMH Data Archive (NDA)?

To see what data your project have submitted are being used by a study, simply go the Associated Studies tab of your collection. Alternatively, you may review an NDA Study Attribution Report available on the General tab.
Can I get a supplement to share data from a completed research project?

Often it becomes more difficult to organize and format data electronically after the project has been completed and the information needed to create a GUID may not be available; however, you may still contact a program staff member at the appropriate funding institution for more information.
Can I get a supplement to share data from a research project that is still ongoing?

Unlike completed projects where researchers may not have the information needed to create a GUID and/or where the effort needed to organize and format data becomes prohibitive, ongoing projects have more of an opportunity to overcome these challenges. Please contact a program staff member at the appropriate funding institution for more information.

Glossary

Data Structure

A defined organization and group of Data Elements to represent an electronic definition of a measure, assessment, questionnaire, or collection of data points. Data structures that have been defined in the NDA Data Dictionary are available at https://nda.nih.gov/general-query.html?q=query=data-structure
Data Type

A grouping of data by similar characteristics such as Clinical Assessments, Omics, or Neurosignal data.
Shared

The term 'Shared' generally means available to others; however, there are some slightly different meanings based on what is Shared. A Shared NDA Study is viewable and searchable publicly regardless of the user's role or whether the user has an NDA account. A Shared NDA Study does not necessarily mean that data used in the NDA Study have been shared as this is independently determined. Data are shared according the schedule defined in a Collection's Data Expected Tab and/or in accordance with data sharing expectations in the NDA Data Sharing Terms and Conditions. Additionally, Supporting Documentation uploaded to a Collection may be shared independent of whether data are shared.

Contact NDA Help Desk

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 NDA 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 ID	Study	Title	Journal	Authors	Date	Status
No records found.

helpcenter.collection.publications-tab

Collection - Publications

The number of Publications is displayed in parentheses next to the tab name. Clicking on any of the Publication Titles will open the Publication in a new internet browsing tab.

Collection Owners, Program Officers, and users with Submission or Administrative Privileges for the Collection may mark a publication as either Relevant or Not Relevant in the Status column.

Frequently Asked Questions

How can I determine if a publication is relevant?

Publications are considered relevant to a collection when the data shared is directly related to the project or collection.
Where does the NDA get the publications?

PubMed, an online library containing journals, articles, and medical research. Sponsored by NiH and National Library of Medicine (NLM).

Glossary

Create Study

A link to the Create an NDA Study page that can be clicked to start creating an NDA Study with information such as the title, journal and authors automatically populated.
Not Determined Publication

Indicates that the publication has not yet been reviewed and/or marked as Relevant or Not Relevant so it has not been determined whether an NDA Study is expected.
Not Relevant Publication

A publication that is not based on data related to the aims of the grant/project associated with the Collection or not based on any data such as a review article and, therefore, an NDA Study is not expected to be created.
PubMed

PubMed provides citation information for biomedical and life sciences publications and is managed by the U.S. National Institutes of Health's National Library of Medicine.
PubMed ID

The PUBMed ID is the unique ID number for the publication as recorded in the PubMed database.
Relevant Publication

A publication that is based on data related to the aims of the grant/project associated with the Collection and, therefore, an NDA Study is expected to be created.

Contact NDA Help Desk

Data Expected List: Mandatory Data Structures

These data structures are mandatory for your NDA Collection. Please update the Targeted Enrollment number to accurately represent the number of subjects you expect to submit for the entire study.

For NIMH HIV-related research that involves human research participants: Select the dictionary or dictionaries most appropriate for your research. If your research does not require all three data dictionaries, just ignore the ones you do not need. There is no need to delete extra data dictionaries from your NDA Collection. You can adjust the Targeted Enrollment column in the Data Expected tab to “0” for those unnecessary data dictionaries. At least one of the three data dictionaries must have a non-zero value.

Data Expected	Targeted Enrollment	Initial Submission	Subjects Submitted	Initial Share	Subjects Shared	Status
No Mandatory Data Expected

To create your project's Data Expected list, use the "+New Data Expected" to add or request existing structures and to request new Data Structures that are not in the NDA Data Dictionary.

If the Structure you need already exists, locate it and specify your dates and enrollment when adding it to your Data Expected list. If you require changes to the Structure you need, select the indicator stating "No, it requires changes to meet research needs," and upload a file containing your requested changes.

If the structure you need is not yet defined in the Data Dictionary, you can select "Upload Definition" and attach the necessary materials to request its creation.

When selecting the expected dates for your data, make sure to follow the standard Data Sharing Regimen and choose dates within the date ranges that correspond to your project start and end dates.

Please visit the Completing Your Data Expected Tutorial for more information.

Data Expected List: Data Structures per Research Aims

These data structures are specific to your research aims and should list all data structures in which data will be collected and submitted for this NDA Collection. Please update the Targeted Enrollment number to accurately represent the number of subjects you expect to submit for the entire study.

Data Expected	Targeted Enrollment	Initial Submission	Subjects Submitted	Initial Share	Subjects Shared	Status
Medical History	404	02/29/2016	404	07/15/2016	404	Approved
Abnormal Involuntary Movement Scale (AIMS)	404	02/29/2016	370	07/15/2016	370	Approved
Vital Signs Assessment	404	02/29/2016	402	07/15/2016	402	Approved
Quality of Life Assessment	404	02/29/2016	404	07/15/2016	404	Approved
Positive and Negative Syndrome Scale (PANSS)	404	05/09/2016	404	07/15/2016	404	Approved
Medications	404	02/29/2016	404	07/15/2016	404	Approved
Substance Use Survey	272	05/09/2016	404	07/15/2016	404	Approved
Treatment Form	404	05/09/2016	404	07/15/2016	404	Approved
Family Assessment Measure	404	02/29/2016	294	07/15/2016	294	Approved
Brief Assessment of Cognition	363	05/09/2016	402	07/15/2016	402	Approved
Clinical Lab Tests	399	05/09/2016	363	07/15/2016	363	Approved
Beliefs about Medications and Psychotherapy	404	02/29/2016	399	07/15/2016	399	Approved
Outcome Questionnaire	404	02/29/2016	272	07/15/2016	272	Approved
Satisfaction with Hospital Care Questionnaire	403	05/09/2016	403	07/15/2016	403	Approved
Calgary Depression Scale	363	05/09/2016	404	07/15/2016	404	Approved
Clinical Global Impression of Severity	404	05/09/2016	404	07/15/2016	404	Approved
Service Utilization and Resources Quarterly Form for Schizophrenia	404	02/29/2016	404	07/15/2016	404	Approved
Service Utilization and Resources Monthly Form for Schizophrenia	404	02/29/2016	404	07/15/2016	404	Approved
Recovery and Stigma	272	05/09/2016	404	07/15/2016	404	Approved
Psychological Well-Being Summary	404	02/29/2016	404	07/15/2016	404	Approved
Stigma Scale	404	05/09/2016	404	07/15/2016	404	Approved

Structure not yet defined

No Status history for this Data Expected has been recorded yet

helpcenter.collection.data-expected-tab

Collection - Data Expected

The Data Expected tab displays the list of all data that NDA expects to receive in association with the Collection as defined by the contributing researcher, as well as the dates for the expected initial upload of the data, and when it is first expected to be shared, or with the research community. Above the primary table of Data Expected, any publications determined to be relevant to the data within the Collection are also displayed - members of the contributing research group can use these to define NDA Studies, connecting those papers to underlying data in NDA.

The tab is used both as a reference for those accessing shared data, providing information on what is expected and when it will be shared, and as the primary tracking mechanism for contributing projects. It is used by both contributing primary researchers, secondary researchers, and NIH Program and Grants Management staff.

Researchers who are starting their project need to update their Data Expected list to include all the Data Structures they are collecting under their grant and set their initial submission and sharing schedule according to the NDA Data Sharing Regimen.

To add existing Data Structures from the Data Dictionary, to request new Data Structure that are not in the Dictionary, or to request changes to existing Data Structures, click "+New Data Expected".

For step-by-step instructions on how to add existing Data Structures, request changes to an existing Structure, or request a new Data Structure, please visit the Completing Your Data Expected Tutorial.

If you are a contributing researcher creating this list for the first time, or making changes to the list as your project progress, please note the following:

Although items you add to the list and changes you make are displayed, they are not committed to the system until you Save the entire page using the "Save" button at the bottom of your screen. Please Save after every change to ensure none of your work is lost.
If you attempt to add a new structure, the title you provide must be unique - if another structure exists with the same name your change will fail.
Adding a new structure to this list is the only way to request the creation of a new Data Dictionary definition.

Frequently Asked Questions

What is an NDA Data Structure?

An NDA Data Structure is comprised of multiple Data Elements to make up an electronic definition of an assessment, measure, questionnaire, etc will have a corresponding Data Structure.
What is the NDA Data Dictionary?

The NDA Data Dictionary is comprised of electronic definitions known as Data Structures.

Glossary

Analyzed Data

Data specific to the primary aims of the research being conducted (e.g. outcome measures, other dependent variables, observations, laboratory results, analyzed images, volumetric data, etc.) including processed images.
Data Item

Items listed on the Data Expected list in the Collection which may be an individual and discrete Data Structure, Data Structure Category, or Data Structure Group.
Data Structure

A defined organization and group of Data Elements to represent an electronic definition of a measure, assessment, questionnaire, or collection of data points. Data structures that have been defined in the NDA Data Dictionary are available at https://nda.nih.gov/general-query.html?q=query=data-structure
Data Structure Category

An NDA term describing the affiliation of a Data Structure to a Category, which may be disease/disorder or diagnosis related (Depression, ADHD, Psychosis), specific to data type (MRI, eye tracking, omics), or type of data (physical exam, IQ).
Data Structure Group

A Data Item listed on the Data Expected tab of a Collection that indicates a group of Data Structures (e.g., ADOS or SCID) for which data may be submitted instead of a specific Data Structure identified by version, module, edition, etc. For example, the ADOS Data Structure Category includes every ADOS Data Structure such as ADOS Module 1, ADOS Module 2, ADOS Module 1 - 2nd Edition, etc. The SCID Data Structure Group includes every SCID Data Structure such as SCID Mania, SCID V Mania, SCID PTSD, SCID-V Diagnosis, and more.
Evaluated Data

A new Data Structure category, Evaluated Data is analyzed data resulting from the use of computational pipelines in the Cloud and can be uploaded directly back to a miNDAR database. Evaluated Data is expected to be listed as a Data Item in the Collection's Data Expected Tab.
Imaging Data

Imaging+ is an NDA term which encompasses all imaging related data including, but not limited to, images (DTI, MRI, PET, Structural, Spectroscopy, etc.) as well as neurosignal data (EEG, fMRI, MEG, EGG, eye tracking, etc.) and Evaluated Data.
Initial Share Date

Initial Submission and Initial Share dates should be populated according to the NDA Data Sharing Terms and Conditions. Any modifications to these will go through the approval processes outlined above. Data will be shared with authorized users upon publication (via an NDA Study) or 1-2 years after the grant end date specified on the first Notice of Award, as defined in the applicable Data Sharing Terms and Conditions.
Initial Submission Date

Initial Submission and Initial Share dates should be populated according to these NDA Data Sharing Terms and Conditions. Any modifications to these will go through the approval processes outlined above. Data for all subjects is not expected on the Initial Submission Date and modifications may be made as necessary based on the project's conduct.
Research Subject and Pedigree

An NDA created Data Structure used to convey basic information about the subject such as demographics, pedigree (links family GUIDs), diagnosis/phenotype, and sample location that are critical to allow for easier querying of shared data.
Submission Cycle

The NDA has two Submission Cycles per year - January 15 and July 15.
Submission Exemption

An interface to notify NDA that data may not be submitted during the upcoming/current submission cycle.

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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.

Study NameFilter by Study Name	AbstractFilter by Abstract	Collection/Study SubjectsFilter by Collection/Study Subjects	Data UsageFilter by Data Usage	StateFilter by State
The Frequency of Symptom-Based Phenotypes of Mental Disorders is Long-Tailed	The heterogeneity of symptoms among individuals diagnosed with the same mental disorder has been blamed to hinder research in mental health and the development of effective treatments. Although widely acknowledged as problematic, the characteristics of this heterogeneity are largely unknown. We assessed the frequency of symptom phenotypes across a variety of clinical and non-clinical populations and found a consistent, long-tailed distribution. This distribution represents a mixture of a few very commonly expressed phenotypes and the sum of many, each only rarely displayed ones. As a consequence, the non-normality of this distribution induces a systematic bias, affecting all research and treatments relying on a symptom-based definition of mental disorders.	404/5743	Secondary Analysis	Shared
Causal Pathways to Social and Occupational Functioning in the First Episode of Schizophrenia: Uncovering Unmet Treatment Needs	We aimed to identify unmet treatment needs for improving social and occupational functioning in early schizophrenia using a data-driven causal discovery analysis. Demographic, clinical, and psychosocial measures were obtained for 279 participants from the Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) trial at baseline and six-months, along with measures of social and occupational functioning from the Quality of Life Scale. The Greedy Fast Causal Inference algorithm was used to learn a partial ancestral graph modeling causal relationships across baseline variables and six-month functioning. Effect sizes were estimated using a structural equation model. Results were validated in an independent dataset (N=187). In the data-generated model, greater baseline socio-affective capacity was a cause of greater baseline motivation (ES = 0.77), and motivation was a cause of greater baseline social and occupational functioning (ES = 1.5 and 0.96, respectively), which in turn were causes of their own six-month outcomes. Six-month motivation was also identified as a cause of occupational functioning (ES = 0.92). Cognitive impairment and duration of untreated psychosis were not direct causes of functioning at either timepoint. The graph for the validation dataset was less determinate, but otherwise supported the findings. Results from our data-generated model suggest baseline socio-affective capacity and motivation may be the most direct causes of occupational and social functioning six months after entering treatment in early schizophrenia. These findings indicate that social cognitive abilities and motivation are specific high-impact treatment needs that must be addressed in order to promote optimal social and occupational recovery.	404/591	Secondary Analysis	Shared
Impact of tobacco, alcohol and cannabis use on treatment outcomes among patients experiencing first episode psychosis: Data from the national RAISE-ETP study	The primary aim of this study was to examine the effect of recent tobacco, alcohol and cannabis use on treatment outcomes among participants experiencing first episode psychosis (FEP). Secondary data analyses were conducted on 404 participants enrolled in the Recovery After an Initial Schizophrenia Episode—Early Treatment Program (RAISE-ETP) study. RAISEETP investigated the effectiveness of a coordinated specialty care (CSC) intervention for FEP in community mental health agencies in the United States. Generalized estimating equations were used to examine whether recent tobacco smoking, alcohol, and cannabis use at baseline were associated with illness severity, number of antipsychotic pills missed, psychiatric symptoms and quality of life during the 24-month treatment period, after controlling for duration of untreated psychosis and treatment group. At baseline, roughly 50% (n = 209) of participants reported recent tobacco, 28% (n = 113) alcohol and 24% (n = 95) cannabis use. Tobacco smokers had higher levels of illness severity (β = .24; P < .005), a higher number of missed pills (β = 2.89; P < .05), higher psychiatric symptoms and lower quality of life during treatment relative to non-smokers. Alcohol users had a higher number of missed pills (β = 3.16; P < .05) during treatment and cannabis users had higher levels of illness severity (β = .18; P < .05) and positive symptoms (β = 1.56; P < .05) relative to non-users. Tobacco, alcohol and cannabis use are common in youth seeking treatment for FEP. Tobacco smoking was associated with more negative clinical outcomes. These findings have implications for including interventions targeting these areas of substance use within current CSC models.	404/404	Secondary Analysis	Shared
Racial-Ethnic Disparities in First-Episode Psychosis Treatment Outcomes From the RAISE-ETP Study.	Abstract OBJECTIVE: This study examined racial and ethnic differences in treatment outcomes among participants in a randomized controlled trial of an intervention for first-episode psychosis called NAVIGATE. METHODS: Secondary data analyses were conducted for participants randomly assigned to usual community care (N=181) and NAVIGATE (N=223). Generalized estimating equations assessed whether race and ethnicity were associated with psychiatric symptoms and service use (medication management, family psychoeducation, and individual therapy) over a 24-month treatment period, accounting for baseline symptoms, duration of untreated psychosis, and insurance status. RESULTS: Among persons in usual community care, non-Hispanic blacks scored significantly higher throughout treatment on measures of positive symptoms (β=2.15, p=.010), disorganized thoughts (β=1.15, p=.033), and uncontrolled hostility (β=.74, p=.027), compared with non-Hispanic whites, and non-Hispanic blacks were less likely than non-Hispanic whites to receive individual therapy (OR=.45, p=.001). Families of Hispanic participants in usual community care were less likely than non-Hispanic white families to receive family psychoeducation (OR=.20, p=.01). For NAVIGATE participants, race and ethnicity were not associated with differences in psychiatric symptoms over time; families of non-Hispanic black participants were less likely than those of non-Hispanic white participants to receive family psychoeducation (OR=.53, p=.009). Hispanic participants in NAVIGATE were more likely than non-Hispanic white participants to receive medication management (OR=2.93, p=.001). CONCLUSIONS: In usual community care, non-Hispanic blacks scored higher on measures of psychiatric symptoms and were less likely to receive important services, compared with non-Hispanic whites. In NAVIGATE, racial and ethnic differences in psychiatric symptoms were not evident, although non-Hispanic blacks were less likely than non-Hispanic whites to receive family psychoeducation.	404/404	Secondary Analysis	Shared
Smoking is related to reduced motivation, but not global cognition, in the first two years of treatment for first episode psychosis	Smoking is highly prevalent in people with psychotic disorders, even in the earliest phases of the illness. The neural mechanisms of nicotine dependence and psychosis overlap and may also be linked to deficits in neurocognition and motivation in psychosis. Both neurocognition and motivation are recognized as important clinical targets, though previous research examining the effects of smoking on these features has been inconsistent. Here we examine the relationships between smoking status and neurocognition and motivation over the first two years of treatment for psychosis through a secondary analysis of the Recovery After an Initial Schizophrenia Episode – Early Treatment Program (RAISE–ETP) dataset. In a sample of 404 individuals with first-episode psychosis, we examined linear mixed-effects models with the group (smoker vs. non-smoker) by time (baseline, 12-month, 24-month) interaction as a predictor of global cognition and motivation. While all individuals showed enhanced global cognition and motivation over the 24-month course of treatment, non-smokers showed significantly greater gains in motivation. These changes in motivation also corresponded to improvements in functioning over the 24-month period. No significant effects of smoking were observed for global cognition. Our findings suggest that motivation and smoking cessation may be important early treatment targets for first-episode psychosis programs.	404/404	Secondary Analysis	Shared
Suicidal Ideation in First-Episode Psychosis (FEP): Examination of Symptoms of Depression and Psychosis Among Individuals in an Early Phase of Treatment	First-episode psychosis (FEP) is a particularly high-risk period for suicide, in which risk elevates by 60% within a first year of treatment as compared to later stages of illness. To date, much of the literature has focused on individuals with a longer duration of psychosis; thus, there is an urgency for research to examine suicide risk among individuals in FEP in the beginning stage of treatment. This study aimed to identify the relationships between demographic characteristics, symptoms of depression, psychosis (particularly positive symptoms of psychosis), and suicidal ideation among individuals in FEP. Secondary data were obtained from National Institute of Mental Health’s Early Treatment Program of the Recovery After an Initial Schizophrenia Episode project (N = 404). Consistent with prior research, participants who experienced suicidal ideation during the study period reported having a longer duration of untreated psychosis and greater symptoms of depression. Further, positive symptoms of psychosis, namely hallucinations and delusions, were found to increase the odds of experiencing suicidal ideation. Findings point toward the implication that depression and positive symptoms of psychosis relate to the experience of suicidal ideation among individuals with a FEP and should be evaluated for and treated in the early stages of treatment.	404/404	Secondary Analysis	Shared
Trajectories of suicidal risk among individuals with first-episode psychosis: Relationship to recovery and symptoms	This study examined trajectories of suicide-risk and their relationship to symptoms, recovery, and quality of life over time. Data was obtained from the Recovery after an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) study. 404 individuals with first-episode psychosis (FEP) completed measures of suicide-risk, depression, positive symptoms, recovery, and quality of life at baseline, 6mo, 12mo, 18mo, and 24mo. Latent class analysis was used to identify temporal trajectories of suicide-risk. General linear mixed models for repeated measures were used to examine the relationship between the latent trajectories of suicide-risk and clinical variables. Results identified three latent trajectories of suicide-risk (low-risk, worsening, and improving). The low-risk and improving classes experienced improvements in depression, positive symptoms, quality of life, and recovery over time. The worsening class experienced improvements in positive symptoms and quality of life, but no change in depression or recovery. These results suggest that some individuals with FEP are at risk for persistent depression and worsening suicide-risk during treatment despite experiencing improvements in positive symptoms and quality of life. These findings have important clinical implications, as persistent depression and worsening suicide-risk might be masked by the primary focus on positive symptoms and quality of life in most FEP clinics.	404/404	Secondary Analysis	Shared

* Data not on individual level

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Collection - Associated Studies

Clicking on the Study Title will open the study details in a new internet browser tab. The Abstract is available for viewing, providing the background explanation of the study, as provided by the Collection Owner.

Primary v. Secondary Analysis: The Data Usage column will have one of these two choices. An associated study that is listed as being used for Primary Analysis indicates at least some and potentially all of the data used was originally collected by the creator of the NDA Study. Secondary Analysis indicates the Study owner was not involved in the collection of data, and may be used as supporting data.

Private v. Shared State: Studies that remain private indicate the associated study is only available to users who are able to access the collection. A shared study is accessible to the general public.

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Studies are associated to the Collection automatically when the data is defined in the Study.

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Associated Studies Tab

A tab in a Collection that lists the NDA Studies that have been created using data from that Collection including both Primary and Secondary Analysis NDA Studies.

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