Clinical Core

Who make up the Clinical Core and what do they do?

The Clinical Core is made up of the Director of the Clinical Core (Monica Calkins, Ph.D.), the Clinical Research Manager (CRM; Sage Rush-Goebel, M.S.Ed.), and the coordinators who administer clinical assessments (also referred to as clinical assessors, raters, or interviewers). The Clinical Core is responsible for overseeing the clinical assessments administered in our section. The Director and CRM conduct training and didactic sessions, offer supervision to assessors/raters, design and implement clinical assessments in our databases, and manage the clinical data.

What are clinical assessments?

Clinical assessments (also referred to as clinical interviews) are used in research to evaluate symptoms, functioning, and outcome variables, and can allow for making research-grade diagnoses based on the American Psychiatric Association’s (APA's) Diagnostic and Statistical Manual for Mental Disorders (DSM). Clinical data are related to other data such as MRI, cognition, or biomarkers.

There are many different clinical interviews that assess different domains, such as symptoms of depression, mania, anxiety, substance use, etc. There are also different ways we administer assessments.

Some assessments are administered as "structured" interviews in which the rater can only ask the questions that are listed in the order they are listed and with the exact wording written on the instrument. As such these types of interviews require little clinical skill.
There are also "unstructured" interviews where there are general guidelines for content areas but questions, their timing, order and so on are not scripted and as such require a high degree of clinical training and skill. These types of interviews are often used in clinical settings with patients and are rarely used in research with the exception of a Natural Language Processing (NLP) interview.
Lastly, there are "semi-structured" interviews, which are in between structured and unstructured. There are predetermined questions that the rater must ask verbatim but also the rater needs to ask additional clinical probes that are not written to make necessary ratings and gather information needed to solidify a diagnosis. These types of interviews require a good amount of clinical training and skill.

Which clinical assessments does the Neurodevelopment & Psychosis section use?

The clinical assessments we use in our section examine psychiatric symptoms such as depression, mania, psychosis, and substance use, and personality traits in children, adolescents, and adults. We currently administer the below clinical assessments and offer training services for them. If your protocol is planning to use a clinical assessment/interview that is not on the below list, please do not hesitate to reach out to the Director and CRM with training or implementation needs.

CAPA (Computer Assisted Psychopathology Assessment): The CAPA is a compilation of semi-structured instruments and scales designed to assess the presence/absence of DSM disorders (current/past) as well as the presence/absence of sub-threshold symptoms of psychosis via the SIPS (Structured Interview for Psychosis-Risk Syndromes). We currently focus on ADHD, depression, mania, psychosis, PTSD, and substance use disorders, though there are sections on anxiety as well, though less commonly used due study protocol or due to time constraints. The CAPA is often preferred over the SCID (see below) for kids and adolescents, and has been validated for ages 8 and up. When the CAPA is used with ages 8-10, only a collateral informant (i.e., parent or legal guardian) completes the interview, for ages 11-17 both the proband (i.e., the research participant) and collateral complete it, and for 18 and older typically only the proband completes the CAPA.
SCID (Structured Clinical Interview for DSM Disorders): The SCID is a semi-structured interview for making diagnoses according to the diagnostic criteria published in the DSM. With the release of the fifth edition (DSM-5), the SCID for DSM-5 (SCID-5) was published in 2013 and is the latest version available. Our protocols utilizing the SCID currently access it through purchasing a license with NetSCID Telesage. You can read more about NetSCID and purchasing here: https://telesage.com/netscid-5/
PSYCHS (Positive Symptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS): The PSYCHS is a new (as of 2022) CHR assessment that will likely become more widely used in the future. It includes 15 positive items (P1-P15) and allows you to formulate CHR groupings based on SIPS criteria and CAARMS criteria.
GOASSESS: The GOASSESS is a highly structured comprehensive screener for many domains of psychopathology ranging from depression, mania, anxiety disorders, eating disorders, externalizing disorders such as ODD and Conduct and so on. Similar to the CAPA, the GOASSESS has been validated for ages 8 and up. When the GOASSESS is used with ages 8-10, only a collateral informant (i.e., parent or legal guardian) completes the interview, for ages 11-17 both the proband (i.e., the research participant) and collateral complete it, and for 18 and older typically only the proband completes the GOASSESS. There are current efforts underway in assessing the validity of using the GOASSESS with a younger population.
CAINS (Clinical Assessment Interview for Negative Symptoms): The CAINS includes items assessing motivation, pleasure and emotional expression.
PANSS (Positive and Negative Syndrome Scale): The PANSS is widely used in clinical trials of schizophrenia and other disorders and is considered the "gold standard" for assessment of antipsychotic treatment efficacy. It measures positive and negative symptoms of psychosis, and other general areas such as mood, motor, and anxiety symptoms.
CDSS (Calgary Depression Scale for Schizophrenia): The CDSS is a 9-item interview that was designed to specifically assess depression independently of symptoms of psychosis in schizophrenia. Items measure depression symptoms such as mood, guilt, sleep, and suicidal ideation.
C-SSRS (Columbia Suicide Severity Rating Scale): The C-SSRS is a quick and efficient way to measure suicidal thinking and behavior. There is a free online training that can be accessed here: https://cssrs.columbia.edu/training/training-research-setting/
Global Assessment of Functioning (GAF): The GAF is a scale used to rate the severity of illness and measures how much a person's symptoms affect their daily life such as their social or role functioning on a scale of 0 to 100. Higher scores represent higher functioning. Typically the GAF can be rated based on information collected in other parts of an interview. In our section, we use the SIPS GAF with the CAPA, and the C-GAS for the GOASSESS.
Social and Occupational Functioning Assessment Scale (SOFAS): The SOFAS is similar to the GAF in that it is a scale used to measure a person's functioning on a 0 to 100 scale. It differs from the GAF by focusing on social and occupational functioning independent of overall severity of the individuals' psychological symptoms, and it includes impairments that are caused by both physical and mental disorders thereby making it a useful assessment tool for traumatic brain injury and other neurological disorders.
Global Functioning: Role (GF: Role) and Global Functioning: Social (GF: Social): The GF: Role and GF: Social are brief and easy to use interviews that assess role and social functioning independently of one another unlike the GAF and SOFAS. These interviews assess for functional impairments and/or declines over a specified period of time.
FIGS (Family Interview for Genetic Studies): In this interview, participants are asked to provide information on their family mental health history, typically for their first degree relatives. Please note that CHOP and Penn have different guidelines on what information can be collected during the FIGS, bringing up the issue that family members did not consent to release information about their mental health history in the current study.
BPRS (Brief Psychiatric Rating Scale): The BPRS is another common scale used in schizophrenia research and clinical trials. It measures a wide range of symptoms and experiences such as somatic concern, anxiety, depression, suicidality, positive symptoms, etc. It also has a number of items that are based solely on the rater's observation such as affect, emotional withdrawal, distractibility, etc.
NSI-PR (Negative Symptoms Inventory-Psychosis Risk): The NSI-PR was designed to assess negative symptoms in a Prodromal/Clinical High Risk for Psychosis population. It includes 5 domains: avolition, asociality, anhedonia, blunted affect, and alogia.
Self-report scales: Our section also utilizes a number of different self-report scales to assess psychopathology symptoms, environmental risk factors, substance use, among other areas of interest. We have a common battery of self-report scales, which is a fixed order battery that was implemented in many projects around 2018 onwards. We are also working on developing a new LiBI battery of recommended self-report measures.

Clinical training

The Clinical Core conducts comprehensive training programs to ensure high reliability, validity, and standardization across raters (also referred to as assessors or interviewers). Training is tailored to the specific clinical assessment; however, it generally follows the below procedure:

Trainee reviews pre-training materials such as assigned readings, interview manuals (if applicable), and gaining familiarity with the interview
Trainee attends didactic sessions, including section by section or item by item review of the assessment or scale
Trainee completes training exercises - group and individual
Mock sessions with colleagues or peers (where the trainee practices the interview)
Supervised mock sessions with the CRM (where the trainee practices the interview with the CRM who provides real-time feedback and guidance)
Trainee completes what are referred to as "observations" where the trainee administers the interview to real participants with either the Director or CRM observing. Each observation is followed by a 1-2 hour feedback session where the observer provides feedback, guidance, rating and diagnoses (if applicable) review, and answers any questions.

The number of observation sessions needed for certification depends on the type of clinical interview (e.g., structured versus semi-structured). Structured interviews require less observations than semi-structured interviews and therefore typically take less time for trainees to be certified. Training time ranges from 1-6 months depending on a variety of factors such as the trainee's progress, participants showing up for scheduled appointments, participants endorsing enough symptoms for the observer to evaluate the trainee and so on.

After certification, raters/assessors are re-observed to ensure administration is conducted in a reliable, valid, and standardized manner every 6-12 months.

Clinical data review process

For structured interviews such as GOASSESS the rater is responsible for reviewing the item level data ensuring accuracy and completion. There is also a peer review process that adds a more thorough review of the data, ensuring the utmost accuracy and completion.

For briefer interviews such as the BPRS, PANSS or CDSS, the rater is responsible for reviewing the item level data and reaching out to their PI or the CRM if they have questions on ratings.

For diagnostic assessments such as CAPA or SCID there are two forms of "case" review:

Case Conference: Case Conference is where we come to a consensus on ratings and diagnoses for pts that are meeting for psychotic disorders or are meeting Prodromal/Clinical High Risk criteria. Psychologists, psychiatrists, raters/assessors, and students meet every week to review such cases.
Low Risk Review (LRR; i.e., "Faculty Review"): LRR is conducted by assigned faculty with the help of the CRM or the protocol rater. Participants who do not meet CHR criteria or for a psychotic disorder are reviewed via LRR. For internal diagnostic interviews (e.g., CAPA, SCID), faculty should follow the below steps to complete the LRR process. For multi-site studies the review process is handled separately and per project.

Log onto the Neurospych REDCap Server (axis)
Click on "My Projects" towards the upper left-hand side
Go to "Common Interview Scales #collection" project
On the left-hand side, you will see "Reports" under the "Data Collection" and "Applications" tabs. Under the "Reports" tab, click on your respective protocol's LRR project e.g., Low Risk Review Report (Raquel), Low Risk Review Report (Monica), etc
Click on the link/number underneath "REDCap ID" to navigate to the record that needs review.
On the left-hand side, you will see all of the Interview Sections. Click “Narrative Summary Print” and review the summary (it will also include the assessor's diagnostic impression and ratings).
After reviewing the summary, navigate to the left-hand side again and click on "Review Documentation". There are 2 things you will need to edit/mark at the top of this page: 7a. Fill in the date of review (i.e., "Consensus Date") and check your name under "Consensus/Reviewing Faculty". 7b. Indicate whether you agree or disagree with the assessor's impressions. If you disagree, add what needs to be changed in the note field.
To close and exit, scroll to the bottom of the page and select Save & Exit Record (you may need to click on the drop down arrow and choose it there). Return to the report by following Step 4 and continue with the other records.

Clinical Core SOPs

The CRM does a general overview of the below SOPs found on Saturn for all raters/assessors during their BIT onboarding process.

Documentation (how to document note to files [NTF] and how to document interview responses and information during a clinical assessment): /new_directory_structure/clinical_assessment/sops/documentation_sop_[version date]
Interview Generation and Information (how to generate interview records and complete post-review steps): /new_directory_structure/clinical_assessment/sops/interview_generation_redcap_sop_[version date]
Self Report Generation and Information (how to generate self-report records and how to administer them): /new_directory_structure/clinical_assessment/sops/self_report_scales_sop_[version date]
Case Summary (how to prepare narrative summary reports after diagnostic assessments): /new_directory_structure/clinical_assessment/sops/case_summary_sop_[version date]
Clinical Incident Reporting (what to do when a participant reports suicidal/homicidal thinking or child abuse): /new_directory_structure/clinical_assessment/sops/clinical_incident_reporting_sop_[version date]
Feedback Scheduling (how to set up clinician feedback sessions with participant and/or their family): /new_directory_structure/clinical_assessment/sops/feedback_scheduling_sop_[version date]
GF: Role and GF: Social Interviews COVID Modifications_(adjustments that were made to administration and scoring of GF interviews during COVID-19 pandemic_: /new_directory_structure/clinical_assessment/sops/global_functioning_role_social_covid_mods_sop_[version date]
Peer Review Process (for interviews such as the GOASSESS there is a peer review process to ensure the utmost data accuracy and completion): /new_directory_structure/clinical_assessment/sops/clinical_interview_peer_review_sop_[version date]

General FAQ

My PI needs me to administer a clinical assessment. What do I do?

Either your PI can train you on the measure, or they can reach out to the Director and CRM requesting you be trained on the measure. We will work with you to get you trained and certified on the measure ASAP.

REDCap or the electronic platform I use for my assessment is down, what should I do?

It is critical that you always have back up paper copies of the interview or self-report measure so you can still administer them if technology fails. For self-report measures, however, if the participant is not onsite then you may need to reschedule the visit for when the platform is working.

What do I do if my participant reports suicidal thinking or behavior?

Please refer to the Clinical Incident Reporting SOP for information on what questions to ask, how to respond, who to contact, and so on.

Where does the clinical data live?

DSM-IV diagnoses are entered in Oracle under the "Diagnosis" table. DSM-5 diagnoses currently live in REDCap, though we are actively working on moving these to Oracle as well. SIPS data are entered in Oracle under the "Scales" table. NetSCID data is downloaded in reports and saved to Saturn or bblrepo.

I created an interview record in REDCap that I don't need anymore (e.g., pt no-showed, testing record), what should I do?

Please send a link to the record on the #clinical Slack channel and tag the CRM. They can delete it for you. As always, please double check that there is no data included in the record before requesting for it to be deleted.

Can we make diagnoses from the GOASSESS?

No. The GOASSESS is a highly structured interview that does not allow for additional clinical probing, as in semi-structured interviews, which is needed to make accurate, valid, and reliable diagnoses.

What interviews can provide diagnoses?

The CAPA, SIPS, PSYCHS, and SCID are considered to be "diagnostic assessments", which means they allow for research-grade DSM diagnoses to be made. It should be noted that the SIPS and PSYCHS are typically used in Prodromal/Clinical High Risk for Psychosis populations and the CHR "grouping" is not actually a DSM diagnosis.

CAPA specific questions

If a participant's PCP prescribes psychiatric medicine should I code that as yes to the question about mental health treatment under the General Probes section?

Yes. PCP's count under "...or some other professional" and it is important to capture that they have talked to a PCP about problems with their moods or behaviors, which led to the prescribed medication. You would need to clarify, however, the number of sessions with the PCP where they discussed problems with their mood or behaviors to accurately reflect the number of talk sessions related to mental or behavioral health problems.

SCID specific questions

GOASSESS specific questions

Important documentation notes

Beginning 12/19/2019 the Clinical Core began assigning DSM-5 diagnoses in addition to the DSM-IV diagnoses. All participants cased/reviewed on or after 12/19/2019 have an associated DSM-5 diagnosis(es). As of Spring 2022, clinical core and BIT are actively working on updating the Diagnosis Store in Oracle to enter the DSM-5 diagnoses there as well. For now, DSM-5 diagnoses can be found in the Common Interview Scales #collection project and Assessment & Diagnosis Entry #collection (depending on the protocol).
DSM-5-TR was released in March 2022. You can read about updated changes here: https://psychnews.psychiatryonline.org/doi/10.1176/appi.pn.2022.03.3.28 and https://www.psychiatry.org/newsroom/news-releases/apa-releases-diagnostic-and-statistical-manual-of-mental-disorders-fifth-edition-text-revision-dsm-5-tr On 5/2/2022, the new disorder "F43.8, Prolonged grief disorder" was added to the DSM-5 diagnosis table.
Beginning in February 2021, the Common Interview REDCap project underwent a version change for the Substance section. All protocols are using this new version - all of the variable names are the same with the exception of dsm_5 being added. One of the more significant changes from DSM-IV to DSM-5 included a reconstruction of how substance use disorders are classified. Under DSM-IV, it was classified as [substance] Abuse or [substance] Dependence. However, under DSM-5, it will now be classified as [substance] Use Disorder, mild, moderate, or severe. Abuse and Dependence are no longer used in DSM-5. Because of this DSM change, the way in which substance section was administered needed to be changed. Previously there was branching logic that prevented all of the questions from showing if they were not needed e.g., if a participant met criteria for substance dependence then the abuse questions did not need to be administered. The new DSM-5 substance version in REDCap was updated so that all abuse/dependence symptom questions appear for the assessor to ask. We began making changes to the section in May 2020; however, in January 2021, the BIT team realized this should have been a new version from the start. This means that there were some substantial changes made to the original DSM-IV substance section (specifically to the branching logic). It was not until February 2021 that assessors began using the DSM-5 substance sections.

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