Feasibility of an Early Detection Program for Early Psychosis on a College Campus
Conditions: Psychosis, First Episode Psychosis, Clinical High Risk for Psychosis
Sponsor: University of New Mexico

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
Page 1 of 19
Version Date: 7/05/2022
PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students 
PRINCIPAL INVESTIGATOR:
Name: Annette S. Crisanti, PhD
Department: Department of Psychiatry and Behavioral Sciences
Telephone Number: 808-895-3240
Email Address: acrisanti@salud.unm.edu
VERSION NUMBER: 10
VERSION DATE: 07/05/2022

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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Version Date: 7/05/2022
1.0
Objectives
Increased duration of untreated psychosis (DUP), defined as the time from 
manifestation of the first psychotic symptom(s) to initiation of evidence-based treatment, 
is associated with poorer clinical and functional outcomes (Fusar-Poli et al., 2009). 
Factors associated with longer DUP include perceived barriers to care among those 
experiencing psychotic-like symptoms and feelings of not being listened to or not being 
offered the opportunity to make decisions regarding treatment (referred to as shared-
decision making). The primary objective of our proposed study is to investigate the 
association between DUP and perceptions regarding barriers to care and shared-
decision making among college students. The secondary objective is to conduct a 
process evaluation of the inclusion of a screening tool (the Prodromal Questionnaire 
Brief- PQ-B developed by Loewy et al., 2011) during triage at University of New Mexico 
Student Health and Counseling Center (SHAC). SHAC implemented the PQ-B August 
1st, 2020 to improve quality of clinical services by identifying students at risk of first 
episode psychosis (FEP) and referring those identified at high risk to coordinated 
specialty care programs (i.e., Early and CONNECT) in the Department of Psychiatry and 
Behavioral Sciences, University of New Mexico. The Early Program is a coordinated 
specialty care program for the young adults experiencing first episode psychosis (FEP) 
while the CONNECT program provides stepped care to young individuals at clinical high 
risk (CHR) of developing psychosis. 
The specific aims are to:
1.
Measure DUP among University of New Mexico (UNM) college students enrolled in 
the Early or CONNECT Programs in the Department of Psychiatry and Behavioral 
Sciences and identify other factors that may contribute to longer DUP, such as 
perceptions relating to barriers to mental health care and shared decision-making. 
We hypothesize that there will be: (1) a positive association between DUP and the 
number of perceived barriers to care, and (2) a negative association between DUP 
and feelings of shared-decision making. 
2. Collect process level data related to the implementation of the PQ-B at SHAC, 
including the number of PQ-Bs completed by students at SHAC; the number of 
students who meet the cut-off score on the PQ-B; responses to specific items on the 
PQ-B; and basic demographic and clinical characteristics for those who complete the 
PQ-B [i.e., age, gender, ethnicity, level of education,  feelings of depression as 
measured by the Patient Health Questionnaire-9 (PHQ-9) and feelings around 
alcohol use as measured by the CAGE. CAGE stands for Cut, Annoyed, Guilty and 
Eye based on the four questions in the screening tool that indicates a substance 
abuse problem. The four questions include: (1) Have you ever felt you should cut 
down on your drinking? (2) Have people annoyed you by criticizing your drinking? (3) 
Have you felt bad or guilty about your drinking? And (4) have you ever had a drink 
first think in the morning to steady your nerves or to get rid of a hangover (eye-
opener)? All of these data are collected as part of standard clinical practice at triage 
among students seeking services at SHAC. Among those students who meet the 
cutoff, we are also interested in tracking the number of students who are referred to 
Early and CONNECT and, if not referred, the reasons for not being referred. 
2.0
Background
2.1 General Background. Clinical and general population studies on FEP have 
generated enough evidence to have confidence in three issues. First, the DUP is a 
strong predictor of outcome, such that current clinical recommendations are <3-6 months 

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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(Compton et al., 2008). Second, in the U.S., individuals are still presenting with DUP on 
average of two years (Marshall et al., 2005). Third, the reasons for treatment delay are 
multiple and complex (Apelodoorn et al., 2014). Various classifications have been 
developed to categorize the factors that contribute to an extended DUP. Compton and 
Broussard (2011) for example, identified six categories, including: (i) demographic, (ii) 
premorbid and onset-related, (iii) illness-related, (iv) family-level, (v) societal, and (vi) 
health system and service level factors. 
With the first symptoms of psychosis being most likely to surface around ages 15 to 24, 
college age young adults are at increased risk of FEP and CHR of psychosis (Kessler et 
al., 2007; Simon et al., 2017). Studies on the course of schizophrenia indicate that the 
initial onset of the disorder shows a steep increase during adolescence and young 
adulthood and then begins to decrease around the age of 25 (Hafner et al., 1993; Sham 
et al., 1994). Simon et al., (2017) reported a FEP incidence rate of 86 per 100,000 
among ages 15-29 compared to 46 per 100,000 among 30-59 across a variety of care 
settings. There are other environmental risk factors unique to college students that may 
increase risk of psychosis and contribute to increased DUP. First, attending college can 
be a stressful time for many students, learning to live independently and handle college 
level work load. Second, there are higher rates of illicit and prescription drug use among 
college students. Third, lack of identification of mental health symptoms and/or treatment 
have surfaced as system-level challenges on college campuses. This contributes to the 
persistence of mental health problems among students, partly due to the under-
resourcing of college mental health services in relationship to needs. Lastly, many 
college students are in the process of transitioning between adolescence to adulthood 
and may be less likely to recognize when to seek help or to feel comfortable with 
accessing services independent of family support. 
Screening has been shown to be a valid and reliable way of identifying individuals at 
high risk of psychosis, and those who have a higher likelihood of transition to psychosis 
in various contexts for clinical referral (Jarrett et al., 2012; Kline and Schiffman, 2014). 
When Rietdijk and colleagues screened all individuals between the ages of 18 and 35 
entering secondary mental health services for non-psychotic conditions with the 
Prodromal Questionnaire (PQ) 92-item version, a three-fold higher prevalence of at-risk 
mental states was detected among the population that was universally screened 
compared to a population that was referred to a diagnostic center of an early psychosis 
clinic based on clinical concerns alone (Rietdijk et al., 2012). Studies on the 
effectiveness of screening for psychosis among college students are scarce. Loewy et 
al., assessed the rates of self-reported “prodromal” psychotic symptoms and related 
distress among 1,020 college students at a university in California using the PQ 92-item 
version (Lowey et al., 2007). Forty-three percent of students reported ≥ 8 items (the 
suggested cutoff from the initial PQ validation study). The proportion was 2% when the 
cutoff was modified to ≥8 items rated as distressing (the addition of a distress qualifier is 
intended to improve specificity and thereby reduces the number of false positives). A 
Chinese version of the PQ-16 was used to determine the prevalence of attenuated 
psychotic syndrome among 579 college students in China (Chen et al., 2014). Using a 
cutoff of ≥ six, 9.3% screened positive. Among 49 who completed a follow-up interview, 
20 (40%) met the criteria for a prodromal risk syndrome as per the Structured Interview 
for Psychosis-Risk Syndrome (SIPS) diagnostic criteria. 

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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2.2 Scientific Rational. 
Little is known about DUP among college students. Our research will fill this gap. 
With respect to barriers to care, research has shown that as high as 85% of college-age 
students do not seek treatment when experiencing a mental health problem (Blanco et 
al., 2008) despite estimates of mental health problems among college students ranging 
from 9% to 33% (Hunt and Eisenberg, 2010). Not engaging in treatment for mental 
health problems can significantly interfere with educational outcome (Eisenberg et al., 
2009).  There are numerous barriers that hinder access to mental health services, 
especially for college age young adults. Barriers include, for example, stigma, negative 
attitudes about treatment providers, poverty, lack of symptom recognition, lack of 
knowing where to get help, lack of transportation, and feelings of disempowerment 
(Jennings et al., 2017). Furthermore, in the literature on why people fail to engage or 
disengage from care, not feeling listened to and not being offered the opportunity to 
make decisions and collaborate in treatment (O’Brien et al., 2009) have been identified 
as contributors. Indeed, shared-decision making, an approach to providing person-
centered care, has been shown to be a critical factor associated with engagement in 
coordinated specialty care for first episode psychosis (Hamilton et al., 2018; Heinssen et 
al., 2014). The goal will be to transfer what we learn about perceived barriers to care and 
shared-decision making into practice by developing strategies or interventions to reduce 
the modifiable barriers or increase feelings of shared-decision making so that fewer 
college students will go without necessary mental health care and specialty services.
 
While research on screening for first episode psychosis among college students is 
limited, in general behavioral health-related screening (e.g., for depression, suicidal 
ideation, alcohol use) among college populations has proven to be effective and to 
increase access to care (Shepardson et al., 2014).  As summarized by Savill et al., 
“Screening for psychosis may represent a fast, effective solution to identification of early 
psychosis, without the need for additional expertise” (pg. 689) Savill et al., 2018). 
2.3. Contribution to the Literature. Upon successful completion of the proposed 
research, we expect our contribution to the literature to be preliminary data on DUP 
among college students and perceptions regarding barriers to receiving mental health 
care and shared-decision making.
The quality improvement data will also contribute to the literature on screening for first 
episode psychosis among a college population. 
3.0  Inclusion and Exclusion Criteria
3.1 Screening for Eligibility. Screening will be conducted among UNM college students 
who present to either Early Program or the CONNECT Program, Department of 
Psychiatry and Behavioral Sciences for an intake assessment. The Early Program is a 
coordinated specialty care program for the young adults experiencing a FEP while the 
CONNECT program provides stepped care to young individuals at clinical high risk of 
developing psychosis. Evidence of psychosis or psychosis risk syndrome will be 
assessed during the intake visit through a clinical assessment and the Structured 
Interview of Prodromal Symptoms (SIPS) (Miller et al., 2003) The SIPS will be 
completed by Early or CONNECT Program clinicians, who are certified in its 
administration. The SIPS is a structured diagnostic interview and includes the Scale of 

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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Prodromal Symptoms (SOPS); Schizotypal Personality Disorder Checklist, a family 
history questionnaire and a well-anchored version of the Global Assessment of 
Functioning Scale. The SIPS takes approximately 60-90 minutes to complete depending 
on clinical status. Those determined eligible for either program based on the clinical 
assessment and SIPS will be invited to participate in the study.  A copy of the SIPS has 
not been included as attachments as it is a   copyrighted instruments. More information 
about the SIPS can be found on the Prime Psychosis Prodrome Research Clinic 
website. 
https://medicine.yale.edu/psychiatry/research/programs/clinical_people/prodome.aspx?o
rganizationId=109519. 
It is important to note that patients who enter either program may complete other clinical 
assessments as part of standard clinical care. While results from these assessments will 
not be used to determine eligibility for this study, they may be used in the proposed 
study to describe the study population. We will be asking permission to use the data 
from these standard clinical assessments through the consent process.
3.2 Inclusion and Exclusion Criteria. Eligible participants included in the study will be: (1) 
15-30 year-old UNM college students who present to the UNM Early Program or the 
UNM CONNECT program for an intake, (2) who screen positive for clinical high risk or 
FEP , and (3) agree to participate in the study. Participants will be excluded if: (1) they 
are below the age of 15 years old or above the age of 30, (2) are not UNM college 
students, (3) screen negative for clinical high risk or FEP, (4) refuse to participate in the 
study, and/or (5) are cognitively unable to provide informed consent as demonstrated by 
a brief cognitive screen prior to completion of the enrollment interview. Cognitive 
capacity to consent to research participation will be assessed by the research 
coordinator using the form included in Attachment 1 - Evaluation to Sign an Informed 
Consent Document for Research.  
There are no exclusion or inclusion criteria specific to the PQ-B screening tool 
implemented at SHAC. The triage process at SHAC has included universal 
screens for depression, anxiety and substance use for years. As of August 1st, 
2020, SHAC extended the universal screening to include risk of psychosis 
through the inclusion of the PQ-B. Universal screening means that all students 
who seek counseling services at SHAC complete the PQ-B at triage. 
Inclusion of Special Populations. 
Adults unable to consent: Those determined unable to provide consent through the brief 
cognitive screen in Attachment 1 will not be enrolled in the study (see Attachment 1 - 
Evaluation to Sign an Informed Consent Document for Research).  
Individuals who are not yet adults (infants, children, teenagers): While we expect the 
majority of participants to be between 18 and 30, participants as young as 15 may be 
enrolled into the study. Participants younger than 18 will indicate their assent to 
participate in the study by signing a child assent form, which will be co-signed by a 
parent or legal guardian (See consent form). Both the child and the parent/ legal 
guardian must consent for the participants between the ages of 15 and 17 to participate 
in the research. 

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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According to UNM main campus enrollment reports, approximately 1% of students are 
less than 18 years of age. While it will be unlikely that a student less than 18 years of 
age will complete the PQ-B the NM Statutes stipulate that “A child fourteen years of 
age or older has the right to consent to and receive individual psychotherapy, 
group psychotherapy, guidance counseling or other forms of verbal therapy and 
information regarding such counseling is confidential. This means that students 
ages 16 or 17who enter SHAC for counselling will be asked to complete the PQ-
B as part of standardized  SHAC triage process
Pregnant women: 
Pregnant women are not the focus of this study, and research deals with mental health 
issues of the young in general.
Students at SHAC may be pregnant when accessing counseling services. As a result, 
they may complete the PQ-B screening tool. There is no evidence to suggest that the 
completion of the screening tool will be harmful to pregnant women.
Prisoners:  Prisoners will not be included in the study.
Prisoners will not be completing the PQ-B screening tool. Only students seeking 
counseling services at SHAC will complete the screening tool.
4.0
Study-Wide Number of Subjects
Not Applicable - This is not a multicenter study – see Section 22 for number of subjects
5.0
Study-Wide Recruitment Methods
Not Applicable - This is not a multicenter study – see Section 21 for number of subjects
6.0
Multi-Site Research
Not Applicable - This is not a multicenter study
7.0
Study Timelines
7.1. Duration of an individual subject’s participation in the study. Participation in the 
study is brief. Data will only be collected at one time-point, which will be after the 
consent process. 
7.2. Duration of anticipated time to enroll all study subjects. It is expected that all 
participants will be enrolled by one year from the start of the study. 
7.3. Estimated date for the investigators to complete this study (complete primary 
analyses)
It is expected that data analyses will be ongoing throughout the study and that 
final analysis and publication of study data will occur in the 12-months following the end 
of study enrollment.
8.0
Study Endpoints
8.1 Primary and secondary study endpoints. This is not an outcome study, data will only 
be collected at one time-point, which will be immediately following the consent process. 
8.2
Primary or secondary safety endpoints. NA  

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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9.0
Procedures Involved
9.1
Overview of the study design. The study will use a correlational research design 
in which we will collect data for each participant only once.  
Overview of research procedures being performed and when they are performed. 
Participants will be recruited among UNM college students and who are determined 
eligible for the proposed study (see inclusion criteria Section 3.2).  Once determined 
eligible, individuals will be invited to participate in the research. Those who agree to 
participate will complete the consent process.  The research coordinator (Justine 
Saavedra) or PI (Dr. Crisanti) will be responsible for consenting the individual and data 
collection. Data will be collected through completion of standardized tools that have all 
been determined to be reliable, valid and appropriate for the study population (described 
in 9.3). Data will be collected either through (i) face to face interviews, (ii) phone, or (iii) 
HIPAA Compliant Zoom Account. These last two options have been put in place to 
accommodate the social distancing and public health stay at home orders that have 
been put in place by the NM Governor during COVID. Data will be collected after the 
consent process. We will aim to collect data at one point in time. However, due to the 
illness associated with the target population, we may need to split the interview over two 
time periods. Participants will be provided with a $20.00 amazon merchandise card per 
hour to standardized compensation across participants. We will always round up. For 
example: if a participant completes the surveys in 45 minutes we will give them a $20.00 
merchandise card; if a participant completes the surveys in an hour and a half we will 
give them two $20.00 merchandise cards.  
9.2  What data will be collected, including long-term follow-up. This is not an outcome 
study so no long-term follow-up data will be collected. Data will only be collected at one-
point, following the consent process. In addition to the SIPS, which will be completed by 
clinicians during the determination of eligibility process, participants will complete the 
instruments listed below. Noteworthy, is that during the consent process, we will ask 
students their permission to use their data collected during the determination of eligibility 
process as well as data from other standard clinical assessments that were conducted 
on intake. The following instruments will take approximately 2-3 hours to complete. 
Demographic Data: Basic demographic data will be collected on each participant, 
including city of birth, phone number and email (for future contact), current education 
year, date of birth, sex, gender, race and ethnicity. City of birth and full date of birth are 
required to obtain a Global Unique Identifier (GUID) in the NIMH Data Archive. A GUID 
is a subject ID allowing researchers to share data specific to a study participant without 
exposing personally identifiable information. A copy of the demographic form has been 
attached.
Structured Clinical Interview for DSM-5 (SCID-5) (First et al., 2015). The SCID-5 
Research Version will be used to confirm clinical diagnoses for all participants enrolled in 
the research study. Only the sub-units for psychosis, mood disorders, substance abuse 
and trauma-related disorders will be completed. The SCID-5 will be administered by the 
research coordinator who has been trained in its use and achieved sufficient reliability 
for research purposes. 
Duration of Untreated Psychosis (DUP) will be collected using the Circumstances of 
Onset and Relapse Schedule (CORS) (Norman and Malla, 2002). The CORS includes 

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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the Topography of Psychotic Episode (TOPE), which together traces the process of 
seeking treatment by identifying step-by-step contacts with medical and mental health 
services in the pathway toward contact with early psychosis services. The CORS 
protocol includes specific questions and follow-up prompts to help determine the onset 
of prodromal and psychotic symptoms and pathways to care (Attachment 2). The CORS 
has well established psychometric properties and takes approximately an hour to 
complete. It will be completed by the Research Coordinator or PI through semi-
structured interviews. While participants identified as at CHR for psychosis, by definition, 
would not yet have had a psychotic episode, we will similarly record onset of attenuated 
psychosis symptoms in order to better understand barriers and pathways to care for this 
group.
Barriers to care data will be collected using the Barriers to Seeking Psychological Help 
Scale (BSPHS) that was developed to measure barriers related to psychological help-
seeking for college students (Topkaya et al., 2017). The BSPHS is a self-report survey 
with established psychometric properties. It includes 17 items measured on a 5-point 
Likert-type scale ranging from strongly disagree to strongly agree (Attachment #3). The 
items are summed, and higher scores indicate higher obstacles. We added an open-
ended question to the BSPHS that provides an opportunity for participants to identify 
barriers not addressed, such as cultural beliefs that impede help-seeking. We 
determined this additional item to be important given the high prevalence of Hispanics, 
and to a lesser extent, Native Americans among our target population. The BSPHS 
takes approximately 5 minutes to complete.
Data on shared-decision making will be collected via the CollaboRATE Shared Decision 
Making in Clinical Encounters PhenX Measure (Barr et al., 2014; Forcino et al., 2018). 
CollaboRATE is a component of the PhenX Toolkit, a set of well-established and 
validated measures relevant to biomedical research chosen by consensus of domain 
experts and sponsored by National Institute of Health. CollaboRATE is self-administered 
and includes 3-items scored on a 5-point Likert-type scale. Higher scores indicate 
greater shared decision making. It takes about a minute to complete. A copy of 
CollaboRATE is attached (#4).
The PQ-B is completed during triage by all students seeking counseling services at 
SHAC. The PQ-B takes approximately 2-3 minutes to complete and is completed 
electronically. The PQ-B is a self-report checklist of symptoms associated with psychosis 
and psychosis risk syndromes. Respondents indicate whether they have had any of the 
21 thoughts, feelings and/or experiences in the past month by checking “yes” or “no”. 
They are asked to exclude any experiences that occurred only while under the influence 
of alcohol, drugs, or medications that were not prescribed to them. If respondents 
answer yes to any of the items, they are then asked to indicate how distressing that 
experience had been on a Likert-type scale ranging from “strongly disagree” to “strongly 
agree”.  Two scores are generated, a total PQ-B score and a total distress score. A copy 
of the PQ-B is attached. 
A counselor at SHAC (Mr. Ruben Zurita) will maintain and share a limited dataset with 
the research team which will include process level data related to the implementation of 
the PQ-B at SHAC. The limited data set includes two dates: the completion date of the 
PQ-B and, for those students who meet the cutoff on the PQ-B, the date of referral to 
Early and/or CONNECT. These dates are required in the process evaluation to be able 
to describe the number of PQ-Bs completed and referrals on a monthly basis.  A list of 
the variables that will be included in the limited dataset is attached. The variables 

PROTOCOL TITLE: Duration of Untreated Psychosis and Perceived Barriers to Mental 
Health Care Among College Students
HRRC#: 19-174
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selected will allow us to summarize, at an aggregate level, the number of PQ-Bs 
completed by students at SHAC; the number of students who meet the cut-off score on 
the PQ-B; responses to specific items on the PQ-B; and basic demographic and clinical 
characteristics for those who complete the PQ-B (i.e., age, gender, ethnicity, level of 
education, presence of co-occurring symptoms of depression as measured by the PHQ-
9, and signs for alcohol dependence as measured by the CAGE). Among those who 
meet the cut-off, the limited dataset will include information on who was referred to Early 
or CONNECT and among those not referred, the reasons for not being referred. 
Mr. Zurita will be responsible for assigning a unique identifier to every student at SHAC 
and this unique identifier will be entered into the excel spreadsheet that will be shared 
with the research team. The limited data set will be shared and stored on a shared drive 
created by HSC IT. The shared drive is located under the secure Psychiatry O: drive. 
Only Dr. Crisanti, Ms. Saavedra, Dr. McIver (SHAC, Counseling Director) and Mr. Zurita 
have access to this shared drive. The limited data set excel sheet is also password 
protected. 
A letter from Dr. Stephanie McIver, SHAC Counseling Director supporting this sharing of 
information has also been attached. 
A chart review will also be conducted for those students who were referred to 
CONNECT and completed a SIPS, but were then determined ineligible for enrollment in 
the program based on the results. These students were never enrolled in Early or 
CONNECT and were therefore never eligible to be enrolled in the R34 research project. 
We will access their EHR to get basic demographics such as sex, gender, race and 
ethnicity, age at assessment as well as the results of their SIPS assessment to 
determine why students were deemed ineligible. These limited deidentified data will be 
entered into a password protected excel spreadsheet.
One of the goals of this study is to determine if the Prodromal Questionnaire-Brief (PQ-
B) is an appropriate psychosis screening tool among a college population. We currently 
have three excel files that have been populated over the study period. 
The first excel file (referred to as the triage limited database) is maintained by SHAC. 
This excel file includes demographic (e.g., gender, age, ethnicity, program year) and 
clinical information (e.g., the results of the PQ-B, PHQ-9 and CAGE) of all students who 
complete the PQ-B.  To de-identify these data, SHAC assigns unique identifiers to 
students.
The second excel file (referred to as the secondary phone screen database) is 
maintained by the Department of Psychiatry and Behavioral Sciences. This excel file 
includes information on students who are referred to coordinated specialty care 
(CONNECT/Early) and who contacted the 888-referral number. 237 people in total called 
the 888-referral number. Of those 237 students, only 57% (n = 136) signed a Release of 
Information (ROI) which allowed us to look up their demographic and clinical data in the 
database maintained by SHAC. Because we do not have an ROI for 43% (N = 101), we 
are missing PQ-B scores, and other valuable demographic and clinical information. As a 
result, we are unable to fully understand the PQ-B scores among those students who 
are referred to coordinated specialty care, who ends up completing a secondary screen 
and who eventually gets enrolled. With missing information on demographic and clinical 
information (including the PQ-B) score on almost half of those students who reached out 

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Health Care Among College Students
HRRC#: 19-174
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for a secondary screen we will not be able to determine whether the Prodromal 
Questionnaire-Brief (PQ-B) is an appropriate psychosis screening tool among a college 
population (a primary goal of this research). 
The third  excel file includes 21 participants who were enrolled in the research arm of 
this study through the PQ-B screening. Nine of these  21 participants did not sign an ROI 
at SHAC to allow access to their PQ-B scores. This is a critical piece of data we need in 
order to get a full picture of how this screening tool identifies individuals at risk for 
psychosis. 
To address this limitation, we are proposing to use an honest broker process to merge 
all three databases  to\ allow us to fully understand what PQ-B scores indicate clinically 
within this population.  An honest broker is an IRB recommended practice for merging 
data. We have identified Dr. Tyler Kincaid (statistician and Department of Psychiatry and 
Behavioral Sciences faculty member) to serve as the honest broker. 
Using the master key with client names and unique identifiers for records in the triage 
limited database, the honest broker will be responsible for merging the three excel files 
to create a complete dataset.  Once completed, the final merged limited dataset- 
containing both initial screening information from SHAC, secondary screening 
information from Psychiatry and research data- will be stripped of any identifying 
information and returned to the study team.
10.0
Data and Specimen Banking
The Early Psychosis data repository will be used to store demographic and clinical 
information collected from consenting participants who agree to have their information 
stored in the data repository. This centralized database will store information for future 
unspecified use. In doing so, this will allow for a less burdensome and more efficient 
process for collecting information routinely utilized by all researchers. Consent for data 
to be included in the repository will be obtained during the consent process. Data will be 
stored for 20 years at which time the electronic repository and the database will be 
cleared. Re-consent will be attempted in person when those who already consented 
return for follow-up visits, if we can do so. For those that we can’t meet in person, we will 
re-consent by phone. Those who cannot be contacted, either in person or by phone will 
be flagged in the repository and data for these individuals will only be kept for 10 years.
The data from the process evaluation will NOT be stored in the Early Psychosis 
Repository.
11.0
Data and Specimen Management
11.1
Describe the data analysis plan, including any statistical procedures.  The goals 
of this study are to (1) measure DUP and perceptions regarding barriers to care and 
shared-decision making, and (2) conduct a process evaluation of the implementation of 
the PQ-B (a screening tool to identify risk of psychosis) at SHAC. Descriptive statistics 
(e.g., means, standard deviations, medians, quartiles) and summary statistics (for the 
process evaluation) statistics (will be calculated to summarize the characteristics of the 
student population,  to summarize instrument scores, and to summarize process data 
regarding the PQ-B at an aggregate level . DUP among those with FEP and duration of 

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Health Care Among College Students
HRRC#: 19-174
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attenuated symptoms among those with CHR will be reported in days as a mean and 
95% exact Poisson CIs. We will report the mean BSPHS summed scores and 95% CIs. 
11.2 Provide a power analysis, if necessary. Not Applicable
11.3
Steps that will be taken to secure the data to maintain confidentiality during 
storage, use, and transmission. To assure confidentiality all study personnel will be 
trained and certified in basic human subject’s research protections by the UNM HSC 
CITI Training Program. In addition, the PI will administer ongoing training and 
supervision of the research coordinator to assure confidentiality and privacy for 
participants and participant data. Hard copies of the consent will be separated from any 
hard copies of data and will be stored in a locked file cabinet in the Research 
Coordinator’s office located in the UNM’s Department of Psychiatry and Behavioral 
Sciences, Division of Community Behavioral Health (CBH). CBH is located at 4001 
Indian School Street, 87106. The PI also has an office at CBH. Only the PI and research 
coordinator will have keys to the locked file cabinet. Paper records may be kept for five 
years following the conclusion of the research. In addition, study records of minors (less 
than 18 years old) enrolled into the study will be retained until they turn 22 years old. 
Eventually, copies of the consents and contact information will be scanned and stored 
on the University’s secure O drive, under the Psychiatry folder for an additional five 
years at which time the information will be permanently deleted. The O drive is a domain 
share (health.unm.edu) that is setup between groups and users within this domain. 
Security for the O drive is controlled by login for the domain, with a username and 
password. Access to the O drive is controlled by UNM admins. As hardcopy data are 
collected, the research coordinator will transcribe the raw data to an electronic REDCap 
database. Data may also be collected directly via tablet into REDCAP databases. All 
REDCAP databases will be password protected and only the PI and research 
coordinator will have access to the data. Participants will be assigned a participant ID 
number at the first stage of data processing.  The participant ID number will be written at 
the top of paper symptom scales and only participant ID numbers will be entered into the 
electronic databases. Data will never be directly linked to participant identifying data. An 
electronic Access database with links between participant identifying information and ID 
numbers will be kept on the secure UNM HSC O-drive. Only research personnel will 
have access to those links.
The limited data set will be shared and stored on a shared drive created by HSC IT. The 
shared drive is located under the secure Psychiatry O: drive. Only Dr. Crisanti, Ms. 
Saavedra, Dr. McIver and Mr. Zurita have access to this shared drive. The limited data 
set excel sheet will also be password protected. 
Ms. Saavedra will be responsible for assigning a unique identifier to every student who 
received a SIPS assessment and did not qualify for enrollment and this unique identifier 
will be entered into the excel spreadsheet that will be shared with the research team. 
The limited data set will be shared and stored on a shared drive   created by HSC IT. 
The shared drive is located under the secure Psychiatry O: drive. Only research team 
members will have access to this shared drive. The limited data set excel sheet is also 
password protected.
The final merged limited dataset created by the honest broker will be housed under the 
secure Psychiatry O:drive in a password protected excel sheet. Only the research team 
will have access to the final dataset.

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11.4 Procedures that will be used for quality control of collected data: Double entry data 
transcription will be used when data are transcribed from paper-and-pencil forms to the 
electronic REDCap database. Standard REDCap data backup and data protections will 
be used during the electronic data storage phase.
12.0
Provisions to Monitor the Data to Ensure the Safety of Subjects
Not Applicable: The proposed research does not involve more than minimal risk to 
subjects.
13.0
Withdrawal of Subjects
13.1 Circumstances under which subjects will be withdrawn from the research without 
their consent
The only anticipated circumstances for which participants may be withdrawn from 
the study without their consent is if they indicate cognitive decline during the interview 
and no longer able to complete the measures.
Data for those individuals who withdraw from the study will continue to be used in 
the analysis unless participants notify the PI of wanted to withdraw their authorization 
through writing. Participants will be notified though the consent process of how to cancel 
their authorization. 
13.2 Procedures for orderly termination.
While this will be very unlikely in the proposed study, if the research coordinator 
or PI are concerned about the participant continuation in the study, they will terminate 
the  participation and explain to the participant the reasons for this action and, that their 
termination in the study does not impact their receipt of clinical services. 
13.3 Procedures that will be followed when subjects withdraw from the research
Participants are free to leave the study at any time, which will be communicated to 
them during the informed consent process. There is no penalty to participants for leaving 
the study. They will still be eligible for services in the EARLY or CONNECT programs. 
14.0
Risks to Subjects
14.1 Foreseeable Risks
The overall risk to subjects is thought to be very low for this study. Participants 
will be asked to share private information about their pathways to care and their 
symptoms that may be uncomfortable for them to discuss and share. Participants may 
also experience some anxiety or fatigue related to answering the questions in the 
survey. Participants will be monitored during the data collection process and will be 
given the opportunity to take breaks or reschedule data collection for another time if 
needed. The risk of a breach in confidentiality is also minimal. All study data will be de-
identified to minimize the risk of breach of confidentiality to participants. As a further 
protection, participant identifying information and study data will be stored separately. 
Only the PI and research coordinator will have access to participant identifying 
information. 
14.2 Procedures that may have risks to the subjects that are currently unforeseeable. 
Ongoing training and monitoring of participant confidentiality and data safety will 
occur in weekly staff meeting. If a breach of confidentiality is identified or suspected, the 
research coordinator will consult with the PI to address the issue, and the PI will report 

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HRRC#: 19-174
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the breach to the Psychiatry Department Research Committee and to the UNM HSC 
HRRC.  
14.3 Risks to an embryo or fetus should the subject be or become pregnant.
 NA  - there are no known risks to an embryo or fetus.
14.4 Risks to others who are not subject
NA
15.0
Potential Benefits to Subjects
15.1 Potential Benefits
There are no potential benefits for individuals who participate in this study. 
Participants will be eligible for services in the Early or CONNECT programs regardless 
of their participation.  
15.2 Indicate if there is no direct benefit. Do not include benefits to society or others.
No direct benefit
16.0
Vulnerable Populations
16.1 Although unlikely, participants may be under the age of 18. They will be protected 
from the possibility of coercion or undue influence by the inclusion of a parent or legal 
guardian in the consent process. In addition, parents and legal guardians may 
participate in the data collection process if they choose to do so. Another population that 
may vulnerable to coercion or undue influence are patients with diminished capacity or 
reasoning. Patients who do not have capacity to understand the nature of informed 
consent will be identified during the consent process and will not be admitted into the 
study.  
17.0
Community-Based Participatory Research
Not Applicable
18.0
Sharing of Results with Subjects
Statistical analysis and interpretation of group data will be made available to participants 
in community presentations and scientific journals. 
19.0
Setting
Determination of eligibility through the SIPS or SCID interviews will be conducted in the 
EARLY or CONNECT programs clinical offices located in the: (1) Psychiatric Research 
Building, (2) University Psychiatric Center, or (3) Cimarron Building. The consent 
process and completion of the instruments described in Section 9.3 above will occur in: 
(1) a private office at the Psychiatric Research Building, (2) a private office at CBH, or 
(3) a private location that is convenient for the participant which may include utilizing the 
clinical offices. At all times, sites for data collection will ensure privacy and 
confidentiality. 
20.0
Resources Available

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Research team members will have HRRC-required CITI Training, COI training, and 
HIPAA Compliance training. Dr. Lenroot, Clinical Director of both the Early and 
CONNECT programs (added to this study) will provide clinical consultation to the study. 
All scientific data analysis and publication of results will be done under the supervision of 
Dr. Crisanti.
Determination of eligibility will occur in Early and CONNECT programs treatment 
facilities designed to provide adequate privacy for patients and HIPAA-compliant 
protection of data. Hard copies of data sheets, and consents will be stored in the 
research coordinators’ office in CBH, in a locked file cabinet. The entrance to CBH is 
also password protected. Copies of the consents and contact information will be 
scanned and stored on the University’s secure O drive, under the Psychiatry folder. The 
O drive is a domain share (health.unm.edu) that is setup between groups and users 
within this domain. Security for the O drive is controlled by login for the domain, with a 
username and password. Access to the O drive is controlled by UNM admins.
It is unlikely that either medical or psychological resources will be required as a result of 
study procedures. Decisions regarding when and how to administer medical or 
psychological resources will be the responsibility of the PI, the research coordinator and 
Dr. Lenroot, Clinical Director of the Early and CONNECT programs.    
21.0
Recruitment Methods
Participants will be recruited among UNM college students who are determined eligible 
for the proposed study (see inclusion criteria Section 3.2).  Once determined eligible, 
individuals will be briefly told about the study by the clinician who conducted the 
assessment and if he/she is interested in participating in the study they will be connected 
to the research coordinator. The clinical team will be communicating with the research 
time when referrals who are UNM students will be coming in for an intake assessment 
so that they can be approached for consent. The research coordinator or PI will be 
responsible for providing all of the details of the study to the individual and completing 
the consent process. 
During COVID, these conversations will be conducted either by phone or via HIPAA 
compliant Zoom Account. 
Noteworthy is that we will not be reviewing PHI (i.e. patient name, medical record 
number, medical history, etc.) to identify eligible subjects. 
22.0
Number of Subjects
We expect to enroll approximately 40 students into the study over the study period. 
23.0
Provisions to Protect the Privacy Interests of Subjects
Data collection will be completed in offices or a private space maximizing privacy during 
data collection procedures. The participant’s legal guardian may also be present at the 
time of data collection.  During the consent process, we will obtain permission from the 
participant to access his/her clinical record to access the results of the SIPS or SCID 
interview and other data from standard clinical assessments. These data will be de-
identified before entering them into the REDCAP database. All data will be presented in 

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aggregate form only in reports or manuscripts. Only the PI and research coordinator will 
have access to links between study data and identifiers.
24.0
Compensation for Research-Related Injury
Not applicable, this study involves minimal risk to participants.
25.0
Economic Burden to Subjects
Not applicable, there will be no cost of study participation for participants. 
26.0
Consent Process
Participant informed consent will be indicated by their signature or that of a parent or 
legal guardian on an HRRC-approved informed consent instrument. The consent 
process will occur in: (1) a private office at the Psychiatric Research Building, (2) a 
private office at CBH,  (3) a private location that is convenient for the participant which 
may include clinical offices, (4) by phone, or (5) via a HIPAA compliant zoom account. At 
all times, sites for data collection will ensure privacy and confidentiality. The consent 
process will take place after informing the prospective subject about the study. Through 
the consent process, participants will learn what will be required of them should they 
consent to participate in the study. The consent process will also ask participants for 
their permission to (1) obtain results of assessments that were conducted as part of 
standard clinical care, (2) keep and use their information collected in the proposed study 
in a repository for future research that involves early psychosis or shared with other 
researchers who are studying early psychosis without their additional informed consent 
(see attached Consent form Appendix for Data Repository), (3) be contacted in the 
future for participation in other research opportunities around early psychosis. They will 
also be asked if we can share their de-identified data with the National Institute of Health 
(NIH) Data Archive as required by the grant. A protocol has been submitted to the IRB 
for the Early Psychosis Repository. When consent is conducted via phone or HIPAA 
compliant zoom account, we will need to delay obtaining a documented signature. In this 
case, we will log this into the non-reportable RNI log and file a “note-to-file” with the 
consent. We will attempt to get a documented signature as soon as possible.
  
Once informed consent procedures are completed, study data will be collected. 
After a verbal description of the study is given by the research coordinator or the PI and 
all of the questions posed by the potential participant have been answered, the following 
will occur to document informed consent in writing: 
•
The participant or participant’s legal guardian will sign and date the consent 
document. 
•
The individual obtaining consent will sign and date the consent document. 
•
A copy of the signed and dated consent document will be provided to the participant. 
If a potential participant who is under the age of 18 is able to demonstrate that they 
understand the voluntary nature of research participation and the research procedures, 
the potential risks and benefits involved with the research, the alternatives to 
participation, and the procedures to follow if they wish to withdraw from the study, they 
will be allowed sign the informed consent document demonstrating that they have given 
their assent for participation in the study. Parents or legal guardian will co-sign the 
document according to the procedures described in the preceding paragraph. 

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Following approval of modification #3, we will re-consent those who already consented 
by person if we can do so. For those that we can’t meet in person, we will re-consent by 
phone. Those who cannot be contacted, either in person or by phone will be flagged in 
the repository and data for these individuals will only be kept for 10 years.

Non-English Speaking Subjects
All participants must be able to speak and read fluent English in order to 
be able to review and understand the consent form. The consent form 
has not been translated to Spanish. We are excluding Spanish speaking 
subjects because not all of the standardized survey instruments are 
available in Spanish. Based on Dr. Lenroot’s clinical experience with this 
population over the past three years, 0% of her clients have been only 
Spanish speaking. That is, they have all been English speaking. 
However, if we observe that Spanish speaking participants are being 
excluded once we start participant recruitment, we will: (1) collect Spanish 
versions of the instruments that are available, (2) translate instruments 
that are not available into Spanish, and (3) apply for a modification to our 
protocol to include Spanish speaking subjects. 

Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
   NA. There will be no waiver or alteration of the consent process. 

Subjects who are not yet adults (infants, children, teenagers)
Patients younger than 18-years-old will have the opportunity to participate in the 
research study. They will indicate their assent to participate in the study by 
signing a child assent form, which will be co-signed by a parent or other legal 
guardian.
27.0
Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements. 
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including:
1.
Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap.
2.
Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include if the 
data is entered or stored using an untrusted device or storage.

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3.
Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to 
be carried out in such a way as to avoid creating/retaining files on untrusted 
storage devices/computers. Trusted devices are HSC managed and provide one 
or more of following safeguards: access logs, encryption keys, backups, 
business continuity and disaster recovery capabilities.
4.
Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards.
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