Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
Phase: NA
Conditions: Major Depressive Disorder, Major Depressive Episode
Sponsor: Milton S. Hershey Medical Center

 
 
 
 
This supplement contains the following items: 
Original protocol including statistical analysis plan, final protocol, summary of changes. 
 

 
Page 1 of 41 (V.04/27/2017)  
                                                                                        
 
HRP-591 - Protocol for  
Human Subject Research 
 
Protocol Title: 
Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder 
 
Principal Investigator: 
Name: Deepa L. Sekhar 
Department: Pediatrics 
Telephone: 717-531-8006 
E-mail Address:  dsekhar@pennstatehealth.psu.edu 
 
Version Date: 
August 16, 2018 
 
Clinicaltrials.gov Registration #: 
This study will be registered as a clinical trial, as recommended by HSPO staff. 
 
Important Instructions for Using This Protocol Template: 
1. 
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic Information” 
page, item 7.  
2. 
This template is provided to help investigators prepare a protocol that includes the necessary information needed 
by the IRB to determine whether a study meets all applicable criteria for approval.  
3. 
Type your protocol responses below the gray instructional boxes of guidance language.  If the section or item is 
not applicable, indicate not applicable. 
4. 
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, delete the 
instructional boxes from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  For all 
other research, do not delete the instructional boxes from the final version of the protocol. 
5. 
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the Study 
Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.  
 
If you need help… 
University Park and other campuses: 
Office for Research Protections Human Research Protection Program 
The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
College of Medicine and Hershey Medical Center: 
Human Subjects Protection Office 
90 Hope Drive, Mail Code A115, P.O. Box 855 
Hershey, PA 17033 
(Physical Office Location: Academic Support Building Room 1140) 
Phone: 717-531-5687 
Fax number: 717-531-3937 
Email: irb-hspo@psu.edu 
 
 
 

 
Page 2 of 41 (V.04/27/2017)  
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Confidentiality, Privacy and Data Management 
10.0 
Data and Safety Monitoring Plan 
11.0 
Risks 
12.0 
Potential Benefits to Subjects and Others 
13.0 
Sharing Results with Subjects 
14.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
15.0 
Economic Burden to Subjects 
16.0 
Resources Available 
17.0 
Other Approvals 
18.0 
Multi-Site Research 
19.0 
Adverse Event Reporting 
20.0 
Study Monitoring, Auditing and Inspecting 
21.0 
Future Undetermined Research: Data and Specimen Banking 
22.0 
References 
 
 

 
Page 3 of 41 (V.04/27/2017)  
1.0 
Objectives 
 
1.1 
Study Objectives 
OBJECTIVE1. Partnering with 8-12 PA public high schools (letters of commitment obtained) serving an estimated 
9,650 predominantly minority, rural and/or low socioeconomic status (SES) students, we will conduct a 
randomized controlled trial, with student randomization by grade, to compare the effectiveness of universal 
school-based screening for adolescent major depressive disorder (MDD) versus the existing process of targeted 
screening based on concerning behavior. 
 
Hypothesis 1: Universal screening will increase the number of adolescents with MDD screened, 
identified and engaged in treatment (MDD composite). 
 
Hypothesis 2 (Moderating): Universal screening will increase MDD screening, identification and 
treatment engagement for minorities. 
 
Hypothesis 3 (Moderating): Universal screening will increase the historically poorer rates of 
MDD screening, identification and treatment engagement for females  
OBJECTIVE 2. Analyze the impact of MDD screening on secondary outcomes currently collected by the school’s 
Student Assistance Program (SAP) and the school district. These data will be obtained in aggregate by grade level 
at each participating school (a total of 32 data points for each item; 4 grades x 8 schools). 
 
Hypothesis 1. Rates of missed schools days will improve in school populations with universal MDD 
screening secondary to earlier identification, treatment referral and engagement. 
 
Hypothesis 2. Grade point averages (GPA) will be improved among school populations with the 
universal MDD screening approach. 
 
Hypothesis 3. Rates of grade advancement/graduation will be improved among school populations 
with the universal MDD screening approach. 
 
Hypothesis 4. Student school policy violations and suspensions will remain unchanged among 
school populations with the universal MDD screening approach. 
 
1.2 
Primary Study Endpoints 
MDD composite which includes MDD screen positive for the universal screening arm (or concern in the 
targeted screening group),MDD identification, and MDD treatment engagement. Each of the primary 
study endpoints will be collected at the individual level by the school district by the end of the school 
year. No identifiable information will be collected by study staff.  
 
1.3 
Secondary Study Endpoints 
 
The secondary endpoints listed below are individual level data points that will be obtained from the school 
district and/or SAP.  No identifiable information will be collected by study staff.   
 
MDD screen positive  
MDD concern prompting Student Assistance Program triage 
Suicidal adolescent (includes suicidal thoughts [positive response to PHQ-9 item 9], attempts and 
completed) 
MDD identification 
MDD treatment engagement 
 
The secondary endpoints listed below are aggregate data points that will be obtained from the school 
district and/or SAP.  No identifiable information will be collected by study staff.   
Grade point averages 
Attendance 
Grade advancement or graduation rates 
School policy violations and/or suspensions 
 

 
Page 4 of 41 (V.04/27/2017)  
 
Additional data points to be obtained for grades 9-12 include: 
 
At the individual level, the following moderator variables will be collected (each 
obtained from the school districts) : 
o Ethnicity - Hispanic vs. non-Hispanic  
o Race - white, black or other 
o Sex - male or female 
 
At the aggregate level, the following mediator variables will be collected: 
o District socioeconomic status - dichotomized into <50% vs. >50% based on data 
from PA School Performance Profile 
o Urban vs. rural – school districts will be categorized as urban vs. rural based on 
the definition applied by The Center for Rural PA, a Legislative Agency of the PA 
General Assembly 
o School size – school enrollment will be included as a continuous variable. Data 
will be obtained from school districts based on enrollment as of October 1 of 
the RCT 
o Ratio of guidance counselors/students – The ratio of counselors to students will 
be obtained from each school district 
o School-based mental health services – schools will be categorized by the 
availability of school-based mental health services (yes vs. no) based on 
information obtained from each school district.  
 
We need to collect data at the individual level for 3 main reasons.  First, we expect 
approximately 20% of students to opt out from the study, with opt out rates varying by grade.  
Aggregate data would necessarily include outcomes for students who are not enrolled in the 
study.  This is particularly problematic for the universal screening group because students who 
opt out will not be offered the depression screening tool (PHQ-9).  Second, we need to obtain 
gender and race/ethnicity to conduct important planned secondary analyses (subgroup 
analyses) that will examine efficacy of universal screening by these groups.  In particular, we 
expect that females and minority students will have much higher rates of major depression 
disorder identified in the universal screening group.  Third, in the universal screening group, we 
will be able to link responses to the PHQ-9 to outcomes, which will allow for estimation of 
important measures such as the false positive rate of the PHQ-9 (score ≥11, but SAP process 
determines no further referrals are needed).  These measures will inform decision-making 
regarding the potential for implementation of the intervention (in other schools) should the 
results of the trial ultimately show efficacy.   
 
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
The prevalence of annual major depressive disorder (MDD) episodes among US adolescents rose from 
8.3% in 2008 to 12.5% in 2015.1 Close to 30% of adolescents with MDD reported suicidality in the prior 
year, with more than one in ten making a suicide attempt.2 As a result, suicide was the 2nd leading 
cause of death among youth 10-24 years of age as of 2014.3 Baseline data from HealthyPeople.gov 
found that only 2.1% of adolescent primary care office visits included depression screening in the years 
2005-2007.4 Additionally, Zenlea et al’s work found primary care adolescent MDD screening was 80% 
less likely for Hispanic compared to non-Hispanic white adolescents.5 Similar inequalities were reported 
for women who are three times more likely to have MDD, but less likely to be treated than males.1,2,6 In 
response to the growing mental health crisis, the US Preventive Services Task Force (USPSTF) endorsed 

 
Page 5 of 41 (V.04/27/2017)  
universal screening for adolescent MDD in primary care in 2009.7,8 The HealthyPeople.gov 2020 goal is a 
10% increase in screening to a rate of 2.3%, which fails to address this adolescent 
public health crisis.4 The USPSTF universal MDD screening recommendation was based on evidence that 
treatment of MDD is associated with moderate benefit.7,8 While most experts in family medicine, 
pediatrics, psychology and child psychiatry agree that surveillance of adolescents at high-risk for 
MDD is warranted, the USPSTF updated their recommendations in 2016 with a call to address 
several knowledge gaps: 
1) Does screening increase the proportion of adolescents identified with MDD? 
2) What are the benefits and unintended consequences of MDD screening for subgroups: 
age, sex, race, ethnicity and socioeconomic status (SES)? 
3) What are the benefits and unintended consequences of screening in nonclinical settings?8 
We propose that schools may provide an effective setting to conduct universal MDD screening. While 
over half of US adolescents do not have annual preventive health visits, regardless of race, ethnicity or 
SES most attend school.9 The regular contact with schools compared to contact with the medical setting 
has been used to advocate for many school-based universal health screenings that impact academic 
success (e.g. vision, hearing). However, while current school screenings address multiple physical health 
domains, none address mental health.10 Targeted mental health screening is the current school process 
for students who display signs concerning for MDD and results in referral to the school’s Student 
Assistance Program (SAP). SAP operates in all 500 Pennsylvania school districts and functions similar to a 
triage service by assessing symptom severity, and then if appropriate, providing referrals to school or 
community-based mental health resources.11 Students may self-refer, but all other SAP referrals depend 
upon a student exhibiting concerning behavior that is detected by school staff, peers or parents, which 
results in a targeted screening process with obvious limitations. 
 
2.2 
Previous Data 
Our research team is acutely aware of the concerns the topic of adolescent depression screening may 
raise among school staff, providers, parents and adolescents. We have had ample opportunity in our 
pilot work to discuss and address many of these issues as outlined below. First, from April-Sept 2016 we 
conducted eight focus groups (7-10 participants each, n=62) to better understand the perspective of key 
stakeholders regarding Whole Child Health, specifically the importance of both physical and mental 
wellness. These focus groups included 2 parent groups, 2 school nurse groups, 2 groups of school 
teachers and administrators and 2 groups of medical providers (pediatrics and family medicine). The 
work was funded by the Penn State Social Science Research Institute-Children, Youth and Families 
Consortium. Participant conversations were instrumental in shaping the current proposal. In addition, 
following the aforementioned focus groups, we conducted a Community Engagement Studio in August 
2017 funded by the Penn State Center for Translational Science Institute. These 2 hour sessions are 
specifically intended to inform grant proposals that depend upon successful community engagement. 
Participant perspectives ranged from adolescent to parent, school staff, the leaders of two mental 
health and suicide prevention organizations (Aevidum and the Jana Marie Foundation), a Behavioral 
Health Managed Care company representative and the project director of Pennsylvania’s Garrett Lee 
Smith Youth Suicide Prevention Grant in addition to our Penn State Research team.  
 
2.3 
Study Rationale 
Rates of major depression are rising among US adolescents paralleled by a rise in the rate of adolescent 
suicides. The most recent data indicates that 1 in 8 adolescents (12.5%) experienced an MDD episode in 
the past 12 months.1 From 2005-2014 a significant increase in MDD episode trends was observed for all 
racial and ethnic groups except Non-Hispanic Blacks who demonstrated a smaller, statistically 
nonsignificant increasing trend.6 The most striking increase in MDD trends was for females across all 
racial and ethnic groups. Adolescent females demonstrated rates of MDD episodes over 3 times that of 
males (19.5% vs. 5.8%).1,6 Some authors have suggested that adolescent females have increased 
exposure to depression risk factors including cyberbullying, mobile phone use and texting.6 Along with 

 
Page 6 of 41 (V.04/27/2017)  
the rise in MDD episodes, adolescent females have demonstrated a significant rise in emergency 
department visits for nonfatal self-inflicted injuries with rates since 2009 increasing by 19% annually 
from 110 in 2009 to 318 per 100,000 in 2015.12 Self-inflicted injury is one of the strongest risk factors for 
suicide, and the suicide rate for female adolescents reached its highest in the past 40 years according to 
2017 Centers for Disease Control and Prevention data.13,14 
Adolescent MDD has negative effects on academic performance, with increasing severity of depressive 
symptoms linked to a lower grade point average as well as subjective assessments of increased school 
workload and concentration difficulties. Adolescents with untreated MDD experience poorer 
interpersonal relationships, lower self-esteem, social isolation, and increased risk-taking behaviors 
including substance use, as well as multiple physical and mental health comorbidities in adulthood.7,8,15-
17 For 60-90% of adolescents, symptoms of a MDD episode may remit within in a year. The larger 
problem is that 50-75% of these adolescents will develop subsequent MDD episodes within 5 years, 
resulting a chronic or relapsing disorder.18 Studies also suggest that recovery is not complete between 
episodes, with most individuals reporting residual symptoms or impairment.18 
Despite the rising rates of depression, there has been no change in mental health treatment among 
adolescents with a MDD episode from 2005-2014.6 Only 36-44% of children and adolescents with MDD 
receive treatment, underscoring that MDD is underdiagnosed and undertreated.6 This disparity is 
especially pronounced for disadvantaged populations. Specifically, Black and Hispanic adolescents are 
significantly less likely to be diagnosed with mental illness and referred for treatment compared to their 
White counterparts.5,19 These disparities often stem from lack of access to primary care.20 Even for those 
who have a primary care provider, data from HealthyPeople.gov indicates a steady decline in rates of 
screening with only 1.4% of primary care office visits including MDD screening as of 2009- 
2011.4 In addition to minorities, rural youth and those of lower SES receive fewer preventive 
care services than their white, urban, high SES counterparts, further limiting their access to 
MDD screening in the context of well-care.20,21 
 
3.0 
Inclusion and Exclusion Criteria 
 
3.1 
Inclusion Criteria 
Students in grades 9-12 at eight public schools XXXXXXXXXXXXXXXXXXXXX) in Pennsylvania that 
previously committed to partner with us in this project. HRP-504- School Permission to Conduct 
Research forms will be included in our CATS application documentation for each participating district to 
show district approval of the opt out procedure and to agree with their 3rd Party Protection of Pupil 
Rights Amendment (PPRA) policies. Further, included as supporting documents are letters from 
XXXXXXXXXXXXXXXXXXXXXXX who have all acknowledged and shown support of the opt out approach.  
 
 
3.2 
Exclusion Criteria 
Students whose parents complete the opt-out consent 
Students not enrolled in one of the participating 8 schools 
Students not in grades 9-12 
Students with disabilities that are deemed unable to participate by the school district 
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 Criteria for removal from study 
N/A 
3.3.2 
Follow-up for withdrawn subjects 
N/A 
 

 
Page 7 of 41 (V.04/27/2017)  
4.0 
Recruitment Methods 
 
4.1 
Identification of subjects 
Eight PA public schools committed to partner with us to complete the proposed work. PI XXXXXXXXXX 
and co-investigator XXXXXXXXXXi have previously partnered with several of these school districts 
through their prior research. In total, the schools serve over 9,000 students and were selected as they 
represent a large number of minorities, low SES and/or rural student populations who have known 
disparities in mental health services. 
 
4.2 
Recruitment process 
After discussion with our stakeholders and the Penn State Institutional Review Board, we will pursue 
opt-out consent for screening given the importance of MDD screening and the low-risk aside from 
identification of a suicidal student. Parents will be informed of their child’s enrollment in screening and 
given the opportunity to opt out prior to the fall intervention. For this proposal, in cases of a shared 
custody agreement, if either parent or guardian opts out of the study, the student will be considered 
ineligible for enrollment. In this case, no information will be collected, even in the case of students 
randomized to the targeted screening arm, which is the usual school process. Also, any participating 
student randomized to the universal screening arm who does not assent at the time of screening will not 
be required to complete the screening form. Students 18 years and older are anticipated to be a small 
minority of the students at the start of the academic year, but they will also have the opportunity to opt 
out of study involvement if desired. 
 
4.3 
Recruitment materials 
No recruitment materials will be needed for this study. However, a letter will be sent home to parents to 
inform them of their child’s enrollment in the screening and given the opportunity to opt out prior to 
the intervention. If they do not wish to participate, parents will be asked to return the Opt-Out form in-
person or by mail. Opt-out letters will be printed on district letterhead to include the participating 
school’s mailing address. Parents may also return the form signed and scanned, if the school decides to 
send the letter via email. A copy of the PHQ-9 questionnaire will be included in the letter sent to the 
parents. Additionally, the opt-out letter will be translated into a Spanish by the Department of Care 
Coordination and provided to each school. 
 
4.4 
Eligibility/screening of subjects 
N/A 
 
5.0 
Consent Process and Documentation  
 
5.1 
Consent Process  
  
5.1.1 Obtaining Informed Consent 
 
5.1.1.1 Timing and Location of Consent 
N/A 
5.1.1.2 Coercion or Undue Influence during Consent 
N/A 
5.1.2 Waiver or alteration of the informed consent requirement 
We are requesting a waiver of the informed consent requirement. We are pursuing opt-out 
consent for screening given the important of MDD screening and the low-risk aside from 
identification of a suicidal student. At 14 years of age, PA youth are eligible to consent to mental 

 
Page 8 of 41 (V.04/27/2017)  
health services without parental consent. Our use of the opt out is really intended to include 
and engage the parents and communities we are working with. The opt out will be a letter sent 
home to parents (either via email or regular mail as per school preference) giving them the 
option to decline participation for their student. Schools will be responsible for tracking students 
whose parents have opted-out. In addition, students in the universal arm will have the option to 
decline participation themselves on the screening day via the iPad handed to them. The first 
screen will describe PHQ-9; inform students that participation is voluntary; and participation 
may be stopped at any time and will not affect their school standing or grades. 
 
 
5.2 
Consent Documentation 
 
5.2.1 
Written Documentation of Consent 
N/A 
 
5.2.2 
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.) 
N/A 
 
5.3 
Consent – Other Considerations  
 
5.3.1 
Non-English Speaking Subjects 
A Spanish translator was included in the grant and will join the research team for the MDD 
screening at schools where these services would be needed. In addition, the opt out information 
will be translated and sent in Spanish for those parents who the school indicates would have 
trouble with the English version forms. The assent will also be translated into Spanish for those 
students who indicate that Spanish is their preferred language. The PHQ-9 is already available in 
multiple languages including Spanish. 
 
5.3.2 
Cognitively Impaired Adults 
     N/A 
5.3.2.1 Capability of Providing Consent 
N/A 
 
5.3.2.2 Adults Unable To Consent 
N/A 
 
5.3.2.3 Assent of Adults Unable to Consent 
N/A 
 
5.3.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 Parental Permission 
We are requesting a waiver of informed consent. Rather, parents/guardians will 
receive an opt-out form. We are pursuing opt-out consent for screening given the 
important of MDD screening and the low-risk aside from identification of a suicidal 
student. At 14 years of age, PA youth are eligible to consent to mental health services 
without parental consent. Our use of the opt out is really intended to include and 
engage the parents and communities we are working with. 

 
Page 9 of 41 (V.04/27/2017)  
5.3.3.2 Assent of subjects who are not yet adults 
Students in the universal arm will have the option to decline participation themselves 
on the screening day via the iPad handed to them. The first screen will describe PHQ-9; 
inform students that participation is voluntary; and participation may be stopped at 
any time and will not affect their school standing. The completion of the PHQ-9 implies 
a student’s voluntary consent to participate in the research. Students who decide not 
to participate will not complete the PHQ-9, but will still be tracked similar to students 
randomized to the targeted screening arm. The study team will obtain their 
demographic information and the student will be followed through the academic year 
for SAP triage intakes initiated by the standard pathway (concern by teachers, nurse, 
parent, peer, or self-referral), any referrals and treatment engagement. No identifiable 
information will be obtained and it will be noted in study records that the student did 
not assent to participate in the MDD screener. A copy of this assent form is included in 
the consent form section. 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
N/A 
 
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
N/A 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
N/A 

 
Page 10 of 41 (V.04/27/2017)  
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
N/A 
 
6.3 
Waiver or alteration of authorization statements of agreement 
N/A 
 
7.0 
Study Design and Procedures 
 
7.1 
Study Design 
Due to the timeline for this funding opportunity, with an anticipated July 2018 start, 4 schools will 
engage in the randomized control trial (RCT) in study year 1 and the additional 4 schools in study year 2. 
Many large scale randomized control trials do not enroll all participants at one time point, and in many 
cases enrollment occurs slowly over the course of several years. We do not anticipate there will be 
major changes over the course of two academic years that would significantly alter the results compared 
to conducting the RCT in the same academic year, especially because students will be randomized within 
schools. Finally, staggering enrollment will give the research team the opportunity to troubleshoot any 
unanticipated issues with the first 4 participating schools. 
 
7.2 
Study Procedures 
 
7.2.1 
Enrollment 
Parents will be informed of their child’s enrollment in screening and given the opportunity to opt 
out prior to the fall intervention. The opt out will be a letter sent home to parents (either via email or 
regular mail as per school preference) giving them the option to decline participation for their student. 
The study team will provide each school with unique study IDs to be assigned to every student, grades 9-
12. Study IDs will include 8 numbers, the first two representing the school, the second two the grade 
and the remaining 4 will be unique to each participating student. Schools will be required to assign these 
unique study IDs to each student, grades 9-12. Schools will complete a linking list (spreadsheet 
template) ensuring that all students, grades 9-12 are included. A completed linking list will include 
student names (first and last), PASECURED ID, unique study ID and demographics information (grade, 
age, sex, race and ethnicity). Schools will remove student names and PASECUREID before sending the 
spreadsheet to the study team. The full linking list (including student name and PASECURIEDID) will 
remain on the school’s spreadsheet and in the school’s possession for tracking of study outcomes 
through the year. By using a unique study ID for each student, the study team will never receive 
identifiable information of students. If a parent returns the opt-out form, school staff will still assign a 
student a unique study ID but no demographic information will be included. This is so the study team 
may properly report the number of opt-out letters returned. This procedure ensures that students 
whose parents have opted-out are not tracked throughout the year.  
 
At the time of the actual universal screening students will also be provided the chance to opt out by 
clicking the appropriate opt out box on the iPad handed to them. We anticipate this will lead to study 
enrollment of 80% of eligible students.  The first screen will describe PHQ-9 and that proceeding is 
voluntary. The completion of the PHQ-9 implies a student’s voluntary consent to participate in the 
research. Unless the parent opt out is returned, participants in both arms will be followed through the 
school year for SAP triage, follow-up referrals and treatment engagement. Those students in the 
universal screening arm with PHQ-9 scores > 11 (MDD screen positive) corresponding to moderate 
depressive symptoms, will proceed through the standard process for anyone referred by traditional 
means to a SAP triage interview. The student will either be referred to appropriate community or 

 
Page 11 of 41 (V.04/27/2017)  
school-based treatment or SAP will determine no follow-up is needed. For those who are recommended 
to additional services by SAP, treatment engagement will be tracked per current SAP processes. The 
study team will receive individual level outcome data from the school district, containing no identifiable 
information. 
 
7.2.2 
Randomization 
We will randomize by grade levels within each school to receive either one-time universal screening (via 
PHQ-9) or targeted screening (current SAP process). For the 8 schools included in the study, 4 schools 
(50%) will be randomized such that students in 9th and 11th grades will receive universal screening and 
students in 10th and 12th grades will receive targeted screening, and 4 schools (50%) will be 
randomized such that students in 9th and 11th grades will receive targeted screening and students in 
10th and 12th grades will receive universal screening. Randomization will be done only for students 
whose parents do not signal an unwillingness to participate in the study (“opt out”). Students and study 
personnel will not be blinded to randomized group at each school site. Randomization will be done by 
grade level primarily for pragmatic reasons because many PA health-based screenings are grade-specific 
(e.g. hearing screen in 11th grade) and screenings for a grade occur at the same time. The study will be 
conducted within schools, but it is not a cluster randomized study, in which an entire school (cluster) is 
assigned to one of the study groups. A cluster randomized study was considered but ultimately not 
pursued because randomization within schools controls for (1) within-school (community) factors that 
may contribute to higher or lower rates of SAP referral, (2) differences in school sizes, and (3) potential 
differences in rates of parental opt out among schools. These benefits were balanced against the 
concern of potential contamination between study groups, whereby those in the targeted screening 
group may benefit from the school-wide push to conduct universal screening.  
 
7.2.3 
Universal MDD Screening Arm (Intervention – Treatment) 
Students randomized to the universal screening arm will complete a PHQ-9. This screening tool includes 
nine close-ended questions with a scoring system ranging from 0 to 27. The PHQ-9 screens will be 
administered on an iPad with an internet connection which allows direct entry of the results in REDCap. 
To prevent the duplication of unique study IDs, the study team will have entered all unique IDs into 
REDCap prior to the screening. A list of participant IDs will be provided to the school member present 
during the screening. Once the corresponding unique study ID has been entered, the study staff will give 
the iPad to the student to assent and complete the PHQ-9. This process will ensure that the correct 
study ID is used and prevent duplication of study IDs. Further, this will safeguard against any student 
from participating whose parent returned the opt-out letter. No names or other identifying information 
will be used. Paper copies of the assent and PHQ-9 will be available as a backup should problems arise 
with internet connectivity. The same measures will be taken to ensure no names or other identifying 
information is used or collected.  
 
In order to immediately identify suicidal intent the survey will be set to flag positive questions in real 
time.  When students have completed the PHQ-9 screen the REDCap survey will prompt them to hand 
the completed questionnaire to study staff, who will see a screen indicating a positive flag. Students 
with suicidal intent (question #9 any response besides “Not at all”) will receive immediate evaluation 
and referral to emergency care as per current school protocols. PA schools are required to have a plan 
to address suicidal students (Act 71). A suicidal participant identified during the screening would not be 
allowed to leave the screening area unless accompanied by appropriate school or research staff. This 
student would then proceed through the standard school pathway for managing a student with 
intentions of self-harm. To ensure school staff is comfortable to manage a student in crisis and that this 
persists beyond the period of the grant, at least 5 staff per school in addition to at least 4 Penn State 
research staff will complete online evidence-based suicide prevention training (Question, Persuade, and 
Refer [QPR] Suicide Triage Training). In addition, all school crisis plans will be carefully reviewed with 
staff following the training to ensure the steps are realistic and staff is comfortable to execute the plan. 

 
Page 12 of 41 (V.04/27/2017)  
The district identified, QPR trained staff member will be available at the time of screening. Study staff 
who are also QPR trained, will be present during the screening.  
 
7.2.4 
Targeted Screening Arm (Current Process – Control) 
Students randomized to the targeted screening arm will complete their routine school-based screenings. 
Students will be followed through the academic year for SAP triage intakes initiated by the standard 
pathway (concern by teachers, nurse, parent, peer, or self-referral), any referrals and treatment 
engagement. 
 
7.2.5 
Sharing Screening Results 
At 14 years of age, PA youth are eligible to consent to mental health services without parental consent, 
therefore, screening results will not be shared with parents. Those students with scores > 11 (MDD 
screen positive) corresponding to moderate depressive symptoms will, however, proceed through the 
standard process for anyone referred by traditional means to a SAP triage interview. The student will 
either refer to appropriate community or school-based treatment or therapy (MDD identified) or SAP 
will determine no follow-up is needed. For those who are recommended to additional services by SAP, 
treatment engagement will be tracked per current SAP process. As per current school policy, students 
with suicidal feelings will receive immediate referral to emergency care and parents will be notified by 
the school. 
 
 
7.3 
Duration of Participation 
The student’s participation is limited to the 5 minutes it takes for them to participate in the screening 
process. 
 
8.0 
Subject Numbers and Statistical Plan 
 
8.1 
Number of Subjects 
The 8 schools to be included in the study have an estimated total enrollment of approximately 9650 
students. The overall rate of parental opt out is expected to be around 20%, resulting in approximately 
7720 students included in the study. We assumed a 15% attrition rate for students who move, drop out 
of school, or opt out later in the school year. Thus, the study is expected to include 6550 students. 
 
8.2 
Sample size determination 
A total of 3275 students in each randomized group (an overall sample size of 6550) yields >99% 
statistical power to detect a difference of 3% versus 6% using a 2-sided test conducted at a Type I error 
rate of 5% in a mixed effect logistic regression model. 
 
8.3 
Statistical methods 
The principles of intention-to-treat (ITT) will be used for all statistical analyses related to primary and 
secondary aims. For the primary aim comparing universal to targeted screening, the statistical analysis 
will be conducted using a mixed effects logistic regression model. The primary outcome, MDD 
composite, will be an indicator whether a student was screen positive (or concerns raised in the 
targeted screening arm), identified as having MDD and subsequently engaged in treatment (1=yes, 
0=no). The model will include a fixed effect for randomized group (0=targeted screening, 1=universal 
screening) and a random effect for school. The random effect accounts for correlation among students 
enrolled within the same school. The primary parameter of interest will be the log odds of MDD 
composite in the universal screening group compared to the targeted screening group. Statistical 
significance of the log odds will be assessed using a 2-sided Wald test. Point estimates for the odds ratio 
along with a 95% confidence interval will be reported. 

 
Page 13 of 41 (V.04/27/2017)  
 
For the analysis of Hypotheses 2 and 3 (Objective 1) evaluating universal screening and targeted 
screening by selected subgroups, the same mixed effects logistic regression modeling framework will be 
used, but the model will be extended by including a fixed effect for subgroup and an interaction effect 
for subgroup by randomized group. The interaction term will be the parameter of interest. A significant 
interaction term indicates that rates of MDD treatment engagement for universal versus targeted 
screening differ by subgroup level (e.g. female vs. male). For the analysis of Hypotheses 1 through 4 
(Objective 2) that evaluates universal screening and targeted screening based on school SAP data, we 
will have only 32 total data points (4 grades in each of 8 schools). Mixed-effects linear (continuous 
outcomes) and logistic regression (binary outcomes) will be used, as appropriate, with a fixed effect for 
randomized group and a random effect for school. The parameter of interest will be the log odds for the 
universal compared to the targeted screening group. Due to the smaller sample size used for these 
outcomes, these analyses will be considered to be primarily hypothesis-generating. Potential mediating 
variables (socioeconomic status, rural vs. urban location, school size, ratio of guidance counselors to 
students and availability of school-based mental health services) will be evaluated for both the Objective 
1 and 2 hypotheses. 
 
Additional secondary outcomes will include MDD screen results, MDD concern prompting Student 
Assistance Program triage, MDD identification and MDD treatment engagement analyzed individually 
(rather than as part of MDD composite). Finally any suicidal adolescents (suicidal thoughts [positive 
response to PHQ-9 item 9], attempts and completed) will be analyzed as a secondary outcome. 
 
We need to collect data for individuals for 3 main reasons.  First, we expect approximately 20% of 
students to opt out from the study, with opt out rates varying by grade.  Aggregate data would 
necessarily include outcomes for students who are not enrolled in the study.  This is particularly 
problematic for the universal screening group because students who opt out will not be offered the 
depression screening tool (PHQ-9).  Second, we need to obtain gender and race/ethnicity to conduct 
important planned secondary analyses (subgroup analyses) that will examine efficacy of universal 
screening by these groups.  In particular, we expect that females and minority students will have much 
higher rates of major depression disorder identified in the universal screening group.  Third, in the 
universal screening group, we will be able to link responses to the PHQ-9 to outcomes, which will allow 
for estimation of important measures such as the false positive rate of the PHQ-9 (score ≥11, but SAP 
process determines no further referrals are needed).  These measures will inform decision-making 
regarding the potential for implementation of the intervention (in other schools) should the results of 
the trial ultimately show efficacy.   
 
Efforts will be made to ensure completeness of data where possible, but missing data will occur for a 
number of anticipated reasons. First, a student may move during the course of the school year to 
another school district or drop out from school entirely. No data will be collected after this time point. 
Second, parents may opt out their child from the study at any time during the school year. Third, 
students who turn 18 during the school may decide to opt out of the study themselves. In both of these 
instances, data from SAP referrals that occur after opting out will not be collected for purposes of the 
study. Fourth, during the one-time universal screening phase, students may decide to leave data forms 
incomplete, including the PHQ-9. To decrease these instances, the PHQ-9 will be taken on an iPad 
program and the survey will alert if the form is left incomplete. 
9.0 
Confidentiality, Privacy and Data Management  
Please see HRP-598 - Research Data Plan Review Form 

 
Page 14 of 41 (V.04/27/2017)  
10.0 Data and Safety Monitoring Plan 
N/A: This study does not involve more than minimal risk to subjects, and the magnitude of harm/discomfort is 
not greater than that ordinarily encountered in daily life. 
 
11.0 Risks 
Risk involved in participating in this study are low aside from identification of a suicidal student, in which case 
measures are already currently in place in each school building to address. 
 
12.0 Potential Benefits to Subjects and Others 
 
12.1 
Potential Benefits to Subjects 
Potential benefit to subjects of positive screenings include a referral to SAP to receive support in 
managing their MDD. 
 
12.2 
Potential Benefits to Others 
The potential public health impact of the proposed project cannot be overstated. MDD is a prevalent, 
disabling and a growing US public health problem. The problem is identified by national organizations 
focused on our country’s health care priorities (Healthy People 2020, US Department of Health and 
Human Services). MDD leads both to functional impairment and higher rates of morbidity and mortality. 
In addition, MDD leads to significant social and economic consequences, including increased use of 
health resources and lost work productivity. A public health goal should include identification of those at 
risk for depression with the delivery of interventions to these individuals. Schools are a point of 
intervention with a high potential for early identification and prevention. Currently, fewer than 2 out of 
every 100 adolescents receives guideline-concordant major depression screening. We propose reaching 
nearly 80 of every 100 adolescents in the school setting, vastly increasing the identification of 
adolescents suffering from MDD with a goal to decrease both morbidity and mortality. Schools are an 
ideal partner for this approach, given their tremendous reach across the nation to nearly all adolescents. 
13.0 Sharing Results with Subjects 
Individual results will not be shared with other participants. 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
N/A 
 
15.0 Economic Burden to Subjects 
 
15.1 
Costs  
There are no financial costs associated with participating in this research. 
 
15.2 
Compensation for research-related injury 
N/A 
 

 
Page 15 of 41 (V.04/27/2017)  
16.0 Resources Available 
 
16.1 
Facilities and locations 
Screening will take place in each of the 8 school buildings previously identified.  
 
16.2 
Feasibility of recruiting the required number of subjects 
All 8 school districts have already expressed interest in participating as evidenced through letters of 
support obtained during the proposal process. Current relationships through past and present 
programming with the school districts created feasibility for recruitment. 
 
16.3 
PI Time devoted to conducting the research 
XXXXXXXXXX will monitor the progress of the study during all phases and hold bi-weekly meetings with 
research staff.   
 
16.4 
Availability of medical or psychological resources 
It is not anticipated that medical or psychological resources will be needed on site, given that study 
procedures are minimal risk. However, students with suicidal intent will receive immediate evaluation 
and referral to emergency care as per current school protocols. PA schools are required to have a plan 
to address suicidal students. A QPR trained staff member will be available at the time of screening. 
Students with a PHQ-9 score >11 will proceed to Student Assistance Program triage as per the standard 
of care by which students exhibiting concerning behavior (outbursts, declining grades) would be 
referred for assessment. 
 
16.5 
Process for informing Study Team 
The investigators and project coordinator/study staff have completed their required Collaborative IRB 
Training Initiative (CITI) in the protection of human research subjects.  The study team will be educated 
on the importance of confidentiality, and proper data handling and storage. Four study team members 
will also complete the Question, Persuade, Refer suicide triage training in order to assist the school staff 
as needed during the time of actual screening. 
 
17.0 Other Approvals 
17.1 
Other Approvals from External Entities 
N/A 
 
17.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library.   
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
 

 
Page 16 of 41 (V.04/27/2017)  
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that 
had been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of 
HRP-901 - Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. 
This form is available in the CATS IRB Library.  
 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way. 
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a 
copy of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This 
form is available in the CATS IRB Library. 
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The 
scientific review requirement may be fulfilled by one of the following: (1) external peer-review 
process; (2) department/institute scientific review committee; or (3) scientific review by the Clinical 
Research Center Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute 
Scientific Review Committee is required if the study involves cancer prevention studies or cancer 
patients, records and/or tissues. For more information about this requirement see the IRB website 
at: http://www.pennstatehershey.org/web/irb/home/resources/investigator  
 
18.0 Multi-Site Research 
 
N/A 
19.0 Adverse Event Reporting 
 
19.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
20.0 Study Monitoring, Auditing and Inspecting 
 
20.1 
Auditing and Inspecting 
 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 

 
Page 17 of 41 (V.04/27/2017)  
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.). 
 
21.0 Future Undetermined Research: Data and Specimen Banking 
 
N/A 
 
21.1 
Data and/or specimens being stored 
N/A 
 
21.2 
Location of storage 
N/A 
 
21.3 
Duration of storage 
N/A 
 
21.4 
Access to data and/or specimens 
N/A 
 
21.5 
Procedures to release data or specimens 
N/A 
 
21.6 
Process for returning results 
N/A 
 
22.0 References 
1. Office of Disease Prevention and Health Promotion. Healthy People.gov. Mental Health 
and Mental Disorders. MNMD-4.1 Reduce the proportion of adoelscents aged 12 to 17 
years who experience major depressive episodes. 
https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4813; Updated 
December 11, 2017. Accessed December 11, 2017. 
2. Avenevoli S, Swendsen J, He JP, Burstein M, Merikangas KR. Major depression in the 
national comorbidity survey-adolescent supplement: prevalence, correlates, and 
treatment. J Am Acad Child Adolesc Psychiatry. 2015;54(1):37-44.e2. 
3. Heron M. Deaths: Leading causes for 2014. National Vital Statistics Reports. 2016;65(5). 
Hyattsville, MD: National Center for Health Statistics. 
https://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_05.pdf. Accessed January 3, 2018. 
4. Office of Disease Prevention and Health Promotion. Healthy People.gov. Mental Health 
and Mental Disorders. MHMD-11.2. Increase the proportion of primary care physician 
office visits where youth aged 12 to 18 years are screened for depression. 
https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4808; Updated 
December 11, 2017. Accessed December 11, 2017. 
5. Zenlea IS, Milliren CE, Mednick L, Rhodes ET. Depression screening in adolescents in 
the United States: a national study of ambulatory office-based practice. Acad Pediatr. 
2014;14(2):186-191. 
6. Mojtabai R, Olfson M, Han B. National trends in the prevalence and treatment of 
depression in adolescents and young adults. Pediatrics. 2016;138(6):e20161878. 
7. Forman-Hoffman V, McClure E, McKeeman J, et al. Screening for major depressive 

 
Page 18 of 41 (V.04/27/2017)  
disorder in children and adolescents: A systematic review for the U.S. Preventive 
Services Task Force. Ann Intern Med. 2016;164(5):342-349. 
8. Siu AL, US Preventive Services Task Force. Screening for depression in children and 
adolescents: U.S. Preventive Services Task Force recommendation statement. Ann 
Internal Med. 2016;164(5):360-366. 
9. Adams SH, Park MJ, Twietmeyer L, Brindis CD, Irwin CE, Jr. Association Between 
Adolescent Preventive Care and the Role of the Affordable Care Act. JAMA Pediatr. 
2017 Nov 6. doi: 10.1001/jamapediatrics.2017.3140. 
10. Pennsylvania House of Representatives. House Co-Sponsorship Memoranda. House of 
Representatives Session of 2015-2016 Regular Session. 
http://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=H&SPi 
ck=20150&cosponId=20186. Published May 6, 2016. Accessed January 3, 2018. 
11. Student Assistance Program FY 2015-2016. Mental Health-Drug and Alcohol Statistical 
Data. https://sapjqrs.org/uploadedfiles/JQRS%20Exec%20Summary%202015-16.pdf. 
Accessed December 11, 2017. 
12. Mercado MC, Holland K, Leemis RW, Stone DM, Wang J. Trends in Emergency 
Department Visits for Nonfatal Self-inflicted Injuries Among Youth Aged 10 to 24 Years 
in the United States, 2001-2015. JAMA.2017;318(19):1931-1933. 
13. Centers for Disease Control and Prevention. QuickStats: Suicide Rates for Teens Aged 
15-19 Years, by Sex – United States , 1975-2015. MMWR Wkly Rep 2017; 66(30):816. 
https://www.cdc.gov/mmwr/volumes/66/wr/mm6630a6.htm. Accessed December 11, 
2017. 
14. National Alliance on Mental Illness. Depression. http://www.nami.org/Learn- 
More/Mental-Health-Conditions/Depression. Accessed January 3, 2018. 
15. Khoddam R, Jackson NJ, Leventhal AM. Internalizing symptoms and conduct problems: 
Redundant, incremental, or interactive risk factors for adolescent substance use during 
the first year of high school? Drug Alcohol Depend. 2016;169:48-55. 
16. Fergusson DM, Woodward LJ. Mental health, educational, and social role outcomes of 
adolescents with depression. Arch Gen Psychiat. 2002;59(3):225-231. 
17. Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 
2012;379(9820):1056-1067. 
18. Thomas JF, Temple JR, Perez N, Rupp R. Ethnic and gender disparities in needed 
adolescent mental health care. J Health Care Poor Underserved. 2011;22(1):101-110. 
19. Lau M, Hua L, Flores G. Racial/ethnic disparities in health and health care among US 
adolescents. Health Serv Res. 2012;47(5):2031-2059. 
20. Irwin CE, Jr., Adams SH, Park MJ, Newacheck PW. Preventive care for adolescents: few 
get visits and fewer get services. Pediatrics. 2009;123(4):e565-572. 
21. Dixon SK, Hoopes AJ, Benkeser D, Grigg A, Grow HM. Characterizing key components 
of a medical home among rural adolescents. Journal Adolesc Health. 2016;58(2):141- 
147. 
 
 

 
Page 19 of 41 (V.04/27/2017)  
                                                                                        
 
HRP-591 - Protocol for  
Human Subject Research 
 
Protocol Title: 
Randomized Controlled Trial of Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder 
 
Principal Investigator: 
Name: Deepa L. Sekhar 
Department: Pediatrics 
Telephone: 717-531-8006 
E-mail Address:  dsekhar@pennstatehealth.psu.edu 
 
Version Date: 
May 15, 2020  
 
Clinicaltrials.gov Registration #: 
NCT03716869  
 
Important Instructions for Using This Protocol Template: 
1. 
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic Information” 
page, item 7.  
2. 
This template is provided to help investigators prepare a protocol that includes the necessary information needed 
by the IRB to determine whether a study meets all applicable criteria for approval.  
3. 
Type your protocol responses below the gray instructional boxes of guidance language.  If the section or item is 
not applicable, indicate not applicable. 
4. 
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, delete the 
instructional boxes from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  For all 
other research, do not delete the instructional boxes from the final version of the protocol. 
5. 
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the Study 
Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.  
 
If you need help… 
University Park and other campuses: 
Office for Research Protections Human Research Protection Program 
The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
College of Medicine and Hershey Medical Center: 
Human Subjects Protection Office 
90 Hope Drive, Mail Code A115, P.O. Box 855 
Hershey, PA 17033 
(Physical Office Location: Academic Support Building Room 1140) 
Phone: 717-531-5687 
Fax number: 717-531-3937 
Email: irb-hspo@psu.edu 
 
 
 

 
Page 20 of 41 (V.04/27/2017)  
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Confidentiality, Privacy and Data Management 
10.0 
Data and Safety Monitoring Plan 
11.0 
Risks 
12.0 
Potential Benefits to Subjects and Others 
13.0 
Sharing Results with Subjects 
14.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
15.0 
Economic Burden to Subjects 
16.0 
Resources Available 
17.0 
Other Approvals 
18.0 
Multi-Site Research 
19.0 
Adverse Event Reporting 
20.0 
Study Monitoring, Auditing and Inspecting 
21.0 
Future Undetermined Research: Data and Specimen Banking 
22.0 
References 
 
 

 
Page 21 of 41 (V.04/27/2017)  
1.0 
Objectives 
 
1.1 
Study Objectives 
OBJECTIVE1. Partnering with 14 PA public high schools (letters of commitment obtained for all 14 high schools) 
serving an estimated 12,582 predominantly minority, rural, urban, and/or low socioeconomic status (SES) 
students, we will conduct a randomized controlled trial, with student randomization by grade, to compare the 
effectiveness of universal school-based screening for adolescent major depressive disorder (MDD) versus the 
existing process of targeted screening based on concerning behavior. 
 
Hypothesis 1: Universal screening will increase the number of adolescents with MDD screened, 
identified and engaged in treatment (MDD composite). 
 
Hypothesis 2 (Moderating): Universal screening will increase the historically poorer rates of 
MDD screening, identification and treatment engagement for females  
 
Hypothesis 3 (Moderating): Universal screening will increase the historically poorer rates of MDD 
screening, identification and treatment engagement for rural adolescents 
OBJECTIVE 2. Analyze the impact of MDD screening on secondary outcomes currently collected by the school’s 
Student Assistance Program (SAP) and the school district. These data will be obtained in aggregate by grade level 
at each participating school (a total of 64 data points for each item; 4 grades x 14 schools, see note below re: 
PCORI). Please note, secondary outcomes may no longer be available due to COVID-19 school closures and 
cancellation of state standardized testing. 
 
 
Hypothesis 1. Standardized test scores (e.g. Keystone exams, PSAT, SAT, ACT) will improve in school 
populations with universal MDD screening secondary to earlier identification, treatment referral and 
engagement. 
 
Hypothesis 2. Student school policy violations and suspensions will remain unchanged among 
school populations with the universal MDD screening approach. 
 
Please note: We recently received funding from the Patient Centered Outcomes Research Institute 
(PCORI) for a complementary project to the one above. Aims for this HRSA study and the PCORI study 
have been adjusted with the permission of both organizations to be complementary but distinct. The 
PCORI project is in contract negotiations but will involve only urban school districts focusing on the 
effectiveness of MDD screening in minority populations (deleted objective #1, hypothesis #2 above) 
HRSA will remain focused on rural schools, which are primarily white (hence the rationale for removing 
objective #1, hypothesis #2). Secondary outcomes have similarly been adjusted to be complementary 
but distinct from each other. The study will be registered as one RCT in clinical trials.gov again with the 
approval of the funding organizations. The final analysis will involve both the HRSA and PCORI funded 
schools.  
 
1.2 
Primary Study Endpoints 
MDD composite which includes MDD screen positive for the universal screening arm (or concern in the 
targeted screening group), MDD identification, and MDD treatment engagement. Each of the primary 
study endpoints will be collected at the individual level by the school district by the end of the school 
year. No identifiable information will be collected by study staff.  
 
Universal Group 
1) Adolescents with PHQ-9 score >11 (screen Sept-March of the school year) or who at any point in 
the year exhibit behavior concerning for MDD prompting a SAP triage request, 2) Adolescents 
identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one 
SAP recommendation 
 
Targeted Group 

 
Page 22 of 41 (V.04/27/2017)  
1) Adolescents with behavior concerning for MDD prompting a SAP triage request, 2) Adolescents 
identified with MDD by SAP triage, and 3) Adolescents who successfully engage with at least one 
SAP recommendation  
 
Concern for MDD based on a primary or secondary potentially MDD related SAP "incoming referral 
reason"  
 
SAP triage is not diagnostic, so MDD identified based on recommendations for MDD related school or 
community services (e.g. mental health treatment services) 
 
 
1.3 
Secondary Study Endpoints 
 
The secondary endpoints listed below are individual level data points that will be obtained from the 
school district and/or SAP.  No identifiable information will be collected by study staff.   
 
MDD screen positive or MDD concern prompting Student Assistance Program triage 
 
Universal screening arm: Adolescents who have a PHQ-9 score >11 (screening with the PHQ-9 is 
planned for September to March) or who at any point in the school year exhibit behavior 
concerning for MDD which prompts self or collateral request for SAP triage. 
 
Targeted screening arm: Adolescents with behavior concerning for MDD which prompts self or 
collateral request for SAP triage at any point during the school year. 
 
Suicidal adolescent (includes suicidal thoughts [positive response to PHQ-9 item 9], attempts and 
completed) 
 
Universal screening arm: Patient health questionnaire positive response to question #9 re: suicidal 
thoughts, which requires management by the state-mandated school crisis plan or student self 
or collateral report of suicidal thoughts, which requires management by the state-mandated 
school crisis plan (source school district). 
 
Targeted screening arm: Student self or collateral report of suicidal thoughts, which requires 
management by the state-mandated school crisis plan (source school district). 
Any student suicide attempts or completed suicides shared with the school district will also be 
included. 
 
MDD identification 
Universal and targeted screening arms: Adolescents who are identified as having MDD based on 
triage by the school SAP team. As SAP triage is not diagnostic, MDD identified will be based on 
SAP recommendations for school or community services which are MDD related (e.g. mental 
health treatment services). 
 
MDD treatment engagement 
Universal and targeted screening arms: Adolescents who successfully engage with at least one 
SAP recommendation. This may be fulfilled by parental report that an appointment was 
successfully scheduled 
 
The secondary endpoints listed below are aggregate data points by grade level that will be obtained 
from the school district and/or SAP.  No identifiable information will be collected by study staff.  Please 

 
Page 23 of 41 (V.04/27/2017)  
note, secondary outcomes may no longer be available due to COVID-19 school closures and cancellation 
of state standardized testing. 
 
Standardized test scores (i.e. Keystone exams, PSAT, SAT/ACT) 
Student school policy violations and/or suspensions 
Missed school days 
Grade point averages 
Grade advancement or graduation rates 
 
Additional data points to be obtained for subgroup analyses include: 
 
At the individual level: 
o Sex - male or female  
o Ethnicity - Hispanic vs. non-Hispanic  
o Race - white, black or other 
o Urban/rural – students will be categorized as enrolled in urban or  rural school 
districts based on the definition applied by The Center for Rural PA, a Legislative 
Agency of the PA General Assembly for the district 
 
 
At the aggregate level, the following variables will be collected: 
o District socioeconomic status  
o School size – school enrollment. Data will be obtained from school districts 
based on enrollment as of October 1 of the RCT 
o Ratio of guidance counselors/students – The ratio of counselors to students will 
be obtained from each school district 
o School-based mental health services – schools will be categorized by the 
availability of school-based mental health services (yes vs. no) based on 
information obtained from each school district.  
 
We need to collect data at the individual level for 3 main reasons.  First, we expect 
approximately 20% of students to opt out from the study, with opt out rates varying by grade.  
Aggregate data would necessarily include outcomes for students who are not enrolled in the 
study.  This is particularly problematic for the universal screening group because students who 
opt out will not be offered the depression screening tool (PHQ-9).  Second, we need to obtain 
gender and race/ethnicity to conduct important planned secondary analyses (subgroup 
analyses) that will examine efficacy of universal screening by these groups.  In particular, we 
expect that females and minority students will have much higher rates of major depression 
disorder identified in the universal screening group.  Third, in the universal screening group, we 
will be able to link responses to the PHQ-9 to outcomes, which will allow for estimation of 
important measures such as the false positive rate of the PHQ-9 (score ≥11, but SAP process 
determines no further referrals are needed).  These measures will inform decision-making 
regarding the potential for implementation of the intervention (in other schools) should the 
results of the trial ultimately show efficacy.   
 
2.0 
Background  
 
2.1 
Scientific Background and Gaps 
The prevalence of annual major depressive disorder (MDD) episodes among US adolescents rose from 
8.3% in 2008 to 12.5% in 2015.1 Close to 30% of adolescents with MDD reported suicidality in the prior 
year, with more than one in ten making a suicide attempt.2 As a result, suicide was the 2nd leading 
cause of death among youth 10-24 years of age as of 2014.3 Baseline data from HealthyPeople.gov 

 
Page 24 of 41 (V.04/27/2017)  
found that only 2.1% of adolescent primary care office visits included depression screening in the years 
2005-2007.4 Inequalities were reported for women who are three times more likely to have MDD, but 
less likely to be treated than males.1,2,6 In response to the growing mental health crisis, the US 
Preventive Services Task Force (USPSTF) endorsed universal screening for adolescent MDD in primary 
care in 2009.7,8 The HealthyPeople.gov 2020 goal is a 10% increase in screening to a rate of 2.3%, which 
fails to address this adolescent public health crisis.4 The USPSTF universal MDD screening 
recommendation was based on evidence that 
treatment of MDD is associated with moderate benefit.7,8 While most experts in family medicine, 
pediatrics, psychology and child psychiatry agree that surveillance of adolescents at high-risk for 
MDD is warranted, the USPSTF updated their recommendations in 2016 with a call to address 
several knowledge gaps: 
1) Does screening increase the proportion of adolescents identified with MDD? 
2) What are the benefits and unintended consequences of MDD screening for subgroups: 
age, sex, race, ethnicity and socioeconomic status (SES)? 
3) What are the benefits and unintended consequences of screening in nonclinical settings?8 
We propose that schools may provide an effective setting to conduct universal MDD screening. While 
over half of US adolescents do not have annual preventive health visits most attend school.9 The regular 
contact with schools compared to contact with the medical setting has been used to advocate for many 
school-based universal health screenings that impact academic success (e.g. vision, hearing). However, 
while current school screenings address multiple physical health domains, none address mental health.10 
Targeted mental health screening is the current school process for students who display signs 
concerning for MDD and results in referral to the school’s Student Assistance Program (SAP). SAP 
operates in all 500 Pennsylvania school districts and functions similar to a triage service by assessing 
symptom severity, and then if appropriate, providing referrals to school or 
community-based mental health resources.11 Students may self-refer, but all other SAP referrals depend 
upon a student exhibiting concerning behavior that is detected by school staff, peers or parents, which 
results in a targeted screening process with obvious limitations. 
 
2.2 
Previous Data 
Our research team is acutely aware of the concerns the topic of adolescent depression screening may 
raise among school staff, providers, parents and adolescents. We have had ample opportunity in our 
pilot work to discuss and address many of these issues as outlined below. First, from April-Sept 2016 we 
conducted eight focus groups (7-10 participants each, n=62) to better understand the perspective of key 
stakeholders regarding Whole Child Health, specifically the importance of both physical and mental 
wellness. These focus groups included 2 parent groups, 2 school nurse groups, 2 groups of school 
teachers and administrators and 2 groups of medical providers (pediatrics and family medicine). The 
work was funded by the Penn State Social Science Research Institute-Children, Youth and Families 
Consortium. Participant conversations were instrumental in shaping the current proposal. In addition, 
following the aforementioned focus groups, we conducted a Community Engagement Studio in August 
2017 funded by the Penn State Center for Translational Science Institute. These 2 hour sessions are 
specifically intended to inform grant proposals that depend upon successful community engagement. 
Participant perspectives ranged from adolescent to parent, school staff, the leaders of two mental 
health and suicide prevention organizations (Aevidum and the Jana Marie Foundation), a Behavioral 
Health Managed Care company representative and the project director of Pennsylvania’s Garrett Lee 
Smith Youth Suicide Prevention Grant in addition to our Penn State Research team.  
 
2.3 
Study Rationale 
Rates of major depression are rising among US adolescents paralleled by a rise in the rate of adolescent 
suicides. The most recent data indicates that 1 in 8 adolescents (12.5%) experienced an MDD episode in 
the past 12 months.1 The most striking increase in MDD trends was for females across all racial and 
ethnic groups. Adolescent females demonstrated rates of MDD episodes over 3 times that of males 

 
Page 25 of 41 (V.04/27/2017)  
(19.5% vs. 5.8%).1,6 Some authors have suggested that adolescent females have increased exposure to 
depression risk factors including cyberbullying, mobile phone use and texting.6 Along with the rise in 
MDD episodes, adolescent females have demonstrated a significant rise in emergency department visits 
for nonfatal self-inflicted injuries with rates since 2009 increasing by 19% annually from 110 in 2009 to 
318 per 100,000 in 2015.12 Self-inflicted injury is one of the strongest risk factors for suicide, and the 
suicide rate for female adolescents reached its highest in the past 40 years according to 2017 Centers for 
Disease Control and Prevention data.13,14 
Adolescent MDD has negative effects on academic performance, with increasing severity of depressive 
symptoms linked to a lower grade point average as well as subjective assessments of increased school 
workload and concentration difficulties. Adolescents with untreated MDD experience poorer 
interpersonal relationships, lower self-esteem, social isolation, and increased risk-taking behaviors 
including substance use, as well as multiple physical and mental health comorbidities in adulthood.7,8,15-
17 For 60-90% of adolescents, symptoms of a MDD episode may remit within in a year. The larger 
problem is that 50-75% of these adolescents will develop subsequent MDD episodes within 5 years, 
resulting a chronic or relapsing disorder.18 Studies also suggest that recovery is not complete between 
episodes, with most individuals reporting residual symptoms or impairment.18 
Despite the rising rates of depression, there has been no change in mental health treatment among 
adolescents with a MDD episode from 2005-2014.6 Only 36-44% of children and adolescents with MDD 
receive treatment, underscoring that MDD is underdiagnosed and undertreated.6 This disparity is 
especially pronounced for disadvantaged populations. Even for those who have a primary care provider, 
data from HealthyPeople.gov indicates a steady decline in rates of screening with only 1.4% of primary 
care office visits including MDD screening as of 2009- 2011.4 In addition to minorities, rural youth and 
those of lower SES receive fewer preventive care services than their white, urban, high SES 
counterparts, further limiting their access to MDD screening in the context of well-care.20,21 
 
3.0 
Inclusion and Exclusion Criteria 
 
3.1 
Inclusion Criteria 
Students in grades 9-12 at 14  public schools (XXXXXXXXXXXXXXXXXXXX) in Pennsylvania that previously 
committed to partner with us in this project. HRP-504- School Permission to Conduct Research forms 
will be uploaded in our CATS application documentation for each participating district to show district 
approval of the opt out procedure and to agree with their 3rd Party Protection of Pupil Rights 
Amendment (PPRA) policies. Further, included as supporting documents are letters from 
XXXXXXXXXXXXXXXXXXXX who have all acknowledged and shown support of the opt out approach.  
 
School staff who assisted with the screener/screening process will be asked to complete a 45 minute 
interview using our Year 1 or Year 2 feedback guide documents (included in supporting documents). 
 
 
3.2 
Exclusion Criteria 
Students whose parents complete the opt-out consent 
Students not enrolled in one of the participating schools 
Students not in grades 9-12 
Students with disabilities that are deemed unable to participate by the school district 
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 Criteria for removal from study 
N/A 

 
Page 26 of 41 (V.04/27/2017)  
3.3.2 
Follow-up for withdrawn subjects 
N/A 
 
4.0 
Recruitment Methods 
 
4.1 
Identification of subjects 
Three PA public schools committed to partner with us to complete the proposed work in the 2018-2019 
school year. Another 6 rural schools will participate in the 2019-2020 school year and this information 
will be submitted to the IRB in advance of the actual screening. PI XXXXXXXXXX and co-investigator 
XXXXXXXXXXi have previously partnered with several of these school districts through their prior 
research. In total, the rural schools serve approximately 3,900 students (HRSA Study) and were selected 
as they represent a large number of low SES, rural student populations who have known disparities in 
mental health services. The additional PCORI funded urban schools XXXXXXXXXXXXXXXXXXXX adds an 
additional 8,150 students. Additionally, we will recruit 1-2 school staff members to participate in our 
feedback guide interview upon completion of the screener/screening process year. We are not 
collecting any PHI, nor will names of the school staff participants be disclosed in the use of manuscripts/ 
written publications.  
 
4.2 
Recruitment process 
After discussion with our stakeholders and the Penn State Institutional Review Board, we will pursue 
opt-out consent for screening given the importance of MDD screening and the low-risk aside from 
identification of a suicidal student. Parents will be informed of their child’s enrollment in screening and 
given the opportunity to opt out prior to the fall intervention. For this proposal, in cases of a shared 
custody agreement, if either parent or guardian opts out of the study, the student will be considered 
ineligible for enrollment. In this case, no information will be collected, even in the case of students 
randomized to the targeted screening arm, which is the usual school process. An additional opt-out 
letter was created for HRSA schools, as one participating school did not send opt-out letters to parents 
whose children were randomized to the target (control) arm of the trial. This letter has been included in 
supporting documents and will be sent in spring 2020, after the intervention has ended. No information 
will be collected for those students whose parents return these opt-out forms by the end of the school 
year. Also, any participating student randomized to the universal screening arm who does not assent at 
the time of screening will not be required to complete the screening form. Students 18 years and older 
are anticipated to be a small minority of the students at the start of the academic year, but they will also 
have the opportunity to opt out of study involvement if desired. We will be contacting our primary 
contacts from each of our participating districts to obtain implied/verbal consent for participating in our 
feedback guide interviews. 
 
4.3 
Recruitment materials 
No recruitment materials will be needed for this study. However, a letter will be sent home to parents to 
inform them of their child’s enrollment in the screening and given the opportunity to opt out prior to 
the intervention. If they do not wish to participate, parents will be asked to return the Opt-Out form in-
person or by mail. Opt-out letters will be printed on district letterhead to include the participating 
school’s mailing address. Parents may also return the form signed and scanned, if the school decides to 
send the letter via email. A copy of the PHQ-9 questionnaire will be included in the letter sent to the 
parents. Additionally, the opt-out letter will be translated into a Spanish by the Department of Care 
Coordination and provided to each school. An additional opt-out letter was created for HRSA schools, as 
one participating school did not send opt-out letters to parents whose children were randomized to the 
target (control) arm of the trial. This letter has been included in supporting documents and will be sent 
in spring 2020, after the intervention has ended. Parents will be asked to email or mail their signed opt-
out letter if they do not want their child to participate in the control arm.  

 
Page 27 of 41 (V.04/27/2017)  
 
4.4 
Eligibility/screening of subjects 
N/A 
 
5.0 
Consent Process and Documentation  
 
5.1 
Consent Process  
  
5.1.1 Obtaining Informed Consent 
 
5.1.1.1 Timing and Location of Consent 
N/A 
5.1.1.2 Coercion or Undue Influence during Consent 
N/A 
5.1.2 Waiver or alteration of the informed consent requirement 
We are requesting a waiver of the informed consent requirement. We are pursuing opt-out 
consent for screening given the important of MDD screening and the low-risk aside from 
identification of a suicidal student. At 14 years of age, PA youth are eligible to consent to mental 
health services without parental consent. Our use of the opt out is really intended to include 
and engage the parents and communities we are working with. The opt out will be a letter sent 
home to parents (either via email or regular mail as per school preference) giving them the 
option to decline participation for their student. Schools will be responsible for tracking students 
whose parents have opted-out. In addition, students in the universal arm will have the option to 
decline participation themselves on the screening day via the iPad handed to them. The first 
screen will describe PHQ-9; inform students that participation is voluntary; and participation 
may be stopped at any time and will not affect their school standing or grades. 
We are requesting a waiver of informed consent by utilizing the HRP-585- HSPO Summary 
Explanation Research document for each of the staff members chosen from our participating 
districts to complete our interview using the Final or Year 2 Feedback Guide Interview 
documents.  
 
 
5.2 
Consent Documentation 
 
5.2.1 
Written Documentation of Consent 
N/A 
 
5.2.2 
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.) 
A summary explanation will be used to inform participants about the study allowing them to 
choose to participate in the study. They will provide us verbal consent. Staff members from two 
schools completed the Final Feedback Guide interview XXXXXXXXXXXXXXXXXXXX as a pilot to 
ensure the final version of the Feedback Guide was thorough and comprehensive. These staff 
members will receive the approved summary explanation, along with a copy of their completed 
feedback guide to ensure final consent. To better understand the feasibility of the screening 
process, study staff created a Year 2 feedback guide as a follow-up. A summary explanation for 
the Year 2 feedback guide will be used to inform participants of the study before participating in 
the Year 2 Feedback guide. This document has been uploaded to the supporting documents 
section.  
5.3 
Consent – Other Considerations  
 

 
Page 28 of 41 (V.04/27/2017)  
5.3.1 
Non-English Speaking Subjects 
A Spanish translator was included in the grant and will join the research team for the MDD 
screening at schools where these services would be needed. In addition, the opt out information 
will be translated and sent in Spanish for those parents who the school indicates would have 
trouble with the English version forms. The assent will also be translated into Spanish for those 
students who indicate that Spanish is their preferred language. The PHQ-9 is already available in 
multiple languages including Spanish. 
 
5.3.2 
Cognitively Impaired Adults 
     N/A 
5.3.2.1 Capability of Providing Consent 
N/A 
 
5.3.2.2 Adults Unable To Consent 
N/A 
 
5.3.2.3 Assent of Adults Unable to Consent 
N/A 
 
5.3.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 Parental Permission 
We are requesting a waiver of informed consent. Rather, parents/guardians will 
receive an opt-out form. We are pursuing opt-out consent for screening given the 
important of MDD screening and the low-risk aside from identification of a suicidal 
student. At 14 years of age, PA youth are eligible to consent to mental health services 
without parental consent. Our use of the opt out is really intended to include and 
engage the parents and communities we are working with. 
5.3.3.2 Assent of subjects who are not yet adults 
Students in the universal arm will have the option to decline participation themselves 
on the screening day via the iPad handed to them. The first screen will describe PHQ-9; 
inform students that participation is voluntary; and participation may be stopped at 
any time and will not affect their school standing. The completion of the PHQ-9 implies 
a student’s voluntary consent to participate in the research. Students who decide not 
to participate will not complete the PHQ-9, but will still be tracked similar to students 
randomized to the targeted screening arm. The study team will obtain their 
demographic information and the student will be followed through the academic year 
for SAP triage intakes initiated by the standard pathway (concern by teachers, nurse, 
parent, peer, or self-referral), any referrals and treatment engagement. No identifiable 
information will be obtained and it will be noted in study records that the student did 
not assent to participate in the MDD screener. A copy of this assent form is included in 
the consent form section. 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 

 
Page 29 of 41 (V.04/27/2017)  
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
N/A 
 
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
N/A 
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
N/A 
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
N/A 
 
6.3 
Waiver or alteration of authorization statements of agreement 
N/A 
 
7.0 
Study Design and Procedures 
 
7.1 
Study Design 
Due to the timeline for this funding opportunity, with an anticipated July 2018 start, 3 schools will 
engage in the randomized control trial (RCT) in study year 1 and the additional 13 schools in study year 
2. Many large scale randomized control trials do not enroll all participants at one time point, and in 
many cases enrollment occurs slowly over the course of several years. We do not anticipate there will be 
major changes over the course of two academic years that would significantly alter the results compared 
to conducting the RCT in the same academic year, especially because students will be randomized within 
schools. Finally, staggering enrollment will give the research team the opportunity to troubleshoot any 
unanticipated issues with the first 3 participating schools. The intervention ended early in study year 2 
(March 2020) due to the COVID-19 pandemic and schools subsequently ending in-person instruction. 

 
Page 30 of 41 (V.04/27/2017)  
The study team was unable to complete PHQ-9 screeners with two participating schools 
XXXXXXXXXXXXXXXXXXXX. SAP outcome data will still be collected for all enrolled students (i.e., those 
whose parents did not return the opt-out form) for the 2019-2020 (study year 2) school year.  
At the completion of the year one screener/ screening process, school staff will be asked to complete 
the Final Feedback Guide document to assist in our research/ knowledge of the study process and 
procedures. Staff members from two schools completed the Feedback Guide interview 
XXXXXXXXXXXXXXXXXXXX as a pilot to ensure the final version of the Feedback Guide was thorough and 
comprehensive.  
At the completion of the of the 2019/2020 school year, the 3 schools that participated in the RCT during 
the 2018/2019 school year, will be asked to complete the Year 2 feedback guide interview document to 
assist in our research/knowledge of the long-term feasibility and sustainability of study processes and 
procedures. During their second year of study participation, school participants will be asked to 
complete the feedback guide interview with research personnel. Due to the COVID-19 pandemic 
occurring during the 2019-2020 school year, we have added questions relevant to student mental health 
concerns.  
The remaining 13 schools who participated in the RCT during the 2019/2020 school year will be asked to 
go through the Final Feedback guide. Research personnel will contact school staff and go through the 
Final Feedback guide at the end of the 2019/2020 school year. Due to the COVID-19 pandemic occurring 
during the 2019/2020 school year, we have updated the Final Feedback guide to include questions 
relevant to student mental health concerns.  
 
7.2 
Study Procedures 
 
7.2.1 
Enrollment 
Parents will be informed of their child’s enrollment in screening and given the opportunity to opt 
out prior to the fall intervention. The opt out will be a letter sent home to parents (either via email or 
regular mail as per school preference) giving them the option to decline participation for their student. 
The study team will provide each school with unique study IDs to be assigned to every student, grades 9-
12. Study IDs will include 8 numbers, the first two representing the school, the second two the grade 
and the remaining 4 will be unique to each participating student. Schools will be required to assign these 
unique study IDs to each student, grades 9-12. Schools will complete a linking list (spreadsheet 
template) ensuring that all students, grades 9-12 are included. A completed linking list will include 
student names (first and last), PASECURED ID, unique study ID and demographics information (grade, 
age, sex, race and ethnicity). Schools will remove student names and PASECUREID before sending the 
spreadsheet to the study team. The full linking list (including student name and PASECURIEDID) will 
remain on the school’s spreadsheet and in the school’s possession for tracking of study outcomes 
through the year. By using a unique study ID for each student, the study team will never receive 
identifiable information of students. If a parent returns the opt-out form, school staff will still assign a 
student a unique study ID but no demographic information will be included. This is so the study team 
may properly report the number of opt-out letters returned. This procedure ensures that students 
whose parents have opted-out are not tracked throughout the year.  
 
At the time of the actual universal screening students will also be provided the chance to opt out by 
clicking the appropriate opt out box on the iPad handed to them. We anticipate this will lead to study 
enrollment of 80% of eligible students.  The first screen will describe PHQ-9 and that proceeding is 
voluntary. The completion of the PHQ-9 implies a student’s voluntary consent to participate in the 
research. Unless the parent opt out is returned, participants in both arms will be followed through the 
school year for SAP triage, follow-up referrals and treatment engagement. Those students in the 
universal screening arm with PHQ-9 scores > 11 (MDD screen positive) corresponding to moderate 
depressive symptoms, will proceed through the standard process for anyone referred by traditional 
means to a SAP triage interview. The student will either be referred to appropriate community or 

 
Page 31 of 41 (V.04/27/2017)  
school-based treatment or SAP will determine no follow-up is needed. For those who are recommended 
to additional services by SAP, treatment engagement will be tracked per current SAP processes. The 
study team will receive individual level outcome data from the school district, containing no identifiable 
information. 
 
Additionally, we will recruit 1-2 school staff members to participate in our feedback guide interview 
upon completion of the screener/screening process year. We are not collecting any PHI, nor will names 
of the school staff participants be disclosed in the use of manuscripts/ written publications. Staff 
members from two schools were recruited and completed the Final Feedback Guide interview 
XXXXXXXXXXXXXXXXXXXX as a pilot to ensure the final version of the Feedback Guide was thorough and 
comprehensive.  
 
To better understand the long-term feasibility of the screening process, school contacts who 
participated in the first year of screening will be asked to participate in a Year 2 feedback guide 
interview. This guide will provide information about the screening process impacts and sustainability in 
XXXXXXXXXXXXXXXXXXXXXXXXXX high schools. The remaining schools who participated in screenings 
during the 2019-2020 school year, will participate in the Year 2 feedback guide interview at the end of 
the 2020-2021 school year.  
 
 
7.2.2 
Randomization 
We will randomize by grade levels within each school to receive either one-time universal screening (via 
PHQ-9) or targeted screening (current SAP process). For the schools included in the study, half of the 
schools (50%) will be randomized such that students in 9th and 11th grades will receive universal 
screening and students in 10th and 12th grades will receive targeted screening, and the other half (50%) 
will be randomized such that students in 9th and 11th grades will receive targeted screening and 
students in 10th and 12th grades will receive universal screening. Randomization will be done only for 
students whose parents do not signal an unwillingness to participate in the study (“opt out”). Students 
and study personnel will not be blinded to randomized group at each school site. Randomization will be 
done by grade level primarily for pragmatic reasons because many PA health-based screenings are 
grade-specific (e.g. hearing screen in 11th grade) and screenings for a grade occur at the same time. The 
study will be conducted within schools, but it is not a cluster randomized study, in which an entire 
school (cluster) is assigned to one of the study groups. A cluster randomized study was considered but 
ultimately not pursued because randomization within schools controls for (1) within-school (community) 
factors that may contribute to higher or lower rates of SAP referral, (2) differences in school sizes, and 
(3) potential differences in rates of parental opt out among schools. These benefits were balanced 
against the concern of potential contamination between study groups, whereby those in the targeted 
screening group may benefit from the school-wide push to conduct universal screening.  
 
7.2.3 
Universal MDD Screening Arm (Intervention – Treatment) 
Students randomized to the universal screening arm will complete a PHQ-9. This screening tool includes 
nine close-ended questions with a scoring system ranging from 0 to 27. The PHQ-9 screens will be 
administered on an iPad with an internet connection which allows direct entry of the results in REDCap. 
To prevent the duplication of unique study IDs, the study team will ensure all students have been 
assigned a unique study identification number prior to the screening. A list of participant IDs will be 
provided to the school member present during the screening. Once the unique study ID has been 
entered into REDCap, the study staff will give the iPad to the student to assent and complete the PHQ-9. 
This process will ensure that the correct study ID is used and prevent duplication of study IDs. Further, 
this will safeguard against any student from participating whose parent returned the opt-out letter. No 
names or other identifying information will be used. Paper copies of the assent and PHQ-9 will be 

 
Page 32 of 41 (V.04/27/2017)  
available as a backup should problems arise with internet connectivity. The same measures will be taken 
to ensure no names or other identifying information is used or collected.  
 
In order to immediately identify suicidal intent the survey will be set to flag positive questions in real 
time.  When students have completed the PHQ-9 screen the REDCap survey will prompt them to hand 
the completed questionnaire to study staff, who will see a screen indicating a positive flag. Students 
with suicidal intent (question #9 any response besides “Not at all”) will receive immediate evaluation 
and referral to emergency care as per current school protocols. PA schools are required to have a plan 
to address suicidal students (Act 71). A suicidal participant identified during the screening would not be 
allowed to leave the screening area unless accompanied by appropriate school or research staff. This 
student would then proceed through the standard school pathway for managing a student with 
intentions of self-harm. To ensure school staff is comfortable to manage a student in crisis and that this 
persists beyond the period of the grant, at least 5 staff per school in addition to at least 4 Penn State 
research staff will complete online evidence-based suicide prevention training (Question, Persuade, and 
Refer [QPR] Suicide Triage Training). In addition, all school crisis plans will be carefully reviewed with 
staff following the training to ensure the steps are realistic and staff is comfortable to execute the plan. 
The district identified, QPR trained staff member will be available at the time of screening. Study staff 
who are also QPR trained, will be present during the screening.  
 
7.2.4 
Targeted Screening Arm (Current Process – Control) 
Students randomized to the targeted screening arm will complete their routine school-based screenings. 
Students will be followed through the academic year for SAP triage intakes initiated by the standard 
pathway (concern by teachers, nurse, parent, peer, or self-referral), any referrals and treatment 
engagement. 
 
7.2.5 
Sharing Screening Results 
At 14 years of age, PA youth are eligible to consent to mental health services without parental consent, 
therefore, screening results will not be shared with parents. Those students with scores > 11 (MDD 
screen positive) corresponding to moderate depressive symptoms will, however, proceed through the 
standard process for anyone referred by traditional means to a SAP triage interview. The student will 
either refer to appropriate community or school-based treatment or therapy (MDD identified) or SAP 
will determine no follow-up is needed. For those who are recommended to additional services by SAP, 
treatment engagement will be tracked per current SAP process. As per current school policy, students 
with suicidal feelings will receive immediate referral to emergency care and parents will be notified by 
the school. 
 
 
7.3 
Duration of Participation 
The student’s participation is limited to the 5 minutes it takes for them to participate in the screening 
process. 
 
The school staff members who participate in the feedback guide interview is limited to the 45 minutes it 
takes for them to complete it. 
 
8.0 
Subject Numbers and Statistical Plan 
 
8.1 
Number of Subjects 
The 9 HRSA funded schools to be included in the study have an estimated total enrollment of 
approximately 3,900 students (the PCORI funded urban schools have a total enrollment of 
approximately 8,150 students). The overall rate of parental opt out is expected to be around 20%, 

 
Page 33 of 41 (V.04/27/2017)  
resulting in approximately 9,640 students included in the study. We assumed a 15% attrition rate for 
students who move, drop out of school, or opt out later in the school year. This number will be finalized 
once we have a final confirmed list of participating schools. However, as the total number of students is 
greater than that originally projected below, the sample size determination section will be unchanged. 
 
8.2 
Sample size determination 
A total of 4,820   (estimated) students in each randomized group (an overall sample size of 9,640   
[estimated]) yields >99% statistical power to detect a difference of 3% versus 6% using a 2-sided test 
conducted at a Type I error rate of 5% in a mixed effect logistic regression model. 
 
8.3 
Statistical methods 
The principles of intention-to-treat (ITT) will be used for all statistical analyses related to primary and 
secondary aims. For the primary aim comparing universal to targeted screening, the statistical analysis 
will be conducted using a mixed effects logistic regression model. The primary outcome, MDD 
composite, will be an indicator whether a student was screen positive (or concerns raised in the 
targeted screening arm), identified as having MDD and subsequently engaged in treatment (1=yes, 
0=no). The model will include a fixed effect for randomized group (0=targeted screening, 1=universal 
screening) and a random effect for school. The random effect accounts for correlation among students 
enrolled within the same school. The primary parameter of interest will be the log odds of MDD 
composite in the universal screening group compared to the targeted screening group. Statistical 
significance of the log odds will be assessed using a 2-sided Wald test. Point estimates for the odds ratio 
along with a 95% confidence interval will be reported. 
 
For the analysis of Hypotheses 2 and 3 (Objective 1) evaluating universal screening and targeted 
screening by selected subgroups, the same mixed effects logistic regression modeling framework will be 
used, but the model will be extended by including a fixed effect for subgroup and an interaction effect 
for subgroup by randomized group. The interaction term will be the parameter of interest. A significant 
interaction term indicates that rates of MDD treatment engagement for universal versus targeted 
screening differ by subgroup level (e.g. female vs. male). For the secondary analyses (Objective 2) that 
evaluates universal screening and targeted screening based on school SAP data, we will have only 64  
total data points (4 grades in each of  the 14  schools). Mixed-effects linear (continuous outcomes) and 
logistic regression (binary outcomes) will be used, as appropriate, with a fixed effect for randomized 
group and a random effect for school. The parameter of interest will be the log odds for the universal 
compared to the targeted screening group. Due to the smaller sample size used for these outcomes, 
these analyses will be considered to be primarily hypothesis-generating. Potential mediating variables 
(socioeconomic status, ratio of guidance counselors to students and availability of school-based mental 
health services) will be evaluated for both the Objective 1 and 2 hypotheses. 
 
Additional secondary outcomes will include MDD screen results, MDD concern prompting Student 
Assistance Program triage, MDD identification and MDD treatment engagement analyzed individually 
(rather than as part of MDD composite). Finally any suicidal adolescents (suicidal thoughts [positive 
response to PHQ-9 item 9], attempts and completed) will be analyzed as a secondary outcome. 
 
We need to collect data for individuals for 3 main reasons.  First, we expect approximately 20% of 
students to opt out from the study, with opt out rates varying by grade.  Aggregate data would 
necessarily include outcomes for students who are not enrolled in the study.  This is particularly 
problematic for the universal screening group because students who opt out will not be offered the 
depression screening tool (PHQ-9).  Second, we need to obtain gender and race/ethnicity to conduct 
important planned secondary analyses (subgroup analyses) that will examine efficacy of universal 
screening by these groups.  In particular, we expect that females and minority students will have much 
higher rates of major depression disorder identified in the universal screening group.  Third, in the 

 
Page 34 of 41 (V.04/27/2017)  
universal screening group, we will be able to link responses to the PHQ-9 to outcomes, which will allow 
for estimation of important measures such as the false positive rate of the PHQ-9 (score ≥11, but SAP 
process determines no further referrals are needed).  These measures will inform decision-making 
regarding the potential for implementation of the intervention (in other schools) should the results of 
the trial ultimately show efficacy.   
 
Efforts will be made to ensure completeness of data where possible, but missing data will occur for a 
number of anticipated reasons. First, a student may move during the course of the school year to 
another school district or drop out from school entirely. No data will be collected after this time point. 
Second, parents may opt out their child from the study at any time during the school year. Third, 
students who turn 18 during the school may decide to opt out of the study themselves. In both of these 
instances, data from SAP referrals that occur after opting out will not be collected for purposes of the 
study. Fourth, during the one-time universal screening phase, students may decide to leave data forms 
incomplete, including the PHQ-9. To decrease these instances, the PHQ-9 will be taken on an iPad 
program and the survey will alert if the form is left incomplete. 
9.0 
Confidentiality, Privacy and Data Management  
Please see HRP-598 - Research Data Plan Review Form 
10.0 Data and Safety Monitoring Plan 
N/A: This study does not involve more than minimal risk to subjects, and the magnitude of harm/discomfort is 
not greater than that ordinarily encountered in daily life. 
 
11.0 Risks 
Risk involved in participating in this study are low aside from identification of a suicidal student, in which case 
measures are already currently in place in each school building to address. 
 
12.0 Potential Benefits to Subjects and Others 
 
12.1 
Potential Benefits to Subjects 
Potential benefit to subjects of positive screenings include a referral to SAP to receive support in 
managing their MDD. 
 
12.2 
Potential Benefits to Others 
The potential public health impact of the proposed project cannot be overstated. MDD is a prevalent, 
disabling and a growing US public health problem. The problem is identified by national organizations 
focused on our country’s health care priorities (Healthy People 2020, US Department of Health and 
Human Services). MDD leads both to functional impairment and higher rates of morbidity and mortality. 
In addition, MDD leads to significant social and economic consequences, including increased use of 
health resources and lost work productivity. A public health goal should include identification of those at 
risk for depression with the delivery of interventions to these individuals. Schools are a point of 
intervention with a high potential for early identification and prevention. Currently, fewer than 2 out of 
every 100 adolescents receives guideline-concordant major depression screening. We propose reaching 
nearly 80 of every 100 adolescents in the school setting, vastly increasing the identification of 
adolescents suffering from MDD with a goal to decrease both morbidity and mortality. Schools are an 
ideal partner for this approach, given their tremendous reach across the nation to nearly all adolescents. 

 
Page 35 of 41 (V.04/27/2017)  
13.0 Sharing Results with Subjects 
Individual results will not be shared with other participants. 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
N/A 
 
15.0 Economic Burden to Subjects 
 
15.1 
Costs  
There are no financial costs associated with participating in this research. 
 
15.2 
Compensation for research-related injury 
N/A 
 
16.0 Resources Available 
 
16.1 
Facilities and locations 
Screening will take place in each of the 4 school buildings previously identified for the 2018-2019 school 
year. The study team will submit a finalized list of schools in advance of the 2019-2020 screenings. 
 
16.2 
Feasibility of recruiting the required number of subjects 
All 4 school districts for the 2018-19 year have already expressed interest in participating as evidenced 
through letters of support. Current relationships through past and present programming with the school 
districts created feasibility for recruitment. 
 
16.3 
PI Time devoted to conducting the research 
XXXXXXXXXX will monitor the progress of the study during all phases and hold bi-weekly meetings with 
research staff.   
 
16.4 
Availability of medical or psychological resources 
It is not anticipated that medical or psychological resources will be needed on site, given that study 
procedures are minimal risk. However, students with suicidal intent will receive immediate evaluation 
and referral to emergency care as per current school protocols. PA schools are required to have a plan 
to address suicidal students. A QPR trained staff member will be available at the time of screening. 
Students with a PHQ-9 score >11 will proceed to Student Assistance Program triage as per the standard 
of care by which students exhibiting concerning behavior (outbursts, declining grades) would be 
referred for assessment. 
 
16.5 
Process for informing Study Team 
The investigators and project coordinator/study staff have completed their required Collaborative IRB 
Training Initiative (CITI) in the protection of human research subjects.  The study team will be educated 
on the importance of confidentiality, and proper data handling and storage. Four study team members 
will also complete the Question, Persuade, Refer suicide triage training in order to assist the school staff 
as needed during the time of actual screening. 
 

 
Page 36 of 41 (V.04/27/2017)  
17.0 Other Approvals 
17.1 
Other Approvals from External Entities 
N/A 
 
17.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library.   
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy). 
 
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that 
had been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of 
HRP-901 - Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. 
This form is available in the CATS IRB Library.  
 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way. 
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a 
copy of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This 
form is available in the CATS IRB Library. 
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The 
scientific review requirement may be fulfilled by one of the following: (1) external peer-review 
process; (2) department/institute scientific review committee; or (3) scientific review by the Clinical 
Research Center Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute 
Scientific Review Committee is required if the study involves cancer prevention studies or cancer 
patients, records and/or tissues. For more information about this requirement see the IRB website 
at: http://www.pennstatehershey.org/web/irb/home/resources/investigator  
 
18.0 Multi-Site Research 
 
N/A 

 
Page 37 of 41 (V.04/27/2017)  
19.0 Adverse Event Reporting 
 
19.1 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
20.0 Study Monitoring, Auditing and Inspecting 
 
20.1 
Auditing and Inspecting 
 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.). 
 
21.0 Future Undetermined Research: Data and Specimen Banking 
 
N/A 
 
21.1 
Data and/or specimens being stored 
N/A 
 
21.2 
Location of storage 
N/A 
 
21.3 
Duration of storage 
N/A 
 
21.4 
Access to data and/or specimens 
N/A 
 
21.5 
Procedures to release data or specimens 
N/A 
 
21.6 
Process for returning results 
N/A 
 
22.0 References 
1. Office of Disease Prevention and Health Promotion. Healthy People.gov. Mental Health 
and Mental Disorders. MNMD-4.1 Reduce the proportion of adoelscents aged 12 to 17 
years who experience major depressive episodes. 
https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4813; Updated 

 
Page 38 of 41 (V.04/27/2017)  
December 11, 2017. Accessed December 11, 2017. 
2. Avenevoli S, Swendsen J, He JP, Burstein M, Merikangas KR. Major depression in the 
national comorbidity survey-adolescent supplement: prevalence, correlates, and 
treatment. J Am Acad Child Adolesc Psychiatry. 2015;54(1):37-44.e2. 
3. Heron M. Deaths: Leading causes for 2014. National Vital Statistics Reports. 2016;65(5). 
Hyattsville, MD: National Center for Health Statistics. 
https://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_05.pdf. Accessed January 3, 2018. 
4. Office of Disease Prevention and Health Promotion. Healthy People.gov. Mental Health 
and Mental Disorders. MHMD-11.2. Increase the proportion of primary care physician 
office visits where youth aged 12 to 18 years are screened for depression. 
https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4808; Updated 
December 11, 2017. Accessed December 11, 2017. 
5. Zenlea IS, Milliren CE, Mednick L, Rhodes ET. Depression screening in adolescents in 
the United States: a national study of ambulatory office-based practice. Acad Pediatr. 
2014;14(2):186-191. 
6. Mojtabai R, Olfson M, Han B. National trends in the prevalence and treatment of 
depression in adolescents and young adults. Pediatrics. 2016;138(6):e20161878. 
7. Forman-Hoffman V, McClure E, McKeeman J, et al. Screening for major depressive 
disorder in children and adolescents: A systematic review for the U.S. Preventive 
Services Task Force. Ann Intern Med. 2016;164(5):342-349. 
8. Siu AL, US Preventive Services Task Force. Screening for depression in children and 
adolescents: U.S. Preventive Services Task Force recommendation statement. Ann 
Internal Med. 2016;164(5):360-366. 
9. Adams SH, Park MJ, Twietmeyer L, Brindis CD, Irwin CE, Jr. Association Between 
Adolescent Preventive Care and the Role of the Affordable Care Act. JAMA Pediatr. 
2017 Nov 6. doi: 10.1001/jamapediatrics.2017.3140. 
10. Pennsylvania House of Representatives. House Co-Sponsorship Memoranda. House of 
Representatives Session of 2015-2016 Regular Session. 
http://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=H&SPi 
ck=20150&cosponId=20186. Published May 6, 2016. Accessed January 3, 2018. 
11. Student Assistance Program FY 2015-2016. Mental Health-Drug and Alcohol Statistical 
Data. https://sapjqrs.org/uploadedfiles/JQRS%20Exec%20Summary%202015-16.pdf. 
Accessed December 11, 2017. 
12. Mercado MC, Holland K, Leemis RW, Stone DM, Wang J. Trends in Emergency 
Department Visits for Nonfatal Self-inflicted Injuries Among Youth Aged 10 to 24 Years 
in the United States, 2001-2015. JAMA.2017;318(19):1931-1933. 
13. Centers for Disease Control and Prevention. QuickStats: Suicide Rates for Teens Aged 
15-19 Years, by Sex – United States , 1975-2015. MMWR Wkly Rep 2017; 66(30):816. 
https://www.cdc.gov/mmwr/volumes/66/wr/mm6630a6.htm. Accessed December 11, 
2017. 
14. National Alliance on Mental Illness. Depression. http://www.nami.org/Learn- 
More/Mental-Health-Conditions/Depression. Accessed January 3, 2018. 
15. Khoddam R, Jackson NJ, Leventhal AM. Internalizing symptoms and conduct problems: 
Redundant, incremental, or interactive risk factors for adolescent substance use during 
the first year of high school? Drug Alcohol Depend. 2016;169:48-55. 
16. Fergusson DM, Woodward LJ. Mental health, educational, and social role outcomes of 
adolescents with depression. Arch Gen Psychiat. 2002;59(3):225-231. 
17. Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 
2012;379(9820):1056-1067. 
18. Thomas JF, Temple JR, Perez N, Rupp R. Ethnic and gender disparities in needed 
adolescent mental health care. J Health Care Poor Underserved. 2011;22(1):101-110. 

 
Page 39 of 41 (V.04/27/2017)  
19. Lau M, Hua L, Flores G. Racial/ethnic disparities in health and health care among US 
adolescents. Health Serv Res. 2012;47(5):2031-2059. 
20. Irwin CE, Jr., Adams SH, Park MJ, Newacheck PW. Preventive care for adolescents: few 
get visits and fewer get services. Pediatrics. 2009;123(4):e565-572. 
21. Dixon SK, Hoopes AJ, Benkeser D, Grigg A, Grow HM. Characterizing key components 
of a medical home among rural adolescents. Journal Adolesc Health. 2016;58(2):141- 
147. 

 
Page 40 of 41 (V.04/27/2017)  
 
Summary of Changes 
IRB Approvals 
Study ID 
Type of Submission 
Date submitted 
Date 
approved 
Content of Submission 
STUDY00010090 
Study created 
6/19/2018 
8/27/2018 
  
MOD00016541 
Modification 
9/19/2018 
10/10/2018 
Modification request from IRB to address the question of Data Transfer.  
MOD00016962 
Modification 
10/22/2018 
12/12/2018 
Protocol updates to include the addition of PCORI funding, as well as 
updates to study aims to differentiate between HRSA and PCORI funding. 
Language has been updated to match what has been submitted to 
ClinicalTrials.gov. Also added our Clinicaltrials.gov number to the protocol. 
Additionally, the PCORI specific opt-out letters (English and Spanish) have 
been included in this modification. Modifications have also been made to 
the previously approved HRSA opt-out letters (English and Spanish) to 
allow for flexibility of return date by each high school. A Letter of Support 
from XXXX High School, who participated in the first round of screenings 
has also been uploaded.  
MOD00018762 
Modification 
3/26/2019 
4/11/2019 
Protocol updates to sections 3-7 to include language regarding Feedback 
Guides, created/uploaded the Feedback Guide as a supporting document, 
added XXX to the study team (as well as updated the Study Team 
Qualifications document). 
MOD00019992 
Modification 
7/1/2019 
7/11/2019 
Protocol updated to include all participating schools, as well as letters of 
support. 
MOD00020599 
Modification 
8/15/2019 
8/23/2019 
Added study team members XXX and XXX. Removed XXX as a study team 
member. 
 
Updated HRP-591 Protocol- Sections 1.0, 3.0, 4.0 and 8.0 (updates relate 
to the total number of schools, total anticipated sample size based on 
participating schools).  
MOD00020855 
Modification 
9/3/2019 
9/9/2019 
Updated the first phone number for questions/concerns for the study 
team to the following documents: PCORI Opt-Out Letter (Spanish), PCORI 
Opt-Out Letter (English), HRSA Opt-out Letter (Spanish), and HRSA Opt-out 
Letter English. 
MOD00021609 
Modification 
10/30/2019 
11/14/2019 
Added study team member XXX. 
RNI00005068 
Reportable New 
Information 
11/26/2019 
12/2/2019 
Submitted RNI to notify IRB that XXX has opted to not continue with the 
study. 
MOD00022346 
Modification 
1/9/2020 
NA 
DISCARDED TO ADD UPDATES TO STUDY TEAM. Updated HRP-591 
Protocol sections 1.0, 3.0, 4.0, and 8.0 that XXX is no longer participating. 
Updated study related numbers to reflect this change. 

 
Page 41 of 41 (V.04/27/2017)  
MOD00022348 
Modification 
1/9/2020 
2/13/2020 
Updated HRP-591 Protocol sections 1.0, 3.0, 4.0, and 8.0 that XXX is no 
longer participating. Updated study related numbers to reflect this 
change. XXX was added as a study team member and HRP-509 was 
updated. 
MODCR0004732` 
Modification/CR 
3/24/2020 
4/9/2020 
Continuing review submitted; modifications made to HRP-591 Protocol to 
remove XXX as a participant; XXX's LOS was marked as INACTIVE. 
MOD00023506 
Modification 
4/9/2020 
4/9/2020 
Removed XXX as a team member, updates made to HRP-509. 
MOD00023579 
Modification 
4/14/2020 
4/17/2020 
Updates made to Feedback Guides to include questions relating to COVID 
19. Year 2 Feedback Guides were also added to supporting documents. 
Edits made to HRP-591. 
MOD00023958 
Modification 
5/15/2020 
6/5/2020 
Added XXX as a team member; updates to HRP-591 sections 4.2 and 4.3 to 
include verbiage re: XXX's opt-out letter. Issue was that this school did not 
send opt-out letters to parents whose students were randomized to the 
target (control) arm of the trial. An updated letter was included in 
supporting documents to be sent in spring 2020, after the intervention 
ended. No information will be collected for those students whose parents 
return these opt-out forms by the end of the school year. Also, 
intervention timeline extensions (Sept-Mar), and intervention/data 
collection updates due to COVID-19 were added. 
RNI00005568/RNI00005583 
Reportable New 
Information 
5/15/2020 
5/19/2020 
Discarded 
Corresponding RNI to MOD00023958, included signed report from DSMB 
meeting on May 11, 2020. Discarded on 5/19, per IRB Request. IRB 
contacted team on 5/15 to confirm that this should not have been 
discarded because it was a protocol deviation. Resubmitted on 5/15 as, 
RNI00005583:  Protocol Deviation and Protocol/Intervention Updates. 
RNI00006159 
Reportable New 
Information 
1/12/2021 
3/22/2021 
Per our protocol, every student at a participating school receives a unique 
study identification number, ensuring any student whose parents have 
opted-out are not tracked throughout the year. In turn, this safeguards 
against any student whose parents opt-out from participating in the 
screening process. While comparing screening data (saved in REDCap) and 
completed school spreadsheets, the study team realized 4 students at XXX 
High School whose parents had provided opt-out letters did participate in 
the mental health screener. Our biostatistician was made aware of the 
situation ahead of analysis and this matter was added to our DSMB 
meeting agenda on February 11, 2021. A supporting letter from the DSMB 
indicating the study could continue as planned was added to this RNI.  
MODCR00005258 
Modification/CR 
1/27/2021 
2/8/2021 
Continuing review submitted; modifications to update team member 
profile.