ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff
Phase: NA
Conditions: Mental Health Wellness 1, Burnout, Professional, Self Efficacy
Sponsor: Duke University

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ABC Mental Health: A behavioral study of K-12 teachers and 
school staff 
Phase: N/A – a behavioral intervention 
 
 
Funding Sponsor: 
The Eunice Kennedy Shriver National Institute of Child Health and Human 
Development (NICHD) 
 
 
Protocol Date: 
27 Feb 2022 
Protocol Version: 
1.8 
NCT Number: 
NCT05574764 
Principal Investigator: 
 
Emily M. D’Agostino, DPH, MS, MEd, MA 
Assistant Professor of Orthopedics 
Director of Community-Engaged Research 
Practice 
Department of Orthopaedic Surgery  
Duke University School of Medicine 
311 Trent Drive 
Durham, NC 27710 
Email: emily.m.dagostino@duke.edu 
 
 

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STATEMENT OF COMPLIANCE 
 
This study will be conducted in compliance with the protocol, International Council for 
Harmonisation (ICH) E6 (R2) guideline for Good Clinical Practice (GCP), and the applicable 
regulatory requirements from the United States Code of Federal Regulations (CFR), including 
45 CFR 46 (Human Subjects Protection); 21 CFR 50 (Informed Consent), 21 CFR Part 54 
(Financial Disclosure), and 21 CFR 56 (Institutional Review Board [IRB]); as well as 
international regulatory requirements, if applicable. 
All individuals who are responsible for the conduct, management, or oversight of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
 
 

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STUDY PRINCIPAL INVESTIGATOR 
 
The signature below documents the review and approval of this protocol and the attachments, 
and provides the necessary assurances that this clinical study will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality and according to 
local legal and regulatory requirements and to the principles outlined in applicable United States 
(U.S.) and international regulations and ICH guidelines. 
 
 
 
 
 
Principal Investigator Name (Print or Type)  
 
 
 
 
 
 
Study PI Signature 
 
Date 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
Table of Contents ........................................................................................................................ 4 
List of Abbreviations .................................................................................................................... 6 
Protocol History of Changes........................................................................................................ 7 
Protocol Synopsis ....................................................................................................................... 8 
Schematic/Description of Study Design ...................................................................................... 9 
1 
Key roles ............................................................................................................................ 9 
2 
Background Information and Rationale ............................................................................... 9 
2.1 
Background Information .......................................................................................... 9 
2.1.1 
Background of Child Mental Health During COVID-19 ................................. 9 
2.1.1 
Background of Professional Development Workshop and Evaluation ........ 10 
2.2 
Scientific Rationale ............................................................................................... 10 
2.3 
Potential Benefits .................................................................................................. 11 
2.4 
Known Potential Risks .......................................................................................... 11 
3 
Objectives and Outcome Measures .................................................................................. 12 
4 
Study Design .................................................................................................................... 12 
4.1 
Overall Design ...................................................................................................... 12 
4.2 
Scientific Rationale for Study Design .................................................................... 13 
4.3 
Study Definition of Enrollment ............................................................................... 13 
4.4 
Study Definition of Completion .............................................................................. 13 
5 
Study Population .............................................................................................................. 13 
5.1 
Selection of the Study Population ......................................................................... 13 
5.2 
Inclusion/Exclusion Criteria ................................................................................... 13 
5.3 
Participant Discontinuation/Withdrawal ................................................................. 14 
5.3.1 
Participant/Parent Decides to Withdraw Consent ...................................... 14 
5.3.2 
Handling of Withdrawals ............................................................................ 14 
6 
Study Procedures ............................................................................................................. 14 
6.1 
Summary of Procedures ....................................................................................... 14 
6.2 
Enrollment/Baseline .............................................................................................. 14 
6.3 
Intervention ........................................................................................................... 15 
6.4 
Follow-up .............................................................................................................. 15 
6.4.1 
CARE Assessments for Teachers and Staff .............................................. 15 
6.5 
Evaluation Details ................................................................................................. 15 
6.5.1 
Summary of Evaluations ........................................................................... 15 
6.5.2 
Demographic Variables ............................................................................. 15 
6.5.3 
CARE Assessments .................................................................................. 16 
6.6 
Participant Compensation ..................................................................................... 16 
7 
Assessment of Safety ....................................................................................................... 16 
8 
Study Termination ............................................................................................................ 16 
9 
Statistical Considerations ................................................................................................. 17 
9.1 
Study Endpoints .................................................................................................... 17 
9.1.1 
Primary Endpoints ..................................................................................... 17 
9.1.2 
Exploratory Endpoints ............................................................................... 17 
9.2 
Analysis Population .............................................................................................. 17 

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9.2.1 
Per-protocol Population ............................................................................. 18 
9.3 
Analysis Plan ........................................................................................................ 18 
9.3.1 
Primary Analysis ....................................................................................... 18 
9.3.2 
Exploratory Analysis .................................................................................. 18 
9.4 
Sample Size Considerations ................................................................................. 18 
10 
Future Use of Study Records ........................................................................................... 19 
11 
Source Documents and Access to Source Data/Documents ............................................ 19 
12 
Quality Control and Quality Assurance ............................................................................. 19 
13 
Ethics/Protection of Human Participants ........................................................................... 19 
13.1 
Informed Consent Process ................................................................................... 19 
13.2 
Documentation of Permission, and Consent ......................................................... 20 
13.3 
Confidentiality and Privacy .................................................................................... 20 
14 
Data Handling and Record Keeping ................................................................................. 21 
14.1 
Data Handling ....................................................................................................... 22 
14.2 
Data Management Responsibilities ....................................................................... 22 
14.3 
Data Capture Methods .......................................................................................... 22 
14.4 
Types of Data ....................................................................................................... 22 
14.5 
Study Records Retention ...................................................................................... 22 
14.6 
Protocol Deviations ............................................................................................... 22 
14.7 
Data Sharing ......................................................................................................... 22 
15 
Publication Policy ............................................................................................................. 22 
16 
Literature References ....................................................................................................... 23 

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LIST OF ABBREVIATIONS 
CARE 
Cultivating Awareness and Resilience in Education 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CoC 
Certificate of Confidentiality 
COVID-19 
Coronavirus Disease 2019 
DCRI 
Duke Clinical Research Institute 
DUHS 
Duke University Health Systems 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Council for Harmonisation 
IRB 
Institutional Review Board 
NIH 
National Institutes of Health 
NICHD 
National Institute of Child Health and Human Development 
PI 
Principal Investigator 
PP 
Per-protocol 
U.S. 
United States 
 

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PROTOCOL HISTORY OF CHANGES 
Version 
Date 
Summary of Changes 
1.0 
29 Sep 2022 
N/A Original protocol 

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PROTOCOL SYNOPSIS 
Protocol Title: 
ABC Mental Health: A behavioral study of K-12 teachers and school staff 
NCT # 
Pending 
Phase: 
N/A, a behavioral intervention 
Study 
Intervention: 
Behavioral 
Objectives: 
Primary: Evaluate the impact of a teacher resilience program on mental health 
and well-being outcomes of K-12 teachers and staff 
 
Exploratory: Examine teacher and staff classroom instruction and behavior 
management 
 
Study Design: 
Prospective, multi-site 
Study 
Population: 
Kindergarten through 12th grade (K-12) school employees 
Inclusion / 
Exclusion 
Criteria: 
Inclusion Criteria:  
- 
Adult participant, defined as an adult (18 years or older) employed by a 
school working with youth in kindergarten through 12th grade.  
- 
Fluent in the English language   
 
Exclusion Criteria: N/A 
 
Number of 
Participants: 
Up to 1,000  
Number of Sites: 
Single coordinating site, direct-to-participant 
Duration of 
Participation: 
School employees will participate in the intervention up to 1 year; the study will 
last up to 2 years.  

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SCHEMATIC/DESCRIPTION OF STUDY DESIGN 
 
 
1 
KEY ROLES 
Principal Investigator  
Emily M. D’Agostino, DPH, MS, MEd, MA 
Assistant Professor 
Duke University Medical Center 
Durham, NC 27701 
Phone: 646-853-1223 
E-mail: emily.m.dagostino@duke.edu 
 
 
2 
BACKGROUND INFORMATION AND RATIONALE  
2.1 
Background Information  
2.1.1 Background of Child Mental Health During COVID-19 
As of December 2020, the severe acute respiratory virus coronavirus 2 (SARS-CoV-2) has 
caused over 74 million confirmed cases of Coronavirus Disease 2019 (COVID-19) and over 1.6 
million deaths globally.1 Initially, children were thought to be minimally affected by this disease, 
representing < 2% of confirmed cases.2 However, more recent studies describe increased 
incidence of multisystem dysfunction and some association to prior or concurrent SARS-CoV-2 
infections in children.3 Thus, spread of SARS-CoV-2 remains an issue. Viral spread and 
increased infections has spurred non-pharmaceutical measures in children’s environment, 
especially schools. Strategies to limit the spread of infection has included closure of most public 
spaces, including school buildings. Students have been required to learn from their homes, and 
many lost access to meals and other services provided at schools and structures vital to their 
physical, mental, social, and emotional well-being.  
Considering the potentially detrimental effect of school building closures on students and 
families, school leaders across North Carolina sought partnerships with scientists, physicians, 
and public health specialists from Duke University and the University of North Carolina to better 
understand the science and data about COVID-19 and K-12 schools. Together, through the 
ABC Science Collaborative, school leaders and scientists monitored data from school districts 
choosing to gradually return to school buildings. Scientists interpreted the data and identified 
that contrary to existing assumptions, schools with mitigation strategies in place were not the 
1 - 4  days 

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source of infection spread; in fact, data suggested that school buildings were likely safer than 
surrounding communities. ABC scientists published these results and discussed them with local, 
state, national, and international leaders. Ultimately, the results led to policy changes and 
guidance that changed the paradigm of children returning safely to school amidst a global 
pandemic. Perhaps most importantly, the collaboration between schools and scientists resulted 
in actionable, on-the-ground plans for safe school return that took into account the unique 
features and needs of each school district and local community.  
Now that school buildings have reopened and K-12 students have returned, another crisis for 
children and families persists – COVID-19-related impacts on mental health. Health systems 
and schools have seen suicides skyrocket, schools are facing unprecedented classroom 
behavioral disruptions, and students with anxiety and depression have risen significantly. 
According to the Adolescent Behaviors and Experiences Survey (ABES) collected by the CDC 
in 2021, 37% of high school students reported experiencing poor mental health, and 44% 
indicated persistently feeling sad or hopeless during the pandemic.4 Schools and school 
systems are once again requesting support. 
2.1.1 Background of Professional Development Workshop and Evaluation 
In addition to the direct pandemic-mediated impact on children, teachers’ attitudes can impact 
their students’ mental health.5 We also suspect school staff may play a role in students’ mental 
health. Thus, Cultivating Awareness and Resilience in Education (CARE) has been proposed as 
a potential professional development workshop to help improve teachers’ and staff’s mental 
health, well-being, effectiveness and student wellness. CARE provides teachers and staff with 
tools and resources to reduce stress, prevent burnout, enliven teaching, and help students 
thrive socially, emotionally, and academically. The program will be presented in one to four 
face-to-face training sessions, spread out over one to four months, and provides post-training 
resources as additional support. CARE blends instruction with experiential activities, reflection, 
and discussion. Tools used by the program include mindful awareness practices, emotion, and 
caring skills training to support more equitable and caring classrooms. Research showed CARE 
workshops help improve emotional awareness, self-regulation,6 well-being, cardiovascular 
health,7 efficacies, mindfulness, and burnout/time-related stress.8 Improving teachers’ ability to 
handle their own stress allows them to provide better emotional support to their students and 
may also help reduce schools’ teacher attrition.9  
As part of this study, people who participate in CARE will be asked to answer questionnaires 
about demographic information, mental health, well-being, classroom instruction, and behavior 
management prior to the workshop and two times after completing the workshop. The ABC 
Science Collaborative is providing this professional development workshop as a service that 
participating schools offer to all teachers and staff. Those that want to participate in pre- and 
post-intervention assessments will be consented prior to doing so. Participation in the 
intervention and assessment completion is optional.  
2.2 
Scientific Rationale  
This study will examine the mental health and well-being of school teachers and staff after 
providing professional development to address teacher and staff self-efficacy, burnout, anxiety, 
depression, and stress. This behavioral intervention approach is necessary because the mental 
health of teachers, school staff, and children has declined since the beginning of the COVID-19 
pandemic.  
Teachers and staff can play a pivotal role in students’ lives by developing supportive 
relationships and a classroom climate that promotes positive developmental outcomes and is 

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more conducive to learning. The ability of teachers and staff to play this role is compromised by 
the highly stressful emotional situations they encounter in the school environment that can lead 
to burnout. Teachers that exhibit burnout create learning environments that may cause harmful 
effects on students, especially those already at risk of mental health problems.5 This behavioral 
intervention may help teachers and staff apply concepts to reduce stress, and aid teachers 
improve classroom management and climate that could positively impact children’s mental 
health. Specifically, a growing body of evidence has demonstrated a positive relationship 
between teacher well-being, school climate, and student outcomes, such as learning, growth, 
and mental health. Moreover, we can help promote student mental health and young people’s 
ability to cope with daily stresses by supporting school personnel and promoting their self-
efficacy to teach effectively, manage behavioral disruptions, avoid burnout, and reduce their 
levels of anxiety, depression, and stress. This intervention therefore adopts a “whole-school 
approach” to support teacher and staff and student wellness.10   
2.3 
Potential Benefits 
Direct benefit may include reduced stress and improved performance in teachers and staff. The 
intervention may benefit the mental health and well-being of teachers and staff participating in 
the intervention, as well as the mental health of children. 
2.4 
Known Potential Risks 
This study is minimal risk, with the only identifiable risk being the potential loss of confidentiality.   
Potential Risk of Loss of Confidentiality: 
Loss of confidentiality is a potential risk. There is a potential risk of loss of confidentiality with 
identifiable data collected directly from the participant. Every effort will be made to protect the 
participants’ protected health information as well as other identifying information, but this cannot 
be guaranteed.  
 
 

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3 
OBJECTIVES AND OUTCOME MEASURES 
 
 
Objective 
Outcome Measures 
Endpoints 
Primary: 
Evaluate the  
impact of a 
teacher 
resilience 
program on 
mental health 
and well-being 
outcomes of K-
12 teachers and 
staff  
CARE assessments, 
including Teachers’ Sense 
of Efficacy Scale, Maslach 
Burnout Inventory, 
Symptoms of anxiety 
Generalized Anxiety 
Disorder 7 (GAD7), 
Symptoms of depression - 
Patient Health 
Questionnaire 8 (PHQ-8), 
Perceived Stress Scale 
(PSS) 
Change in CARE 
assessments after the 
intervention compared 
to before  
Exploratory:  
Examine 
teacher and 
staff classroom 
instruction and 
behavior 
management 
 
Experiences with the 
CARE for Teachers and 
Staff Professional 
Development Program1 
 
Teacher and staff 
perceptions of changes 
in classroom instruction 
and behavior 
management after 
professional 
development (post-test 
only) 
 
  
4 
STUDY DESIGN 
4.1 
Overall Design 
Study design: This is a prospective behavioral intervention. The intervention is a professional 
development program for K-12 teachers and staff. The primary objective is to evaluate the 
impact of a professional development intervention on school teacher and staff mental health and 
well-being outcomes, such as their self-efficacy and stress. Exploratory objectives include 
change in teacher and staff classroom instruction and behavior management after participating 
in the intervention. Individual participant-level data will be collected directly from teachers and 
staff who consent to participate in the intervention. A pre-intervention assessment and two post-
intervention assessments will be collected. The consent will be administered once, 
electronically, via REDCap before collecting pre-intervention assessments. All assessments will 
be administered via REDCap.  
Study intervention: A prospective behavioral intervention  
Duration of participant’s enrollment: Up to 1 year  
Duration of study: Up to 2 years 
Safety: N/A  
                                               
1 Based on the scale there is no pre-intervention validated measurement so only a post-intervention 
measurement is being used. 

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4.2 
Scientific Rationale for Study Design 
School employees will participate in the intervention for up to 1 year. The pre-intervention CARE 
assessment battery for teachers and staff will be distributed for completion up to one month 
prior to the CARE teacher and staff resiliency workshop. The post-intervention CARE 
assessment battery will be distributed for completion at one-week post intervention and two 
months post-intervention.   
Based on clinical experience of the investigators and published data, the one-week post 
intervention time point provides insight into the immediate uptake of skills and improvement in 
emotional well-being of participants who have completed a resiliency workshop. The two-month 
post-intervention time frame aids in the determination of which skills and concepts endured over 
time.11 
The resiliency workshop is delivered across one to four days during a one to four-month period 
to provide teachers and staff the opportunity to practice skills they have learned prior to being 
introduced to new concepts and techniques. The CARE team follows up with participants via 
email on a weekly basis to provide reminders of prior practices and context for their use. This 
approach has been shown to be effective for promoting teacher and staff mental health and 
well-being in prior iterations of this workshop. Staff will be identified as either non-administrative 
staff or administrative staff. Non-administrative staff and teachers attend CARE workshops 
together and do not include administrative staff to promote openness and feedback. 
Administrative staff attend CARE workshops that are designed to meet the unique needs of 
principals and administrators. Specifically, at least six studies have investigated effectiveness of 
CARE on improving classroom learning, general participant well-being, self-efficacy, reduced 
burnout, improved self-awareness, self-care and compassion, and mindfulness. 6,7,8,12,13,14  
Additional work has demonstrated the impact of CARE on teachers’ cardiovascular health, 
including lower heart rate.6   
4.3 
Study Definition of Enrollment 
Study enrollment is defined as the participant has provided informed consent and completed the 
pre-intervention CARE assessment battery measures (see Section 6.1). 
4.4 
Study Definition of Completion 
Study participation is defined as complete after teachers and staff complete the 2-month post-
intervention CARE assessment battery. 
 
5 
STUDY POPULATION 
5.1 
Selection of the Study Population 
Adults will be screened for participation according to the criteria in Section 5.2.  
5.2 
Inclusion/Exclusion Criteria 
Inclusion 
Criteria 
- 
Adult participant, defined as an adult (18 years or older) employed by a 
school working with youth in kindergarten through 12th grade. 
- 
Fluent in the English language  

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Exclusion 
Criteria 
N/A 
 
5.3 
Participant Discontinuation/Withdrawal 
5.3.1 Participant/Parent Decides to Withdraw Consent  
Participants may voluntarily withdraw consent to participate in the study at any time. Participants 
are not obligated to state the reason for withdrawal.  No additional study data will be collected 
after consent has been withdrawn, however, all data collected prior to consent withdrawal will be 
maintained in the database.  
5.3.2 Handling of Withdrawals 
The reasons for withdrawal, or failure to provide a reason, must be documented. 
Reasons of withdrawal may include the following: 
1. Participants who withdraw consent to participate in the study.  
2. Study Investigator/Sponsor decision 
 
6 
STUDY PROCEDURES 
6.1 
Summary of Procedures 
Procedure 
Enrollment/ 
Baseline 
Intervention 
Follow-up 
Teacher and staff informed consent 
X 
 
 
CARE assessments for teachers and staff 
X1 
 
X2 
CARE teacher and staff resiliency workshop 
 
X 
 
 
1 Pre-intervention CARE assessment to be distributed for completion up to one month prior to the CARE teacher and 
staff resiliency workshop (intervention). 
2 Post-intervention CARE assessment to be distributed for completion one week post-intervention and two months 
post-intervention.  
 
6.2 
Enrollment/Baseline  
The following data will be obtained at the time of enrollment. 
• 
Adult teacher and staff informed consent 
• 
CARE assessments for teachers and staff, pre-intervention (including collection of 
demographic variables) 
o To be distributed for completion up to one month prior to the intervention. 

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6.3 
Intervention 
The intervention will be a professional development workshop for teachers and staff delivered 
across one to four days. The CARE intervention aims to help teachers and staff handle the 
stresses of school-related work by offering tools and resources for reducing stress, preventing 
burnout, enlivening teaching, and helping students thrive socially, emotionally, and 
academically. Tools include mindful awareness practices and caring and emotion skills training. 
Each intervention workshop includes 30 to 35 participants and a facilitator, who is part of the 
CARE team.15 The workshops will be held at a location selected by the school, likely on their 
campus. 
6.4 
Follow-up 
6.4.1 CARE Assessments for Teachers and Staff 
The following data will be distributed for completion one week post-intervention and two months 
post-intervention.  
• 
CARE assessments for teachers and staff, post-intervention (see Section 6.5.3) 
6.5 
Evaluation Details 
6.5.1 Summary of Evaluations 
Applicable informed consent will be documented for all participants. Participants will be asked to 
complete the pre-intervention CARE assessments online at the time of consent (up to one 
month before the intervention). The post-intervention CARE assessments will be completed 
online by participants one week after and two months after the intervention. REDCap will be 
used to distribute electronic consents and the pre- and post-assessments using a public link 
sent to the school administrator(s), who will then distribute it to the participating teachers and 
staff. Participants’ email addresses will be collected within the REDCap survey and will be used 
solely for payment/incentive purposes. No additional assessments will be collected from the 
participants as part of this study. 
Participants will be instructed that all questions are optional. The questionnaire will include the 
following:  
• 
Demographic variables  
• 
CARE Assessments 
6.5.2 Demographic Variables 
Participants will be asked a series of questions about their demographics, including their race, 
ethnicity, gender, school name, school role (administrative staff, non-administrative staff or 
teacher), and the total number of years they have taught, at current grade level and at current 
school. We will not share data categorized by role with school districts. We will only share 
aggregate data grouped by schools with school districts if there are more than 10 participants. If 
there are fewer than 10 participants at a school, we will group schools together to provide a 
summary report. If the number of workshop participants for the administrative or non-
administrative staff group is less than 10, then these participants will be grouped together and 
identified as “staff.”  

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6.5.3  CARE Assessments 
The CARE assessments are a battery of reliable and validated surveys that aim to collect 
teachers’ and staff’s self-reported self-efficacy, burnout, anxiety, depression, and stress.  
The following assessments will be completed before and after the behavioral intervention: 
• 
CARE Assessment Battery: 
a. Teachers’ Sense of Efficacy Scale;  
b. Maslach Burnout Inventory;  
c. Symptoms of anxiety Generalized Anxiety Disorder 7 (GAD7);  
d. Symptoms of depression – Patient Health Questionnaire 8 (PHQ-8);  
e. Perceived Stress Scale (PSS) 
f. Experiences with the CARE for Professional Development Program (post-test 
only) 
6.6 
Participant Compensation 
Participants will receive a $25.00 electronic Amazon gift card after completing each of the 
CARE assessments at baseline, one-week post-intervention, and two months post-intervention 
during afterschool hours. The CARE assessment battery is anticipated to take approximately 45 
minutes to complete. The maximum compensation amount per participant is $75, and a 
maximum of three payments will be distributed to participants. The payment amount is based on 
the 2022-2023 annual salaries for North Carolina teachers.16  Participants’ names and email 
addresses will be shared with Amazon, Inc. so they can send participants the $25 electronic gift 
card to their email address. A third-party vendor, Amazon, Inc., will be used to distribute 
payments. 
 
7 
ASSESSMENT OF SAFETY 
No safety will be recorded as part of this study. 
 
8 
STUDY TERMINATION 
This study may be terminated at any time by NICHD or the study principal investigators.  
Reasons for termination may include but are not limited to, if in their judgment, no further 
benefits are to be achieved from the study. If the study is terminated, notifications will be made 
to the IRB of record and study participants, in accordance with all applicable regulations 
governing the study and site/investigator. 
 

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9 
STATISTICAL CONSIDERATIONS 
9.1 
Study Endpoints 
9.1.1 Primary Endpoints 
Primary Objective: Examine the impact of a teacher resilience program on mental health and 
well-being outcomes of K-12 teachers and staff (administrative and non-administrative).  
Primary Endpoint: Change in CARE assessment scores after the intervention compared to 
before. 
• 
Teacher cohort 1: Change in raw CARE assessment scores (Teachers’ Sense of 
Efficacy Scale; Maslach Burnout Inventory; Symptoms of anxiety Generalized 
Anxiety Disorder 7 (GAD7); Symptoms of depression - Patient Health Questionnaire 
8 (PHQ-8); Perceived Stress Scale (PSS)) 
• 
Staff-non administrative cohort 2:  Change in raw CARE assessment scores 
(Teachers’ Sense of Efficacy Scale; Maslach Burnout Inventory; Symptoms of 
anxiety Generalized Anxiety Disorder 7 (GAD7); Symptoms of depression - Patient 
Health Questionnaire 8 (PHQ-8); Perceived Stress Scale (PSS)) 
• 
Staff administrative cohort 3: Change in raw CARE assessment scores (Teachers’ 
Sense of Efficacy Scale; Maslach Burnout Inventory; Symptoms of anxiety 
Generalized Anxiety Disorder 7 (GAD7); Symptoms of depression - Patient Health 
Questionnaire 8 (PHQ-8); Perceived Stress Scale (PSS)) 
9.1.2 Exploratory Endpoints  
Exploratory Objective: Examine teacher and staff (administrative and non-administrative) 
classroom instruction and behavior management.  
Exploratory Endpoint: Teacher and staff (administrative and non-administrative) perceptions of 
changes in classroom instruction and behavior management after professional development 
(post-test only).  
• 
Teacher cohort 1: Change in raw perceived changes in classroom instruction and 
behavior management after professional development  
• 
Staff non-administrative cohort 2: Change in raw perceived changes in classroom 
instruction and behavior management after professional development  
• 
Staff administrative cohort 3: Change in raw perceived changes in classroom 
instruction and behavior management after professional development 
9.2 
Analysis Population 
All participants enrolled to the study who completed the intervention will be included in the 
analysis population used for primary and exploratory objectives. 
The number of participants who either completed the study or discontinued early from the study 
will be summarized using a CONSORT diagram. Demographic and characteristics at study 
baseline (1 week prior to intervention) will be summarized. 

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9.2.1 Per-protocol Population 
For the primary endpoint, participants must have completed the pre and post-CARE 
assessment to be included in the per-protocol (PP) population.   
For the exploratory endpoint, participants must have completed the post-CARE assessment, to 
be included in the per-protocol (PP) population.   
9.3 
Analysis Plan 
Summary statistics of the schools and staff in the three cohorts (teacher, staff administrative 
and staff non-administrative) will be presented using data collected during pre- and post-CARE 
assessment.  We will not share data categorized by role with school districts. We will only share 
aggregate data grouped by schools with school districts if there are more than 10 participants. If 
there are fewer than 10 participants at a school, we will group schools together to provide a 
summary report.  If the number of workshop participants for the administrative or non-
administrative staff group is less than 10, then these participants will be grouped together and 
identified as “staff.” Under these circumstances, there will be two cohorts instead of three. 
Means/medians with standard deviations (and interquartile ranges) will be tabulated.  
Descriptive statistics (i.e. number of observations, mean, standard deviation, median and 
interquartile range) will be presented for continuous variables (e.g. as age, weight, etc.). Other 
descriptive statistics such as counts, proportions, and/or percentages will be presented to 
summarize discrete variables (such as race, sex, etc.). All descriptive analyses will be presented 
by appropriate stratification group and overall as specified under each analysis section.  
The analysis and PP populations will be used for the primary and exploratory analyses, unless 
otherwise specified. A detailed description of statistical methods for all analyses will be prepared 
and presented in the statistical analysis plan prior to data lock for final analyses.  
9.3.1 Primary Analysis 
For the first primary endpoint for the teacher, staff administrative and staff non-administrative 
cohorts (change in CARE assessment scores after professional development intervention 
compared to before), the overall proportions will be reported and the change from pre- to post- 
will be presented in graphical form (bar chart).  
95% confidence intervals for raw change in pre-post assessment scores for each assessment 
will be computed using a non-parametric bootstrap. 
9.3.2 Exploratory Analysis  
For the exploratory endpoint for the teacher and staff cohorts (teacher, staff administrative and 
staff non-administrative perceptions of changes in classroom instruction and behavior 
management after professional development), descriptive statistics will be reported and raw 
mean change from pre- to post- will be presented in graphical form (bar chart).  
 
9.4 
Sample Size Considerations 
No formal sample size calculation was completed for this study. This study will enroll as many 
adults as possible during the study period, up to 1,000 total participants. 
 

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FUTURE USE OF STUDY RECORDS  
The research data collected in this study, and provided to the sponsor, will be kept indefinitely.  
Information about this study, including study results, will be published without further permission 
from the participant as detailed in the informed consent form. Participants will not be identified in 
any publications or presentations made about the study.  
After the study is completed, information about the study, including study data, may be provided 
to the National Institutes of Health (NIH). Identifiable data will be kept at the DCRI and the DCRI 
will not share these data with the NIH. With NIH approval, the data submitted may be used by 
other researchers for future research. The study data submitted will be de-identified, meaning it 
will not include any information that can identify the participant. The study team may also share 
the de-identified study data with other researchers. When the participant’s de-identified study 
data are provided to other researchers for the purposes of future research, it will be done 
without obtaining additional permission. 
  
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE 
DATA/DOCUMENTS  
All data collected in this study will be entered by the participant directly into REDCap. 
   
12 
QUALITY CONTROL AND QUALITY ASSURANCE  
The principal investigator will ensure that all study personnel are appropriately trained and 
applicable documentations are maintained. The DCRI will implement quality control procedures 
beginning with the data entry system and generate data quality control checks that will be run 
on the database. 
  
13 
ETHICS/PROTECTION OF HUMAN PARTICIPANTS  
13.1 Informed Consent Process 
Informed consent procedures, as applicable per Section 13.2, are initiated prior to an individual 
agreeing to participate in the study and continuing throughout the individual’s study 
participation. The ABC Science Collaborative is providing this professional development 
workshop as a service that participating schools offer to all teachers and staff. Those that want 
to participate in pre- and post-intervention assessments will be consented prior to doing so. 
Participation in the intervention and assessment completion is optional. Risks and possible 
benefits of participation in this study will be provided to the participants, as appropriate, prior to 
consenting via REDCap. The study team will distribute the public REDCap eConsent link to 
school administrator(s) who will then distribute the link to the participating teachers and staff. 
Administrators, school teachers, and staff will not have access to data submitted via REDCap, 
nor will they know who completed the surveys.  

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Consent forms with detailed descriptions of the study procedures, risks, and potential benefits 
will be approved by the IRB. Consent forms will be provided to the participant electronically to 
read and note any questions. The consent must be completed prior to performing any study-
specific procedures, unless documentation of written consent is waived by the local IRB. 
Participants will at least be given overnight to consider whether or not they would like to 
participate. The consent and the opportunity to complete the pre-intervention CARE assessment 
will be provided up to one month prior to the intervention. 
DCRI will not take part in the consent process, as the consent will be integrated into REDCap. 
The informed consent forms indicate that participation is completely optional, participants may 
withdraw at any time, and participants are not obligated to state the reason for withdrawal.  If 
information emerges about new potential risks related to participating in this study or if 
procedures are modified, the consent forms will be updated to reflect those potential risks, and 
the participants currently active in the study will be re-consented with the updated consents. If 
the consent forms are changed for any other reason and the local IRB requires re-consenting of 
active participants, participants will be asked to review and complete the new consent forms 
electronically. 
A copy of the executed informed consent documents will be provided to participants for their 
records.  
13.2 Documentation of Permission, and Consent 
Permission, and consent must be documented using forms and processes determined by the 
Duke University Health System (DUHS) IRB and the IRB of record, if different.   
Prior to enrollment of participants into this study, the protocol, the applicable informed consent 
template, and any materials or advertisements presented to participants will be reviewed and 
approved by the DUHS IRB.  
Should amendments to the protocol and consent documents be required, the amendments will 
be written by the sponsor and approved by the DUHS IRB. 
Recruitment efforts approved by the IRB prior to participants consenting may be used; however, 
before any protocol-specific procedures are performed, informed consent or waiver of informed 
consent must be obtained. The informed consent process will be conducted and the form fully 
executed before participants undergo any study-specific procedures. 
13.3 Confidentiality and Privacy 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s) and their agents. Therefore, the study protocol, documentation, 
data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior 
written approval of the sponsor. 
Data entered into REDCap will contain personal identifiers, including names, email addresses, 
and physical addresses. Participant names will be collected for the purpose of consent and 
payment. Participant email addresses, and physical addresses will be collected for the purpose 
of payment. Participants’ names and email addresses will be shared with Amazon, Inc so they 
can send participants the $25 electronic gift card. Participants will be informed that they may 
choose not to share their physical address, and email address and still complete the 
questionnaires. If they choose not to share their physical address, and email address, they can 
still participate, but they cannot be paid for completing each of the questionnaires. Payment 

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information is restricted to a few DCRI team members, and access to this information is 
restricted by the assigned REDCap role. This study is direct to participant, and no sites will have 
access to data.  
REDCap will assign a unique ID to each participant rather than using a name. Participants will 
also be asked to select the name of the school where they work and identify whether they are 
administrative staff, non-administrative staff, or a teacher from a dropdown menu within 
REDCap. We will not share data categorized by role with school districts. We will only share 
aggregate data grouped by schools with school districts if there are more than 10 participants. If 
there are fewer than 10 participants at a school, we will group schools together to provide a 
summary report. If the number of workshop participants for the administrative or non-
administrative staff group is less than 10, then these participants will be grouped together and 
identified as “staff.”  
REDCap will be used to distribute consents, and the pre- and post-assessments using a public 
link sent to the school administrator(s) who will then distribute it to the participating teachers and 
staff. The school administrator will not know who did or did not complete the assessments.  
The principal investigator will ensure that the use and disclosure of protected health information 
obtained during a research study complies with the Health Insurance Portability and 
Accountability Act (HIPAA) Privacy Rule. The rule provides U.S. federal protection for the 
privacy of protected health information by implementing standards to protect and guard against 
the misuse of individually identifiable health information of participants participating in clinical 
trials. Authorization is required from each research participant (i.e., specific permission granted 
by an individual to a covered entity for the use or disclosure of an individual’s protected health 
information). A valid authorization must meet the implementation specifications under the 
HIPAA Privacy Rule. Authorization may be combined in the informed consent document (if 
approved by the IRB). 
The study participant’s contact information will be securely stored for use during the study. At 
the end of the study, all records will continue to be kept in a secure location for as long a period 
as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at the DCRI. Individual participants and their 
research data will be identified by a unique study identification number. All study data systems 
used by the DCRI research staff will be secured and password protected.  
To further protect the privacy of study participants, this study is covered by a Certificate of 
Confidentiality (CoC) from the National Institutes of Health. The CoC limits the ability of courts 
and other agencies from forcing the study team to share participant information or body fluids 
during a legal or legislative action without the participant’s permission. 
  
14 
DATA HANDLING AND RECORD KEEPING 
The investigator is obligated to conduct this study in accordance with U.S. Federal Regulation 
21 CFR 312.60-68 as specified by applicable state and federal laws, and the International 
Council for Harmonisation: Good Clinical Practice: Consolidation Guideline.  

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14.1 Data Handling 
Data will be captured using REDCap. All data collected in the context of this study will be stored 
and evaluated per applicable regulatory requirements and guidance for electronic records.  
Data will be stored and evaluated in a manner that protects participant confidentiality in 
accordance with the legal stipulations applying to confidentiality of data. 
14.2 Data Management Responsibilities 
The DCRI will be responsible for data management, quality review, analysis, and reporting of 
the study data. 
14.3 Data Capture Methods 
Teachers and school staff data will be entered directly into REDCap. 
14.4 Types of Data 
Data for this study will include demographics and information reflecting the mental health and 
well-being (self-efficacy, burnout, anxiety, depression, perceived stress) and effectiveness of 
teachers and staff at the individual level. Participants’ personal identifiers will be collected, 
including names, email addresses, and physical addresses. Participant names will be collected 
for the purpose of consent and payment. Participant email addresses, and physical addresses 
will be collected for the purpose of payment.  
14.5 Study Records Retention 
All records will be retained for at least 5 years after study completion, per Duke Policy. 
14.6 Protocol Deviations 
A protocol deviation is any noncompliance/unplanned excursion from approved investigational 
plan (e.g., protocol, MOP), or ICH GCP guidelines. The noncompliance may be on the part of 
the participant, investigator, or study staff. No protocol deviations will be reported for this study, 
but indirectly tracked via missing data in the database.  
14.7 Data Sharing 
Individual-level data, including demographics and responses to the CARE assessments, may be 
shared with participating NC school districts and collaborators of the ABC Science 
Collaborative, but will only be shared as aggregate, summary-level data. No raw, individual-level 
data will be shared. Data may also be shared via publications or presentations. 
 
15 
PUBLICATION POLICY  
The ABC study will adhere to authorship standards described in the International Committee of 
Medical Journal Editors’ Recommendations for the Conduct, Reporting, Editing, and Publication 
of Scholarly Work in Medical Journals. Authorship credit should be based on: 

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• 
Substantial contributions to conception and design, acquisition of data, or analysis 
and interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
• 
Agreement to be accountable for all aspects of the work in ensuring that questions 
related to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved 
Additional authorship requirements imposed by individual journals will also be met. Authorship 
credit will be assigned in an equitable fashion and will be commensurate with participation and 
effort on the individual manuscript. Committee members will appear as authors on manuscripts 
based solely on actual contributions to the writing of the manuscript. 
All investigators funded by the NIH must submit or have submitted for them to the National 
Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed 
manuscripts upon acceptance for publication, to be made publicly available no later than 12 
months after the official date of publication. The NIH Public Access Policy ensures the public 
has access to the published results of NIH-funded research. It requires investigators to submit 
final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed 
Central upon acceptance for publication. Further, the policy stipulates that these papers must be 
accessible to the public on PubMed Central no later than 12 months after publication.  
Refer to: 
http://publicaccess.nih.gov/  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html 
 
16 
LITERATURE REFERENCES 
1. 
Hopkins J. COVID-19 Map FAQ. https://coronavirus.jhu.edu/map-faq.html. 
 
2. 
Covid, C. D. C., et al. "Severe outcomes among patients with coronavirus disease 2019 
(COVID-19)—United States, February 12–March 16, 2020." Morbidity and mortality weekly 
report 69.12 (2020): 343. doi:http://dx.doi.org/10.15585/mmwr.mm6912e2. 
 
3. 
Jones, Veena G., et al. "COVID-19 and Kawasaki disease: novel virus and novel 
case." Hospital pediatrics 10.6 (2020): 537-540. doi:10.1542/hpeds.2020-0123. 
4. 
Centers for Disease Control and Prevention. March 31, 2022. New CDC data illuminate 
youth mental health threats during the COVID-19 pandemic. 
https://www.cdc.gov/media/releases/2022/p0331-youth-mental-health-covid-19.html. 
5. 
Jennings, Patricia A., and Mark T. Greenberg. "The prosocial classroom: Teacher social 
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educational research 79.1 (2009): 491-525. doi: 10.3102/0034654308325. 

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6. 
Schussler, Deborah L., et al. "The relationship between adopting mindfulness practice 
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2567-2582. https://doi.org/10.1007/s12671-019-01228-1. 
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Mihić, Josipa, et al. "Effectiveness of mindfulness-based social-emotional learning 
program CARE for teachers within Croatian context." Mindfulness 11.9 (2020): 2206-2218. 
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8. 
Jennings, Patricia A., et al. "Improving classroom learning environments by Cultivating 
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trial." School Psychology Quarterly 28.4 (2013): 374. https://doi.org/10.1037/spq0000035. 
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Public Schools of North Carolina. (2022). 2020-2021 State of the Teaching Profession in 
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Gray, Christina, Gabrielle Wilcox, and David Nordstokke. "Teacher mental health, school 
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Benn, Rita, et al. "Mindfulness training effects for parents and educators of children with 
special needs." Developmental psychology 48.5 (2012): 1476. 
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Schussler, Deborah L., et al. "Improving Teacher Awareness and Well-Being Through 
CARE: a Qualitative Analysis of the Underlying Mechanisms." (2015). 
https://doi.org/10.1007/s12671-015-0422-7. 
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Sharp, Jennifer E., and Patricia A. Jennings. "Strengthening teacher presence through 
mindfulness: What educators say about the cultivating awareness and resilience in education 
(CARE) program." Mindfulness 7.1 (2016): 209-218. https://doi.org/10.1007/s12671-015-0474-
8. 
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Jennings, Patricia A., et al. "Improving classroom learning environments by cultivating 
awareness and resilience in education (CARE): Results of two pilot studies." The Journal of 
classroom interaction (2011): 37-48. 
15. 
Create for Education Care Team. Updated 2022. Accessed September 28, 2022. 
https://createforeducation.org/about-us/our-team/. 
16. 
North Carolina Department of Public instruction. Fiscal Year 2022 – 2023 North Carolina 
Public School Salary Schedules. Retrieved from 
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