Effectiveness and Implementation of an Early Childhood School-Based Mental Health Intervention in Low-Resource Communities
Phase: NA
Conditions: Child Development
Sponsor: NYU Langone Health

Official Title: 
Effectiveness and Implementation of an Early Childhood School-Based 
Mental Health Intervention in Low-Resource Communities  
NCT Number:
NCT04383327
Study Number:
20-00117 
Document Type:
Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
August 10, 2020 

Study number: S20-00117
Page i 
Version date: 8/7/2020 
 
 
Effectiveness and Implementation of an Early Childhood School-Based Mental Health 
Intervention in Low-Resource Communities 
Principal Investigator:
Keng-Yen Huang, PhD
Department of Population Health
NYU School of Medicine 
227 E. 30th Street, 7th Floor (Rm. 726) 
New York, NY 10016 
Keng-Yen.Huang@nyulangone.org 
646-501-2879 
 
Additional Investigators: 
Janet Nakigudde PhD;  
Faculty and Psychologist in the Department of Psychiatry; 
Makerere University College of Health Sciences;  
PO Box 7072, Kampala; 
Janet.Nakigudde@gmail.com  
+256 772 407 885;  
 
Laurie Miller Brotman, Ph.D. 
Department of Population Health, NYU School of Medicine  
227 E. 30th Street, First Floor, New York, NY 10016 
Laurie.Brotman@nyulangone.org 
646-754-4999 
 
Andrea B. Troxel, Sc.D. 
Department of Population Health, NYU School of Medicine  
650 First Avenue. Fifth Floor, 521, New York, NY 10016 
Andrea.Troxel@nyulangone.org 
212-263-6527
NYULH Study Number:
S20-00117 
Funding Sponsor:
National Institute of Mental Health
ClinicalTrials.gov 
Number                
Pending
Initial version: 4/14/2020 
Amended: 8/7/2020 
 
 
Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection 
of Human Subjects (45 CFR Part 46), any other applicable US government research regulations, 
and institutional research policies and procedures. The Principal Investigator will assure that no 
deviation from, or changes to the protocol will take place without prior agreement from the sponsor 
and documented approval from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of 
this study have completed Human Subjects Protection Training. 
 

Study number: S20-00117
Page ii
Version date: 8/7/2020 
 
 
Table of Contents 
 
PROTOCOL SUMMARY .............................................................................................................................. 1
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 5
FIGURE 1.  DIAGRAM OF ENROLLMENT AND RANDOMIZATION.........................................................5
FIGURE 2.  IMPLEMENTATION PARTNERSHIP AND STUDY TEAM STRUCTURE .............................. 5
1 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 1
1.1
BACKGROUND INFORMATION AND RELEVANT LITERATURE................................................................1
1.2 
RATIONALE.................................................................................................................................... 5
1.3 
POTENTIAL RISKS & BENEFITS ........................................................................................................ 7
1.3.1
Known Potential Risks............................................................................................................. 7
1.3.2 
Known Potential Benefits ........................................................................................................ 8
2 
OBJECTIVES AND PURPOSE ........................................................................................................... 8
2.1
PRIMARY OBJECTIVE......................................................................................................................8
2.2
SECONDARY OBJECTIVES (IF APPLICABLE) ......................................................................................8
3 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 8
3.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................... 8
4 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................... 8
4.1 
INCLUSION CRITERIA ...................................................................................................................... 8
4.2 
EXCLUSION CRITERIA ..................................................................................................................... 9
4.3 
VULNERABLE SUBJECTS................................................................................................................. 9
4.4 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 10
4.5 
DURATION OF STUDY PARTICIPATION............................................................................................ 12
4.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 13
4.7 
PARTICIPANT WITHDRAWAL OR TERMINATION................................................................................ 14
4.7.1 
Reasons for Withdrawal or Termination ................................................................................ 14
4.7.2 
Handling of Participant Withdrawals or Termination ............................................................. 14
4.7.3 
Premature Termination or Suspension of Study ................................................................... 14
5 
BEHAVIORAL/SOCIAL INTERVENTION ......................................................................................... 14
6
STUDY PROCEDURES AND SCHEDULE .......................................................................................15
6.1 
STUDY PROCEDURES/EVALUATIONS/PROCEDURES/TIMELINE ........................................................ 15
7 
SAFETY AND ADVERSE EVENTS ................................................................................................... 17
7.1.1 
Definitions .............................................................................................................................. 18
SEVERITY OF EVENT ................................................................................................................................. 18
7.1.2 
Relationship to Study Intervention......................................................................................... 18
7.2 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP.................................... 18
7.2.1 
Event Reporting ..................................................................................................................... 19
7.3 
SAFETY OVERSIGHT ..................................................................................................................... 19
8 
CLINICAL MONITORING .................................................................................................................. 20
9 
STATISTICAL CONSIDERATIONS .................................................................................................. 20
10
QUALITY ASSURANCE AND QUALITY CONTROL ....................................................................... 23
11
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 23
11.1
ETHICAL STANDARD ..................................................................................................................... 23
11.2
INSTITUTIONAL REVIEW BOARD..................................................................................................... 23

Study number: S20-00117
Page iii
Version date: 8/7/2020 
 
 
11.3
INFORMED CONSENT PROCESS .................................................................................................... 23
11.4
PARTICIPANT AND DATA CONFIDENTIALITY ....................................................................................25
12
DATA HANDLING AND RECORD KEEPING ................................................................................... 26
12.1
STUDY RECORDS RETENTION ....................................................................................................... 28
12.2
PROTOCOL DEVIATIONS ...............................................................................................................28
12.3
PUBLICATION AND DATA SHARING POLICY..................................................................................... 28
13
STUDY FINANCES ............................................................................................................................ 28
13.1
FUNDING SOURCE........................................................................................................................28
13.2
COSTS TO THE PARTICIPANT ......................................................................................................... 28
13.3
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 28
14
STUDY ADMINISTRATION...............................................................................................................28
14.1
STUDY LEADERSHIP ..................................................................................................................... 28
15
CONFLICT OF INTEREST POLICY .................................................................................................. 29
16
REFERENCES...................................................................................................................................30
 
 
 

Study number: S20-00117
Page iv
Version date: 8/7/2020 
 
 
List of Abbreviations 
 
AE
Adverse Event/Adverse Experience
CFR
Code of Federal Regulations
CRF
Case Report Form
CSOC
Clinical Study Oversight Committee
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data and Safety Monitoring Board
FFR
Federal Financial Report
FWA
Federalwide Assurance
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act 
ICF
Informed Consent Form 
IRB
Institutional Review Board
ISM 
Independent Safety Monitor
MOP
Manual of Procedures
N
Number (typically refers to participants)
NIH
National Institutes of Health
OHRP 
Office for Human Research Protections
OHSR 
Office of Human Subjects Research
PI 
Principal Investigator
QA 
Quality Assurance 
QC 
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SOP
Standard Operating Procedure
US 
United States

Study number: S20-00117
Page 1
Version date: 8/7/2020 
Protocol Summary

Study number: S20-00117
Page 2
Version date: 8/7/2020 
 
 
Title 
Effectiveness and Implementation of an Early Childhood School-Based Mental Health 
Intervention in Low-Resource Communities
Short Title 
School-Based Mental Health Effectiveness Study 
Brief 
Summary 
Promoting child mental health in low-resource or low-income country settings faces numerous 
challenges in global health research. Although efforts have been made to improve mental 
health interventions and services for young children, evidence-based interventions (EBIs) for 
children in low-and middle-income countries (LMICs) are limited. Most mental health EBIs in 
LMICs have not been scaled widely, and do not focus on early childhood. Mechanisms of 
action and effectiveness are not well understood. Additionally, most EBIs in LMICs rely on 
community health workers (CHWs) or a task-shifting approach of implementation because of 
resource barriers and shortage of mental health professionals (MHPs). However, challenges 
related to task-shifting (e.g., CHW stress and job burnout) have rarely been studied. For task-
shifting to be successful, strategies to overcome challenges faced by CHWs and 
understanding mechanisms to conduct effective task-shifting are paramount. The overall goal 
of this study is to address these EBI effectiveness and implementation knowledge gaps by 
providing a preventive EBI (ParentCorps-Professional Development; PD) that utilizes a task-
shifting and a scalable implementation model to promote early childhood students’ mental 
health in a LMIC—Uganda. PD is a school-based EBI and preventive mental health service 
provision model that supports teachers and school personnel to apply EBI strategies to 
promote young children’s mental health. The PD approach represents a task-shifting model of 
mental healthcare by shifting mental health preventive duties from professionals to teachers 
to optimize school children’s mental health. Therefore, teachers are considered as CHWs. 
This study examines impacts and cost-effectiveness of the EBI/PD on teachers and students, 
as well as examines underlying mechanisms (or theories of change) that contribute to 
intervention effect. In addition, considering most Ugandan teachers (or CHWs) experience 
occupational stress that threatens PD uptake, effectiveness, and sustainment, this study will 
also test a teacher stress management package (T-Wellness, adapted from EBIs) as an 
enhancement to PD. This study will investigate whether PD + T-Wellness (PDT) is more 
effective for CHWs/teachers than PD alone. 
Phase 
Phase II/III 
Objectives 
This study include three specific aims: 
Aim 1. To evaluate the short- and longer-term effectiveness of, PD alone (PD), PD + T-
Wellness (PDT), and control (C, provision of child mental health and referral information). 
Hypotheses: (a) PD is more effective than control; and (b) PD with T-Wellness (PDT) is more 
effective for CHWs/teachers than PD alone; and (c) PDT has a more favorable cost-
effectiveness ratio than PD alone; 
Aim 2. To examine effectiveness mechanisms and theory of change underlying the EBIs. 
Hypotheses: the mediational mechanisms of PD (teacher EBI strategy use as a mediator 
between intervention and child outcomes) and PDT (teacher stress management and EBI 
strategy use as mediators) will be supported; 
Aim 3. To examine implementation contextual factors and mechanisms that contribute to 
CHWs’ (teachers’) uptake and sustainment of EBI strategies within PD and PDT schools. 
Hypotheses: better fidelity, teacher mental health and more supportive contexts will be 
associated with better teacher uptake and sustainment of EBI strategies and more effective 
task-shifting. 

Study number: S20-00117
Page 3
Version date: 8/7/2020 
 
 
Methodolog
y 
A cluster randomized controlled trial (cRCT), single blind and mixed-methods design will be 
applied. All study activities will be conducted in Uganda. Thirty-six public primary schools (18 
urban and 18 rural), 540 teachers (~15 per school) and 1,980 parent-child pairs (~55 per 
school) will be recruited. Schools will be assigned to one of three conditions (PD, PDT, 
control). A stratified-block randomization procedure will be applied to ensure approximately 
similar characteristics across study regions and conditions. 
Endpoint
Effectiveness outcomes will be assess 3 times (Time 1= before intervention; Time 2= 
immediate after PD/PDT intervention; Time 3= 12 months after Time 2).  The primary teacher 
effectiveness outcomes (or intermediate effectiveness outcomes) are teachers’ EBI strategy 
use and teacher stress management. The primary child effectiveness outcomes are child 
externalizing and internalizing problems (mental health outcomes). The secondary child 
effectiveness outcomes are emotion regulation, executive functioning (ability for cognitive 
processes that are foundation for the cognitive control of behavior), and social relationship 
(student-teacher relationship, peer relationship). 
Study 
Duration 
This is a four-year study. Year 1 will be focused on study preparation (including conducting 
user-centered testing for the T-Wellness package and finalizing the PDT contents), 
developing implementation partnership, and capacity building for the PD/PDT implementers 
(Trainers from Teacher Training Colleges/TTCs and mental health institutions). Years 2-4 are 
intervention implementation, evaluation data and cost-benefit data collection, and data 
analyses. 
Participant 
Duration 
Participation duration will be varied by types of participants.
 The intervention implementers (TTC trainers and mental health professional trainers) will 
participate in study for 4 years.  
 Teachers participants for the T-Wellness Package User-centered & Optimization testing will 
participate in the study for 6 months (during Year 1 preparation only).  
 Primary school teachers and selected school leadership staff (Head teacher, PTA leaders) 
will participate in the evaluation study for 2 years. Teachers (i.e., pre-primary and primary 1st
to 4th grade, serving students between the ages of 3 and 10 years) and PTA leaders are the 
primary targets of the PD/PDT. 
 Children and caregivers will participate in the evaluation study for 18 months.   
  
Duration of 
behavioral 
intervention 
Intervention schools’ teachers (pre-primary to 4th grade teachers) and representative PTA 
leaders will participate in PD (3 days) or PDT workshop (4 days) in their regional Teacher 
Training College (TTC) during their 1st year of participation and before the 1st school term. 
Following the workshop training, they will also receive 8 sessions (12 hours) of face-to-face 
group-based coaching during the 1st and 2nd terms. For the teachers in the PDT group, 
additional stress management group coaching activities will also be integrated (3 additional 
monthly 1-hr wellness sessions for teachers as a group in each school).   
Population 
The study populations include: (1) Teachers for the T-Wellness User-centered & Optimization 
testing (n=60; from 4 non-RCT schools in year 1); (2) Intervention implementers (n=8; 6 TTC 
trainers and 2 mental health professionals from urban/Kampala and rural/Hoima regions; (3) 
Primary school teachers/head teachers (n=540) from 36 schools and PTA leaders (n=24) 
from 24 intervention schools; and (4) Children and caregivers (n= 1980 parent-child pairs) 
form 36 study schools. 
Study Sites 
36 schools (12 receiving PD, 12 receive PDT, and 12 control). 
Number of 
participants 
2544 adults and 1980 children for Aims 1-3 (This is not including 60 teachers for the T-
Wellness User-centered testing during Year 1 preparation year).  

Study number: S20-00117
Page 4
Version date: 8/7/2020 
 
 
Description 
of Study 
Intervention/
Procedure 
Prior to the RCT study (or during Year 1), T-Wellness Package (a brief teacher stress 
management psychoeducation package, adapted from EBIs and including a half-day 
workshop for common stress management and a half-day for burnout management, and 
three follow-up group support sessions) will be tested to insure user-centeredness. we will 
recruit 4 study schools and applying factorial design to test the effect of each component (1 
Common Stress management; 1 Burnout Stress management; 1 Combined Common and 
Burnout Stress management; 1 control; with ~15 teachers in each condition).  Both groups’ 
will also receive 3 post-workshop group support sessions. We will compare pre-post 
differences on teacher stress management and mental health using a mixed-methods data 
collection.  
 To implement PD/PDT using a scalable approach, we will formalize partnership with the 
Ugandan Ministry of Education (MOE), Ministry of Health (MOH), academic medical center, 
and Teacher Training Colleges (TTCs) stakeholders in Year 1. The partnership and 
intervention implementation team will receive training from NYU PD trainers, and implement 
PD/PDT in Years 2-4.  
 To study effectiveness-implementation aims (Aim 1-3), a cRCT will be conducted. Public 
primary schools from Kampala/urban and Hoima/ rural will be recruited. A stratified-block 
randomization procedure will be applied to ensure approximately similar characteristics 
across geographic regions and three intervention conditions (PD, PDT, and control). 
Teachers from the PD will receive a 3-day training, and teachers from the PDT will receive a 
4-day training. Both intervention groups will receive 8 group-coaching sessions (with 
teachers from their own school). Teachers from the control schools will receive child mental 
health promotion materials. They will receive T-Wellness in Year 4 after the evaluation study 
is completed. Given the large numbers of students in schools, research staff will randomly 
select 10% of students and families from each school for participation in the evaluation 
study. A total of 1,980 families (parent-child pairs) from 36 schools (averaging 55 
families/per school) will participate in the evaluation study. Effectiveness outcomes will be 
assessed at 3 time points over 18 months (baseline/T1, post-PD or PDT, 5-6 month/T2, and 
16-18-month follow-up/T3). Objective observation, implementers, school staff, parent, and 
child report data (quantitative and qualitative) will be gathered. 
 To study underlying mechanisms, we will use the evaluation data describe above to 
examine whether intervention effects on children’s mental health outcomes is mediated 
through improvement on teachers’ EBI practices (primary) and teacher stress coping. To 
study moderation mechanisms, geographic region, fidelity (including adherence, quality of 
program implementation, engagement, exposure) and other implementation contextual 
factors (i.e., EBI fidelity, school climate), guided by the Consolidated Framework for 
Implementation Research, will be studied.  
 Identifiers will be removed from the identifiable survey and field notes. Data may be used for 
future research studies or shared with other researchers and we will not request additional 
informed consent from you to use these specimens as we have noted here.  
Reference 
Therapy 
Multi-level Mixed Effect Model and Structural Equation Model are the statistical analysis 
approaches planned for this study.  
Key 
Procedures 
36 schools (12 receiving PD, 12 receive PDT, and 12 control). 
Statistical 
Analysis 
2544 adults and 1980 children for Aims 1-3 (This is not including 60 teachers for the T-
Wellness User-centered testing during Year 1 preparation year).  
 

Study number: S20-00117
Page 5 
Version date: 8/7/2020
Schematic of Study Design
Figure 1.  Diagram of Enrollment and Randomization
Figure 2.  Implementation Partnership and Study Team Structure

Study number: S20-00117
Page 6
Version date: 8/7/2020 
 
 
Key Roles
Name
Title on 
Project
Institution
Address
Phone 
Number 
Email
Role and Data Access 
Keng-
Yen 
Huang, 
Ph.D. 
Principal 
Investigator 
Department 
of Population 
Health, NYU 
School of 
Medicine 
227 E. 
30th 
Street, 
Seventh 
Floor, 
New 
York, NY 
10016 
646-
501-
2819 
Keng-
Yen.Hua
ng@nyu
langone.
org 
PI; will oversee all study 
activities; work with Dr. Toxel on 
quantitative data analysis; work 
with Dr. Nakigudde closely to 
monitor research activities 
Laurie 
Miller 
Brotman, 
Ph.D. 
Sub-
Investigator
Department 
of Population 
Health, NYU 
School of 
Medicine 
227 E. 
30th 
Street, 
First 
Floor, 
New 
York, NY 
10016 
646-
754-
4999 
Laurie.B
rotman
@nyula
ngone.o
rg 
PD developer; lead PD 
intervention capacity building 
design; have access to the de-
identify data.    
Andrea 
B. Troxel, 
Sc.D. 
 
Sub-
Investigator 
Department 
of Population 
Health, NYU 
School of 
Medicine  
 
180 
Madison 
Ave, New 
York, NY 
10016 
212-
263-
6527 
Andrea.
Troxel@
nyulang
one.org 
A biostatistician; will oversee 
analytical models; have access to 
the de-identify data 
Yesim 
Tozan, 
PhD 
Subcontract 
Sub-
Investigator  
College of 
Global Public 
Health, NYU 
411 
Lafayette 
St. 5FL, 
New York
212-
998-
2121 
Tozan@
nyu.edu 
A health economist will oversee 
cost-effective analysis; will have 
access to the de-identify data.  
Tracy 
Dennis 
Expert 
Consultant 
Director of 
the Stress, 
Anxiety, and 
Resilience 
Research 
Center, The 
City 
University of 
New York 
695 Park 
Av. New 
York, NY 
10065 
212-
650-
3878 
Tracy.de
nnis@h
unter.cu
ny.edu 
Wellness intervention expert; will 
work with PI on T-wellness; have 
access to de-identify data.  
Janet 
Nakigudd
e, PhD 
Ugandan- 
Local 
Principal 
Investigator 
Department 
of 
Psychiatry, 
Makerere 
University 
PO Box 
33842, 
Kampala, 
Uganda 
+256-
772-
407885 
Janetna
kigudde
@gmail.
com 
Will oversee Ugandan research 
activities, supervise research 
staff’s work; lead qualitative data 
analysis.  

Study number: S20-00117
Page 1
Version date: 8/7/2020 
1 
Introduction, Background Information and Scientific Rationale 
1.1 
Background Information and Relevant Literature 
Unmet Needs of Ugandan Children. Children in Uganda comprise 55% of the total population1,2, and face 
enormous health and educational challenges1,3. More than one-quarter of Ugandan children have externalizing 
or internalizing mental health problems4-6 and only 53% achieve grade-level academic competency in 6th
grade3. The large mental health and educational gaps can be attributed to high rates of chronic poverty (38-
43%)7,8, community violence (53-58%)8,9, cultural practice of harsh/abusive discipline at home and schools (64-
84%)4, and other health burdens (28% caregiver depression, 56-80% malaria)8,10,11. Adverse circumstances 
experienced early in life interfere with children’s brain development and acquisition of adaptive self-
regulation12-21, setting the stage for poor mental health and risky behaviors in adolescence and adulthood22-24. 
Despite the emerging research suggesting the feasibility of adapting and transporting child mental health EBIs 
to Sub-Saharan Africa (SSA)25-27, large scale effectiveness research with diverse populations in SSA is still 
lacking. Most child mental health research in SSA has focused on regional conflict or HIV/AIDS-affected 
children. Limited effort has been invested in developing accessible preventive child mental health services in 
communities, promoting population-level early childhood mental health, or understanding mechanisms to 
provide effective interventions28. 
 
Public Health Approaches to Address Mental Health of Children in LMIC Settings 
 
Global Agenda and Strategies for Mental Health Burden Control. To address the mental health burden 
in LMICs, providing informal preventive services to promote population mental health has become a priority. 
WHO developed  the Comprehensive Mental Health Action Plan29 and the Optimal Mix of Mental Health 
Services Pyramid framework30 to guide the design of mental health systems in LMICs. The Action Plan 
proposes strengthening governance, providing integrated mental health services in communities, and 
implementing strategies for mental health promotion. The Service Pyramid proposes that the majority of mental 
health service planning should focus on services outside the traditional healthcare delivery system and in 
communities because of high need and relatively low cost29,30. 
 
 School-Based and Population-level Approaches to Preventive Interventions for Mental Health. In 
line with this global agenda, systems-oriented school-based prevention offers a solution for promoting child 
mental health at the population level. The school approach can address a wide range of individual, family, and 
service needs31,32. It has been shown to be a cost-effective approach to reduce health problems (e.g., HIV, 
nutrition) in LMICs33,34.  Similarly, a large body of developmental research demonstrates that supporting 
teachers and families of young children has the potential to have meaningful and life-long benefits for 
children’s health and wellbeing35,36.  Although a school-based approach can be effective for child population 
health promotion37-40, this type of preventive mental health intervention has not been widely applied in LMICs. 
In Uganda, 95% of children are enrolled in primary (~23% enrollment in pre-primary schools)3,41, the majority of 
schools do not have mental health professionals (MHPs). To provide accessible services in schools requires 
systems intervention and a trained embedded workforce who can implement the EBI strategies to support 
children and families.  
 
Scalable Strategies to Provide School-Based, Population-level Preventive Interventions in Low-
Resource Settings. This effectiveness study will integrate three strategies that have been identified as 
effective for providing public health interventions at scale in low-resource settings.  

Study number: S20-00117
Page 2
Version date: 8/7/2020 
 
 
A task-shifting strategy, endorsed by the WHO, offers a solution to overcome workforce barriers in 
schools. Task-shifting involves redistributing tasks from professionally trained workers to those with less 
training and fewer qualifications in the specific area of expertise42,43. Under the right conditions (e.g., political 
support, appropriate training), this approach can lead to significant public health gains44-47. Uganda, like many 
other LMICs, has few mental health workers (0.09 psychiatrists and 0.02 psychologists per 100,000 population, 
compared with 10-60 in developed countries)48-50. Ugandan schools also do not have MHPs, and teachers are 
not trained in mental health promotion. Therefore, redistribution of responsibilities and task-shifting of 
prevention knowledge and skills from MHPs to teachers/school personnel is required. A successful task-
shifting of intervention involves: 1) training teachers to apply evidence-based mental health promotion 
strategies, including applying EBI strategies in daily practice during interactions with children and families and 
sharing knowledge and strategies with community members; and 2) engaging and providing adequate 
consultation and support to teachers so that they can confidently and effectively apply EBI strategies. 
 
 
 
A system-level intervention strategy that applies an integrated scalable implementation framework, as 
suggested by the WHO’s Scaling Up51 and Chamber et al.’s Dynamic Sustainability frameworks52, can address 
existing policy implementation gaps. Since 2007, the Ugandan government has proposed a series of reforms 
aimed at strengthening the country's mental health sectors53,54. However, these have not resulted in 
meaningful changes55. Therefore, strengthening the existing system and further developing a scalable 
implementation structure guided by recommended frameworks are necessary51,56. To establish a school-based 
EBI, the scalable approach must be compatible with local school ecological systems (e.g., policy, practices)52. 
The implementation structure and workforce development needs to match available local resources51,56 and 
incorporate strategies to overcome a range of organizational- and system-level barriers51.  
 
 
 

Study number: S20-00117
Page 3
Version date: 8/7/2020 
 
 
A partnership strategy (including task-sharing and interagency collaboration)57 relies on each partner’s 
expertise to accomplish an overall objective57. Research suggests that a cross-disciplinary and cross-agency 
partnership strategy can be used to overcome systems barriers when existing structures do not have sufficient 
capacity for large-scale public health program implementation56,58,59. This strategy has been used to provide 
and sustain EBIs at scale in many countries60-62. In Uganda, Teacher Training Colleges (TTCs) are core 
institutions that provide in-service training for teachers. Therefore, they can be served as the key partner to 
provide school-based EBIs. Most TTCs (96%) are owned and funded by the government, and all TTCs are 
monitored and supported by the Ministry of Education(MOE)63. Although MOE has recommended a holistic 
approach to improve teacher competencies including strategies for promoting child mental health, such training 
is underdeveloped in the current system. The Principal Medical Officer at the Ministry of Health (MOH) is in 
charge of mental health services and is responsible for overseeing public education and mental health 
programs across the country. Most formal collaborations between the governmental agencies for mental health 
services and those for primary/community health have focused on adults. Because of the limited number of 
MHPs in the country, and the lack of child mental health training in TTCs, a formal collaboration among MOH, 
MOE, TTCs, and MHP training institutions has the potential to create a sustainable structure and curriculum to 
prepare teachers to promote child mental health64. ParentCorps-Professional Development to Address 
Child Mental Health Needs in LMICs. The EBI considered in this study is one component of ParentCorps. 
ParentCorps is a multi-component school-based intervention that promotes early childhood mental health and 
development; it was built on an extensive body of cross-cultural parenting and child development research23,65-
71. ParentCorps includes: 1) a Professional Development (PD) component for teachers and school personnel, 
and 2) a Family Program for caregivers and their children. The program is aimed to increase teachers’ and 
caregivers’ child mental health knowledge and EBI strategy practices at school and home, and enhance 
children’s social-emotional and behavioral regulation skills foundational for mental health. The PD and Family 
Program encourage consistent use of a set of EBI strategies by teachers and families. To achieve population-
level reach and impact, ParentCorps is embedded in early childhood education programs as part of the 
normative school experience for all children served in a low-income setting. Two RCTs in the United States 
(US) found that ParentCorps resulted in a broad range of long-term benefits for low-income children, including 
better mental health and academic performance three years post-intervention65,72-74. In the US, ParentCorps 
MHPs provide PD to teachers and other school-based MHPs. School-based MHPs implement the Family 
Program. Because most LMICs do not have school-based MHPs, implementing PD and the Family Program 
with existing resources is not feasible or scalable. Given these resource limitations in LMICs and efforts to 
provide preventive intervention broadly in LMIC settings, we carried out a series of investigations to test one 
component of ParentCorps-PD as a task-shifting model of mental healthcare in urban Uganda (RCT in 10 
schools; 1R21MH-097115-01A1)27 and rural Nepal (pre-post change in 30 schools; UBS foundation). PD was 
carried out in cross-agency collaboration with MOE and MOH using appropriate localized implementation 
models and has reached over 300 teachers and 26,000 students in Uganda and Nepal. These initial PD 
studies focused on 4 efficacy-practice-related questions: 1) Can a train- the-trainer model and US-Uganda a 
distance capacity building approach be applied to support an implementation team in LMICs to provide PD with 
fidelity?;2) Can teachers be trained to apply EBI strategies in their daily practices and interactions with children 
and families as a task-shifting strategy43?; 3) Is the PD content culturally relevant for LMICs, and what 
adaptations need to be made to improve fit?; and 4) What are the estimated impacts of PD on child mental 
health? Table 1 summarizes ParentCorps content, implementation models, and impact evidence (d=effect 
size) from the US and LMIC studies. The magnitude of impact from PD in LMICs was comparable to US 
studies of ParentCorps and to other teacher-focused EBI training programs (d=.22-.57 for child mental 
health)75,76. Collectively, these studies support the transportability of PD from US to LMICs and highlight the 
potential of PD alone as an effective approach to achieving population-level impact on child mental health in 
LMICs. Building on this strong evidence, the proposed study extends the existing partnerships with Ugandan 
MOE, and MOH, and further develops localized scalable structure for early childhood mental health promotion 
and examines PD effectiveness in multiple regions (both rural and urban)51,52. In the US, Co-I Brotman 
(ParentCorps developer) is currently partnering with the State Office of Mental Health and the Local 
Department of Education in scaling ParentCorps throughout New York City, which includes more than 1800 
early childhood education sites serving 70,000 four-year-olds annually. Under this scale-up effort (launched in 
2015), Brotman and colleagues (including PI Huang and Co-I Troxel) have established the research 
architecture and partnership processes to conduct three hybrid cRCTs (in nearly 200 schools). These studies 
address critical policy and practice questions including the relative value of PD alone versus the full 

Study number: S20-00117
Page 4
Version date: 8/7/2020
ParentCorps model when implemented at scale and in diverse settings.The proposed PD study in Uganda will 
leverage this work and benefit from and contribute to scale-up of partnerships and effectiveness-
implementation knowledge both domestically and internationally. 
Table 1. ParentCorps implementation models and impact evidence27,65,72,73,77-79
Additional CHW Engagement Strategies Required to Overcome the Critical Practice Barrier of Teacher 
Stress in LMICs. Teachers in Uganda and other LMICs are vulnerable to job burnout and stress80.  Sources 
that contribute to teacher stress include teaching stress (i.e., 7 stress domains: poor school environment, 
student misbehavior, poor working conditions, personal concerns of teachers, relationships with parents, time 
pressures, and inadequacy of training81) and out-of-school stress (e.g., personal, family, and larger 
ecological environmental stress). Data from our RCT work in Uganda revealed that 79% of Ugandan teachers 
reported significant burden of stress (e.g., 70% workload, 41% job effectiveness, 23% emotional distress, 9% 
job dissatisfaction-related stress). PD coaching data also revealed that many Ugandan teachers asked for 
stress management support from PD coaches outside of the PD program. Teacher stress can result in anger, 
frustration, depression, exhaustion, and job ineffectiveness, and can have negative consequences for schools, 
teachers, students, and importantly long-term EBI effectiveness82,83. In planning for a large-scale EBI 
implementation in high-stress contexts, teacher stress must be considered. Teachers suffering from stress 
might be less engaged in the PD, have reduced motivation and ability to apply EBI strategies over time or 
difficulty in sustaining the added responsibility resulting from task-shifting. This effectiveness study will test an 
integrated evidence-based stress-management package (T-Wellness) as a complement to PD, and examine 
underlying mechanisms that teacher stress and stress management contribute to effectiveness and EBI 
strategy uptake and sustainment. T-Wellness will be optimized before conducting the cRCT (see Research 
Method below). T-Wellness is based on Stress and Coping (an EBI), which has been shown to reduce stress 
for Ugandan adults impaired by distress in PI-Nakigudde’s prior work84,85, and Rational-Emotive Health 
Education Intervention, which has been shown to be effective in reducing teacher stress and burnout in 
LMICs80,86 (described in detail below).

Study number: S20-00117
Page 5
Version date: 8/7/2020 
 
 
1.2 
Rationale 
 
This study involves efforts to advance the science of prevention in early childhood mental health in low-
resource communities. We will investigate the effectiveness, practical implementation strategies, and 
underlying mechanisms of the PD in urban and rural Uganda. We will compare effectiveness of two PD 
implementation approaches (with and without T-Wellness) using a hybrid effectiveness-implementation 
cRCT87. Figure 3 shows the conceptual model for PD and PDT Theory of change in LMIC contexts, which 
considers intermediate intervention effectiveness outcomes (teacher EBI practice) and distal effectiveness 
outcomes (including primary child mental health outcomes and secondary child behavioral outcomes, defined 
in Table 2). PD is expected to change teachers’ EBI practices; and the impact of PD on distal child mental 
health outcomes will be mediated primarily through changes in teachers’ practice of EBI strategies. Similarly, 
we expect that PDT (PD+T-Wellness) will also have impact on distal child mental health outcomes, and this will 
be mediated primarily through improvement in both teachers’ EBI practices/behaviors and teachers’ stress 
management skills (cognitive and behavioral control/ coping of stress). We anticipate changes in child 
behaviors will be observed in the secondary outcome domains before the mental health outcomes (primary 
distal outcomes). Because PD/PDT will be implemented in diverse contexts, our theory of change also 
considers moderators from aspects of the Consolidated Framework for Implementation Research (CFIR)88, 
which proposes that five domains of contextual factors can impact effectiveness-implementation. Specifically, 
we expect that certain individual, intervention implementation, and school contexts may also influence (or 
moderate) intervention effectiveness 44,88-91. We consider geographic region (urban/ rural) as the primary 
moderator, and other CFIR factors listed in the figure as secondary moderators. This theory of change has 
been partially tested (constructs in ‘red’ in Figure 3) and supported in previous PD studies27. This study will 
formally examine the cost-effectiveness and test the PD/PTD theory of change with a larger diverse sample 
and using scalable approaches. We select a foreign low-resource country as our study site because it provides 
an ideal setting to test how a mental health system can be strengthened through careful consideration of 
strategies while simultaneously examining effectiveness outcomes of an EBI. Also, Ugandan context is similar 
to other underserved and under-resourced communities in the US and other LMICs. Therefore, knowledge 
generated from our study will be relevant globally. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study number: S20-00117
Page 6
Version date: 8/7/2020
Figure 3. Hypothesized Mechanisms for PD & PDT impact on Teachers and Children
INNOVATION 

Study number: S20-00117
Page 7
Version date: 8/7/2020 
 
 
The project is innovative in its scale, methods, scientific contribution, and structure. 1) We have brought 
together a team of international experts in policy, intervention content development, large-scale program 
implementation, biostatistics, and health economics to launch the largest population-based early childhood 
mental health prevention trial in low-resource African contexts paired with a comprehensive plan to support 
MOH, MOE, and TTC to set up a sustainable school-based preventive mental health training and service 
structure. 2) Studying effectiveness and theory of change of a population-based mental health preventive 
intervention in Ugandan and US context simultaneously is innovative. In partnership with public stakeholders, 
PD is currently being tested in the US context (also led by this investigation team, but with separate funding 
sources). The support from NIH of this PD scale-up effort in Uganda will provide a unique opportunity to study 
effectiveness as well as to compare underlying mechanisms across two countries. Lessons learned from this 
effectiveness and theory of change testing will inform generalizability of intervention and theory across 
contexts, as well as facilitate new innovations to address similar mental health disparities in countries with 
similar adversity and resource barriers globally. 3) Our localized scalable implementation models (for urban 
and rural Uganda) and teacher task-shifting preventive service model is innovative in LMIC contexts. Our 
scalable approaches integrate MOH and MOE policy efforts and consider a localized multi-stakeholder task-
shifting/ task-sharing collaborative approach. This approach ensures local fit and adaptability of implementation 
systems to support EBIs in diverse contexts. Furthremore, by training teachers to apply mental health 
promotion EBI strategies in daily practice, it has the potential to not only promote children’s mental health, but 
also to strengthen school mental health systems and service (e.g., increase workforce, EBI knowledge sharing 
from teachers to other community members). Our approach also lays out a service model for WHO’s Action 
Plan and Service Pyramid frameworks, which suggest providing accessible population-based child mental 
health preventive intervention in schools. 4) Studying workforce/teacher stress management strategies and 
underlying mechanisms using the MOST design in the context of effectiveness RCT is innovative. Our study 
addresses a critical CHW workforce stress/job burden issue that has been frequently reported in LMICs. 
Applying the pragmatic MOST design increases reserach efficiency, provides an opportunity to further optimize 
EBIs, and ensures expected T-Wellness impact before conducting the cRCT. Our study contributes to new 
knowledge and new solutions that may overcome workforce stress, which may also maximize EBI uptake, 
effectiveness, and sustainability. Findings will also inform policy decisions in EBI programming and workforce 
development. 5) Our design integrating multiple implementation science frameworks is innovative. We 
integrate several recently developed conceptual models from scale-up and implementation science51,52,88. This 
provides a new way to synthesize conceptual models that is more in line with complex real-world large-sale 
intervention implementation. Evidence from our research can inform new integrated frameworks to guide 
scaling-up research and better understand practice relevant behavioral change processes.   
 
1.3 
Potential Risks & Benefits 
1.3.1 Known Potential Risks 
There are no known physical risks associated with the study. However, there is the possibility that teachers, 
principals, PTAs, parents or students will experience some inconvenience, embarrassment, or distress while 
completing the interviews/questionnaires or when being observed. In addition, because teacher recruitment 
and intervention program implementation will be carried out in a group format (including Pre-primary to Primary 
1-4 grade teachers from study schools), it is not feasible to guarantee complete confidentiality to teachers who 
decline to participate, as other participating teachers may notice teachers who are not present in the training. 
Furthermore, adult participants will be made aware of the limits to confidentiality, especially in adhering to legal 
status regarding reporting to child protection agencies information if study children are found to be at-risk for 
abuse or neglect or are being abused or neglected. To minimize these risks, we have developed plans to 
protect research participants through consents, preventive actions, and risk mitigation. 
 
 
 
 
 
 

Study number: S20-00117
Page 8
Version date: 8/7/2020 
 
 
1.3.2
Known Potential Benefits
The training of the TTC faculty, school teachers and PTAs can strengthen local child mental health preventive 
service capacity. Teachers/PTAs/TTC staff who participate in PD/PDT may develop new knowledge and skills 
that are useful to promote their children/students’ mental health. They may also benefit from the support of 
professionals and their colleagues. In addition, parents and children of the participated schools will benefit from 
their teachers. Teachers/PTAs may improve skills in promoting parent involvement and child social emotional 
and mental health. The minor risks of participation are considered reasonable in relation to the anticipated 
benefits to subjects and the knowledge that may result from this study. 
 
2 
Objectives and Purpose 
 
Aim 1. To evaluate the short- and longer-term effectiveness of PD and PDT.  
Hypotheses: (a) PD, implemented using localized scalable approaches, is more effective than control; and (b) 
PDT is more effective for CHWs/teachers than PD alone; and (c) PDT has a more favorable cost-effectiveness 
ratio than PD alone. 
 
Aim 2. To examine effectiveness mechanisms and theory of change underlying the EBIs.  
Hypotheses: the mediational mechanisms of PD (teacher EBI strategy use as a mediator between intervention 
and child outcomes) and PDT (teacher stress management and EBI strategy use as mediators) will be 
supported. 
 
Aim 3. To examine implementation contextual factors and mechanisms that contribute to CHWs’ 
(teachers’) uptake and sustainment of EBI strategies within PD and PDT schools 
 
2.1 
Primary Objective 
The primary teacher effectiveness outcomes (or intermediate effectiveness outcomes) are teachers’ EBI 
strategy use, teacher stress management. The primary child effectiveness outcome is child mental health 
(externalizing and internalizing problems) 
2.2 
Secondary Objectives (if applicable) 
The secondary child effectiveness outcomes are three behavioral-cognitive domains: emotion regulation), 
social relationships (student-teacher & peer relationship), and executive functioning (cognitive system 
function). 
 
3 
Study Design and Endpoints 
3.1 
Description of Study Design 
Study Overview. We will study the effectiveness and mechanisms of PD/PDT in diverse Ugandan contexts. 
Year 1 will be the preparation period, in which we will establish localized scalable PD implementation 
structures in two study regions, and to optimize the T-Wellness by caring out a user-centered testing study with 
4 schools (~60 teachers) (in a 4-6 month time frame in Year 1). In Years 2-4, we will carry out a cRCT to study 
effectiveness, cost-effectiveness, and underlying mechanisms. Drs. Troxel and Huang with expertise in RCTs 
and quantitative analyses will guide the effectiveness and mechanism analyses. For the cost-effectiveness 
comparisons, Dr. Tozan will guide the planning and analyses. Dr. Nakigudde, with expertise in stress 
management and qualitative studies, will guide the T-Wellness testing and qualitative analyses. 
 
4 
Study Enrollment and Withdrawal 
4.1 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 

Study number: S20-00117
Page 9
Version date: 8/7/2020 
 
 
1. The inclusion criteria for the school staff (teachers, head teachers) are: they must be in the recruited 
study schools and teaching in Pre-Primary to Primary 4 classrooms or holding the head 
teachers/administration leadership position in school.  The inclusion criteria for Parent Leaders are: 
they must be at least 18 years old and have served as a Parent-Teacher-Association member or Parent 
Leader in the school for at least 1 year.   
 
2. The inclusion criteria for the PD/PDT program implementers are: they must have current employment 
with eligible partners (i.e., medical/mental health institutions, Teacher Training Colleges), with 
professional experiences in teacher training or mental health training.  
 
3. The inclusion criteria for parents are: caregivers must be at least 18 years old, their children must be 
enrolled in Pre-Primary or Primary 1 to 4 classes (or between 3 to 10 years old) in the recruited 
schools, and willing to have their child to be assessed by research staff. Parents and children will have 
diverse characteristics (e.g., randomly selected from school student lists). About 10% families will be 
randomly selected from the student lists. The proposed study will be open to both men and women 
caregivers 
 
 
4.2 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
1. Evidence of psychopathology or cognitive impairment severe enough to preclude giving consent, or 
completing the survey instruments or the focus group of the study.   
 
2. Minors (age <18) will also be excluded. Additional criteria should be included as appropriate for the 
study design and risk. 
4.3 
Vulnerable Subjects 
 
The key intervention targets for this study are teachers, and evaluate whether impacts on teachers will improve 
child mental health. For schools where the principal agree to participate in the PD/PDT, individual teachers will 
still have the right to refuse to participate at any time during the study.  Research staff will ensure that the 
school staffs are aware of this during the consent process. To ensure that non-participating teachers are not 
discriminated against by principals, school personnel, or participating teachers, we have worked with MOE 
partners and developed several policies, which will be in place from the start of the study.  One, we will apply a 
recruitment approach that will “normalize” the decision not to participate. Specifically, when consenting 
principals and teachers, we will explicitly explain that the study aims to test a new school approach to help 
promote students’ health and development, and that we are asking for volunteer schools and teachers to 
participate and provide their feedback. We will notify principals upfront that teacher participation is completely 
voluntary and does not reflect on the community or researchers’ views about principals’ leadership or the 
image of their school and teachers. We will also notify teachers that there are many reasons why some 
teachers may not participate, including having unique responsibilities (either personal or professional) that 
other teachers may not have. We will strongly urge school teachers to be respectful of others’ choices to not 
participate, given a range of possible circumstances. This recruitment approach will likely minimize any 
potential feelings of discomfort for non-participating teachers, and will minimize potential discrimination toward 
non-participating teachers.   

Study number: S20-00117
Page 10
Version date: 8/7/2020 
 
 
Although the intervention is not directly targeted on children, and there will be indirect benefit on children 
(through positive changes on teachers).  Because the primary effectiveness outcomes are focusing on 
children; therefore, we will include children as our study subjects and ask children’s own perception of their 
behaviors and environment. We will obtain parent’s permission/consent (which will be documented) and the 
study child’s assent before conducting child assessment. The child assessment will be conducted by trained 
research staff, and will take about 20-30 minutes.  All research staff who conduct child testing/assessment will 
be trained and equipped with skills to manage children distress. Research staff will also work with the targeted 
students’ teachers to schedule appropriate time for assessments, so it will not interrupt study children’s class 
activities or impact on their right to attend classes. If children have limited capability and cannot reasonably 
respond to assessment questions, research staff will stop the assessment. The intervention and child 
assessment are no greater than minimal risk, and the child assessments can help better understand impacts 
through children’s own perspective. This research presents an opportunity to further the understanding 
children’s need and impacts of prevention.   
 
 
 
 
 
4.4 
Strategies for Recruitment and Retention 
 
The target of the intervention for this proposed project is school staff (i.e., teachers and Parent-Teacher-
Association [PTA] members/Parent Leaders). The intervention is at a system-level, which is to train school staff 
to provide preventive intervention to students and parents. Subjects for the teacher and children’s 
effectiveness outcomes will be reported by teachers, parents, and students. Objective observation (by trained 
study staff) on teachers’ EBI practice in classrooms will also be conducted.        
 
Recruitment and Referral Sources: 
• Intervention Implementer/ Trainer:  Drs. Huang and Nakigudde We will work with TTC and, MOE, and MOH 
to finalize the referral and recruitment process. Trainers will be identified and invited to participate. Participation 
will be completely voluntary, with no consequence for opting out of participation due to personal reasons. 
• Schools: We will work with Ministry of Education (MOE) to finalize the referral and recruitment procedure.  In 
general, public primary schools in targeted districts will be identified from governmental school lists in two 
study districts (urban and rural) provided by MOE. Principals of these schools will be invited to attend one of 
the information sessions hosted by the Ugandan intervention implementation team. During the recruitment 
session, principals will be provided with details of study requirements and intervention. They will have an 
opportunity to ask questions and also complete a questionnaire that seeks to gather information on school 
demographics, commitment to remain in a randomized condition, willingness to facilitate data collection, and 
allocate staff time to participate in the study. Eligible schools will be selected based on school leaders’ and 
principals’ expressed of interest and their agreement to allow teachers’ voluntary participation. To ensure 
approximately similar characteristics in the intervention and control conditions, a statistician, unfamiliar with 
study schools, will match schools on size (i.e., number of teachers and students), location (urban/rural), and 
quality/performance from the eligible school list. A stratified-block randomization design will be applied. We will 
work with MOE to finalize a systematic approach to select the final 36 schools. 

Study number: S20-00117
Page 11
Version date: 8/7/2020 
 
 
• Teachers and PTA Members: For the selected 36 schools, all pre-primary and Primary 1 to 4 teachers, 
serving students between 3 and 10 years old will be eligible to participate. Teachers’ participation will be 
completely voluntary, with no consequence for opting out of participation due to personal reasons (see human 
subjects section for detail about teacher protection).  PTA members from 24 intervention schools will be 
recruited to participate. For schools that do not have a PTA, Parent Leaders will be recruited. PTA members 
and Parent Leaders that are actively involved and have at least a year of experience in working with schools 
will be eligible. We will work with the intervention school to plan for recruitment and training of one PTA 
member from each intervention school (control schools will not have an identified PTA members). We 
anticipate that 540 teachers from 36 schools will participate in the evaluation study; and 360 intervention 
school teachers will be participated in intervention. 
• Families (Parent & child pairs): Ugandan primary schools have on average about 550 students. Given the 
large numbers of students in schools, research staff will randomly select 10% of students and families from 
each school based on student lists provided by teachers (using random number generator software). Teachers 
will be informed of the students randomly selected for participation in the assessments and asked to introduce 
the study to the selected parents or primary caregivers. Targeted parents will be invited to consent for 
interviews, for teachers to complete ratings on their child’s behavior, and for research staff to carry out 
objective assessments with their child.  
Procedures for monitoring enrollment and tracking/retaining participants for follow-up assessments: 
 
We have developed a procedure to ensure timely subject enrollment and data collection. Because of multiple 
samples (school staff & families), our monitoring and data collection procedure will occur in blocks based on 
sources of sample and carried out using a multiple-team-approach (a teacher/school staff data collection team, 
a parent-interview team, a child-assessment team, and a teacher EBI practice observation team).  Designated 
research coordinators will be responsible for coordinating, tracking and collecting data from the school staff 
(head teachers, teachers, PTA) and families.  
 
Research teams and coordinators will be trained to use a secure data tracking system to track and monitor the 
data tracking system on a weekly basis during enrollment or data collection periods. The monitoring will be 
conducted at the school level. For schools that do not meet the expected enrollment or assessment numbers 
will be flagged for additional actions.  Research coordinators will follow up on those flagged schools to ensure 
they complete assessment according to the study timeline.  The research coordinators will meet weekly with 
PIs to discuss the progress and share experience. We have applied this tracking approach in our previous 
studies. 
  
 
Strategies for Ensuring a diverse, representative sample: 
 
For teacher sample, all primary school teachers are eligible to participate. No one will be excluded. For 
families, they will be randomly selected from student lists provided by schools/teachers. Only 10% families will 
be selected for the evaluation study.  Therefore, it is expected that our teacher and family recruitment samples 
will be representative. 
 
Potential recruitment/enrollment challenges and strategies for overcoming shortfalls: 
 
For school personnel recruitment, we anticipate that most teachers (>90%) will sign up for the study based on 
our prior experience. However, we anticipate some teachers will be on maternity leave, sick leave, or 
transferred to different schools during the study period. For those teachers, we will work with principals to 
determine alternative approaches to contact these teachers to gather data. A phone interview may be applied if 
such contact option is appropriate.   
 

Study number: S20-00117
Page 12
Version date: 8/7/2020 
 
 
For families, we anticipate parents with low-literacy or struggling with poverty related stressors might be difficult 
to reach. If the situation happens, we will reach out to teachers and PTA for assistance in family recruitment 
and engagement. We will also applied strategies that we have learned from our previous studies, including 
sending home a reminder note to parent with students; calling parents; carrying out parent interview through 
home visits or phone calls.   
  
Evidence to support the feasibility of enrollment  
 
Our research team has track record in conducting large scale studies both in the US and in Ugandan contexts. 
We have developed family and school engagement strategies to ensure high rate of enrollment. We have also 
applied a multiple-team approach (by having multiple research coordinators) and a partnership approach 
(partnering with research network, academic social science/public health departments, and community 
networks to utilize additional network strategies) to ensure target enrollment and timely data collection. Given 
our prior experience, we have demonstrated the feasibility of our enrollment approach 
4.5 
Duration of Study Participation 
During Year 1, we will establish a localized scalable PD implementation team structure and train a group of 
PD/PDT implementers (N=8; using a TTC-MOE-Mental Health partnership structure) 51,52,57. We will train an 
implementation team that includes 6 TTC trainers and 2 MHPs (i.e., clinical psychologists, senior psychiatric 
nurses) and additional educational stakeholders (i.e., governmental stakeholders from MOE, MOH) from the 2 
regions. As with the methods that we have applied before, we will refine and formalize the partnership by using 
a muli-stakeholder participatory approach60,92 and principles of effective partnership57. Our partnership process, 
meetings, field interview notes, and qualitative data will be documented and analyzed. The implementation 
team members will participate in the study for 4 years. 
T-Wellness Package User-Centered & Optimization Study (N=60). T-Wellness Package 
will be based on the Stress and Coping (SC), a group-approach EBI that has been 
shown to reduce stress for Ugandan adults impaired by distress in PI-Nakigudde’s prior 
RCT work (effect size d=.35)84,85. The SC focuses on understanding personal 
stress/adversity, and strategies for managing problems/stress, mood, strengthening 
social support, and staying well84,85. To effectively address teacher burnout, we will add 
additional strategies from the Rational-Emotive Health Education Intervention (REHET), 
which focuses on evidence-based strategies to improve cognitive-behavioral skills and 
techniques to help teachers manage workplace burnout stress and overcome irrational 
beliefs in teaching86. These strategies have shown to be effective in reducing teacher burnout related stress in 
LMICs80,84,86. Our T-Wellness package will optimize these two core components of the evidence-based stress 
and support interventions that are relevant to teacher stress and have been reported in the literature84,93-96(see 
Box1 for T-Wellness contents). To ensure the expected impacts for T-Wellness, we will recruit 4 study schools 
and applying factorial design to test the effect of each component (1 Common Stress management; 1 Burnout 
Stress management; 1 Combined Common and Burnout Stress management; 1 control; with ~15 teachers in 
each condition). Teacher participants will participate in the study for 4-6 months. We will collect pre- and post- 
intervention data using a mixed-methods design to evaluate the effect of each component on stress 
management indicators (e.g., stress management skills, competency, burnout, general personal stress). 
Results will be used to optimize stress intervention components to be included in the Year 2-4 RCT). PI 
Nakigudde and consultant Dr. Dennis with stress management expertise will lead this effort.   
 
Two Advisory Boards (N=10; 1 rural and 1 urban advisory board) will be established to ensure that the PD 
effectiveness-implementation study aligns with Ugandan school/health system policies and practices in 
communities to pave the way for a sustainability policy plan should the intervention be effective. The Board in 
the urban setting will include 6 representatives, including 2 Ministry stakeholders, 1 researcher, 1 NGO 
stakeholder, 1 teacher, and 1 parent leader. The Board in the rural setting will include 4 representatives, 
including 1 local-MOE leader, 1 researcher, 1 teacher, and 1 parent leader. The teacher and parent leader will 
be selected based on school stakeholders’ recommendation. The advisory boards will meet regularly (2 times 
a year) throughout the 4 study years and provide guidance on programming, finding interpretation, and 
dissemination. Meeting notes will be documented for analyses.  

Study number: S20-00117
Page 13
Version date: 8/7/2020
In Years 2-4, we will carry out a cluster randomized controlled trial to study effectiveness and mechanisms of 
intervention with 36 schools. Implementation and evaluation activities will be carried out in two-cohort 
sequence by recruiting school staff and families (children and their caregivers). 
Primary school teachers and selected school leadership staff (Head teacher, PTA leaders) will 
participate in the evaluation study for 2 years. Teachers (i.e., pre-primary and primary 1st to 4th grade, 
serving students between the ages of 3 and 10 years) and PTA leaders are the primary targets of the 
PD/PDT.
Children and caregivers will participate in the Year 2-4 RCT evaluation study for 18 months which will 
include surveys/Questionnaires/Individual Interviews for the caregivers and game-like activities for children 
that assess childrens’ attention, memory, and social emotional wellbeing.
4.6
Total Number of Participants and Sites 
This study is carried out in Uganda with support from the US. Recruitment, informed consent, intervention, and evaluation 
of all school staff and participating families will occur in Uganda. For the PD/PDT effectiveness evaluation, participants will 
include 540 school staff (i.e., teachers/principals from 36 schools), 24 PTA members from intervention schools, and 8 
implementers (from TTCs and mental health institutions). There will be 1980 parent-child pairs (including 1980 
parents/caregivers and 1980 children). We expect that most teachers and primary caregivers/ parents will be female 
(75%), and equal % for children will be male and female (50% for each group). Participants numbers break down by site 
(rural and urban) are presented in the figure below.

Study number: S20-00117
Page 14
Version date: 8/7/2020 
 
 
4.7 
Participant Withdrawal or Termination 
4.7.1 Reasons for Withdrawal or Termination 
Participant will be free to withdraw from participation in the study. Participants can request to discontinue 
participation at any time. The decision to participate or not participate, or to withdraw, will not affect participant 
employment and/education opportunity 
4.7.2 Handling of Participant Withdrawals or Termination 
To leave the study, Ugandan participants will be asked to send a written notice to Janet Nakigudde and Keng-
Yen Huang, Ph.D. at the following address: (Department of Psychiatry, Makerere University, Kampala, 
Uganda), or email Drs. Nakigudde and Huang. 
4.7.3 Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. If 
the study is prematurely terminated or suspended, the PIs will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Insufficient compliance with protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination of futility 
 
5 
Behavioral/Social Intervention 
 
The EBI considered in this study is ParentCorps-Professional Development (PD), a school-based EBI and 
preventive service provision model that supports teachers and school personnel to apply EBI strategies to 
promote young children’s mental health in impoverished areas. The PD approach represents a task-shifting 
model of mental healthcare by shifting mental health preventive duties from professionals to teachers to 
optimize school children’s mental health. Therefore, teachers are considered as CHWs. Two efficacy studies of 
PD from our work in urban Uganda (RCT in 10 schools; 1R21MH-097115-01A1) and rural Nepal (pre-post 
comparison in 30 schools; UBS Foundation) demonstrate feasibility, acceptability, and positive impacts on 
teachers’ use of EBI strategies and students’ mental health. The current study builds on this work and further 
tests scalable PD implementation approaches and investigates PD effectiveness in multiple regions (urban and 
rural) in Uganda. In addition, based on previous findings that nearly 80% of Ugandan teachers (the EBI 
strategy users) experience occupational stress that threatens PD uptake, effectiveness, and sustainment, this 
study will also test a teacher stress management package (T-Wellness, adapted from EBIs) as an 
enhancement to PD. 
 
The 24 schools assigned to the intervention conditions will receive PD (12 with and 12 without T-Wellness) 
during their 1st year of participation. In the PD group, teachers and PTAs will participate in a 3-day 
ParentCorps-PD training before the 1st school term. For the PDT group, one additional training day will be 
added for stress management). Teachers in both PD implementation conditions will also receive 8 sessions 
(12 hours) of face-to-face group-based coaching during the 1st and 2nd terms. Coaching sessions are to help 
teachers apply EBI strategies in their classrooms, engage families, and develop competencies. For the 
teachers in the PDT group, additional stress management group coaching activities will also be integrated into 
the 8 sessions (3 additional monthly 1-hr wellness sessions for teachers as a group in each school) and 
receive a total 15 hours of coaching.    

Study number: S20-00117
Page 15
Version date: 8/7/2020 
 
 
6
Study Procedures and Schedule
6.1 
Study Procedures/Evaluations/Procedures/Timeline 
The three effectiveness and mechanism testing aims (Aim 1-3) will be accomplished by applying a matched-
pair cRCT and hybrid effectiveness-implementation design87,97.  A mixed methods design with qualitative and 
quantitative data collection will be applied. The school will be the unit of randomization because the program is 
applied at the school-level and builds a “school community” of teachers who promote students’ mental health. 
The three-arm cRCT design allows us to simultaneously test PD effectiveness and study the added value of a 
package (T-Wellness) to address a critical practical task-shifting challenge (teacher stress). In addition, the 
Hybrid design that considers CFIR domains of implementation contexts (in Figure 1) allows us to rigorously 
study other EBI effectiveness-implementation mechanisms, which can further inform decisions about optimal 
deployment and generalized impact, and may accelerate the introduction of other valuable innovations into 
practice87. Study tasks and timeline are listed in Table 1 below. 
 
For effectiveness, intervention theory of change (mediation mechanisms), and cost-benefit evaluations, the 
child and teacher effectiveness outcomes will be assessed and evaluated across 3 time points- baseline (T1, 
before PD), immediately after the PD/PTD (T2, about 3-4 months after T1), and 12 months later (T3, about 18 
months after T1). Data from multiple sources will be collected. For child effectiveness outcomes, the primary 
outcome is mental health (externalizing and internalizing problems), and the secondary outcome is behavioral 
and cognitive domains (see Table 2 for measures). Parent and child report data will be used. Parents of target 
students will be interviewed by trained research staff (using English or Luganda, lasting 30-45 minutes). Child 
assessment will be carried out in school by research staff (lasting about 20-30 mins). For teacher effectiveness 
outcomes, the primary teacher outcome is EBI practice, which will be based on objective observation by an 
independent observation team (primary data source) and teacher-report (secondary data source). The 
observation measure has been validated and published in our previous trial study (see Huang KY, Nakigudde 
J, et al. Transportability of an Evidence-based Early Childhood Intervention in a Low-Income African Country: 
Results of a Cluster Randomized Controlled Implementation Study. Prevention Science. 2017;18:964-75). The 
secondary teacher outcome will be social process (i.e., teacher-student and teacher-family relationship), based 
on parent and child report. All primary outcomes and most secondary outcome measures have been used and 
validated in our previous Ugandan studies77,98,99 (see Table 2 for measures and reliability information from our 
Ugandan studies). Costs will be measured using an activity-based micro-costing approach100 in the intervention 
cluster (school), and in the extended implementation phase in all clusters from 6 through 12 months (n=36 
clusters). Costs of the intervention will include all program costs incurred (for PD/PDT training, coaching, and 
materials/resources). Research costs will be excluded. Cost data collection will utilize existing standardized 
cost extraction forms and procedures that have been validated from Co-I Tozan’s work in Uganda and 
LMICs101-105. Prior to use, these tools will be tailored and customized. Research staff for family and 
observation data collection will be masked to intervention conditions. To ensure masking, we will have an 
independent assessment team (led by a separate research coordinator), and members will not participate in 
any intervention activities. We will also train implementation team on protocol to prevent releasing assigned 
condition information. Teacher-report data collection will not be masked. The tablet and team approach of data 
collection that we used in our previous studies will be applied. 
For study implementation moderation mechanisms, the selected key moderators from the 5 CFIR domains 
include target individuals’ charateristics (teachers and childrend), school, and intervention implementation 
contexts will be studied (listed in Table 2). Most CFIR measures have been validated in our previous PD pilot 
trial98,99. PD/PDT implementation fidelity will be assessed, characterized, and examined for moderation effects 
(on teacher effectiveness outcomes). Four fidelity measures106 will be considered, including adherence (the 
extent to which the TTC trainers deliver the core intervention content and as per program guidelines), quality of 
program implementation (assessed based on teacher satisfaction with the PD/PDT and ratings of TTC 
Coaches’ competence); engagement (assess trainees’ level of PD knowledge improvement from pre- to post- 
training72); and exposure (measured by attendance of PD and coaching sessions)106.  
 
To have a more comprehensive understanding of possible mechanisms, we also plan to conduct qualitative 
interviews, which will purposively select PD trainers (n=8), teachers (n=40; 20 from intervention and 20 from 
control across two sites) and our Advisory Board members, and conduct interviews at 4 time points (T1, T2, T3, 

Study number: S20-00117
Page 16
Version date: 8/7/2020 
 
 
and Year 4). Interview guides will comprise semi-structured questions relating to experience with PD/PDT. 
Participants will also be asked to provide a narrative account of partnership approaches, efforts to implement 
PD/PDT, including barriers and facilitators experienced. The group interview guides will be adapted from our 
previous pilot PD implementation studies.  
 
 

Study number: S20-00117
Page 17
Version date: 8/7/2020 
 
 
Table 1. Study Timeline (including recruitment and assessment timeline)
 
Table 2. Key Study Measures for Effectiveness-Implementation Study: Constructs and Measures  
Dimensions 
Constructs & Data Sources 
Measures 
Child 
Effectiveness  
Outcomes  
(T1-T3) 
a) Mental Health (Primary): Exteranlizing & Internalizing 
b)RDoC domains (Secondary): Negative valence (emotion 
disregulation), social processes (student-teacher & peer 
relatinship); cognitive system (executieve functioning) 
a) Strengths & Difficulties Questionnaire 
-
(P); 
b) Emotion-regulation 
 (P); Relationship with Teachers 
 & 
Peer relationship 
; Comprehensive Computerized Battery for Child 
Psychological  Assessment (C) (for cognitive system, executive functioning)
 
Teacher 
Effectiveness 
Outcomes  
(T1-T3) 
a) Teacher EBI Practice (Primary):  EBI Practices 
(including a range of behavior management and social 
emotional promotion practices (T & O);  
b) Teacher Stress &Management (Primary for PDT)(T)
c) Teacher social process (secondary)- relationship (P) 
a)Teacher EBI Practices
-
; PD 
-
; Determinants of 
Implementation Behavior Questionnaire (DIBQ)
b) Teacher Stress: Stress Questionnaire (T) 114; Stress Management:  Irrational 
Belief Questionnaire 
; Responses to Stress Questionnaire
c) Family and Teacher Relationship Quality (P)
 
Contextual 
Moderators  
 
(Pre/T1 and 
Post PD 
training, and 
during PD 
implementati
on) 
a) Outer setting: Urban/rural region (Primary moderator)
b) Fidelity: 4 PD/PDT measures (F, T) 
c) Inner setting
 
d) Individual/Teacher characteristics 
readiness/attitude; wellness) (T) 
e) Intervention characteristics: Acceptability;  
Appropriateness (T)  
f) Processes:  
teacher/PTA partnership) (T) 
b) 4 Fidelity measures
 (1) Adherence (F) (deliver the core content): PD/PDT 
Quality of implementation (T) (Teacher Satisfaction (T) (post PD training and 
and ratings of
Engagement (T) Strategy 
Knowledge
(T) (
-after training) (test-
-
;(4) Exposure (F): 
; C) School Environment 
Survey
-
; 
d) Teacher demographic
; PHQ-mental health 
; EBP Attitude Scale
;  
e)Applied Mental Health Research Dissemination and Implementation 
Measurements (AMHRG)
; f) Partnership Questionnaire
 
Demo (T1)
-being) (P) 
Family: Demo
;  Parent EBI Practices 
-
 
PD/PDT Cost 
Program implementation costs;  
Implementation costs: actual program costs (with & without monitoring cost)
 
Note
child effectiveness outcomes, primary data source is parent-report (P); and secondary data source is child-report/testing (C) For teacher effectiveness outcomes, primary 
CFIR contextual data  will be gathered from from Training/coaching 
-
Suicidal behaviors are NOT included because this study focuses on preventive intervention and young children 
(ages 4-
orted depressive symptoms will be included
 
7 
Safety and Adverse Events 
The definitions below are included in the protocol as part of the template provided by the NYU School of Medicine IRB.

Study number: S20-00117
Page 18
Version date: 8/7/2020 
 
 
7.1.1
Definitions
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
Unexpected in nature, severity, or frequency (i.e. not described in study-related documents such as the 
IRB-approved protocol or consent form, the investigators brochure, etc) 
 Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
 Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm).
 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during 
the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  results in 
study withdrawal 
is associated with a serious adverse event
 is associated with significant increased clinical signs or symptoms and impair functioning  
 is considered by the investigator to be of clinical significance 
 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
 fatal 
 life-threatening 
 requires or prolongs hospital stay 
 results in persistent or significant disability or incapacity 
 an important medical event 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious adverse 
events.  
Severity of Event
 
For AEs not included in the protocol defined grading system, the following guidelines will be used to describe 
severity. 
 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities.
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
 Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating.} 
7.1.2 Relationship to Study Intervention 
All AEs will have their relationship to study intervention or study participation assessed with a level of 
specificity appropriate to the study design. 
 Related – The AE is known to occur with the study intervention, there is a reasonable possibility that the 
study intervention caused the AE, or there is a temporal relationship between the study intervention and 
event. Reasonable possibility means that there is evidence to suggest a causal relationship between the 
study intervention and the AE. 
 Not Related – There is not a reasonable possibility that the administration of the study intervention 
caused the event, there is no temporal relationship between the study intervention and event onset, or 
an alternate etiology has been established. 
7.2 
Time Period and Frequency for Event Assessment and Follow-Up 

Study number: S20-00117
Page 19
Version date: 8/7/2020 
 
 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant. All AEs including local and systemic reactions not meeting the criteria for 
SAEs will be captured on the appropriate RF. Information to be collected includes event description, time of 
onset, staff’s assessment of severity, relationship to study intervention (assessed only by those with the 
training and authority), and time of resolution/stabilization of the event. All AEs occurring while on study must 
be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, 
the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for 
outcome information until resolution or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the subject 
is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the investigator 
should instruct each subject to report any subsequent event(s) that the subject, or the subject’s personal 
physician, believes might reasonably be related to participation in this study.  The investigator should notify the 
study sponsor of any death or adverse event occurring at any time after a subject has discontinued or 
terminated study participation that may reasonably be related to this study. 
7.2.1 Event Reporting 
The Investigators will be responsible for recording and reporting adverse events and unanticipated problems, 
as defined by the NYU School of Medicine IRB. The Investigators will ensure that they are knowledgeable of 
the definitions for safety and adverse events. All adverse events occurring during the course of the study will 
be recorded. The current study includes surveys and interviews, and does not involve diagnostic procedures or 
clinical treatment. Should an adverse event occur, the event will be recorded and followed until resolution, 
stabilization or until it has been determined that participation in the study was not the cause of the adverse 
event. Serious adverse events that are ongoing at the end of the study will be followed up to determine the 
final outcome. All serious and unexpected adverse events (e.g., hospitalizations, life threatening events, death) 
or other unanticipated problems that involve risk to study participants or others and whether these appeared 
related to the research assessment protocols will be reported to the NYU School of Medicine IRB, the 
Uganda’s National Science and Technology IRB, and the Chair of the DSMB. The DSMB has the authority to 
halt the preventive trial if it perceives that harm is occurring due to the program.  Summaries of adverse events 
reports will be also made to Clinicaltrials.gov bi-annual update/report and NIH in the yearly progress report, 
unless the nature of a particular event is such that it bears reporting to NIH immediately. 
7.3 
Safety Oversight 
DSMB: An independent group of experts that advises the study investigators. The primary responsibilities of 
the DSMB are to 1) periodically review and evaluate the accumulated study data for participant safety, study 
conduct and progress, and, when appropriate, efficacy, and 2) make recommendations concerning the 
continuation, modification, or termination of the trial.  
 
We shall include the following: 
 
 
An expert in the conduct of preventive trials and all phases of intervention research (i.e., Dr. Laurie 
Brotman) 
 
 
Two professionals with substantive expertise in the area of child health promotion (i.e., two Ph.D. level 
researchers: Dr. Demy Kamboukos from the US and Dr. Nakasujja Noeline from Uganda). 
 
 
A biostatistician with expertise in prevention trials (i.e., Dr. Andrea Troxel) 
 
 
The DSMB will perform the following activities: 
o Review the research protocol and plans for data and safety monitoring. 

Study number: S20-00117
Page 20
Version date: 8/7/2020 
 
 
o
Evaluate the progress of the prevention program implementation, including periodic 
assessments of data quality and timeliness, participant recruitment, accrual and retention, 
participant risk versus benefit, performance of trial sites, and other factors that can affect study 
outcome.   
 
o Monitors will also consider factors external to the study when interpreting the data, such as 
scientific or behavioral problem development that may have an impact on the safety of the 
participants or the ethics of the study.   
 
o Make recommendations to the IRB and investigators concerning continuation or conclusion of 
the trial(s). 
 
o Protect the confidentiality of the trial data and the results of monitoring. 
 
The DSMB will meet with PI Huang,  subcontract-PI  Nakigudde and the sub-Investigators  yearly to review 
adverse events reports and dropout rates.  Data will be provided at those meetings by the investigators on key 
variables that may indicate harm. The DSMB biostatistician will evaluate confidentiality and integrity of the 
database, and the procedures for recording and storing confidential files. The DSMB will also review the 
elements of the plan to deal with emergencies.    
8 
Clinical Monitoring 
In the event of a clinical emergency or other crisis, research staff and trainer/implementers (MHPs & TTC 
faculty) will be trained in basic crisis management. Staff will be trained in a manualized protocol for handling a 
variety of crises that may be presented to staff at the schools. The protocol for handling these issues 
addresses the safety of both study participants and study staff. The protocol also details the need for 
supervision in all instances. They will also notify Ugandan PI and Co-I (clinicians and researchers) or contact 
them by mobile phone if needed. Ugandan PI and the Clinical Research Director will oversee our program for 
the study schools and children. If medical attention or follow-up is needed, they will refer them to local Hospital 
or other health agencies.  If additional medical consultation is needed regarding the adverse event, we will 
consult with the needed specialists or consulting services.  
 
Research staff will also be available to talk individually with any participant who becomes distressed during 
program participation, and referrals will be made for participants as needed (e.g., teachers who expresses 
concern about their students’ well-being).> 
 
9 
Statistical Considerations 
 
Data Analysis Plan for Aim 1. Prior to any outcome analyses, we will generate summary statistics for all data, 
summarizing with means and standard deviations for continuous variables and frequencies for categorical 
variables. The distribution of study variables and missing data patterns will be inspected. To estimate 
effectiveness, we will apply intention-to-treat (ITT) analyses and first focus on between-subject comparisons of 
intervention vs. control (comparing PD to control, comparing PDT to control, and comparing PD to PDT). We 
will estimate the impact of PD on children and teachers post-intervention (T2, 4-5 months after T1) and at one-
year follow up (T3, 18 months after T1, or 12 months after T2). Figure 4 below describe the model to be tested 
under Aim 1. School and class nesting will be considered, and a multiple imputation strategy128 will be applied 
to account for missing data. Linear mixed effect models129, using SAS PROC MIXED130, will be applied to 
examine short and longer-term impacts. We will first examine the immediate impact by modeling post-
intervention outcomes (T2) as a function of intervention, adjusting for T1 outcome measures. The model 
accounts for between-subject (within-school and -class) correlation by including school- and classroom-level 
(when appropriate) random intercepts. The outcomes will be modeled as: 
=
+ 
+ 
+
+ 
+
 , where 
is the outcome for the student  in school .  is intervention status (a categorical variable, with 
3 levels) for school , representing two dummy variables (control as the reference).   is the cohort indicator for 

Study number: S20-00117
Page 21
Version date: 8/7/2020 
 
 
school, where C= 1 if is in the second cohort, 0 for the 1st cohort. 
is the baseline value of the outcome for 
student  in school . In the models, 
 represents the intervention impact, 
is the effect of the second cohort, 
is the effect of baseline measure,
is the school-level random effect and 
is the class-level random effect 
(when appropriate), and 
is the error term for student  in school  and k class. Next, we will study longer-
term effectiveness outcomes (T2 to T3) by applying growth curve models and using repeated assessments 
over time. In these growth models, we will add time-relevant parameters to the model above, including school-
level random slopes. The post-baseline scores will be modeled as a linear function of time/slopes, intervention 
indicator, and intervention-by-time interactions, adjusting for T1 scores and cohort. The long-term outcome will 
be modeled as: 
=
+
+
+
+ 
+
+ 
+
.  A significant 
3 would indicate the 
effect of the intervention depends on time; in this case, we will estimate the slopes for each condition, and the 
difference between the conditions with respect to the mean outcome scores. The analytical methods that we 
propose have been applied successfully in our previous US and LMIC studies. Cost-effectiveness analysis of 
PD and PDT implementation models will be examined using approaches that have been applied in previous 
school-based and parenting-based child mental health promotion research131-136. The analysis will center on 
incremental cost-effectiveness ratios (ICERs), where the numerator represents the cost difference between the 
intervention arms and the control, and the denominator represents the difference in average intervention 
effects. To that end, the cost-effectiveness analysis of the intervention will involve examining how much the 
PD/PDT intervention costs to achieve a unit of effect relative to the control group. The effects of the 
intervention will be estimated using the effect sizes d (standardized mean difference between comparison 
groups) from an ITT approach. For the effectiveness outcomes, we will use an effect size of 0.2-0.4 as a 
benchmark; this corresponds to a small to medium effect size according to Cohen. We will calculate the ICERs 
and compute the per-participant cost per 0.2-0.4 SD change for each effectiveness outcome. Reporting of the 
analysis will follow the Consolidated Health Economic Evaluation Reporting Standards (CHEERS)137. 
 
 
Data Analysis Plan for Aims 2. For testing PD/PDT theory of change, Preacher’s Multilevel Structural 
Equation Modeling (SEM)138,139 and MacKinnon’s mediation model testing principles/strategies140,141 will be 
applied. Figure 5 below describes the model to be tested under Aim 2.  Mediators (primary and secondary) will 
be examined separately. Only intermediate outcomes that show significant improvement will be examined in 
the mediation model testing. The mediation model will build on the effectiveness evaluation model (Aim 1 
model), by including changing scores of mediators (T2-T1) and T2 to T3 child outcome trajectory because a 
mediation model is ideally tested in a design demonstrating time precedence in which the intervention occurs 
before the outcome142,143. The mediation mechanism will be modeled as: 
=
+
+
+
+
+ 
+
+ 
+
 .  
 is the value of the mediator at T2 and/or T3 for school j. 
 
  
are the 
school- and class-level random effects. We will compare 
and 
from this model with the 
 and 
from the 
effectiveness models that are not included the moderator (
=
+
+
+
+ 
+
+ 
+
). A significant effect of 
and 
in the mediation model will suggest a mediation effect. A conventional 

Study number: S20-00117
Page 22
Version date: 8/7/2020 
 
 
Sober test described by Baron and Kenny will be applied next to test the significance of the mediation 
model144. This modeling approach has been applied in our previous work145,146. To confirm the model, 
Multilevel SEM138,139 will also be conducted (using Mplus147). 
 
 
 
Data Analysis Plan for Aims 3. For moderation model testing, we will apply similar approaches as in Aim 1 
and add the moderator and moderator-by-intervention interaction terms in the analysis. Figure 6 below 
describes the model to be tested under Aim 3. For models with a significant moderator-by-intervention term on 
teacher effectiveness outcomes, we will then further test mediation-moderation mechanisms by expending the 
mediation model described above. These methods have been utilized in our previous studies79,146,148.  
 
 
 
 
For qualitative interview data, we will apply qualitative analysis methods. Data from partnership meetings, 
partnership processes survey126, field interviews, teacher stress survey, and observational notes will be 
documented and analyzed using quantitative and qualitative analytic approaches. Interview data will be 
transcribed and analyzed using Atlas.ti software. To better understand partnership/scalable approaches, 
coding will focus on themes related to the partnership development process, usefulness of partnership 
frameworks in formalizing processes, scalable strategies, intervention implementation barriers, teacher stress, 
and strategies for overcoming teacher stress and other practices (considering CFIR). These analyses will help 
identify facilitators and barriers for partnership and implementation for carrying out the effectiveness study. For 

Study number: S20-00117
Page 23
Version date: 8/7/2020 
 
 
effectiveness-implementation mechanisms, qualitative analysis will focus on themes related to implementation 
barriers, facilitators, and contextual factors and processes that influence teacher intermediate and child 
effectiveness outcomes.  Coding of qualitative data will follow a constant comparative analysis approach, 
where data are analyzed for themes that reflect project aims, which are then confirmed by further data 
analysis, followed by a third review of the data to identify additional themes149-151.  
 
10 Quality Assurance and Quality Control 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be run 
on the database will be generated. Any missing data or data anomalies will be communicated to the site(s) for 
clarification/resolution. 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 
The investigational site will provide direct access to all trial related sites, source data/documents, and reports 
for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory authorities. 
 
11 Ethics/Protection of Human Subjects 
11.1 Ethical Standard 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection of 
Human Subjects of Research codified in 45 CFR Part 46. 
 
11.2 Institutional Review Board 
The protocol, informed consent forms, recruitment materials, and all participant materials will be submitted to 
the both NYU and Makerere University (Uganda) IRB for review and approval. Approval of both the protocol 
and the consent forms must be obtained before any participant is enrolled. Any amendment to the protocol will 
require review and approval by the both NYU and Makerere University (Uganda)  IRB before the changes are 
implemented to the study. All changes to the consent form will be IRB approved; a determination will be made 
regarding whether previously consented participants need to be re-consented. 
11.3 Informed Consent Process will be conducted in Uganda by Uganda research Staff under PI 
Nakigudde supervision  
Informed Consent and Assent.  All procedures and forms for recruiting, obtaining consent, enrolling subjects, 
and collecting data will be reviewed for compliance with regulations by the NYU School of Medicine IRB, 
Ugandan IRBs, and NIH Clinical Trial guideline. Participation will be voluntary. Consent will be obtained in the 
participants’ native language (English or local language Luganda).  As we have done in previous studies, 
trained research staff will be available in the schools to present the study and answer questions during 
recruitment. Feedback regarding the study procedures and the effect of data collection procedures on school 
operations will be sought from school administrators, faculty and staff on an ongoing basis by PIs.  The 
consent process provides an opportunity for school staff, PTAs and parents to question the research team so 
that they have full clarity about study procedures, their rights and confidentiality. All research participants will 
be inform related to posting of clinical trial information and results through ClinicalTrials.gov, and sharing de-
identify trial evaluation data via the National Database for Clinical Trials related to Mental Illness (NDCT). 
 
To consent school principals, principals from the final selected schools (16 urban and 16 rural) will be given 
a written consent form, which provides the names and contact information of the NYU and Ugandan 
investigators and IRB, a description of the study, a description of potential risks and benefits, a statement of 
confidentiality, and an indication of the right to refuse or withdraw at any time without any consequence.  The 

Study number: S20-00117
Page 24
Version date: 8/7/2020 
 
 
project PIs will review this form in detail with school principals to ensure informed consent. Principals will sign 
the consent forms if they agree to have their schools participate in the study.   
To consent teachers, teachers from participating schools will be given a written consent form, which provides 
the names and contact information of the NYU and Ugandan investigators and Institutional Review Boards, a 
description of the study (including completing surveys, being observed in the classroom), a description of 
potential risks and benefits, a statement of confidentiality, and an indication of the right to refuse or withdraw at 
any time without any consequence.  The Ugandan PI  and/or research staff from Uganda  will review this form 
in detail with teachers to ensure informed consent. Teachers who agree to participate in the study will sign the 
informed consent form and the observation consent forms, which will allow the research team to collect survey 
data, conduct live observation in their classrooms (to evaluate teachers’ behavioral practices, ParentCorps 
strategies utilization). These data collected from multiple sources will be used for evaluation of effectiveness 
and quality of implementation. 
 
For schools where the principal consents to participate in the ParentCorps-PD or PDT, individual teachers will 
still have the right to refuse to participate at any time during the study (as indicated in the proposal, only 
schools that expressed interest to participate and Principals agree to allow teacher voluntary participation will 
be eligible).  Research staff will ensure that the school staffs are aware of this during the consent process.  
Because teacher training and program implementation activities will be carried out in a group format, it is not 
feasible to guarantee complete confidentiality to teachers who decline to participate, as other participating 
teachers may notice teachers who are not present in the training.  To ensure that non-participating teachers 
are not discriminated against by principals, school personnel, or participating teachers, we have worked with 
MOE partners and developed several policies, which will be in place from the start of the study.   One, we will 
apply a recruitment approach that will “normalize” the decision not to participate. Specifically, when consenting 
principals and teachers, we will explicitly explain that the study aims to test a new school approach to help 
promote students’ health and development, and that we are asking for volunteer schools and teachers to 
participate and provide their feedback. We will notify principals upfront that teacher participation is completely 
voluntary and does not reflect on the community or researchers’ views about principals’ leadership or the 
image of their school and teachers. We will also notify teachers that there are many reasons why some 
teachers may not participate, including having unique responsibilities (either personal or professional) that 
other teachers may not have. We will strongly urge school teachers to be respectful of others’ choices to not 
participate, given a range of possible circumstances. This recruitment approach will likely minimize any 
potential feelings of discomfort for non-participating teachers, and will minimize potential discrimination toward 
non-participating teachers.  Two, reasons for non-participation in ParentCorps (if any) will be documented by 
research staff (in order to document barriers to participation) but will not be shared with any school staff.  The 
names/identifying information of these teachers will not be attached to any document and will not be disclosed 
to anyone in the school or community. Three, if any teacher chooses to withdraw from the study, the PIs and 
Ugandan Program Trainers will help these teachers develop strategies to explain to other participating 
teachers reasons for their withdrawal (e.g., personal challenges), and will aim to help these teachers minimize 
any discomfort they may feel regarding interactions with participating teachers.  Four, if a non-participating 
teacher ever feels any discomfort or discrimination for their non-participation, they can contact the PIs and 
voice their concerns, and the PIs will respond with appropriate actions (e.g., by reiterating confidentiality and 
non-discrimination practices to the teachers involved in trainings). Our teacher recruitment approach has been 
successfully applied in our previous studies both in Uganda, Nepal and in the United States.  
 
In both principals’ and teachers’ consents, we will explain that individual data collected by the research team 
(as part of the program evaluation and monitoring) will not be shared with any school staff, including principals 
or other school officials. Specifically, principals and school officials will not have access to the results from 
assessment of individual teachers (e.g., teacher performance and competence during the PD training). The 
research team will only analyze and report data at the aggregate level, and will not analyze individual teacher 
data. Additionally, we will train our research staff and Ugandan PD trainers/implementers and ensure that they 
will not share individual data/ results with school personnel, teachers or anyone outside of the research team. 
All these steps are to ensure that teacher performance in the ParentCorps will not impact employment 
decisions about the participating teachers.  
 

Study number: S20-00117
Page 25
Version date: 8/7/2020 
 
 
To consent PTA members/Parent leaders, the procedures will be similar to teacher consent. PTAs will be 
given a written consent form.  The Ugandan PI and/or research staff from Uganda will review this form in detail 
with PTAs to ensure informed consent. PTAs who agree to participate in the study will sign the informed 
consent form and the observation consent forms, which will allow the research team to collect survey data and 
conduct live observation. These data collected from multiple sources will be used for evaluation of PD 
effectiveness and quality of implementation. 
 
To consent parents, written or oral consent will be applied using local language (Luganda) or English, 
depending on parents’ preference. Parents will be inform about the limitation to confidentiality, especially in 
adhering to legal status regarding reporting to child protection agencies if study children are found to be at-risk 
for abuse or neglect or are being abused or neglected. For parents who are literate, a written consent will be 
given, which will provide the names and contact information of the NYU and Ugandan investigators and 
Institutional Review Boards, a description of the study, including completing interviews (by research staff), 
allowing their child’s teachers to provide data on their child behaviors at schools, allowing research staff to test 
their children, a description of potential risks and benefits, a statement of confidentiality, and an indication of 
the right to refuse or withdraw at any time without any consequence. The study staff will review this form in 
detail with parents to ensure informed consent. Parents who agree to participate in the study will sign the 
informed consent form. These data will be used for evaluation of PD effectiveness and quality of 
implementation. For parents who are illiterate or unaccustomed to dealing with forms, an oral consent will be 
given.  Although oral consent does not require providing information on paper, the research staff are required 
to provide all the necessary information (describe above) to parents before obtaining their consent. For our 
study, we will provide an Oral Consent Card that provides the consent information in a bulleted listed to 
parents. Information about the names and contact information of the NYU and Ugandan investigators and 
Institutional Review Boards Research staff will also be provided. Research staff will document the oral consent 
using digital recorder and in the research staff’s notes.  All parents of nursery to 4th grade students in 
intervention schools will be informed about PD program in their child’s school. As part of the universal early 
childhood program provided by schools, families do not need to be consented. Only those participated in 
research activities will be consented.  
 
Child assents to research will be obtained from the children above age 7 of parents who consent to the study 
 
11.4 Participant and Data Confidentiality 
All procedures for recruiting subjects, obtaining consent, enrolling subjects, and collecting data will be reviewed 
for compliance with regulations by the IRBs of NYU School of Medicine and Makerere University 
(Uganda)IRBs. To ensure the protection of the rights of research participants, several aspects of the study 
protocol will be planned.   
 
 
All personnel and members of the study staff will complete training in human subject protection, as 
required. This training consists of completion of the formalized training program sponsored by the NYU 
School of Medicine IRB as well as ongoing training by the PI in all aspects of human subjects’ protection.  
 
 
All study procedures are reviewed with staff from the perspective of ensuring the protection of the rights of 
study participants.  This includes training of study staff in consent and enrollment procedures to minimize 
coercion and ensure the principles of informed consent, maintaining study material and information in order 
to protect study participants’ privacy and confidentiality, and ensuring that assessment procedures are 
conducted in a manner that protects study participants’ privacy and rights.  In addition, NYU provides study 
participants with access to an independent institutional representative who can discuss with participants 
their rights. Subjects will be informed that they can discontinue participation in research at any time or 
choose not to complete a specific questionnaire or answer certain questions. 
 
 
Staff will be trained in the requirement to adhere to legal statutes regarding reporting to child protection 
agencies information obtained in the course of the study that leads a staff member to suspect that a child is 
at risk for abuse or neglect or is being abused or neglected.  There is a protocol detailing the responsibility 

Study number: S20-00117
Page 26
Version date: 8/7/2020 
 
 
of staff members to share information with the PIs immediately or as soon as possible after the information 
has been obtained.  The protocol requires review of the information to determine whether a report to the 
protection agency is required. In the case of abuse towards the child or caregivers, we will contact the 
Local Council (LC) administrator for the home community of the child and caregivers. The Local Council for 
the community where the child and family lives is typically the best person to advise us on the necessity for 
police action at the district level, depending on what is an appropriate level of response for that occurrence 
and situation. 
 
 
All personnel working on the project will be educated about the importance of strictly respecting subjects 
and rights to confidentiality. Both study participants and staff will also be made aware of the limits to 
confidentiality.  School staff, PTAs, and parents will be fully informed of these limits at the time of consent.
 
 
All information collected from study participants during the course of the project is kept confidential.  This 
includes information collected and stored in written and electronic form.  All procedures for data collection 
and management have been developed to ensure the confidentiality of data collected. All data will be de-
identified and presented at the group level. All responses of individual participants will be kept confidential, 
and will not include any identifying information. Paper copies of identifying information, assessment 
measures, and other study materials will be maintained in locked research files in locked offices.  
Electronic data are secured by server maintenance that includes password protection, limited access to 
data by staff, different levels of access depending on the person’s specific position on the team, and server 
securities, which, in combination, ensure a high degree of protection from unauthorized users. Information 
will be coded by participant identification number. Linking of identifying information to research data will be 
kept to a minimum.  The identity of study participants will not be revealed in presentations or publications of 
study findings.   
 
 
One of the risks of participating in research studies is the potential loss of confidentiality. Measures taken 
to minimize this risk are noted below. The risks of loss of confidentiality are minimal. During our previous 
studies, there were no adverse events related to loss of confidentiality. The minor risks of participation are 
considered reasonable in relation to the knowledge that may result from this study. 
 
 
At weekly study meetings, participant reactions to obtaining consent and evaluations will be reviewed. PIs 
(Drs. Huang and Nakigudde) will meet regularly with mental health professionals & implementers (from 
Teacher Training Colleges) to provide supervision. 
 
 
The project staff will continuously evaluate the experience of study participants and risk exposure.  Trends 
in data and findings will be examined yearly in order to identify any changes in risk/benefit ratios that might 
necessitate a modification of the protocol for assessments. In the unlikely event that monitoring reveals 
unanticipated or negative findings, the PIs will report these findings to the field and assess what 
characteristics of the protocol contributed to the findings. As we have done in our previous international 
research, the study team will secure a Certificate of Confidentiality from the Department of Health and 
Human Services in order to ensure the privacy of our participants. A Certificate of Confidentiality provides 
protection to researchers and research institutions from being forced to provide identifying information on 
study participants to any federal, state or local authority. Authorization comes from NIH through section 301 
(d) of the Public Health Service Act (42 U.S.C. 241 (d)) which provides the Secretary of Health and Human 
Services the authority to protect the privacy of study participants. 
 
12 Data Handling and Record Keeping 
All data will be managed and entered into RedCap an electronic data capture system approved by NYU, which 
will be secure and include password protection, limited access to data by staff and different levels of access 
depending on the person’s position on the research team. Qualtrics will also be used when collecting data in 
the field through the offline mobile app function. When using Qualtrics offline mobile app no Identifying 
information will be collected. Qualtrics mobile app uses Transport Layer Security (TLS) encryption (also known 
as HTTPS) and data entered into the mobile app cannot be re-accessed in the front-end. Only selected staff 

Study number: S20-00117
Page 27
Version date: 8/7/2020 
 
 
members with have access to the data in the back-end through password protected accounts. Data will be 
entered using only the unique study identification number.  Qualtrics data will then be transfer backed into 
RedCap as our database management system.  Implementation data of teachers will be captured through a 
Ugandan and Makarere IRB approved system. The system is developed and managed by the Uganda team 
and will use HIPAA-compliant technology (this is part of their scope of work as the subcontract).  The 
implementation data will then be entered into Redcap by the Uganda research staff. Staff entering 
implementation data will not have access to research data. All final study files for analyses will be captured and 
finalized ensuring that no personal identifiable information (PII), including students’, parents’ or teachers’ 
names, and contact information are included. Electronic data entered that include contact identifying 
information (e.g., master list of consenting information, contact information/address) will be securely saved, 
and will not be linked to the study data. There will be additional levels of protection and additional restricted 
access to this information.  
 
Only the approved study staff will have access to the database and identifying information. Files with 
identifying information will be restricted to the Principal Investigators, Sub-Investigators and research staff with 
limited access depending on scope. Linking of identifying study information to research data (which will be 
identified only with a unique study identification number) will be kept to a minimum. The identity of study 
participants will not be revealed in presentations or publications of study findings.All participants will be 
assigned a unique study identification number. This identification number will be used to link each participant’s 
assessment (students) and parent survey to measure change across time. School-based assessments with 
children and parent surveys will be completed with study staff in person or over the phone; responses to the 
surveys will be captured or entered electronically into an NYU approved system. School-based assessments 
will not include any personal identifiable information (PII), including site name and participants’ names, or 
capture IP addresses. Parents’ contact information will not be part of the study record, and only used for 
contact purposes. Teacher data and Implementer data will also be enter into a NYU approved system.    

Study number: S20-00117
Page 28
Version date: 8/7/2020 
 
 
Consent containing any identifying information will be stored in locked cabinets separately from other data. 
Contact forms will not include information (such as a unique study identification number) that can link the 
participant to research data. For data collection purposes, a master list will be developed with the participants’ 
names and unique study identification number. The master file linking the contact information (i.e., name) to 
the unique identification number will be stored securely with limited access to study staff, and stored separately 
from the study data, and will be used for the purposes of contacting parents for the follow-up surveys, and 
linking surveys over time.   
12.1 Study Records Retention 
Study documents will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the sponsor to inform the investigator when these documents no longer need to be retain. 
 
12.2 Protocol Deviations 
The Principal Investigators will continuously monitor the study procedures and timelines (on a weekly 
basis).and will identify and report deviations to the protocol, within 5 working days of the protocol deviation, or 
within 2 working days of the scheduled protocol-required activity. Protocol deviations will be reported to the 
NYU School of Medicine IRB, and the Makerere University IRB, per their guidelines. The Principal 
Investigators will be responsible for knowing and adhering to the IRB guidelines.  
 
12.3 Publication and Data Sharing Policy 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. 
 
13 Study Finances 
13.1 Funding Source 
This study will be funded by NIMH 
13.2 Costs to the Participant 
There is no cost to participant to be part of this study.  
13.3 Participant Reimbursements or Payments 
Because the training will be provided during non-school days and outside of the school, each teacher will 
receive US $50 to compensate for travel and time. For PTAs’ participation in training and engaging families, a 
small stipend of US $30/month will be provided for the month they provide support.  To increase control school 
motivation to participate and assist with data collection, a donation of US $400 will be provided to each school 
at the end of the 1st year of participation in the study. In the later 2nd year of participation (after completion of 
the effectiveness evaluation), control schools will receive a one-day T-Wellness workshop (without PD) and 3 
monthly follow-up group-support session. 
 
14 Study Administration 
14.1 Study Leadership 
The study team includes implementation research leadership teams from the US and Uganda. The leadership 
teams are to collaborate with Ugandan Ministry of Education (MOE) and Ministry of Health (MOH) to develop 

Study number: S20-00117
Page 29
Version date: 8/7/2020 
 
 
infrastructure, and to coordinate, integrate, monitor, implement, and disseminate knowledge related to 
ParentCorps-Professional Development (PD) across sites. Overall, the US research-clinical team (lead by Dr. 
Huang) will work closely with the Ugandan Research-Policy-NGO leadership team to set-up a system to 
support PD implementation and evaluation. The US team will also work closely with Ugandan leadership team 
on research administrative activities, design, data analysis, report writing, and result dissemination. The 
Ugandan Research-Policy-NGO Leadership team (lead by Dr. Nakigudde) will work closely with Ugandan 
MOE, MOH, and AfriChild leadership and will play leadership roles in: 1) developing and training localized 
implementation teams in urban and rural sites that include Teacher Training College (TTC) Principals, TTC 
teacher trainers/PD trainers, and mental health professional (MHP)/psychiatric medical officer; 2) developing 
and training independent research monitoring/evaluation teams in urban and rural sites that include Research 
Directors, data collection Research Assistants (RAs), and independent classroom observers); 3) working with 
local PD implementation teams from Advisory Boards (one in Urban and one in Rural region) to facilitate 
regulate Advisory Board meetings (3 times a year)  in order to gain guidance related to program improvement, 
outcome interpretation and result dissemination; 4) providing oversight for all team management and 
effectiveness study activities; 5) facilitating knowledge sharing and learning collaboration between urban and 
rural sites; and 6) collaborating with the US team on design, data analysis, report writing, and result 
dissemination. For Implementation and effectiveness study, two site teams with parallel structure will be 
established- one for urban site, and the other for rural site.  For each site, there will be a PD Implementation 
Team that leads by the TTC Principal, and an Independent Research Evaluation Team that leads by a 
Research Director. The TTC Principals from each site will work with Ugandan Research-Policy-NGO 
leadership team to recruit and train PD trainers (including two TTC Trainers/PD implementers, and one mental 
health professional or senior psychiatric nurse). The Research Director from each site will work with the 
Ugandan leadership team to recruit and train 5 part-time RAs and 2 independent classroom observers. They 
will not involve in any implementation activities (to maintain blind to study conditions). Both local 
Implementation team and Research Team will also work with the Ugandan Leadership Team to set-up 
Advisory Boards and conduct regular Advisory Board meetings.  The Central Leadership team will also set-up 
regular cross-site meetings (or conference calls) for two cross-site teams to share knowledge and 
research/practice strategies.  
 
15 Conflict of Interest Policy 
There is no conflict of interest.  
 
 
 
 

Study number: S20-00117
Page 30
Version date: 8/7/2020 
 
 
16
References
1. 
UNICEF. Uganda Statistics. http://www.unicef.org/infobycountry/uganda_statistics.html. Published 
2014. Accessed April, 2014.
2. 
Population Reference Bureau. 2009 World Population Date Sheet. Population Reference Bureau. 
http://www.prb.org/pdf09/09wpds_eng.pdf. Published 2009. Updated January 2011. Accessed. 
3.
Ministry of Education Uganda. Education and Sports Sector Fact Sheet 2002-2016. Ministry of 
Education and Sports. 
http://www.education.go.ug/files/downloads/FACT%20%20%20SHEET%202016.pdf. Published 2013. 
AccessedMay, 2017. 
4. 
Huang K-Y, Gumikiriza JL, Schmidt-Sane M, Abura G, Nakigudde J. The influence of parent childhood 
abuse experience on parenting practice and child mental health functioning. World Psychiatry 
Association Regional Conference; 2014; Kampala, Uganda. 
5. 
Belfer ML. Child and adolescent mental disorders: the magnitude of the problem across the globe. 
Journal of Child Psychology and Psychiatry. 2008;49(3):226-236. 
6. 
Huang K-Y. Need Assessment for Children and Families in Disadvantage Neighborhoods in Kampala, 
Uganda In: iHUG/ NYU Child Study Center; 2010. 
7. 
CPRC. Summary: Does chronic poverty matter in Uganda? 2005. 
http://www.chronicpoverty.org/uploads/publication_files/2_CPR-Uganda2005_Summary.pdf. Accessed 
January 2011. 
8. 
UNICEF. Multiple Indicator Cluster Survey - Country Statistics. UNICEF. 
http://www.unicef.org/statistics/index_countrystats.html. Published 2014. Accessed April, 2014. 
9. 
Koenig MA, Lutalo T, Zhao F, et al. Domestic violence in rural Uganda: evidence from a community-
based study. Bulletin of the World Health Organization. 2003;81:53-60. 
10. 
Brownstein JN, Bone LR, Dennison CR, Hill MN, Kim MT, Levine DM. Community Health Workers as 
Interventionists in the Prevention and Control of Heart Disease and Stroke. American journal of 
preventive medicine. 2005;29(5S1):128-133. 
11. 
Huang K-Y, Abura G, Theise R, Nakigudde J. Parental depression and associations with parenting and 
children’s physical and mental health in Sub-Saharan African settings. Child Psychiatry and Human 
Development. 2017;48:517-527. 
12. 
Shonkoff J, Garner A, Committee on Psychosocial Aspects of Child and Family Health, Committee on 
Early Childhood Adoption and Dependent Care, Section on Developmental and Behavioral Pediatrics. 
The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012;129(1):e232-e246. 
13. 
Heckman J. The economics of inequality: The value of early childhood education. American Educator. 
2011;Spring:31-47. 
14. 
McClelland MM, Morrison FJ, Holmes DL. Children at risk for early academic problems: The role of 
learning-related social skills. Early Childhood Research Quarterly. 2000;15(3):307-330. 
15. 
Moffitt T, Arseneault L, Belsky D, et al. A gradient of childhood self-control predicts health, wealth and 
public safety. PNAS. 2011;108(7):2693-2698. 
16. 
Olds D, Kitzman H, Cole R, et al. Effects of nurse home-visiting on maternal life course and child 
development: Age 6 follow-up results of a randomized trial. Pediatrics. 2004;114(6):1550-1559. 
17. 
Pianta R, Mashbum A, Downer B, Justice L. Effects of web-mediated professional development 
resources on teacher-child interactions in pre-kindergarten classrooms. Early Childhood Research 
Quarterly. 2008;23:431-451. 
18. 
Raver C, Zigler E. Social competence: An untapped dimension in evaluating Head Start's success  
Early Child Research Quarterly. 1997;12(4):363-385. 
19. 
Raver C, Jones S, Li-Grining C, Zhai F, Bub K, Pressler E. CSRP's impact on low-income preschooler's 
pre-academic skills: Self-regulation as a mediating mechanism. Child Development. 2011;82:362-378. 
20. 
Rhoades B, Warren H, Domitrovich C, Greenberg M. Examining the link between preschool social-
emotional competence and first grade achievement: The role of attention skills. Early Child Research 
Quarterly. 2011;26(2):182-191. 
21. 
Brotman LM, Gouley KK, Huang K-Y, Kamboukos D, Fratto C, Pine DS. Effects of a psychosocial 
family-based preventive intervention on cortisol response to a social challenge in preschoolers at high 
risk for psychopathology. Archives of General Psychiatric. 2007;64(10):1172-1179. 
22. 
Patel V, Fisher AJ, Hetrick S, McGorry P. Mental health of young people: a global public-health 
challenge. Lancet. 2007;369(9569):1302-1313. 

Study number: S20-00117
Page 31
Version date: 8/7/2020 
 
 
23.
Lansford JE, Dodge KA. Cultural norms for adult corporal punishment of children and societal rates of 
endorsement and use of violence. Parenting: Science & Practice. 2008;8(3):257-270. 
24. 
Patel V, Kleinman A. Poverty and common mental disorders in developing countries. Bulletin of the 
World Health Organization. 2003;81:609-615. 
25. 
Baumann AA, Powell BJ, Kohl PL, et al. Cultural adaptation and implementation of evidence-based 
parent-training: a systematic review and critique of guiding evidence. Children and Youth Services 
Review. 2015;53:113-120. 
26. 
Gardner F, Montgomery P, Knerr W. Transporting evidence-based parenting programs for child 
problem behavior (age 3–10) between countries: systematic review and meta-analysis. Journal of 
Clinical Child & Adolescent Psychology. 2015;18:1-14. 
27. 
Huang KY, Nakigudde J, Ruhule D, et al. Transportability of an Evidence-based Early Childhood 
Intervention in a Low-Income African Country: Results of a Cluster Randomized Controlled 
Implementation Study. Prevention Science. 2017;18:964-975. 
28. 
Fazel M, Patel V, Thomas S, Tol W. Mental health interventions in schools in low-income and middle-
income countries. The Lancet Psychiatry. 2014;1(5):388-398. 
29. 
WHO. Mental Health Action Plan 2013-2020. World Health Organization. 
http://www.who.int/mental_health/action_plan_2013/en/. Published 2013. Accessed2015. 
30. 
WHO. Improving Health Systems and Services for Menatl Health. 2009. 
http://apps.who.int/iris/bitstream/10665/44219/1/9789241598774_eng.pdf. 
31. 
Huang K-Y, Calzada E, Cheng S, Brotman LM. Physical and mental health disparities among young 
children of Asian immigrants. Journal of Pediatrics. 2012;160:331-336. 
32. 
United Nations Development Programme. MDGs in Uganda. UNDP. http://www.undp.or.ug/mdgs/25#. 
Published 2008. AccessedFeb 2011. 
33. 
Kinsman J, Nakiyingi J, Kamali A, et al. Evaluation of a comprehensive school-based AIDS education 
programme in rural Masaka, Uganda. Health Education Research 2001;16(1):8-100. 
34. 
Sherman J, Muehlhoff E. Developing a nutrition and health education program for primary schools in 
Zambia. Journal of Nutrition Education and Behavior. 2007;39:335-342. 
35. 
Shonkoff J, Phillips DA. From Neurons to Neighborhoods: The Science of Early Childhood 
Development. Washington, D.C.: National Research Council and Institute of Medicine: National 
Academy Press; 2000. 
36. 
Minkovitz CS, Strobino D, Mistry KB, et al. Healthy Steps for Young Children: Sustained Results at 5.5 
years. Pediatrics. 2007;120(3):e658-e668. 
37. 
August GJ, Realmuto, G. M., Hektner, J. M., & Bloomquist, M. L. An integrated components preventive 
intervention for aggressive elementary school children: The Early Risers Program. Journal of 
Consulting and Clinical Psychology. 2001;69:614-626. 
38. 
Kellam SG, Poduska JM, Brown H, Windham A, Ialongo N. Effects of two universal interventions 
directed at first grade classroom behavior and achievement on the prevention of tobacco, alcohol and 
illicit drug use. Paper presented at: 13th Annual Meeting of the Society for Prevention Research2005; 
Washington, D.C. 
39. 
Reid MJ, Webster-Stratton C, Baydar N. Halting the development of conduct problems in head start 
children: the effects of parent training. Journal of Clinical Child & Adolescent Psychology. 
2004;33(2):279-291. 
40. 
Dawson-McClure SR, Sandler IN, Wolchik SA, Millsap R. Risk as a moderator of the effects of 
prevention programs for children of divorce: A six-year longitudinal study. . Journal of Abnormal Child 
Psychology. 2004;32:175-190. 
41. 
The World Bank. School Enrollement, Primary (% net). The World Bank. 
http://data.worldbank.org/indicator/SE.PRM.NENR. Published 2014. Accessed April, 2014. 
42. 
PEPFAR, UNAIDS. Task shifting-Global Recommendation and Guidlines. WHO. 
http://data.unaids.org/pub/Manual/2007/ttr_taskshifting_en.pdf. Published 2007. Updated August 2012. 
Accessed. 
43. 
WHO. Task shifting to tackle health worker shortages. World Health Organization. 
http://www.who.int/healthsystems/task_shifting_booklet.pdf. Published 2007. Accessed. 
44. 
Health Resources and Services Administration (HRSA). Community Health Worker National Workforce 
Study. 2007. 

Study number: S20-00117
Page 32
Version date: 8/7/2020 
 
 
http://bhpr.hrsa.gov/healthworkforce/supplydemand/publichealth/communityhealthworkforcebibliograph
y.pdf. 
45.
WHO. Treat, train, retain. The AIDS and health workforce plan. Report on the consultation on AIDS and 
human resources for health. In: Geneva: WHO; 2006: 
http://www.who.int/hiv/pub/meetingreports/TTRmeetingreport2.pdf. Accessed 2013. 
46.
Mutamba BB, van Ginneken N, Paintain LS, Wandiembe S, Schellengerg D. Roles and effectiveness of 
lay community health workers in the prevention of mental, neurological and substance use disorders in 
low and middle income countries: a systematic review. BMC health services research. 2013;13:412. 
47. 
Mendenhall E, De Silva MJ, Hanlon C, et al. Acceptability and feasibility of using non-specialist health 
workers to deliver mental health care: Stakeholder perceptions from the PRIME district sites in Ethiopia, 
India, Nepal, South Africa, and Uganda. Social science & medicine. 2014;118:33-42. 
48. 
Kigozi F, Ssebunnya J, Kizza D, Cooper, S., Ndyanabangi S, the Mental Health and Poverty Project. 
An overview of Uganda's mental health care system: results from an assessment using the world health 
organization's assessment instrument for mental health system (WHO-AIMS). International Journal of 
Mental Health System. 2010;4(1):1-9. 
49. 
International Institute for Legislative Affairs. Mental Health in Kenya: Unpacking the Issues. ILA. 
Legislative Digest Web site. http://www.unicef.org/about/annualreport/files/Uganda_COAR_2010.pdf. 
Published 2011. Accessed April, 2014. 
50. 
Semrau M, Evans-Lacko S, Alem A, et al. Strengthening mental health systems in low- and middle-
income countries: the Emerald programme. BMC Med. 2015;13:79. 
51. 
WHO. Nine steps for developing a sacling-up strategy. 2010. 
https://apps.who.int/iris/bitstream/handle/10665/44432/9789241500319_eng.pdf?sequence=1. 
52. 
Chambers DA, Glasgow RE, Stange KC. The dynamic sustainability framework: Addressing the 
paradox of sustainment amied ongoing change. Implementation Science. 2013;8. 
53. 
Ssebunnya J, Kigozi F, Ndyanabangi S. Developing a national mental health policy: a case study from 
Uganda. PLoS medicine. 2012;9:e1001319. 
54. 
Uganda Ministry of Health. Child and Adolescent Mental Health Guideline Uganda Ministry of 
Health;2013. 
55. 
Ejuu G. The status of implementation of the education sector early childhood development policy in 
Uganda. 2012. 
http://www.education.go.ug/files/downloads/Early%20Childhood%20Development%20Policy%20Revie
w.pdf. Accessed Sep 2014. 
56. 
Iwelunmor J, Blackstone S, Veira D, et al. Toward the sustainability of health interventions implemented 
in sub-Saharan Africa: a systematic review and conceptual framework. Implementation science : IS. 
2016;11:43. 
57. 
Huang KY, Kwon SC, Cheng S, et al. Unpacking Partnership, Engagement, and Collaboration 
Research to Inform Implementation Strategies Development: Theoretical Frameworks and Emerging 
Methodologies. Frontiers in public health. 2018;6:190. 
58. 
Aguirre J, Carrion VG. Integrated behavioral health services: a collaborative care model for pediatric 
patients in a low-income setting. Clinical pediatrics. 2013;52(12):1178-1180. 
59. 
Aupont O, Doerfler L, Connor DF, Stille C, Tisminetzky M, McLaughlin TJ. A collaborative care model to 
improve access to pediatric mental health services. Administration and policy in mental health. 
2013;40(4):264-273. 
60. 
Mirzoev TN, Omar MA, Green AT, et al. Research-policy partnership- Experiences of the Mental Health 
and Poverty Project in Ghana, South Africa, Uganda and Zambia. Health Research and Policy and 
Systems. 2012;10:30. 
61. 
Bower P, Gilbody S, Richards DA, Fletcher J, Sutton A. Collaborative care for depression in primary 
care: making sense of a coplex intervention: systematic review and meta-regression. Brtish Journal of 
Psychiatry. 2006;189:484-493. 
62. 
Gilbody S, Bower P, Fletcher J, Richard D, Sutton A. Collaborate care for depression: a cumulative 
meta-analysis and review of longer-term outcomes. ARCH INTERN Med. 2006;166:2314-2321. 
63. 
Uganda Ministry of Education and Sports. Teacher Edudation. Uganda, MOE. 
http://www.education.go.ug/data/smenu/14/Teacher%20Education.html. Published 2017. Accessed 
May, 2017. 

Study number: S20-00117
Page 33
Version date: 8/7/2020 
 
 
64.
WHO, Uganda MOH. WHO-AIMS report on mental health system in Uganda. 2006. 
http://www.who.int/mental_health/uganda_who_aims_report.pdf. 
65.
Brotman LM, Calzada E, Huang K-Y, et al. Promoting effective parenting practices and preventing 
conduct problems among ethnic minority families from low-income, urban communities. Child 
Development. 2011;82:258-276. 
66. 
Calzada E, Huang K-Y, Anicama C, Fernandez Y, Brotman LM. Test of a cultural framework of 
parenting with Latino families of young children. Culture Diversity and Ethnic Minority Psychology. 
2012;18:285-296. 
67. 
Huang K-Y, Calzada E, Kamboukos D, et al. Applying public health frameworks to advance the 
promotion of mental health among Asian American children. Asian American Journal of Psychology. 
2014;5:145-152. 
68. 
Huang K-Y, Cheng S, Calzada E, Brotman LM. Symptoms of anxiety and associated risk and protective 
factors in young Asian American children. Child Psychiatry & Human Development. 2012;43:761-774. 
69. 
Lawire M. Parenting around the world: Plus ca Change. Journal of Family Studies Special Issue: 
Parenting around the world. 2009;15(3):204-206. 
70. 
Bradley RH, Corwyn RF. Caring for children around the world: A view from HOME. international Journal 
of Behavioral Development. 2005;29(6):468-478. 
71. 
Greenfield PM, Suzuki LK. Culture and human development: Implications for parenting, education, 
pediatrics, and mental health. In: Sigel IE, Renninger KA, eds. Handbook of Child Psychology, Vol.4. 5 
ed. NY: Wiley; 1998:1059-1107. 
72. 
Brotman LM, Kingston S, Bat-Chava Y, Caldwell BM, Calzada E. Training school personnel to facilitate 
a family intervention to prevent conduct problems. Early Education & Development. 2008;19(4):622-
642. 
73. 
Brotman LM, Dawson-McClure S, Kamboukos D, et al. Effects of ParentCorps in pre-kindergarten on 
child mental health and academic performance: follow-up of a randomized clinical trial through 8 years 
of age. JAMA Pediatrics. 2016;170:1-7. 
74. 
Dawson-McClure S, Calzada E, Huang K-Y, et al. A population-level approach to promoting healthy 
child development and school success in low-income, urban neighborhoods: impact on parenting and 
child condut problems. Prevention Science. 2015;16:279-290. 
75. 
Durlak JA, Weissberg RP, Dymnicki AB, Taylor RD, Schellinger KB. The impact of enhancing students' 
social and emotional learning: a meta-analysis of school-based universal interventions. Child Dev. 
2011;82(1):405-432. 
76. 
Korpershoek H, Harms T, de Boer H, van Kuijk M, Doolaard S. A Meta-Analysis of the Effects of 
Classroom Management Strategies and Classroom Management Programs on Students’ Academic, 
Behavioral, Emotional, and Motivational Outcomes. Review of Educational Research. 2016;86(3):643-
680. 
77. 
Huang KY, Nakigudde J, Rana H, Castillo T. Implementing an Early Childhood School-Based Mental 
Health Preventive Intervention in Low-Resource Schools in Nepal and Uganda NIMH/Grand 
Challenges Canada: Transformative Opportunities for Solving the Grand Challenges in Global Mental 
Health; 2017; Bethesta. 
78. 
Huang K-Y, Nakigudde J, Rhule D, et al. Transportability of an Evidence-Based Early Childhood 
Intervention in a Low-Income African Country: Results of a Cluster Randomized Controlled Study. 
Prevention Science. 2017. 
79. 
Dawson-McClure S, Calzada E, Huang K-Y, et al. A population-level approach to promoting healthy 
child development and school success in low-income, urban neighborhoods: impact on parenting and 
child condut problems. Prevention Science. 2014;16:279-290. 
80. 
Ugwoke SC, Eseadi C, Onuigbo LN, et al. A rational-emotive stress management intervention for 
reducing job burnout and dysfunctional distress among special education teachers: An effect study. 
Medicine (Baltimore). 2018;97(17):e0475. 
81. 
Turk DC, Meeks S, Turk LM. Factors contributing to teacher stress: implications for research, 
prevention, and remediation. Behav Couns Q. 1982;2:3-25. 
82. 
Ugandan Ministry of Education and Sports. Teacher Issues in Uganda: a shared vision for an effective 
teachers policy. UNESCO. http://unesdoc.unesco.org/images/0022/002297/229777e.pdf. Published 
2014. Accessed May, 2017. 

Study number: S20-00117
Page 34
Version date: 8/7/2020 
 
 
83.
Adriaenssens J, De Gucht V, Maes S. Causes and consequences of occupational stress in emergency 
nurses, a longitudinal study. J Nurs Manag. 2015;23(3):346-358. 
84. 
Hemdi A, Daley D. The Effectiveness of a Psychoeducation Intervention delivered via WhatsApp for 
mothers of children with Autism Spectrum Disorder (ASD) in the Kingdom of Saudi Arabia: A 
randomized controlled trial. Child: care, health and development. 2017;43(6):933-941. 
85. 
Nakigudde J, Ehnvall A, Mirembe F, Musisi S, Airaksinen E. An exploratory study on the feasibility and 
appropriateness of family psychoeducation for postpartum women with psychosis in Uganda. BMC 
Psychiatry. 2013;8:131. 
86. 
Ugwoke SC, Eseadi C, Igbokwe CC, et al. Effects of a rational-emotive health education intervention on 
stress management and irrational beliefs among technical college teachers in Southeast Nigeria. 
Medicine (Baltimore). 2017;96(31):e7658. 
87. 
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness implementation hybrid designs: 
combining elements of clinical effectiveness and implementation research to enhance public health 
impact. Med Care. 2012;50(217-226). 
88. 
Damschroder LJ, Lowery JC. Evaluation of a Large-scale weight management program using the 
consolidated framework for implemenation research (CFIR). Implementation Science. 2013;8(51):2-17. 
89. 
Wittkowski A, Gardner PL, Bunton P, Edge D. Culturally determined risk factors for postnatal 
depression in Sub-Saharan Africa: a mixed method systematic review. Journal of Affective Disorders. 
2014;163:115-124. 
90. 
Kisia J, Nelima F, Otieno DO, et al. Factors associated with utilization of community health workers in 
improving access to malaria treament among children in Kenya. Malaria Journal. 2012;11(248):1-7. 
91. 
Sengwana MJ, Puoane T. Knowledge, beliefs and attitudes of community health workers about 
hypertension in the Cape Peninsula, South Africa. Curationis. 2004;27(1):65-71. 
92. 
ExpandNet. ExpandNet- Scaling Up for Health Innovations. ExpandNet/WHO. 
http://www.expandnet.net/. Published 2004. Accessed May, 2017. 
93. 
Gilhooly KJ, Gilhooly ML, Sullivan MP, et al. A meta-review of stress, coping and interventions in 
dementia and dementia caregiving. BMC Geriatr. 2016;16:106. 
94. 
Ploeg J, Markle-Reid M, Valaitis R, et al. Web-Based Interventions to Improve Mental Health, General 
Caregiving Outcomes, and General Health for Informal Caregivers of Adults With Chronic Conditions 
Living in the Community: Rapid Evidence Review. J Med Internet Res. 2017;19(7):e263. 
95. 
Ploeg J, Ali MU, Markle-Reid M, et al. Caregiver-Focused, Web-Based Interventions: Systematic 
Review and Meta-Analysis (Part 2). J Med Internet Res. 2018;20(10):e11247. 
96. 
DeHoff BA, Staten LK, Rodgers RC, Denne SC. The Role of Online Social Support in Supporting and 
Educating Parents of Young Children With Special Health Care Needs in the United States: A Scoping 
Review. Journal of medical Internet research. 2016;18(12):e333. 
97. 
Glasgow RE, Lictenstein E, Marcus AC. Why don’t we see more translation of health promotion 
research to practice? Rethinking the efficacy-to-effectiveness transition. Am J Public Health. 
2003;93:1261-1267. 
98. 
Huang K-Y, Abura G, Nakigudde J. The Influence of Parental Depression on Parenting and Young 
Children’s Health and Development in Uganda. BMC Psychiatry. Under Review. 
99. 
Huang KY, Nakigudde J, Calzada E, Boivin M, Ogedegbe G, Brotman LM. A Cluster Randomized 
Controlled Trial of an Early Childhood School-Based Mental Health Promotion Intervention in Low-
Resource Ugandan Schools: Study Protocol Trials. Under review  
100. 
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in Health and Medicine. New York: 
Oxford University Press; 1996. 
101. 
Opoku-Boateng YN, Kretchy IA, Aryeetey GC, et al. Economic cost and quality of life of family 
caregivers of schizophrenic patients attending psychiatric hospitals in Ghana. BMC health services 
research. 2017;17:697. 
102. 
Tozan Y, Headley TY, Sewe MO, et al. A Prospective Study on the Impact and Out-of-Pocket Costs of 
Dengue Illness in International Travelers. The American Journal of Tropical Medicine and Hygiene. 
2019. 
103. 
Tozan Y, Ratanawong P, Sewe MO, Wilder-Smith A, Kittayapong P. Household costs of hospitalized 
dengue illness in semi-rural Thailand. PLOS Neglected Tropical Diseases. 2017;11:e0005961. 
104. 
Liyanage P, Rocklöv J, Tissera H, Palihawadana P, Wilder-Smith A, Tozan Y. Evaluation of intensified 
dengue control measures with interrupted time series analysis in the Panadura Medical Officer of 

Study number: S20-00117
Page 35
Version date: 8/7/2020 
 
 
Health division in Sri Lanka: a case study and cost-effectiveness analysis. The Lancet Planetary 
Health. 2019;3:e211-e218. 
105. 
Thalagala N, Tissera H, Palihawadana P, et al. Costs of Dengue Control Activities and Hospitalizations 
in the Public Health Sector during an Epidemic Year in Urban Sri Lank. PloS Negl Trop Dis. 
2016;10:e0004466. 
106. 
Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation 
fidelity. Implementation science : IS. 2007;2:40. 
107. 
Nakigudde J, Bauta B, Wolf S, Huang K-Y. Screening Child Social Emotional and Behavioral 
Functioning in Low-Income Country Contexts. Jacobs Journal of Psychiatry and Behavioral Science. 
2016;2:016. 
108. 
Gouley KK, Brotman LM, Huang K-Y, Shrout P. Construct validation of the social competence scale in 
preschool-age children. Social Development. 2007;17:380-398. 
109. 
Fasfous AF, Peralta-Ramirez MI, Pérez-Marfil MN, Cruz-Quintana F, Catena-Martinez A, Pérez-García 
M. Reliability and validity of the Arabic version of the computerized Battery for Neuropsychological 
Evaluation of Children (BENCI). Child Neuropsychology. 2015;21:210-224. 
110. 
Brotman LM. Classroom Emotional/Behavioral Climate – PIRS. In: NYU; 2008. 
111. 
Webster-Stratton C, Reid MJ, Hammond M. Preventing conduct problems, promoting social 
competence: A parent and teacher training partnership in Head Start. Journal of Clinical Child 
Psychology. 2001;30:283-302. 
112. 
NECS. User's Manual for the ECLS-K Base Year Public-Use Data Files and Electronic Codebook. The 
National Center for Education Statistics & Education Statistics Services Institute. 
http://nces.ed.gov/pubsearch/pubsinfo.asp?pubid=2001029rev. Published 2001. Accessed. 
113. 
Huijg JM, Gebhardt WA, Dusseldorp E, et al. Measuring determinants of implementation behavior: 
psychometric properties of a questionnaire based on the theoretical domains framework. 
Implementation science : IS. 2014;9:33. 
114. 
Bernard ME. Teacher beliefs and stress. J Rat-Emo Cognitive-Behav Ther. 2016;34:209-224. 
115. 
Connor-Smith JK, Compas BE, Wadsworth ME, Thomsen AH, Saltzman H. Responses to stress in 
adolescence: Measurement of coping and involuntary stress responses. Journal Of Consulting and 
Clinical Psychology. 2000;68(6):976-992. 
116. 
Yao S, Xiao J, Zhu X, et al. Coping and Involuntary Responses to Stress in Chinese University 
Students: Psychometric Properties of the Responses to Stress Questionnaire. Journal of Personality 
Assessment. 2010;92(4):356-361. 
117. 
OPRE. Family and Provider/Teacher Relationship Quality (FPTRQ) Parent Measure. 
https://www.acf.hhs.gov/opre/resource/family-and-provider-teacher-relationship-quality-fptrq-parent-
measure. Published 2015. Accessed.
118.
Brotman LM. ParentCorps Program: A public health approach to promoting parenting and child mental 
health among ethnically diverse children. In: NYU Child Study Center; 2005. 
119. 
Huang K-Y, Nakigudde J, Warugaba C, et al. Early Childhood Mental Health Promotion in Uganda: a 
School-Based Approach of Program Planning and Implementation. The Bulletin of the World Health 
Organization. 2014;Under review. 
120. 
Huang K-Y, Nakigudde J, Kizza D, et al. Physical and Mental Health Needs in Primary Schools in 
Uganda: Implications for service planning in low resource countries. Public Health. 2015;Under Review. 
121. 
Tourangeau K, Nord C, Le TN, Pollack JM, Atkins-Burnett S. Early Childhood Longitudinal Study, 
Kindergarten Class of 1998-99 (ECLS-K), Combined User's Manual for the ECLS-K Fifth-Grade Data 
files and Electronic Codebook (NCES 2006-032). U.S. Department of Education. Washington DC: The 
National Center for Education Statistics & Education Statistics Services Institute; 2006. 
122. 
Akena D, Joska J, Obuku EA, Stein DJ. Sensitivity and specificity of clinician administered screening 
instruments in detecting depression among HIV-positive individuals in Uganda. AIDS Care. 2013;25. 
123. 
Kroenke K, Spitzer R, Williams JB. The PHQ-9 validity of a brief depression severity measure. Journal 
of General Internal Medicine. 2001;16:606-613. 
124. 
Aarons GA, Glisson C, Hoagwood K, Kelleher K, Landsverk J, Cafri G. Psychometric properties and 
U.S. National norms of the Evidence-Based Practice Attitude Scale (EBPAS). Psychol Assess. 
2010;22(2):356-365. 
125. 
Hamdani SU, Akhtar P, Zill EH, et al. WHO Parents Skills Training (PST) programme for children with 
developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for 

Study number: S20-00117
Page 36
Version date: 8/7/2020 
 
 
effectiveness implementation hybrid cluster randomized controlled trial. Glob Ment Health (Camb). 
2017;4:e11. 
126. 
Huang KY, Hoagwood K, Cheng S. Partnership Questionnaire:  Implemenation Team Partners Version. 
In:2018. 
127. 
Ballard T, Coates J, Swindale A, Deitchler M. Household Hunger Scale: Indicator definition and 
measurement guide. USAID & Fhi360. FANTA III Food and Nutrition Technical Assistance Web site. 
http://www.fantaproject.org/downloads/pdfs/HHS_Indicator_Guide_Aug2011.pdf. Published 2011. 
Accessed June, 2013.
128. 
McEwan PJ. Cost-effectiveness analysis of education and health interventions in developing countries. 
Journal of Development Effectiveness. 2012;4(2):189-213. 
129. 
Diggle PJ, Heagerty P, Liang K-Y, Zeger SL. Analysis of Longitudinal Data. New York: Oxford 
University Press; 2005. 
130. 
SAS Institute Inc. Base SAS ® 9.3 Procedures Guide. Cary, NC: Copyright © 2011, SAS Institute Inc.; 
2011. 
131. 
Goldstein H. Multilevel statistical models. 3rd ed. London: Armold; 2003. 
132. 
Tozan Y, Albrecht J, Olaf M. Evaluation of the Affordable Medicines Facility – malaria. The Lancet. 
2013;381:1095. 
133. 
Tozan Y, Eili Y, Klein SD, Rajashree P, Ramanan L, Joel GB. Pre-referral rectal artesunate for 
treatment of severe childhood malaria: a cost-effectiveness analysis. The Lancet 2010;379:1910-1915. 
134. 
Tozan Y, Joel N, James OW. Improving rural health and eliminating extreme poverty: A case study on 
the Millennium Villages Project.” In: , (eds). . In: Blas E, Sommerfeld J, Kurup AS, eds. Social 
determinants approaches to public health: from concept to practice. . Geneva: World Health 
Organization 2011. 
135. 
Tozan Y, Pitcha R, Valérie RL, Pattamaporn K, Annelies W-S. Use of insecticide-treated school 
uniforms for prevention of dengue in school children: A cost-effectiveness analysis. PLoS ONE 
2014;9(e108017). 
136. 
Breitenstein SM, Schoeny M, Risser H, Johnson T. A study protocol testing the implementation, 
efficacy, and cost effectiveness of the ezParent program in pediatric primary care. Contemp Clin Trials. 
2016;50:229-237. 
137. 
Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting 
Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation 
Publication Guidelines Good Reporting Practices Task Force. Value in health : the journal of the 
International Society for Pharmacoeconomics and Outcomes Research. 2013;16(2):231-250. 
138. 
Preacher KJ. Multilevel SEM strategies for evaluating mediation in three-level data. Multivariate 
Behavioral Research. 2011;46:691-731. 
139. 
Preacher KJ, Zyphur MJ, Zhang Z. A general multilevel SEM framework for assessing multilevel 
mediation. Psychological Methods. 2010;15(3):209-233. 
140. 
MacKinnon D, Fairchild A, Fritz M. Mediation Analysis. Annual Review of Psychology. 2007;58:593-
614. 
141. 
MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test 
mediation and other intervening variable effects. Psychological Methods. 2002;7(1):83-104. 
142. 
Cole DA, Maxwell SE. Testing mediational models with longitudinal data: Questions and tips in the use 
of structural equation modeling. Journal of Abnormal Psychology. 2003;112:558-577. 
143. 
Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in 
randomized clinical trials. Archives of General Psychiatry. 2002;59:877-884. 
144. 
Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: 
conceptual, strategic and statistical considerations. Journal of Personality and Social Psychology. 
1986;51:1173-1182. 
145. 
Brotman LM, O’Neal CR, Huang K-Y, Gouley KK, Rosenfelt A, Shrout PE. An Experimental Test of 
Parenting Practices as a Mediator of Preschool Physical Aggression. . Journal of Child Psychology and 
Psychiatry. 2009;50(3):235-245. 
146. 
O'Neal C, Brotman L, Huang KY, et al. Understanding Relations Among Early Family Environment, 
Cortisol Response, and Child Aggression via a Prevention Experiment. Child Development. 
2010;81:290-305. 
147. 
Muthén LK, Muthén BO. Mplus user’s guide (6th edition). Los Angeles, CA: Muthen & Muthen 2010. 

Study number: S20-00117
Page 37
Version date: 8/7/2020 
 
 
148.
Theise R, Huang KY, Kamboukos D, et al. Parental depression, stress and support as moderators in a 
randomized controlled trial: impact for high-risk parents. journal of Clinical Child & Adolescent 
Psychology. 2013. 
149. 
Glaser BG, Strauss AL. The discovery of grounded theory: Strategies for qualitative research. . 
Chicago: Aldine Publishing Co.; 1967. 
150. 
Padgett DL. Qualitative Methods in Social Work Research. London, UK: Sage; 1998. 
151. 
Padgett DK. Qualitative and mixed methods in public health Sage; 2012.