Evaluation of Organizational Skills Training (OST) Program for Upper Elementary Students
Phase: NA
Conditions: Executive Function, Behavioral Research, Schools, Behavior Therapy
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
 
 
 
 
 
 
Evaluation of Organizational Skills Training (OST)  
Program for Upper Elementary Students 
NCT03443323 
June 5, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
ii
Title: Evaluation of Organizational Skills Training (OST) Program for Upper Elementary 
Students 
 
Short Title:  
OST-S RCT 
Sponsor:                            US Department of Education  
 
eIRB Number:  
17-014227 
Protocol Date: 
06/05/2022 
Amendment 1 Date: 11/16/2017 
Amendment 2 Date: 12/07/2017 
Amendment 3 Date: 02/20/2018 
Amendment 4 Date: 05/14/2018 
Amendment 5 Date: 09/06/2018 
Amendment 6 Date: 12/14/2018 
Amendment 7 Date: 02/26/2019                         Amendment 8 Date: 05/02/2019 
Amendment 9 Date: 07/12/2019                        Amendment 10 Date: 12/10/2019 
Amendment 11 Date: 05/19/2020 
Amendment 12 Date: 07/29/2020 
Amendment 13 Date: 08/09/2021 
Amendment 15 Date: 10/26/2021 
Amendment 17 Date: 06/05/2022 
Amendment 14 Date: 10/07/2021 
Amendment 16 Date: 03/10/2022 
 
 
 
Principal Investigator:  Thomas Power, PhD, ABPP  
Children’s Hospital of Philadelphia 
Roberts Center for Pediatric Research 
8th Floor, Room 8283 
Philadelphia, PA 19146 
Phone 215-590-7447 
email: power@chop.edu 
Co-Principal Investigator:  Jenelle Nissley-Tsiopinis, PhD  
Children’s Hospital of Philadelphia 
Roberts Center for Pediatric Research 
8th Floor, Room 8251 
Philadelphia, PA 19146 
Phone 215-590-0144 
email: nissleyj@chop.edu 
Co-Principal Investigator:  Jennifer Mautone, PhD, ABPP  
Children’s Hospital of Philadelphia 
Roberts Center for Pediatric Research 
8th Floor, Room 8282 
Philadelphia, PA 19146 
Phone 267-426-6016 
email: mautone@chop.edu 

 
 
 
 
 
 
 
 
 
 
iii
TABLE OF CONTENTS 
Table of Contents .............................................................................................................................................. iii 
Abbreviations and Definitions of Terms ........................................................................................................... v 
Table 1. Timeline of Study Evaluation and Measurement Completion ...................................................... vii 
Abstract ............................................................................................................................................................ viii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ..................................... 1 
1.2.1 
Intervention Being Evaluated: Organizational Skills Training - School Version (OST-S)
 
1 
1.3 
FINDINGS FROM NON-CLINICAL AND CLINICAL STUDIES ..................................................................... 1 
1.4 
RELEVANT LITERATURE AND DATA ..................................................................................................... 2 
1.5 
COMPLIANCE STATEMENT .................................................................................................................... 5 
2 
STUDY OBJECTIVES .............................................................................................................................. 6 
2.1 
PRIMARY OBJECTIVES (OR AIMS) ......................................................................................................... 6 
2.2 
SECONDARY OBJECTIVES (OR AIMS) .................................................................................................... 6 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 6 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 6 
3.1.1 
Screening Phase ...................................................................................................................... 7 
3.1.2 
Training Phase: Training School Partners to Lead OST-S Groups .................................. 8 
3.1.3 
Implementation of Organizational Skills Training – School Version (OST-S) ................. 8 
3.1.4 
Follow-up Phase ....................................................................................................................... 8 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 9 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 9 
3.3.1 
Duration of Study Participation ............................................................................................... 9 
3.3.2 
Number of Study Sites / Total Number of Subjects Projected ........................................... 9 
3.4 
STUDY POPULATION ........................................................................................................................... 10 
3.4.1 
Inclusion Criteria for School Partners .................................................................................. 10 
3.4.2 
Exclusion Criteria for School Partners ................................................................................ 10 
3.4.3 
Inclusion Criteria for Teachers ............................................................................................. 10 
3.4.4 
Exclusion Criteria for Teachers ............................................................................................ 11 
3.4.5 
Inclusion Criteria for Students .............................................................................................. 11 
3.4.6 
Exclusion Criteria for Students ............................................................................................. 11 
3.4.7 
Inclusion Criteria for Parents/Legal Guardians .................................................................. 11 
3.4.8 
Exclusion Criteria for Parents/Legal Guardians ................................................................. 12 
3.4.9 
Inclusion Criteria for Adult Caregiver .................................................................................. 12 
3.4.10 
Exclusion Criteria for Adult Caregiver ................................................................................. 12 
3.4.11 
Inclusion Criteria for Trainer ................................................................................................. 12 
3.4.12 
Exclusion Criteria for Trainer ................................................................................................ 12 
4 
STUDY PROCEDURES .......................................................................................................................... 12 
4.1 
STUDENT SCREENING / REFERRAL PROCESS....................................................................................... 12 
4.2 
TRAINING PHASE: TRAINING SCHOOL PARTNERS TO LEAD OST-S GROUPS ...................................... 13 
4.3 
INTERVENTION IMPLEMENTATION ...................................................................................................... 14 
4.4 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................................... 15 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 16 
5.1 
SCREENING MEASURES (STUDENTS) .................................................................................................. 16 
5.2 
MEASURES OF PROXIMAL OUTCOMES AND MEDIATORS – OTMP SKILLS AND STUDENT ACADEMIC 
SELF-EFFICACY ............................................................................................................................................... 17 
5.3 
MEASURES OF DISTAL OUTCOMES – ACADEMIC OUTCOMES ............................................................. 17 

 
 
 
 
 
 
 
 
 
 
iv
5.4 IMPLEMENTATION OUTCOME MEASURES .................................................................................................. 18 
5.4 
MEASURES OF SCHOOL AND PARTICIPANT CHARACTERISTICS ........................................................... 19 
5.6 MEASURES OF ADAPTATIONS, FEASIBILITY, USABILITY, AND ACCEPTABILITY OF OST-S ........................ 20 
5.7 COST ANALYSIS MEASURES ...................................................................................................................... 21 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 21 
6.1 
MAIN STUDY ANALYSIS ..................................................................................................................... 21 
6.1.1 
Study Aims .............................................................................................................................. 21 
6.1.2 
Primary Endpoint .................................................................................................................... 22 
6.1.3 
Secondary Endpoints ............................................................................................................ 23 
6.1.4 
Sample Size and Power ........................................................................................................ 23 
6.1.5 
Secondary Objectives ............................................................................................................ 23 
6.2 
PRELIMINARY ANALYSIS TO RESPOND TO PROJECT OFFICER ............................................................. 24 
6.2.1 
Goals of Preliminary Analyses ............................................................................................. 24 
6.2.2 
Statistical Plan for Preliminary Analyses ............................................................................ 25 
7 
SAFETY MANAGEMENT ..................................................................................................................... 27 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 27 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 27 
8 
STUDY ADMINISTRATION ................................................................................................................. 27 
8.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 27 
8.1.1 
Randomization ........................................................................................................................ 27 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 28 
8.3 
CONFIDENTIALITY .............................................................................................................................. 29 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 30 
8.4.1 
Data and Safety Monitoring Plan ......................................................................................... 30 
8.4.2 
Risk Assessment .................................................................................................................... 30 
8.4.3 
Potential Benefits of Trial Participation ............................................................................... 31 
8.5 
RISK-BENEFIT ASSESSMENT ............................................................................................................... 31 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 31 
8.6.1 
Waiver of Consent for Student Screening .......................................................................... 31 
8.6.2 
Consent for Student/Parent/Legal Guardian (and Caregiver if applicable) Dyads ....... 32 
8.6.3 
Verbal Consent for School Partners and Teachers in the Intervention Condition ........ 33 
8.6.4 
Verbal Consent for School Partners and Teachers in the TAU Control Condition ....... 33 
8.6.5 
Verbal Consent for Trainers ................................................................................................. 34 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ..................................................................................................... 34 
9 
PUBLICATION ........................................................................................................................................ 35 
10 
REFERENCES ......................................................................................................................................... 36 
  
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v
ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
(ACES)  
 
 
Academic Competence Evaluation Scales 
(ADHD)  
 
 
Attention Deficit Hyperactivity Disorder 
(ADI)  
 
 
Area Deprivation Index 
(AEs)   
 
 
Adverse Event(s) 
(APR)   
 
 
Academic Progress Report 
(ASRS) 
 
 
Autism Spectrum Rating Scales – Short Form 
(BASC-3) 
 
 
Behavior Assessment System for Children – third edition 
(BDMC)  
 
 
Biostatistics and Data Management Core 
(CFR)  
 
 
Code of Federal Regulations 
(CHOP) 
 
 
Children’s Hospital of Philadelphia  
(CHP)   
 
 
Challenging Horizons Program 
(CIRP)  
 
 
Children’s Intervention Rating Profile 
(CLAS)  
 
 
Child Life and Attention Skills 
(CLS)   
 
 
Child Life Skills 
(COSS)  
 
 
Children’s Organizational Skills Scale 
(COSS-P)  
 
 
Children’s Organizational Skills Scale- Parent version 
(COSS-T)  
 
 
Children’s Organizational Skills Scale- Teacher version 
(DAR)  
 
 
Daily Assignment Record 
(EF)     
 
 
Executive Function 
(GCP)  
 
 
Good Clinical Practice 
(HOPS)  
 
 
Homework, Organization, and Planning Skills 
(HPC)   
 
 
Homework Problem Checklist 
(HPQ-T)  
 
 
Homework Performance Questionnaire- Teacher Version 
(ICC)   
 
 
Intra-cluster Correlations 
(ICE)  
 
 
Incremental cost effectiveness 
(ICH)   
 
 
International Conference on Harmonisation 

 
 
 
 
 
 
 
 
 
 
vi
(IRB)  
 
 
Institutional Review Board 
(LD)   
 
 
Learning Disability 
(NYU)  
 
 
New York University 
(OST)   
 
 
Organizational Skills Training Program 
(OST-C)  
 
 
Organizational Skills Training Program – clinic-based version 
(OST-S)  
 
 
Organizational Skills Training Program – School version  
(OTMP)  
 
 
Organization, time management, and planning skills 
(PALS)  
 
 
Patterns of Adaptive Learning Scales 
(PATHKO) 
 
 
Parent and Teachers Helping Kids Organize 
(PHI)  
 
 
Protected Health Information 
(REDCap)  
 
 
Research Electronic Data Capture 
(RtI)   
 
 
Response-to-intervention 
(SAEs)  
 
 
Serious Adverse Events 
(School Partner) 
School counselor or identified school staff member agreeing 
to support study recruitment and implement the OST-S 
intervention. 
(SD) 
 
 
 
Standard Deviation  
(TAU)   
 
 
Treatment as usual (Control Condition)  
(TEI-SF)  
 
 
Treatment Evaluation Inventory- Short Form 
(URP-IR) 
 
 
Usage Rating Profile Intervention - Revised 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
vii
 TABLE 1. TIMELINE OF STUDY EVALUATION AND MEASUREMENT COMPLETION 
 
*A follow-up questionnaire will be administered to parents 
**Adapted and used with permission, will be collected when feasible within a particular school and based on research team 
staff availability 
Measures: BOTH OST-S and TAU 
Conditions 
Respondent: 
Screening/ 
Eligibility 
Pre-treatment/ 
Baseline 
 
Post-
treatment 
5M 
Follow-up 
12M 
Follow-up 
Measures of Proximal Student Outcomes 
Children’s Organizational Skills Scale 
(COSS)–Teacher (COSS-T)  
Teacher 
 
X 
 
X 
X 
X 
Children’s Organizational Skills Scale 
(COSS)–Parent (COSS-P) 
Parent 
 
X 
 
X 
X 
X 
Patterns of Adaptive Learning Scales (PALS) 
– Academic Efficiency Subscale 
Student 
 
X 
 
X 
X 
X 
Measures of Distal Student Outcomes 
Academic Progress Report (APR)  
Teacher 
 
X 
 
X 
X 
X 
Academic Competence Evaluation Scales 
(ACES) - Reading/ Language Arts & 
Mathematics Subscales ONLY 
Teacher 
 
X 
 
X 
X 
X 
Academic Grades 
Study team 
 
X 
 
X 
X 
X 
Student Homework Completion Survey 
Teacher   
 
X 
 
X 
X 
X 
Homework Performance Questionnaire – 
Teacher (HPQ-T) 
Teacher 
 
X 
 
X 
X 
X 
Homework Problem Checklist (HPC) 
Parent 
 
X 
 
X 
X 
X 
Measures of School and Participant Characteristics 
School Characteristics 
(e.g. subsidized lunch rate & participating 
grade level composition) 
Study team 
X 
 
 
 
 
 
Behavior Assessment System for Children, 
3rd ed. (BASC-3) 
Parent 
Teacher  
 
X 
 
 
 
 
 Autism Spectrum Rating Scales (ASRS) – 
Short Form 
Parent 
 
 
 
X 
 
 
Student Demographics & Medical History (ex: 
student grade level, special education status, 
ADHD symptoms, ADI) 
Parent 
 
 
X 
 
X* 
 
 
X* 
 
 
X* 
 
 
Demographics 
Teacher 
School partner 
Trainer 
 
X 
 
 
 
 
Survey of Current Organizational Supports for 
Students 
Teacher 
 
 
 
X 
 
 
Measures of Implementation Outcomes 
Measures of Intervention Fidelity (School 
Partner) 
Study team 
 
Throughout Duration of Study 
Measures of Stakeholder Engagement 
(School Partner, Student, Parent, Teacher) 
Study team 
 
Throughout Duration of Study 
Organization and Planner Checklists 
(observation)** 
Study team 
 
Throughout Duration of Study 
Measures of Adaptations, Feasibility, Usability, and Acceptability – OST-S condition ONLY 
Treatment Evaluation Inventory – Short Form 
(TEI-SF) 
Parent 
 
 
 
X 
 
 
The Children’s Intervention Rating Profile 
(CIRP)  
Student 
 
 
 
X 
 
 
The Usage Rating Profile–Intervention–
Revised (URP-IR)  
Teacher 
School partner 
 
 
 
X 
 
 
Survey of OST Adaptations and 
Supplementary Supports for Individual 
Students 
School Partner 
 
 
 
X 
X 
X 
Survey of OST Adaptations and 
Supplementary Supports for Groups 
School Partner 
 
 
 
X 
 
 
Measures of Cost 
Labor – school staff and study team members 
Study team 
School staff 
 
Throughout Duration of Study 
Non-labor – supplies/materials 
Study team 
 
Throughout Duration of Study 

 
 
 
 
 
 
 
 
 
 
viii
ABSTRACT 
Context:  Although multiple factors influence school functioning, executive function (EF) 
deficits have been found to be a key predictor of academic achievement (Best et al., 2011). 
EF is a higher order cognitive ability associated with persistent goal-directed behavior (Best 
et al., 2009). Organization, time management, and planning (OTMP) skills are aspects of 
EF that are particularly associated with children’s academic performance (Langberg et al., 
2013). Organizational demands increase over the course of early schooling and are 
relatively high by 3rd through 5th grade. Poor OTMP skills during this period adversely 
impact academic functioning. In the late elementary school grades, as students are 
expected to become more organized, some students have difficulty learning these skills in 
spite of classroom supports provided by teachers, placing them at increased risk for 
academic failure (Abikoff & Gallagher, 2009). 
 
Objectives: The purpose of this Goal 3 efficacy study is to conduct an evaluation of the 
Organizational Skills Training Program – School version (OST-S), a fully developed 
intervention for students in general education. The proposed study builds upon our 
research demonstrating the efficacy of a clinic-based version of the OST intervention (OST-
C) in remediating OTMP skills deficits and improving academic functioning for 3rd, 4th and 
5th graders with ADHD (Abikoff et al., 2013), and our recent pilot research demonstrating 
the feasibility and potential effectiveness of OST-S provided by end users (“school 
partners”) for 3rd through 5th graders. It also builds upon research training school staff to 
implement evidence-based interventions with high fidelity (Eiraldi et al., 2014).  
 
Study Design: This is a cluster-randomized controlled trial with a treatment as usual (TAU) 
control group.  
 
Setting/Participants: Schools are located in Pennsylvania and New Jersey and include at 
least 20 urban and suburban schools serving a diverse population. Students (3rd to 5th 
grade) who are struggling the most with OTMP deficits and whose academic performance 
is negatively impacted by their OTMP deficits will be referred to the study team by their 
general education teachers.  
 
Study Interventions and Measures: OST-S is a small group skills training intervention, 
with parents and teachers supporting children’s use of new skills. The program manual 
includes strategies for training and coaching school staff, referred to as school partners, to 
effectively implement OST-S and guidelines to modify the program for implementation in 
diverse schools with diverse students.  Each student session includes: (a) homework 
review to assess completion of between-session skills implementation; (b) skill-building 
activities, which include the use of modeling, shaping, guided practice, and reinforcement 
for organized behavior; and (c) activities to promote generalization of skills. Sessions 
address four organizational challenges: (a) tracking assignments, (b) managing materials, 
(c) managing time, and (d) planning for long-term assignments. 
 
The study team will measure the following: intervention fidelity, stakeholder engagement, 
student OTMP skills, student academic self-efficacy, student academic outcomes, student 
characteristics, feasibility, usability, and acceptability of OST-S. In addition, the study team 
will track the interventions that are offered as treatment-as-usual in TAU schools. We will 
also complete a cost-analysis related to implementation of OST-S. 

 
 
 
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 
Introduction 
Although multiple factors influence school functioning, executive function (EF) deficits have 
been found to be a key predictor of academic achievement (Best et al., 2011). EF is a 
higher order cognitive ability associated with persistent goal-directed behavior (Best et al., 
2009). Organization, time management, and planning (OTMP) skills are aspects of EF that 
are particularly associated with children’s academic performance (Langberg et al., 2013). 
Organizational demands increase over the course of early schooling and are relatively high 
by 3rd through 5th grade. Poor OTMP skills during this period adversely impact academic 
functioning. In the late elementary school grades, as students are expected to become 
more organized, some students have difficulty learning these skills in spite of classroom 
supports provided by teachers, placing them at increased risk for academic failure (Abikoff 
& Gallagher, 2009).  
 
Given the association between EF/OTMP skills and academic achievement, it is important 
that schools have effective interventions to address these deficits (Langberg et al., 2013; 
Janke et al, 2014; Knouse et al., 2014). Cognitive training interventions targeting EF have 
resulted in changes in children’s performance on laboratory tasks of EF, but improvements 
have not generalized to academic performance (Rapport et al., 2013). In contrast, 
interventions targeting OTMP skills at home and school, which require EF abilities, have 
been found to be effective and to improve academic performance (Evans et al., 2014). 
Members of our investigative team (Abikoff and Gallagher), have developed an effective 
clinic-based organizational skills training intervention (OST-C) for 3rd through 5th grade 
students with ADHD who exhibit difficulties with OTMP skills, which improved children’s 
academic performance with large effect sizes by both parent and teacher report (Abikoff et 
al., 2013).  
 
1.2 
Name and Description of Investigational Product or Intervention 
1.2.1 Intervention Being Evaluated: Organizational Skills Training - School Version 
(OST-S) 
Organizational Skills Training - School Version (OST-S) is a group skills training 
intervention, with parents and teachers supporting students’ use of new skills. The program 
manual includes strategies for training and coaching school staff, referred to as school 
partners, to effectively implement OST-S and guidelines to modify the program for 
implementation in diverse schools with diverse students. The manual is based on the clinic-
based OST intervention (OST-C) and was adapted in a pilot study conducted in New York 
City public schools. In the proposed project, a high level of implementation support (i.e., 
consultation and coaching) will be provided to promote intervention fidelity. 
1.3 
Findings from Non-Clinical and Clinical Studies  
Organizational Skills Treatment, Clinic Version (OST-C). OST-C is a skills training 
intervention for 3rd to 5th grade students with ADHD and OTMP deficits. The program 
includes 20-21 individual child treatment sessions administered twice a week for 10 weeks. 
The majority of each session is spent in direct OTMP skills training with the child, with an 
opportunity for the child to explain their new skill to parents so parents are prepared to 
reinforce skills practice. Also, there are five therapist-teacher contacts; the first one occurs 
in person, and the remainder are by phone (Abikoff et al., 2013). Strong support for OST-

 
 
 
 
 
 
2
C’s efficacy was reported in a large-scale (n=158), NIMH-funded RCT, which compared 
OST-C to a waitlist (WL) control group and a parent-training contingency management 
treatment that reinforced end-point performance (PATHKO; Abikoff et al., 2013). Compared 
to waitlist controls, the OST-C group showed significantly greater improvement in: (a) 
OTMP skills (ratings by teachers: Cohen’s d =1.18, p<.0001; parents: d = 2.77, p <.0001; 
self: d =.69, p <.004); (b) academic functioning (d =.76, p <.0001); (c) academic proficiency 
(d =.42, p <.01); (d) homework performance (d=1.37; p <.001); and (e) percent of children 
no longer meeting OTMP criteria for study entry at post-treatment (60.1% in OST-C vs 3% 
in WL, p<.0001). The parent-training PATHKO treatment also resulted in significant 
improvements relative to waitlist controls. The treatment gains were sustained the following 
school year when evaluated by teachers who were blind to treatment condition. Importantly, 
improvements in children’s OTMP skills mediated the effect of the intervention on children’s 
academic functioning (Abikoff et al., 2014). 
Organizational Skills Treatment, School Version (OST-S). OST-S is an adapted version 
of OST-C, administered by school partners to students with OTMP deficits. Drs. Abikoff and 
Gallagher have developed this intervention in collaboration with the New York City 
Department of Education and have conducted an initial pilot study across three schools with 
a total sample size of 31. OST-S student group sessions were offered twice weekly for 9-10 
weeks, with each session lasting 40 minutes. In addition, teacher consultation and parent 
collaboration were provided at the beginning of the program, with follow-up consultation 
occurring through written updates and periodic in-person contacts. Student groups were 
conducted by a guidance counselor as well as general and special education teachers. 
Findings based on within-group t-tests (Abikoff & Gallagher, 2016) indicated that OST-S 
resulted in significant reductions in students’ OTMP deficits as measured by parent report 
(p<.001, d=.80) and teacher report (p<.001, d=.59), as well as significant reductions in 
parent-rated homework problems (p<.001, d=.88) and significant improvement in teacher-
rated performance in academic subjects (p<.001, d=.62). Teacher ratings of program 
satisfaction were high (Mean = 5.83 on a scale of 1 to 7; 7 = very satisfied). Teachers 
indicated they would recommend the program to other teachers (Mean = 6.27). Parents 
also indicated they would recommend the program to a friend (Mean = 6.11). During the 
pilot, the OST-S manual and supporting materials were refined for use in this study. 
1.4 
Relevant Literature and Data 
Executive Functioning (EF) is a multi-component cognitive process that encompasses the 
planning and execution of goal directed behavior over time (Best et al., 2009; Friedman et 
al., 2006). Longitudinal studies have confirmed that EF is a key predictor of academic 
functioning and adjustment (Best et al., 2011) in students with and without specific learning 
disabilities (Best et al., 2009) and in students with and without ADHD (Rinsky & Hinshaw, 
2011). For example, EF in kindergarten predicts children’s reading and math scores at the 
end of first grade (Monette et al., 2011) and EF deficits in middle childhood predict 
academic functioning in late adolescence (Rinsky & Hinshaw, 2011). The relationship 
between EF and academic performance is strongest when measuring children’s EF in the 
real world via parent and teacher rating scales, rather than by children’s performance on 
laboratory-based tasks (Waber et al., 2006). 
OTMP skills are specific aspects of EF found to be associated with school performance. For 
example, among middle school students with ADHD, Langberg and colleagues (2013) 
found that planning skills and organization of materials were significantly linked to academic 
performance. These OTMP skills were significantly related to children’s homework 
performance over and above the effect of ADHD symptoms. Consistent with this, 

 
 
 
 
 
 
3
organizational problems such as failing to record homework assignments and not 
completing assignments on time were associated with teacher-reported learning problems 
in elementary and middle school (Power et al., 2006). Further, teachers reported lower 
achievement in children who misplaced assignments or took too long getting materials 
ready for class assignments (Langberg et al., 2011). Importantly, treatment-related changes 
in OTMP skills have been found to mediate changes in academic functioning (Abikoff et al., 
2014; Pfiffner et al., 2013). 
Increased recognition of the impact of EF on children’s success in school has led to the 
development of methods to improve EF skills. The goal of broad-based EF interventions is 
to address the cognitive processes presumed to underlie EF impairments using cognitive 
training strategies (e.g., working memory training and computerized, lab-based tasks). If 
effective, EF training programs should result in “top-down” behavioral effects, leading to 
generalization and wide-ranging cognitive and behavioral improvements. Unfortunately, 
there is little support for this hypothesis from randomized controlled trials (Rutledge et al., 
2012). These interventions have demonstrated benefits in performance on lab-based EF 
tasks but limited effects on academic performance (Rapport et al., 2013). Systematic 
research reviews suggest that the targets of intervention for children with EF deficits should 
instead be behavioral manifestations of EF deficits that are more directly related to school 
performance (Chacko et al., 2014; Rapport et al., 2013). Consistent with these 
recommendations, OST-C, a clinic-based intervention for students with ADHD, targets 
OTMP skills and has been demonstrated to significantly improve academic performance 
with large effect sizes by both parent and teacher report. Further, these improvements were 
maintained into the next school year when teachers were blind to children’s treatment 
condition (Abikoff et al., 2013). The success of the OST intervention suggests that 
interventions including OTMP skills training, combined with methods to encourage 
generalization at school and home, hold promise as a potential treatment for the academic 
problems associated with EF deficits.  
Several school-based programs have been developed to support students with OTMP skills 
deficits (see reviews by Storer et al., 2014 and Evans et al., 2014). Langberg and 
colleagues (2012) developed the Homework, Organization, and Planning Skills (HOPS) 
delivered by school mental health providers for middle school students with ADHD. An 
initial study indicated that HOPS participants demonstrated improvements in organizational 
skills and homework performance relative to a waitlist control group, but only by parent-
report. This study demonstrated that it is feasible for middle school staff to deliver 
organizational skills interventions to students.  
Evans and colleagues (2009) included an organizational intervention for middle school and 
high school students with ADHD as part of the Challenging Horizons Program (CHP). The 
organizational skills portion of the intervention addresses difficulties with tracking 
assignments and organizing materials and is conducted during a twice-weekly, year-long, 
after-school tutoring program. Studies evaluating the effectiveness of CHP have shown 
improvements in organizational skills, as well as a significant relationship between these 
changes and improvements in students’ grades (Evans et al., 2011).  
Pfiffner and colleagues (2007) developed the Child Life and Attention Skills program 
(CLAS), a 12-week, clinic-based group intervention for children with the inattentive subtype 
of ADHD. Parents are taught strategies for setting up routines and structures to help 
promote children’s organization and time management skills, and children are taught social 
skills, as well as organization, time management, and planning skills. Results indicated that 
children’s organizational skills improved as a result of the intervention. The CLAS program 
was modified into the Child Life Skills (CLS) program (Pfiffner et al., 2011), a school-based, 

 
 
 
 
 
 
4
multimodal intervention for elementary school students in which school staff led the parent 
and child groups. In a pilot study, Pfiffner and colleagues (2013) found that the CLS 
program could be feasibly administered by school staff and demonstrated evidence of 
improving child outcomes, including OTMP skills. Furthermore, improvements in OTMP 
skills mediated the effects of the intervention on teacher-rated academic skills and parent-
rated homework performance. 
A limitation of existing research for students in grades 3 to 5 is that most programs have 
been developed and evaluated for students in middle and high school (Evans et al., 2011; 
Langberg et al., 2012). An exception is the multimodal intervention (CLS Program) 
developed by Pfiffner and colleagues (2011; 2013; 2014) for students in grades 2 to 5. The 
CLS Program is highly promising; it includes intensive parent training, classroom-based 
behavioral intervention, and 10 sessions of child social and daily living skills training, 
including organization skills training. Because of the multi-component nature of CLS, it is 
not possible to distinguish the effect of each component on children’s OTMP skills and 
academic performance. In addition, the combination of social, daily living, and 
organizational skills training in 10 child sessions raises questions about whether the 
organizational skills component is sufficiently intense to reduce OTMP deficits. Finally, the 
CLS program includes a 10-session parent training program. Engaging parents in such an 
intensive program may not be feasible in many schools. Although parental involvement is 
critical for school success, it is important to identify feasible methods of involving families 
that can be applied across schools serving a diverse population of families.  
Although the clinic-based OST intervention was designed for children with ADHD, it might 
not be feasible or acceptable to parents and school staff to evaluate and diagnose children 
with ADHD prior to enrolling them in OST-S. In fact, in accord with New York City 
Department of Education research regulations, which prohibit diagnosing students to 
determine study inclusion, students were not evaluated for ADHD during our recent school-
based pilot of OST-S. As such, we have designed this study to address this feasibility 
concern. In addition, although deficits in OTMP skills are highly common among students 
with ADHD, they also occur among students with other disorders and without an identified 
disorder (Rinsky & Hinshaw, 2011). There is evidence that impaired organizational 
functioning occurs in approximately 50% of children with ADHD, 30% of children with LD, 
and 10-15% of students with no identified problems (Abikoff & Gallagher, 2009). Notably, 
organizational deficits have an effect on school adjustment and achievement in virtually all 
students (Best et al., 2011; Neuenschwander et al., 2012). As demands for independence 
increase, these deficits place children at increased risk for needing special education. In 
this project we will include all students in general education classrooms demonstrating 
OTMP deficits that may be impacting their academic functioning, regardless of diagnostic 
status. Our recently completed pilot study (See 1.3) demonstrated highly promising 
outcomes targeting students not assessed for ADHD.  
School-based services provide an efficient and cost-effective means of addressing 
children’s educational and mental health needs (e.g., Barrett & Pahl, 2006; Langberg et al., 
2012). However, it often is difficult for school staff to provide evidence-based, manualized 
interventions in a high quality, consistent manner (Eiraldi et al., 2014). Successful 
implementation of school-based programs requires careful consideration of the training and 
supervision needs of school staff to ensure acceptable fidelity and participant engagement. 
For effective implementation, school staff, student, and systems variables should be 
addressed in the training process (Beidas & Kendall, 2010). Practice-based coaching 
models (e.g., Becker et al., 2013) are effective methods by which to support school staff in 
implementing evidence-based practices through ongoing professional development. When 

 
 
 
 
 
 
5
used with school professionals, practice-based coaching, including direct observation and 
fidelity monitoring plus performance feedback, results in improved fidelity and quality of 
implementation of evidence-based interventions (e.g., Sutherland et al., 2015).  
The proposed project includes a structured practice-based coaching model to support 
school staff, who are referred to as ‘school partners,’ in their implementation of the OST-S 
intervention. School partners will receive regular performance feedback and modeling of 
intervention strategies from coaches with the intent of maximizing fidelity and quality of 
OST-S implementation. The OST-S manual includes opportunities to modify procedures 
and supports so the coaching model is appropriately flexible in addressing the needs of 
diverse schools. 
Intervention fidelity is a multi-faceted construct that includes content and process variables 
(Dane & Schneider, 1998; Power et al., 2005; Sanetti & Kratochwill, 2009). In monitoring 
fidelity, it is critical to consider the extent to which the steps in the manual are completed 
and whether those steps are delivered competently. As schools transition to response-to-
intervention (RtI) models, intervention fidelity has become increasingly critical (Burns et al., 
2008; Sanetti & Kratochwill, 2009). Without high fidelity, it is not possible to draw 
conclusions about the relationship between the intervention and student outcomes. Also, 
within RtI, implementation with high fidelity is required before decisions about students’ 
eligibility for more intensive services (e.g., special education) can be made (National 
Association of State Directors of Special Education, 2008). Therefore, assessment of 
fidelity is a key component of implementation of interventions in school. In the proposed 
project, we will assess content and process fidelity and investigate how they are related to 
participant outcomes.  
Treatments for student academic and behavioral deficits require engagement and high-
quality implementation of strategies by participants. Engagement includes attendance, 
active participation in sessions, and adherence to recommended intervention practices 
(Power et al., 2005). Low engagement is common among parents and teachers and is 
related to worse outcomes (Dishion et al., 1992; Hinshaw et al., 2000). Engagement of 
children in skills training interventions and implementation of between-session practice is 
associated with improved child outcomes (Park et al., 2014). The OST-S intervention 
includes strategies to engage participants in the intervention. In addition, we will carefully 
monitor engagement and examine how it is related to outcomes. 
 
1.5 
Compliance Statement 
This study will be conducted in full accordance with all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws 
and regulations including 45 CFR 46, 21 CFR Parts 50, 54, 56, 312, 314 and 812 and the 
Good Clinical Practice (GCP): Consolidated Guideline approved by the International 
Conference on Harmonisation (ICH). All episodes of noncompliance will be documented. 
 
The investigators will perform the study in accordance with this protocol, will obtain consent 
and assent (when appropriate), and will report unanticipated problems involving risks to 
subjects or others in accordance with Children’s Hospital of Philadelphia Institutional 
Review Board (IRB) Policies and Procedures and all federal requirements. Collection, 
recording, and reporting of data will be accurate and will ensure the privacy, health, and 
welfare of research subjects during and after the study.  

 
 
 
 
 
 
6
2 
STUDY OBJECTIVES 
The purpose of this Goal 3 efficacy study is to conduct a cluster, randomized, controlled 
trial of OST-S, a fully developed, preventive intervention for students in general education.  
 
2.1 
Primary Objectives (or Aims) 
The primary objectives of this study are:  
 
• 
Determine the efficacy of OST-S with regard to improving proximal student 
outcomes (OTMP skills, academic self-efficacy) relative to a treatment as usual 
control group (TAU) at post-treatment, as well as 5-month and 12-month follow-up. 
 
• 
Determine the efficacy of OST-S with regard to improving distal student outcomes 
(academic productivity and grades) relative to TAU at post-treatment, as well as 5-
month and 12-month follow up. 
 
2.2 
Secondary Objectives (or Aims) 
The secondary objectives of this study are: 
• 
Explore whether reductions in student OTMP skills deficits and improvements in 
student academic self-efficacy mediate the effect of OST-S on students’ academic 
outcomes. 
 
• 
Investigate whether school partner implementation fidelity and participant 
engagement (student, parent, teacher) are associated with the effect of OST-S on 
student OTMP skills deficits. 
 
• 
Investigate whether student grade level, special education status, and symptoms of 
ADHD, externalizing, internalizing problems, and symptoms of autism spectrum 
disorder moderate the effect of OST-S on student OTMP skills.  
 
• 
Determine the costs associated with providing the OST-S intervention per group per 
school relative to student proximal (OTMP skills, self-efficacy) and distal (academic 
productivity and grades) outcomes.  
 
• 
Investigate child in-session engagement in the OST-S intervention and the clinical 
factors associated with child engagement 
3 
INVESTIGATIONAL PLAN 
3.1 
General Schema of Study Design 
This is a cluster-randomized controlled trial with a treatment as usual (TAU) control group.  
 
The study has two arms: OST-S and TAU. The study is designed to compare OST-S to 
what students typically receive in school to address their organizational skills deficits. 
School officials expressed concerns about participating in the study if identified students 
were not able to obtain OST-S and our study team also has ethical concerns about 
withholding intervention from students in schools assigned to the control group. Therefore, 

 
 
 
 
 
 
7
students in control schools will receive OST-S as a “thank you treatment” after 12-month 
follow-up data are collected. 
 
3.1.1 Screening Phase 
School Selection: We have secured commitments from 20 schools. Schools will be 
matched on subsidized lunch rate and participating grade level composition (e.g., schools 
with participating grades of 3 and 4 versus schools with participating grades of 3,4, and 5) 
and randomly assigned to OST-S or TAU at a 1:1 ratio using a random number generator. 
Due to the nature of school-based research and the potential for school drop out after 
making a commitment to participate, it may be necessary to modify the ratio of school 
randomization assignment to OST-S or TAU if a school drops out of the study and an 
additional school is needed to meet participant recruitment goals. In a case such as this, 
this decision would be made by the principal investigators in consultation with the 
investigative team and documented as necessary. 
Student Screening:  For both OST-S and TAU schools, participating teachers in 3rd to 5th 
grade general education classrooms will receive a flyer or email correspondence including 
a brief description of the study and be asked to identify/nominate students from their class: 
(a) who are struggling the most with OTMP skills, (b) whose OTMP skill deficits are the 
students‘ primary concern (c) whose academic performance is negatively impacted by their 
OTMP deficits, (d) who are in general education classrooms (e) who do not have one to 
one student aids and (f) who have at least one parent who speaks English.  
 
For each identified student, our school partner(s)/study team will ask teachers to fill out a 
short form (or electronic REDCap survey) indicating the extent to which the student’s 
difficulty with organizational skills negatively impacts academic performance. The teachers 
will then notify the school partner (and/or study team) of the students they have identified 
for the study. The school partner (or study team) will assign a screening ID number to each 
identified student (note: if referrals are obtained via an electronic REDCap Survey the 
screening ID number may be created automatically by REDCap). Any correspondence 
between the school partner and the study team during the screening phase with occur 
using students’ screening ID numbers. 
 
If a student is determined to meet all study criteria, the school principal or administrator may 
wish to send a letter to the parent/guardian of students that a member of the school staff 
will be contacting them. The school partner will contact parent(s)/guardian(s) of identified 
students to introduce the study. Parent(s)/guardian(s) who express interest in the study and 
who agree to have their contact information (name, phone, email address) shared with the 
study team will then be contacted by the study team (via phone or email). If a primary adult 
caregiver (other than the parent and/or legal guardian) is involved the child’s care and 
school support, the family may also consider that caregiver participating in the study.  
 
During that initial communication, a member of the study team will verify that the student 
meets eligibility criteria (as noted on the referral forms provided by the school) and 
schedule an in-person meeting with the goal of obtaining consent for study participation. (If 
due to logistical and/or scheduling constraints and/or by request of the school and/or family, 
the consent meeting may be conducted either over the phone or through a web-based 
HIPAA compliant video-conference software approved by CHOP). For each condition 
(OST-S and TAU) in each school, students will be recruited from multiple classrooms of the 
same grade levels when possible. 

 
 
 
 
 
 
8
3.1.2 Training Phase: Training School Partners to Lead OST-S Groups 
Training School Partners: School partners will be trained by the study team during an in-
service to be facilitators for the small group OST-S sessions in participating schools. The 
procedures for training and providing ongoing consultation and coaching to school partners 
are based on our investigative team’s previous experience training school staff to 
implement manualized, evidence-based interventions (Eiraldi et al., 2014) and on our 
experience during the pilot project for OST-S. These meetings may be conducted in-
person, over the phone, or through a web-based HIPAA compliant video-conference 
software approved by CHOP (a combination of these modalities may also be used). 
Prior to their first time participating in OST-S implementation, school partners will participate 
in a training (up to a maximum of 8 hours) that will include a detailed discussion of all of the 
major elements of OST-S, a detailed review of child group behavior management and 
intervention procedures (e.g., modeling, shaping, rehearsal with feedback, contingency 
management techniques), an overview of paperwork that they will need to complete, and an 
introduction to the consultation and coaching model used to support them during 
implementation of the group.  
The in-service training will include didactic presentation, a review and discussion of 
videotaped examples of OST-S techniques and sessions, role-play, and guided practice 
techniques. The initial training will be repeated once a year for each school partner, as they 
prepare to conduct their first OST-S group for the year, with the length of training shortened 
when it is a refresher training for a school partner who was previously trained. This training 
may be conducted in-person, over the phone, or through a web-based HIPAA compliant 
video-conference software approved by CHOP (a combination of these modalities may also 
be used). 
 
3.1.3 Implementation of Organizational Skills Training – School Version (OST-S) 
Coached by the CHOP study team, trained school partners in the intervention condition will 
implement the OST-S intervention in their school with 3-4 students per group. OST-S will 
include 16 activities that will most often be administered in 16 sessions (typically two 
sessions per week) over the course of approximately 8 weeks. Sessions will be 
approximately 40 minutes in duration to align with typical class periods.  
Typically, the OST-S intervention is delivered in-person, administered within a small 
classroom at the school. During the COVID-19 pandemic (or other circumstances that 
warrant the need), virtual learning may also be utilized for delivery of the OST-S 
intervention following the school’s standard educational practice for engaging and 
instructing students (this includes any web-based or electronic platforms that the school 
would typically use in a virtual learning setting). 
During the implementation of OST-S in the intervention condition schools, students in 
schools assigned to the TAU condition will only receive the standard support typically 
provided by school personnel (teachers and school partners) in their building. They will not 
receive any additional support from study team members in regard to organizational skill 
development.    
3.1.4 Follow-up Phase 
In addition to collecting baseline measures, outcome measures will be collected following 
completion of the 8-week OST-S Intervention. The study team will also collect outcome 
measures from students, parents and teachers at 5-months and 12-months from baseline. 

 
 
 
 
 
 
9
Students, parents and teachers assigned to the TAU condition will provide outcome data at 
the same four time points (baseline, post-treatment (approximately 8 weeks from baseline], 
approximately 5-months from baseline and approximately 12-months from baseline).  
At the discretion of a principal investigator or a co-principal investigator, measurement time 
points may be modified on a case-by-case basis due to the logistical and time constraints in 
collecting data from participants within a school-based setting (for example but not limited 
to snow days, holiday break, summer break, and unanticipated school programming.) The 
rationale for such modifications will be documented when applicable. 
Data collection at baseline, post-treatment, 5-month, and 12-month follow-up may be 
collected either (1) in-person on hard-copy paper documents, (2) electronically through 
text/email links from REDCap to allow for off-site data collection or (3) in-person data 
collection utilizing an electronic tablet (that would be given to the participant) to access the 
REDCap link. 
3.2 
Allocation to Treatment Groups and Blinding 
Refer to Section 8.1.1 (Randomization), and in regard to “Blinding” Paragraph 3. 
3.3 
Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
School Partners (OST-S & TAU Groups): Our intention is that one or two school partners 
from each participating school will work with our study team during the school’s participation 
in the study (typically 4 years total); however, we recognize that school staffing might 
change over time. If school administrators request that we change the school partner from 
one year to the next, we will work closely with the school administrator and the new school 
partner to ensure that the new school partner receives the same initial training and support.  
Students: Total participation for students assigned to either condition will span an 
estimated 12 months. After parent consent and student assent is obtained, participation in 
OST-S sessions will be approximately 8 weeks. Data will be collected at baseline, after the 
intervention period ends and approximately 5- and 12-months after baseline data collection. 
Participation in the study is complete after the 12-month follow up data are collected. 
Students assigned to TAU will have the opportunity to receive OST-S after 12-month follow-
up data are collected, however this will not be considered a research procedure. No 
outcome data or recordings will be collected from the TAU students when they receive 
OST-S after their 12-month TAU control group participation period ends. 
Parents/Legal Guardians/Caregivers and Teachers: Total duration of participation for 
parents/legal guardians/caregivers and teachers of participating students will mimic that of 
the students, noted above (12-month maximum).   
Trainers: Total duration of participation for trainers will be the duration of their role as a 
study team trainer on this project. 
 
3.3.2 Number of Study Sites / Total Number of Subjects Projected 
The study will be conducted in at least 20 schools located in PA and NJ and include urban 
schools and suburban schools serving a diverse population. (It is possible that if a school 
drops out of the study that additional schools may need to be recruited to ensure that the 
study meets its enrollment goals. This would increase the number of schools to over 20 

 
 
 
 
 
 
10 
schools.) Schools will be randomly assigned to either OST-S or the control condition (TAU) 
(Refer to Section 8.1.1 for more details regarding participation).  
The participants will include students in grades 3 thru 5 with organization, time 
management and planning (OTMP) skills deficits. We will enroll 3-4 students per grade 
level each year (3-4 students per group per school). Because we will hold 4 total groups at 
each school, the design targets, on average, 14 students per school over the course of the 
study. Therefore, we anticipate a total of 140 students from 10 schools in the OST-S group 
and 140 students from 10 schools in the TAU group. For every enrolled student, we 
anticipate one participating parent (280 parents). For every student, we will also enroll one 
participating teacher. It is possible that an individual teacher may participate with multiple 
students over the course of the study.  
On average, participating schools include 3-4 classrooms per grade level. We plan to enroll 
students from two grade levels per school, although it is possible recruitment could include 
a third grade level. Additionally, there could be teacher turnover during the study, increasing 
the number of possible referring/participating teachers. Finally, because the 12-month 
follow up period will occur during the following school year for students in the study, an 
additional teacher will be enrolled for each student participant. Therefore, we estimate that 
up to 200 teachers will participate over the course of the study.  
It is anticipated that we could enroll up to 40 additional school partners, with the expectation 
that we will have at least one school partner per school (20 total).  We have projected the 
enrollment of 40 school partners to allow for potential school staff turnover within school 
buildings over the duration of the study.  
It is also anticipated that up to 10 trainers will be enrolled as secondary research 
participants over the course of the study. The trainer will be a CHOP employee and study 
team member that will train and support the school partner in a participating school. 
280 Student-Parent/Legal Guardian/Caregiver dyads +  
40 School Partners +  
200 Teachers + 
10 Trainers =  
530 Total Projected Participants.   
 
3.4 
Study Population 
3.4.1 Inclusion Criteria for School Partners 
School partners will be school staff (e.g., counselors, teachers) identified by the school 
principal who volunteer/agree to work with our study team to implement the OST-S program 
either in the intervention condition or as a complementary clinical service in the TAU 
condition.  
3.4.2 Exclusion Criteria for School Partners 
A school partner must be a school staff member other than the teacher of a participating 
student.  
3.4.3 Inclusion Criteria for Teachers 
Teachers will be school professionals at each participating school who refer students to the 
study team for potential participation, complete forms for students at baseline, post-

 
 
 
 
 
 
11 
treatment, and 5- and 12-month follow-up. For students assigned to OST-S, teachers will 
participate in the teacher consultation portion of the intervention. It is likely that at least two 
teachers will participate for each student over the course of study participation as students 
will likely have progressed into the following grade for the 12-month follow-up data 
collection period. 
3.4.4  Exclusion Criteria for Teachers 
Teachers not willing to participate in the school partner-teacher consultation sessions 
(intervention condition only) will be excluded from the study. 
No other exclusionary criteria apply, as a participating student’s teacher is pre-determined 
by the school.  
3.4.5 Inclusion Criteria for Students 
Any student enrolled in grades 3 thru 5 in one of the participating schools who meets the 
following criteria.  
1) First, students will be recommended by their general education teacher if the 
following are true: (a) students who are struggling the most with OTMP skills, (b) 
whose OTMP skill deficits are the students‘ primary concern (c) whose academic 
performance is negatively impacted by their OTMP deficits, and (d) who have at 
least one parent who speaks English.  
2) Second, the teacher must rate the student’s OTMP skills deficits as having a 
negative impact on academic performance (using items 39-42 of the COSS-T) by 
rating one of the four items > 3 on 4-point scale.  
Students with behavior and learning problems, including those classified with 
emotional/behavioral disorders and/or learning disabilities, will be included if it is 
determined that the students’ disabilities are being addressed adequately in the current 
educational program. This determination will be made by the study team in collaboration 
with the student’s teacher and the school partner.  
3.4.6 Exclusion Criteria for Students 
1) Students will be excluded if they are in a pull-out special education classroom for more 
than 50% of the day as the organizational demands for these students may differ from 
those students placed mostly in general education. 
2) Students with a one-to-one aide will be excluded because the presence of an aide 
substantially alters how an organizational intervention is implemented.  
3) Students from families in which both parents/guardians do not speak English will be 
excluded because the program has not yet been developed for non-English speakers.  
4) Only one student per family will be included in the study. 
 
3.4.7 Inclusion Criteria for Parents/Legal Guardians 
One parent/guardian for each student enrolled in the study will complete forms for students 
at baseline, post-treatment and 5- and 12-month follow-up and will participate in the parent 
consultation portion of the intervention. Parents/guardians will consent prior to student 
enrollment in the study. 

 
 
 
 
 
 
12 
3.4.8 Exclusion Criteria for Parents/Legal Guardians 
Parents/guardians of students not enrolled in the study will not be included. The enrolled 
parent/guardian must remain consistent throughout the study (for example, biological father 
cannot complete outcome measures, if biological mother is the consented participant).   
3.4.9 Inclusion Criteria for Adult Caregiver  
A primary adult caregiver (other than the parent or legal guardian) may participate in the 
study if that caregiver is involved with communication and support of the child in school. 
This caregiver would be a participant with the authorization from the parent/legal guardian. 
This adult would complete forms for students at baseline, post-treatment, and 5- and 12- 
month follow-up (in lieu of the parent/legal guardian) and will participate in the parent 
consultation portion of the intervention. Adult caregivers will consent at the time of student 
enrollment in the study. They cannot consent for student enrollment in the study. They will 
only consent for their own participation in the study. 
3.4.10 Exclusion Criteria for Adult Caregiver 
 
Adult caregivers not enrolled in the study will not be included. The designated adult who is 
completing measures for the study must remain consistent throughout the study. That adult 
may be the parent, legal guardian, or adult caregiver. The adult caregiver will be excluded if 
he/she does not speak English because the program has not yet been developed for non-
English speakers. 
3.4.11 Inclusion Criteria for Trainer 
Trainers are individuals employed at Children’s Hospital of Philadelphia and are study team 
members designated to train a school partner in a participating school in the OST-S 
Intervention. This individual will also support the school partner in Consultation and 
Coaching throughout the delivery of the intervention. 
3.4.12 Exclusion Criteria for Trainer 
A trainer would be excluded if they do not consent for be a secondary research participant. 
4 
STUDY PROCEDURES 
4.1 
Student Screening / Referral Process  
For both the OST-S and the TAU conditions, recruitment will be conducted in 3rd, 4th, 
and/or 5th grade general education classrooms. Based on the grade level targeted for a 
particular school, all teachers who educate students at that grade level will be offered a 
description of the study, including a specification of the roles for teachers. Teachers will be 
informed that they will be asked to participate in screening, outcome assessment, and 
consultation conducted by the school partner. Participating (consenting) teachers will be 
asked to identify students from their class using the inclusion (Section 3.4.5) and exclusion 
(Section 3.4.6) criteria outlined above. For each identified student, our school partners will 
ask teachers to fill out a short form indicating the extent to which the student’s difficulty with 
organizational skills negatively impacts his/her academic performance. This form may be 
completed on either a hard-copy paper document or via an electronic survey link from 
REDCap. 
The school partner or study team will determine whether the student meets study criteria. 
The school partner will contact the family of potentially eligible students by phone to 
introduce the study. Families who express interest in the study and who agree to have their 

 
 
 
 
 
 
13 
contact information (phone number/email address) shared with the study team will then be 
contacted by the study team. During that initial contact, a member of the study team will 
verify that the student meets eligibility criteria (as noted on the referral forms provided by 
the school). The study team will then schedule an in-person meeting with the 
parent(s)/guardian(s)/caregiver and student with the goal of obtaining written consent from 
the parent and assent from the student for study procedures, collecting baseline measures 
and conducting the initial parent consultation meeting. An adult caregiver may also be 
enrolled in the study with the permission of a parent/legal guardian. (If due to logistical 
and/or scheduling constraints and/or by request of the school and/or family, the consent 
meeting may be conducted either over the phone or thru a web-based HIPAA compliant 
video-conference software approved by CHOP.) If the family provides consent, a member 
of the study team will inform the student’s teacher of the parent and student’s enrollment in 
the study.  
4.2 
Training Phase: Training School Partners to Lead OST-S Groups 
The initial training of school partners is described above in section 3.1.2.   
Following the initial training, school partners will receive weekly or twice weekly 
consultation and coaching to support high fidelity implementation of OST-S. Consultation 
and coaching may be conducted in-person, over the phone, or through a web-based HIPAA 
compliant video-conference software approved by CHOP (a combination of these 
modalities may also be used). The frequency/duration of meetings as part of Consultation 
and Coaching will also take into consideration if a school partner has already been trained 
in and run the OST-S intervention in a prior year(s) of participation. If this is the case, the 
frequency/duration of these meetings may be adjusted from what is detailed below. 
Consultation sessions (approximately 20 minutes per week) will be designed to prepare the 
school partner for the upcoming group session (e.g., review of key components of 
intervention during the session, plan for encouraging active involvement of student 
participants). Coaching sessions (approximately 20 minutes per week) will include a 
detailed review of the previous session with performance feedback for the school partner. 
Additional consultation and coaching may be provided during the weeks when parent and 
teacher meetings take place.  
As indicated above, all OST-S sessions (student group and teacher and parent contacts) 
will be video and/or audio recorded, and the study team trainer will view the videos and 
listen to the audio to identify examples of effective implementation and areas for 
improvement. During the coaching session, the study team trainer will review brief 
segments of the video and/or audio (i.e., examples of effective and ineffective 
implementation) with the school partner and provide specific performance feedback 
regarding the extent to which OST-S program components were delivered accurately and 
competently (i.e., to encourage high rates of content and process fidelity). In addition, the 
study team trainer and school partner will discuss and practice strategies to address 
implementation difficulties and address concerns about individual students that may arise. 
Consultation and coaching sessions between the study team trainer and school partner will 
be videotaped (and may be audio recorded separately as a back-up method) used in 
supervision of the study team trainer. 
School partners assigned to the TAU condition will not receive any training until the second 
year of participation after 12-month follow-up data have been collected.  

 
 
 
 
 
 
14 
4.3 
Intervention Implementation 
TAU Control Condition: As noted previously, students enrolled in the TAU condition will 
only receive support from their teachers and school staff that they would typically receive if 
not enrolled in this study.  
 
Table 2.  Participants in TAU Control Condition:  
YEAR 
STUDENTS/PARENTS 
SCHOOL PARTNERS 
TEACHERS 
1 
Research Participants: 
Providing data at 4 time 
points 
Collaborator: Support 
recruitment 
Research Participant: 
Complete Demographic Form; 
Collaborator: Support 
recruitment 
Research Participant: 
Complete Demographic 
From;  
2 
Recipient of Free, Clinical 
Intervention; no data 
collected; no recordings.  
Collaborator: Implement 
Clinical Intervention as a 
Professional Development 
Experience; no data collected 
Research Participant: 
Complete Demographic Form if 
new to study;  
Collaborator: Participate in 
Clinical Intervention as a 
Professional Development 
Experience; no data 
collected 
Research Participant: 
Complete Demographic 
Form 
*It is anticipated that teachers in Years 1 and 2 will be different people.  
OST-S Condition: OST-S is a small group skills training intervention, implemented by the 
trained school partner, with parents and teachers supporting students’ use of new skills. 
Each small group session includes: (a) homework review to assess completion of between-
session skills implementation; (b) skill-building activities, which include the use of modeling, 
shaping, guided practice, and reinforcement for organized behavior; and (c) activities to 
promote generalization of skills.  
Sessions address four organizational challenges to students: (a) tracking assignments, (b) 
managing materials, (c) managing time, and (d) planning for long-term assignments.  
Procedures to promote parent and teacher involvement and student skills 
generalization. Once parental consent and student assent are obtained, the school partner 
will meet with the parent (ideally in-person but phone or web-based video software typically 
used by schools to engage with families virtually may also need to be utilized). The purpose 
of the initial meeting between the school partner and parents is to explain OST-S in more 
detail, increase parent investment in participation, and ensure that parents understand their 
role in the intervention. The school partner and parent will collaboratively identify goals for 
the student related to OTMP skills (e.g., bringing home needed papers, writing down 
homework), and the school partner will explain how OST-S can be helpful in addressing 
those goals. Furthermore, the school partner will schedule 1 additional meeting, 
approximately 30-minutes in duration. The meetings will ideally be held in-person, but could 
be done by phone or web-based video software (typically used by schools to engage with 
families virtually) if it is not possible to meet in person.  We could also allow for an email 
exchange if necessary. During these meetings (or contacts with the parent), the school 

 
 
 
 
 
 
15 
partner will review OST-S strategies and collaboratively design home-based methods for 
parents to prompt, monitor, and reinforce the skills students have learned. At the initial 
parent meeting, parents will be given a manual that provides specific guidelines to them 
about how to promote the implementation of their student’s OTMP skills.  These parent 
meetings will be audio and/or video recorded. If there is only an email exchange, the email 
will be printed and coded as study data in place of the video/audio recording. 
Also, after parent consent is obtained, the school partner will arrange a meeting with the 
student’s teacher (ideally in-person but phone or web-based video software typically used 
by schools to engage with families virtually may also be utilized). For feasibility purposes, 
this meeting might occur individually with teachers or in a group format for all of the 
teachers of students involved in the group. The purpose of the meeting is to review the 
goals of OST-S, encourage teacher buy-in, introduce the use of positive behavior supports 
to encourage skill change, and collaboratively plan for use of OST-S strategies in the 
classroom (e.g., Daily Assignment Record). After the initial meeting, the school partner will 
schedule 1 additional 15-minute consultation session with the teacher to review student’s 
progress toward goals and discuss implementation of OST-S strategies in the classroom 
(ideally in-person but phone or web-based video software typically used by schools to 
engage with each other virtually may also be utilized). School partners will give teachers 
handouts after each student session to inform teachers about session content and tips for 
integrating OST-S strategies into the classroom. These teacher meetings will also be video 
and/or audio recorded and evaluated by the study team as implementation fidelity data. 
The goals of the parent and teacher-mediated components are to: (a) address 
generalization challenges by promoting student use of OTMP skills at school and home, 
and (b) increase students’ academic self-efficacy. 
 
Table 3.  Participants in Intervention (OST-S) Intervention Condition:  
YEAR 
STUDENTS/PARENT 
SCHOOL PARTNERS 
TEACHERS 
1 
Research Participants: 
Participate in recorded 
OST-S Intervention & 
provide data at 4 time 
points 
Research Participant: 
Implement recorded OST-S 
Intervention with Students, 
Parents and Teachers; 
Complete Demographic Form 
and additional measures; 
Support Recruitment 
Research Participants: 
Participate in recorded 
OST-S Intervention & 
provide data at 4 time 
points; Support Recruitment 
**Students, School Partners and Teachers in the Intervention Condition are all Research 
Participants as their participation in the intervention is recorded and evaluated for study 
outcomes. 
4.4 
Subject Completion/Withdrawal 
Students, parents and school personnel may withdraw from the study at any time without 
prejudice to their care, education or employment.  They may also be discontinued from the 
study at the discretion of the investigators for lack of adherence to the study and/or 
development of exclusionary criteria.  

 
 
 
 
 
 
16 
If a school partner, withdraws from the study, there will be no impact on his/her 
employment.  The study team will work with the school administration to identify another 
school partner to provide the intervention in the school building.  
If a teacher withdraws from the study, the student and parent may continue their 
participation.  The teacher data moving forward will be missing, but the student will not be 
subsequently withdrawn. 
If a parent chooses not to participate/engage in parent consultation sessions but still 
consents to his/her student’s participation, the student and teacher may continue.  
If a student is withdrawn (or withdraws) from the study, his/her parent and teacher will also 
be withdrawn. Of note, a student may choose to withdraw from the small group sessions, 
but still decide to complete the questionnaires at the remaining time points. In this case, the 
student would not be withdrawn from the study but rather documentation would be made 
that the student declined to continue to participate in the small group sessions, but was 
willing to still complete measures at remaining time points. In this case, the student’s 
teacher and parent would also be asked to continue to complete study measures at the 
remaining time points if they are willing. 
Students will be withdrawn from the study if they develop exclusionary criteria during the 
study. Student well-being will be monitored by the study team trainer in collaboration with 
the school partner throughout participation in the study. If any adverse events occur that 
require clinical intervention during the course of study participation, the study team trainer, 
and/or Dr. Nissley-Tsiopinis, the clinical supervisor, will hold an individual Adjunct Services 
and Attrition (ASAP) session following the protocol outlined in the Multi-modal treatment of 
ADHD (MTA) study (Abikoff et al., 2002). If the investigators become aware of any serious, 
related adverse events after a participant completes or withdraws from the study, the event 
will be recorded in the study files.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
The table on Page vi (Table 1. Timeline of Study Evaluation and Measurement Completion) 
summarizes the sections to follow with detailed descriptions of the study evaluations and 
measurements. Phone, text, and email are means of communication that may be utilized to 
get in touch with families and school staff members to schedule meetings for data 
collection. The study team may communicate with the subject via text after the subject 
provides their permission for this method of communication.  
5.1 
Screening Measures (Students) 
Teachers will be asked to complete a short form to indicate the extent to which the 
student’s difficulty with organizational skills negatively impacts the student’s academic 
performance. The teacher must rate the student’s OTMP skills deficits as having a negative 
impact on academic performance (using items 39-42 of the COSS-T) by rating one of the 
four items > 3 on 4-point scale (COSS-T; Abikoff & Gallagher, 2009). The study team has 
obtained a waiver of consent to conduct this screening procedure. 
 

 
 
 
 
 
 
17 
5.2 
Measures of Proximal Outcomes and Mediators – OTMP Skills and Student 
Academic Self-efficacy 
Measures will be completed at baseline, post-treatment, and at 5-month and 12-month 
follow-up.  
Children’s Organizational Skills Scale, Parent (COSS-P) and Teacher (COSS-T) 
Versions. The COSS-P and COSS-T (Abikoff & Gallagher, 2009) will be used to assess 
OTMP functioning at home and school. COSS total scores have good discriminant validity 
and are sensitive to treatment effects (Abikoff et al., 2013; Pfiffner et al., 2013). Each COSS 
version uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). 
Although the COSS yields three subscale scores, only the total score will be used to reduce 
the number of measures in the analyses.   
Patterns of Adaptive Learning Scales – Academic Efficacy Subscale (PALS). The 5-
item Academic Efficacy subscale of the PALS (Midgley et al., 1998) will be used to evaluate 
students’ perceptions of their competence in completing their classwork. Items are rated on 
a 5-item scale from 1 = not at all true to 5 = very true. 
  
5.3 
Measures of Distal Outcomes – Academic Outcomes 
Measures will be completed at pre- and post-treatment, and at 5-month and 12-month 
follow-up.  
Academic Progress Report (APR; Abikoff et al., 2013). The APR is a teacher-report 
measure that assesses proficiency in seven academic subjects relative to standard 
expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well 
above standard). The sum of ratings across seven academic subjects is the unit of analysis. 
Reliability is acceptable (alpha = .84), and this measure is sensitive to OST treatment 
effects (Abikoff et al., 2013).  
Academic Competence Evaluation Scales (ACES; DiPerna & Elliott, 2000). The ACES is 
a teacher-report scale that assesses the academic competence of students in kindergarten 
through grade 12. The Reading/Language Arts and Math subscales of this measure will be 
used. Alpha coefficients and test-retest correlations for these subscales have been shown 
to be above .90. The average of these subscale scores will be used in the analyses.  
Academic Grades. We will obtain student report card grades for students in OST-S/TAU. 
We will calculate students’ grade point average based on report card grades. 
Homework Survey: Teachers will be asked to complete one question related to the 
percentage of homework assigned (in the school year to date) that they student has turned-
in.  
Homework Performance Questionnaire – Teacher Version (HPQ-T). The HPQ-T 
assesses students’ homework behavior during the past 4 weeks. Each item is rated on a 
five-point scale. The 9-item Student Self-Regulation factor will be used in the analyses. This 
factor has been demonstrated to have strong psychometric properties (Power et al., 2014).  
Homework Problem Checklist (HPC). The HPC is a 20-item parent-report measure that 
assesses student homework performance. The psychometric properties of this instrument 
have been shown to be acceptable (Power et al., 2006), and the HPC was sensitive to 

 
 
 
 
 
 
18 
treatment effects in the OST-C study (Abikoff et al., 2013). The total HPC score will be used 
in the analyses.  
5.4 Implementation Outcome Measures  
Measures of Intervention Fidelity. To ensure treatment components are delivered as 
intended, numerous treatment fidelity procedures will be implemented during each group. 
The procedures are based on those used in the OST-C study. Process fidelity procedures 
will be based on strategies used by Dumas and colleagues (2001) to train school staff. To 
assist with monitoring school partner process and content fidelity, checklists for each OST-
S group session and parent and teacher meeting will be used. Checklists will be used in 
two ways. First, school partners will be encouraged to use the content and process fidelity 
checklists as a guide during sessions. Second, all student small group sessions will be 
video and audio recorded, and parent and teacher consultation meetings will be video 
and/or audio recorded. The study team trainer will observe each video (student group 
sessions) and listen to each video/audio (parent and teacher consultation meetings) and 
code content and process fidelity for use in consultation and coaching meetings. A separate 
member of the Intervention Core team who is not directly involved with a school, will watch 
50% of the videos for each group that are selected at random and code content and 
process fidelity for use as research data. A member of the Intervention team supervisory 
staff will function as the ‘Gold Standard’ coder and will code a randomly selected 25% of 
the videos, which are selected for content and process coding for use in calculating the 
reliability of the coding. When challenges are encountered in administering the intervention, 
portions of these videos may be viewed by the Intervention Core team (Nissley-Tsiopinis, 
Abikoff, Gallagher) during weekly meetings. The Intervention Core will determine how best 
to address the situation in a manner that is consistent with the original intervention. Dr. 
Nissley-Tsiopinis will watch videos of consultation and coaching sessions as needed to 
provide supervisory feedback on the study team trainer’s implementation of the consultation 
and coaching procedure.  
Fidelity content items will specify what to do during sessions and will be rated on a scale 
from 0 to 1 (0 = not implemented; 1 = implemented). These ratings yield a fidelity index, and 
represent the extent to which OST-S content is covered in each session. Process items for 
OST-S sessions (e.g., encouraging all persons to participate), will be rated on a scale from 
0 to 4 (0 = rarely; 4 = all or almost all of the time; Dumas et al., 2001).  
Measures of Stakeholder Engagement. Several measures of school partner, parent, 
student and teacher engagement in the program and adherence with procedures outside of 
sessions will be used. Research assistants will make note of student attendance and arrival 
time at each OST-S session. Also, using a measure used in the OST-C study (Abikoff et al., 
2013) and based on their observation of the student session videotapes, study team 
members who are not directly involved with a group  will watch the videos of a randomly 
selected 50% of student small group sessions per intervention group and listen to a 
randomly selected 50% of audiotapes of each parent and teacher consultation session and 
complete ratings for each group participant regarding the extent to which the student: (a) 
was engaged in in-session activities, (b) appeared to understand the new skill, and (c) was 
able to implement the new skill effectively. A second study team member will independently 
complete the same ratings for 25% of student group session and parent and teacher 
consultations selected for coding. Agreement between the study team coders will be 
calculated as a measure of the reliability of these ratings. At the conclusion of each session, 
OST-S homework assignments will be given. For example, students will be asked to write 
down their assignments daily in their new Daily Assignment Record (DAR). At the beginning 

 
 
 
 
 
 
19 
of the following session, RAs will collect all OST-S homework assignments. These 
assignments will be scored for completion and accuracy using the procedure developed by 
Drs. Mautone and Power (Clarke et al., 2013). The scoring system for student OST-S 
homework assignments has been adapted so that it provides a more useful index of student 
success in acquiring OTMP skills.  
In addition, school partners will record parent attendance at parent consultation sessions 
and will indicate the extent to which the parent: (a) was engaged in discussions during the 
consultation, and (b) appeared to understand consultation content. A similar process will be 
used for teacher consultations. Furthermore, parents and teachers will generate permanent 
products (e.g., daily assignment record, home behavior chart). Students will be asked to 
bring those permanent products to the student group sessions and those permanent 
products will be collected and scored using the procedures developed by Drs. Mautone and 
Power (Clarke et al., 2013) to assess parent and teacher engagement in the generalization 
components of the program. If students forget to bring these permanent products to the 
student session, school partners will ask for them and make copies of them during parent 
and/or teacher consultations. 
Measures of Behavioral Change (Intervention Condition Only). Organization and 
Planner Checklists (Evans et al., 2009; Sadler et al., 2011) will be used to assess how well 
students organize their academic materials and record their assignments in their planner. 
These checklists have been developed for middle and high school students with ADHD, 
and we have adapted them for use with elementary students. The criteria on the checklists 
are behaviorally defined. Scores for “Organization” and “Planner” are calculated by 
determining the percentage of criteria met (Sadler et al., 2011). Study staff will be trained to 
complete these checklists during the intervention group sessions. (Please note: this 
measure will ONLY be collected when feasible within a particular school and based on 
research staff availability.) 
 
5.4 Measures of School and Participant Characteristics  
School Characteristics (as noted in Table 1.) will be collected by the study team about 
participating schools. This information will largely be obtained from publicly available data 
sources including (https://nces.ed.gov/ccd/schoolsearch/).Teacher and parent ratings on 
the Behavior Assessment System for Children – third edition (BASC-3, Reynolds & 
Kamphaus, 2015) will be used to assess child behavioral functioning. The BASC-3 has 
impressive psychometric properties. This measure will be given at baseline to characterize 
the sample and derive an index of ADHD, aggression, and internalizing problems for 
examination of potential moderation effects. If this measure is unable to be collected at 
baseline, an attempt will be made to collect it at a subsequent timepoint. 
Parent ratings on the Autism Spectrum Rating Scales (ASRS)-Short Form (Goldstein, 
S. & Naglieri, J.,2012) – The ASRS Short Form is a 15-item scale designed to differentiate 
children with an Autism Spectrum Disorder from those in the general population, and those 
with other clinical disorders. High scores suggest that many behaviors associated with the 
Autism Spectrum Disorders have been observed. Parents are asked to evaluate how often 
they observed specific behaviors in the child in areas such as socialization, communication, 
unusual behaviors, behavioral rigidity, sensory sensitivity, and self-regulation. T-scores of 
59 or less are within the normal range and usually suggest the absence of an autism 
spectrum condition. T-scores between 60 and 75 are generally considered above average 
or “at-risk” and indicate the presence of mild impairments in this area and the possible 

 
 
 
 
 
 
20 
presence of a mild autism spectrum disorder. T-scores of 76 or higher indicate severe 
impairments in this area and suggest that the child should be evaluated further for the 
presence of an autism spectrum disorder.   
Parents/legal guardians/caregivers will be asked to complete this measure at post-
treatment to reduce the burden on parents at the time of baseline data collection. If the 
measure is unable to be collected at post-treatment (aka approximately 8-weeks after 
baseline), it will be collected at either the 5-month follow-up or 12-month follow-up time-
point. This measure will only be administered to the parent once about the student during 
the duration of study participation. 
Survey of Current Organizational Supports for Students – This measure was 
developed by the investigative team. This measure will be administered to teachers (per 
student) to assess the current level of organizational supports being provided to students in 
their school environment (other than the OST-S intervention). This measure will be 
administered to teachers at post-treatment ONLY. If this measure is unable to be collected 
at post-treatment, an attempt will be made to collect it at a subsequent timepoint. 
Student Demographic Information – To characterize the sample, demographic 
information will be obtained from school records, teacher report, and parent/legal 
guardian/caregiver report. Specifically, we will collect information about special education 
status, amount of special education services being offered, IEP goals, services being 
provided to address organizational problems, school counseling services, medication 
status, and current organizational, supervision, and homework systems in place at school 
and home. An area of deprivation index (ADI) which reflects a geographic areas level of 
socioeconomic deprivation will also be determined for participants to aid characterizing the 
samples socioeconomic status (Kind et al., 2018). A follow-up questionnaire will be 
administered to parent/legal guardian/caregiver at post-treatment, 5-months, and 12-
months to obtain information about utilization of services during the intervention and follow-
up periods.  
School Staff Demographic Form – School partners and teachers will complete a 
demographics questionnaire to collect information regarding staff members’ educational 
experience and background, to help characterize the school staff sample, as well as to 
collect information regarding about TAU organizational skills interventions offered in TAU by 
their schools. 
Trainer Demographic Form – Trainers will complete a demographic form to collect 
information regarding trainers’ educational experience and background. 
5.6 Measures of Adaptations, Feasibility, Usability, and Acceptability of OST-S 
Adaptations to OST-S made by school partners in providing additional support to students 
at the group or student level will be assessed by the following measures. 
Survey of OST Adaptations and Supplementary Supports for Individual Students – 
This measure was developed by the investigative team. This measure will be collected from 
school partners (per student) at post-treatment, 5-month follow-up, and 12-month follow-up. 
The measure is designed to capture when school partners contribute extra supports above 
and beyond what is outlined in the treatment manual for them to provide to students in the 
Organizational Skills Training School-based program (OST-S). 

 
 
 
 
 
 
21 
Survey of OST Adaptations and Supplementary Supports for Groups – This measure 
was developed by the investigative team. This measure will be collected from school 
partners at post-treatment (per group). The measure is designed to capture when school 
partners prepare/provide additional supports for students beyond that outlined in the 
treatment manual as they implement the Organizational Skills Training School-based 
program (OST-S). 
Feasibility and usability will be assessed by monitoring of intervention fidelity, participant 
engagement, and adherence.  
The Treatment Evaluation Inventory – Short Form (TEI-SF), a 9-item measure, will be 
used to assess parents’ views of treatment acceptability (Kelley et al., 1989).  
The Children’s Intervention Rating Profile (CIRP), a 7-item measure, will be adapted to 
assess student’s perceptions of acceptability (Witt & Elliott, 1985).  
The Usage Rating Profile–Intervention–Revised (URP-IR), a 29-item measure, will be 
adapted (with permission) to assess multiple factors that may influence the usage of the 
OST-S intervention in a school-based setting – for example: acceptability, understanding, 
home school collaboration, feasibility, system climate, and system support (Chafouleas, 
Briesch, Neugebauer, & Riley-Tillman, 2011). 
5.7 Cost Analysis Measures 
Main cost item for the OST-S is the time spent by school partners, trainers/consultants, and 
experts from the investigative team on intervention activities which may be collected using 
time diaries. Costs for the OST-S group may include: (a) initial training time of the study 
team trainers; (b) initial training time of the school partners; (c) subsequent supervision time 
of study team trainers; (d) subsequent consultation and coaching time provided to the 
school partners; (e) school partner implementation of OST-S groups with eligible students 
(including consultation with parents and teachers to promote generalization); and (f) 
consultant (post-doctoral fellow) time necessary to maintain relationships with participating 
schools and support ongoing implementation of the OST-S program. For each component, 
two main types of costs will be calculated: (1) cost of physical materials used for training 
and interventions and (2) costs associated with time spent for training, supervision, and 
intervention implementation (Blonigen et al., 2008).  
Intervention and training/consultation times will be derived from administrative records of 
OST-S session times and student attendance, and diaries completed by interventionists, 
trainers/consultants, and experts, during four, 1-week periods throughout the trial.  
6 
STATISTICAL CONSIDERATIONS  
6.1 
Main Study Analysis 
6.1.1 Study Aims 
Aims 1 and 2: Effect of Intervention on Proximal and Distal Outcomes. Linear mixed 
effects models with random intercepts and slopes for school (the cluster), and fixed effects 
for intervention, time, and time-by-intervention interaction (the estimate of interest) will be 
applied. Random effects account for inter-school variation in the effect of the intervention 
over time.  
 

 
 
 
 
 
 
22 
Aim 3: Mediation Effects. This aim explores the effect of potential mediating variables (M; 
OTMP skills, self-efficacy) on the effect of the intervention (A) on student academic 
outcome (Y). Our goal is to understand the mechanism of change in student performance 
due to the planned intervention. In this context, we will examine two levels of mediation: 
school-level 
average 
organization 
skills 
associated 
with 
school-level 
academic 
performance, and student-level organization skills and performance.  
 
Aim 4: Association Between Fidelity/Engagement and Outcomes: To determine 
whether fidelity and engagement are associated with outcomes, we will describe the impact 
of these factors on outcomes, with special attention to variation in outcomes across 
schools. These associations will not benefit from randomization (fidelity and engagement 
are post randomization interim process endpoints). For that reason, our assessments will 
be largely descriptive and qualitative, and will include assessment during the follow-up 
periods.   
   
Aim 5: Effect Modification: Aim 5 explores potential moderating variables (i.e., gender, 
grade level, family SES, special education status, and severity of ADHD, externalizing and 
internalizing behaviors). Because these potential effect modifiers vary within the unit of 
randomization (school), these contrasts are essential within-cluster comparisons with good 
statistical power (see below). Effect modification can be estimated using the mixed effects 
and longitudinal models outlined previously.  
 
Aim 6: Cost and Cost Effectiveness. We will estimate the incremental costs and 
incremental cost effectiveness (ICE) of OST-S. An ICE ratio will be constructed for each 
outcome measure with effects that differ significantly from the control group. The ICE will be 
determined based on differences in direct costs and will be calculated based on differences 
in mean costs for each condition, divided by the mean difference in outcomes (e.g. ratings 
of organizational skills and academic performance). 
 
In many OST-S schools, the same school partner will provide intervention during both years 
of participation. In addition, we expect that many teachers who receive consultation during 
the first time will be involved again the second time. It is possible that school partners and 
teachers will be more effective in implementing OST-S later in the study than earlier, which 
could have some effect on outcomes. Our team will perform sensitivity analyses to 
determine whether response to intervention in OST-S schools differs for students enrolled 
earlier versus later in the study. 
 
We anticipate that some of the students in the study will be medicated for ADHD. 
Medication status did not moderate outcomes for students included in study of OST-C 
(Abikoff, et al., 2014). During baseline, post-treatment, and follow-up assessments, we will 
obtain information about student medication status. In the analyses, we will explore whether 
medication status has an effect on outcomes. 
 
6.1.2 Primary Endpoint 
The primary endpoints are student OTMP skills and student academic self-efficacy, 
measured at post-treatment, 5 months from baseline and 12 months from baseline and 
compared between the intervention condition and the TAU condition. 
 

 
 
 
 
 
 
23 
6.1.3 Secondary Endpoints 
The secondary endpoints are student academic productivity, homework, and academic 
grades. 
 
6.1.4 Sample Size and Power 
Number of students and statistical power. It is anticipated that a total of 140 students will 
participate in the OST-S group and 140 in a treatment as usual (TAU) control group.  
 
Primary Objectives and Secondary Objectives Involving Academic Outcomes: 
 
As is customary, our estimates are in standard deviations (SDs; effect sizes). We examined 
power assuming 20 schools, inclusion of 3-4 students per grade level across two grade 
levels (3.5 students per school), and randomization at the school level. The design targets 
on average 14 students per school, or 280 total. To allow for 15% loss to follow up at the 
student level, we assume 120 students per arm. Each student will have data collected at 4 
time points: baseline, post-treatment, 5-month follow-up, and 12-month follow-up.  For 
analysis, we will use all available data until the time of dropout. For power calculations, we 
assumed conservatively a baseline measure and one follow up per student.  
 
We accounted for the reality that longitudinal measures at the student level increase power 
and clustering of students within schools decreases power. We assumed three relatively 
modest correlations of outcome measures within student over time: 0.5, 0.6 and 0.7, which 
correspond to SDs of change of 1.0, 0.8, and 0.6 for a 1 SD cross sectional difference. 
Correlations of 0.5 lead to no increase in power from the design, and correlations of 0.6 and 
0.7 correspond to approximately 10% and 20% increases in power. To account for 
clustering, we assumed intra-cluster correlations (ICC)=0.01, typical in school-based trials 
(Office 
of 
Behavioral 
and 
Social 
Sciences 
Research, 
NIH: 
http://esourceresearch.org/tabid/384/Default.aspx). We also used ICC=0.038. This ICC 
value corresponds to variation across schools on the order of 0.4 SD of the distribution of 
outcome scores, or the equivalent to a range of means across schools of 1.6 SDs, a 
modest degree of inter-cluster variation. The design effects of these assumptions are 1.03 
(small) and 1.11 (modest), to be expected with a relatively small number of students per 
school, and correspond to a reduction in the effective sample size of 3-11%.        
 
Power calculations were performed using PASS 11 (Hintze, 2011; www.ncss.com), which 
demonstrated 90% power to detect a change in outcomes equivalent to 0.5 or greater in 
cross-sectional SDs, assuming at least 12 students per school and model correlation of 
these scores within student over time (corr=0.7), and assuming an ICC of 0.038 (a relatively 
large degree of variation across schools). A change equivalent to 0.5 cross-sectional SDs in 
outcome scores and 12 students per school is still detectable (power>0.85) if the correlation 
within students over time is 0.7 and the ICC across schools is 0.038. Larger effects can be 
detected with greater power. These power estimates apply to both OTMP skills and 
academic outcomes using intervention as a binary outcome in an intent-to-treat analysis. 
Based on the pilot study of OST-S, we expected effect sizes for outcomes to be in the 0.6 
to 0.8 range. These power calculations are likely conservative; inclusion of covariates might 
actually improve power.   
 
6.1.5 Secondary Objectives 
 

 
 
 
 
 
 
24 
Mediation effects. For this Aim, we rely on our own simulations as well as two programs in 
the R package. We assumed 220 evaluable students across 20 schools, and a design 
effect of 1.1.  In brief, David Kenny’s program “PowMedR” (Kenny 2016) suggests that 
power is adequate to detect an effect size of 0.3 SD for both the effect of treatment (A) on 
the mediator (M) and the effect of M given A on Y (conditional effect of OTMP on outcome). 
Likewise, the R package “medssp” (Vittinghoff 2015) suggests adequate power (> 0.8) to 
detect effect sizes of 0.4 jointly and separately for both the association of A and M (effect of 
intervention on OTMP skills) and OTMP skills on academic performance (association of M 
and Y).  Our own simulations, conducted using Stata v 14.1, to determine power to rule out 
a direct effect (of the intervention on outcomes not mediated by OTMP skills) suggest that 
only a large direct effect can be ruled out at conventional levels of statistical significance 
using the planned sample. 95% confidence intervals of results of all analyses will reflect 
post hoc power. 
 
Association between fidelity/engagement with OST-S, child clinical factors, and 
outcomes. Descriptive and qualitative analyses will be used, so power calculations were 
not conducted.  
 
Moderation effects. Power to detect an interaction of treatment (A) and a modifier with 
25% prevalence was estimated to be greater than 85% assuming a main effect of treatment 
of 0.5 SD and design effects from the clustering of students within school in the range noted 
previously noted, for an interaction effect of 0.67 SD. Owing to the absence of software for 
testing interaction effects, these estimates are based on our simulations conducted using 
Stata v 14.1. While these estimates continue to reflect the clustered (by school) design, the 
design effect in practice for the interaction of an across-cluster (intervention) and a within-
cluster (student characteristic) variable tends to be much lower than for a main effect 
(intervention only). We choose a binary moderator for this calculation, and 25% prevalence, 
to be somewhat conservative. Prevalence of some moderators (e.g., inattention) are likely 
to approach 50%.    
 
Descriptive methods will be used to examine costs and cost effectiveness. As such, power 
calculations were not conducted. 
 
6.2 
Preliminary Analysis to Respond to Project Officer 
6.2.1 Goals of Preliminary Analyses 
Our study team has identified three primary goals to address the question of whether OST-
S is having its intended effect to address the request of the project officer. The goals of the 
preliminary analyses are contained within the original study aims and do not represent new 
aims. 
1. Determine whether OST-S may be effective in improving proximal outcomes 
(students’ organization, time management, and planning [OTMP] skills) 
relative to a treatment as usual, waitlist control group (TAU-WL) at post-
treatment. 
This goal is included within study Aim 1. We will examine only the primary study 
outcome, students’ OTMP skills, assessed by parent and teacher ratings on the 
Children’s Organizational Skills Scale (COSS-P, COSS-T), and we will examine 
outcomes only at post-treatment (not follow-up).  

 
 
 
 
 
 
25 
2. Determine whether there may be a differential effect of OST-S on OTMP skills 
as a function of student grade level (3rd to 5th grade). 
This goal was included as an original study aim. It is especially important to examine 
this goal because there is good reason to believe 3rd graders may not respond as 
well to OST-S as older students. It is also important to examine this goal because by 
chance (due to randomization) the year impacted by COVID included mostly 4th and 
5th graders, whereas the years before this included more younger students. 
Therefore, our sample of 175, which was designed to be evenly distributed across 
the grades, currently underrepresents 5th graders  (Grade 3 – n = 64; Grade 4 – n = 
72; Grade 5 – n = 39). 
3. Determine whether there may be a differential effect of OST-S on OTMP skills 
as a function of the resource level of schools (low, middle, or high subsidized 
lunch rate). This goal was included as an original study aim. It is important to 
examine this goal because prior research has suggested that schools with fewer 
resources (high subsidized lunch rates) might not do as well in implementing such 
interventions given the multiple stressors their staff face. That being said, fidelity 
implementation data suggests that our school partners generally are implementing 
the intervention with high quality regardless of school subsidized lunch rate.  
 
6.2.2 Statistical Plan for Preliminary Analyses 
The study team, led by our statisticians, will compute descriptive statistics (mean, standard 
deviation, and 95% confidence interval) for change scores from baseline to post-treatment 
on the COSS-P and COSS-T in raw score format (mean item score). Descriptive statistics 
will be computed for each of the two arms of the study (OST-S, TAU-WL), as well as each 
grade-level subgroup (Grade 3, 4, 5) and school resource-level subgroup (low, middle, high 
subsidized lunch rate) within each arm.  These descriptive statistics will be highly valuable 
in determining whether there is a signal of overall OST-S effectiveness, differential effects 
for grade-level subgroups, and differential effects for schools with low, middle, and high 
subsidized lunch rates. The study team will evaluate whether the lower limit of 95% 
confidence intervals is above 0, which would be suggestive of a significant difference. In 
addition, the difference in mean change scores between study conditions will be divided by 
the standard deviation of the control group (TAU-WL) standard deviation of change scores 
to provide a rough estimate of effect size for the entire sample, each grade-level subgroup, 
and each school subsidized lunch rate subgroup. Further, descriptive statistics will be 
computed to characterize the OST-S and TAU-WL conditions with regard to child sex, 
grade level, and school subsidized lunch rate subgroup.  
In addition, we will determine whether there is a difference between intervention conditions 
with regard to the proportion of students who demonstrate a small, medium, and large 
degree of change in the expected direction from baseline to post-treat, as well as the 
proportion of students who demonstrate no change and change in the oppositive direction. 
Degree of change on each measure (COSS-P and COSS-T) will be computed for each 
participant by subtracting baseline score from post-treatment score and dividing by the 
standard deviation of change scores for the condition to which the participant was assigned 
(OST-S vs. TAU-WL). Similar to guidelines established by Cohen (1988), effect sizes (ES) 
approximating .20 will be considered small; ES approximating .50 will be medium; and ES 
approximating .80 or higher will be large. We will conduct these analyses with all students 
in OST-S and TAU-WL as well as with subgroups based on grade level and subsidized 
lunch rate. Because we did not include a plan to examine the proportion of students 

 
 
 
 
 
 
26 
responding to each condition in the original analytic plan, we are including a request 
for these analyses in this amendment.  
Descriptive statistics will be computed separately in three samples, First, using an intent-to-
treat approach all enrolled participants will be examined. Second, using a per protocol 
approach most of the participants involved in the study during the COVID-19 shutdown in 
the spring, 2020 will be excluded from the sample. The only participants affected by 
COVID-19 who will be included are those for whom the duration of time between the 
collection of the COSS-P and/or COSS-T was > 8 weeks (56 days) and the collection of 
post-treatment data for the COSS-P and/or COSS-T data occurred within 3 weeks (21 
days) of the first date of shutdown (March 16). Third, using a per protocol approach two 
groups of participants will be excluded: (a) those participants affected by COVID-19 
described earlier in this paragraph, and (b) those participants in the OST-S arm for whom 
COSS-T data were collected after the fourth intervention session (note: study team 
persisted with efforts to collect data in order to minimize missing data), because the initial 
sessions are believed to be critical for intervention success. In our original statistical 
analysis plan, we planned to conduct intent-to-treat analyses, but we did not include 
a plan to conduct per protocol analyses. We are requesting an amendment to 
conduct per protocol analyses, as indicated. 
These exploratory descriptive analyses will be conducted on one occasion and a report will 
be sent to the IES project officer. By conducting the analyses in this way, our team is 
adhering to the approved IRB protocol. We will not conduct any statistical analyses in 
addition to those outlined above. To minimize bias in conducting these descriptive 
analyses, the deidentified data set needed for these analyses will be exported from 
REDCap by a study coordinator and will only include information about study arm (which 
will be deidentified), grade-level subgroup, school subsidized lunch subgroup, child sex, 
COSS-P and COSS-T raw scores at baseline and post-treatment, and sample subgroup 
(intent-to-treat, per protocol excluding most participants affected by COVID-19, and per 
protocol excluding most participants affected by COVID-19 and those in the OST-S 
condition with delayed collection of COSS-T data). A study statistician will conduct the 
analyses using the data set with deidentified study arms, and he will report findings to the 
study coordinator who will indicate the identity of the study arms for interpretation of 
findings.   
If these exploratory analyses reveal there is a signal indicative of a main effect of 
intervention condition and/or an interactive effect of intervention condition and grade level 
and/or an interactive effect of intervention and school subsidized lunch rate subgroup, 
power calculations will be performed to determine the sample size needed to conduct tests 
of significance for the three study goals outlined above, which are the most important study 
aims. We will not perform power calculations again to conduct complex mediation analyses, 
which require a relatively large sample size. We will base power calculations on the same 
assumptions outlined in the original statical analysis plan, including an expected effect size 
of .50 and attrition of 15%.  
This is a one-time request to provide summary statistics to the project officer for the 
purpose of obtaining a financial supplement. If we obtain a supplement from the funding 
agency, we plan to submit another amendment to the IRB to clarify aims, update 
power calculations, and modify the statistical analyses plan. 

 
 
 
 
 
 
27 
7 
SAFETY MANAGEMENT 
7.1 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
7.2 
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review. 
8 
STUDY ADMINISTRATION 
8.1 
Treatment Assignment Methods 
8.1.1 Randomization 
The randomization of the recruited 20 schools to either the OST-S or TAU will be based on 
first & second year recruitment of schools to the interventions.  The ten schools that agreed 
to start the program in the first year of the study will be randomized first and a 
randomization list (LIST1) will be created. Prior to randomization, we will pair schools based 
on grades (3 only; 3 and 4; and 3, 4 and 5) and percentage of students with subsidized 
lunch programs (subsidized lunch percentages ranged from 8% to 100%). Within each of 
the 5 pairs, each school will be randomized to receive one of the two interventions. This will 
result in five schools receiving OST-S and another 5 schools receiving the TAU 
intervention. 
 
During the second year of recruitment, a new 10 schools will be randomized using the 
method described above (LIST2). This will result in additional five schools receiving OST-S 
and another 5 schools receiving the TAU intervention.  Therefore, a total of 10 schools will 
be in the OST-S intervention and another 10 schools in the TAU. The randomization design 
sought to balance relatively few schools two characteristics: one categorical (grade levels) 
and one continuous (% subsidized lunches).    
 
Due to logistical issues related to recruiting larger number of schools (i.e., 40 schools 
instead of 20), more staffing and limiting funding, and in order to maximize the number of 
students per school, the same schools will be recruited again during the third and fourth 
schooling years and will receive the same intervention assignment based on their first year 
or recruitment. So by default, during the second phase of recruitments, schools will know 
their intervention assignment ahead of time. We will examine whether or not such a 
situation biases the effect of intervention by comparing same outcomes obtained in year 1 
verses year 2 by the two intervention arms. 
 
Due to the nature of school-based research, if a school drops out of the study prior to 
enrollment of students or after a single year of participation, the study team will pursue the 
participation of an additional school to support participant recruitment in a subsequent year 
of the study. In this case, the number of participating schools would be over 20 schools. In 
addition, it may be necessary to modify the ratio of school randomization assignment to 

 
 
 
 
 
 
28 
OST-S or TAU if a school drops out of the study and additional schools are needed. In a 
case such as this, this decision would be made by the principal investigators in consultation 
with the investigative team and documented as necessary. 
 
8.2 
Data Collection and Management 
The data collection and management plan is consistent with CHOP Policy A-3-6: 
Acceptable Use of Technology Resources that defines the requirements for encryption and 
security of computer systems.  
• 
Identifiable data will be collected as part of this study. This data includes full 
names/initials, date of birth, address, telephone number, e-mail addresses.  However, 
participants will be identified by numeric code only. This precautionary step allows for 
the electronic transfer of data without using data encryption techniques. At each stage 
of data collection and maintenance, measures are taken to ensure that all identifying 
information is taken out of data archives, and any hard copies of data that could identify 
participants are stored in locked file cabinets with restricted access, and that data files 
are password protected.  Participant identification numbers are used that do not reveal 
the identity of participants (e.g., no use of birth dates, initials, social security numbers, 
etc). Only members of the research team will have access to the data.  If the results of 
this study are presented at scientific meetings or published in professional journals, they 
will not contain information that could be used to identify parents, teachers, students or 
school partners.  
• 
Hard data will be kept in a locked file cabinet with restricted access in the Roberts 
Center for Pediatric Research. Digital video and audio recordings (containing participant 
identifiers) will be transferred from the devices and stored to a CHOP computer network 
drive and analyzed by study team members for the coding of integrity/fidelity. After 
audio/video recordings are saved to the CHOP network space, the recordings will be 
deleted from the digital device. After all analyses are complete, the files will be 
destroyed and personal identifiers will not be retained with the data. All computerized 
study databases for questionnaire data will be kept on a secure Windows NT server 
located at one of the hospital’s research buildings. This server is also protected by a 
firewall to reduce the risk of unauthorized access to study information. 
• 
Data (video and audio recordings of both training sessions and consultation sessions) 
will be shared with co-investigators (external to CHOP) using a secure, web-based, 
HIPAA compliant collaboration platform known as Box.com (provided by CHOP). Data 
will be uploaded to Box.com solely for the purpose of collaboration and consultation to 
ensure that the intervention is implemented as intended, according to the clinical 
manual. The data will be removed from Box.com once reviewed and discussed with 
study team members.  Please refer to Form DCC (attached to the eIRB application) for 
details regarding data sharing with external collaborators. 
• 
Hard-copy paper data collected as part of this study will be entered (data entry from 
CRFs or uploaded from Excel files) and stored using REDCap (Research Electronic 
Data Capture) database, a secure web-based software database supporting clinical and 
translational research databases. When data are unable to be obtained in-person, 
electronic links will be sent to participants via email/text via REDCap surveys. The 
database will be password-protected, stored, and backed up on a daily basis by 
CHOP’s Research Institute. REDCap provides data management functionality; including 

 
 
 
 
 
 
29 
automated export procedures for seamless data downloads to Excel and commonly 
used statistical packages (SPSS, SAS, Stata, R). The database will incorporate range 
checks and between-variables consistency checks to ensure quality control. The 
system will signal the presence of questionable or potentially incorrect items.  After data 
cleaning and quality assurance procedures are completed, pertinent sets of data will be 
converted into SAS format for statistical analysis. The Biostatistics and Data 
Management Core (BDMC) of the Research Institute will provide expertise in REDCap 
database design and implementation, randomization, and statistical analysis under the 
direction of the study’s biostatistician. 
• 
The process for obtaining e-consent thru REDCap will be reviewed and approved by the 
REDCap Team. These electronically signed consent forms will be printed out from 
REDCap and stored with paper consent forms in locked filing cabinets in the Roberts 
Center for Pediatric Research. 
• 
REDCap will be utilized to send e-consent links and/or survey links to participants via 
email as well as via text message (via an integrated text messaging option through a 
company called Twilio (www.twilio.com). Twilio will be used to send survey links, i.e. 
“Click this link to open our survey,” which then opens the survey in Safari or any other 
browser on a participant’s mobile device. The participant then fills out the REDCap 
survey within their browser, exactly as if they received the invitation by email. Links will 
only be sent via text message with prior permission from the participant (otherwise the 
default method, e-mail, will be utilized). 
• 
Data for the “Behavior Assessment System for Children (BASC) – third edition” is 
collected from parents and teachers at baseline. This measure may be administered on 
paper or thru an electronic link provided directly by the publisher, Pearson. If completed 
online thru Pearson, parents/teachers will be providing PHI directly to Pearson. PHI will 
be removed from the source data prior to data analysis. Applicable participant consent 
forms will include Pearson as a party that may have access to participant data. Pearson 
software is required to score this measure so that the data can be analyzed in a 
meaningful way. In addition, the Pearson software requires that participants complete 
all items in this measure. This is a permanent setting in the software that the study team 
is not able to modify. Parents and teachers will be informed that this measure will 
require all items to be entered to be completed. Parents/teachers will still have the 
option to not complete the measure if they are not comfortable answering any of the 
questions. 
8.3 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and that the Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study.  
All identifiable information that is obtained from participants (e.g., names on the signed 
consent form or on rating scales) will be obtained through collection of paper records or 
electronic links generated thru REDCap. Information obtained on paper will be entered into 
REDCap using a student ID number. All data will be coded within the REDCap database. 
Only one electronic file at the CHOP site will hold the link between the student’s ID number 
and their name. The files linking identifiers (PHI) will be retained for a minimum of 6 years 

 
 
 
 
 
 
30 
post the data collection phase. The identifiers will be retained for this duration to comply 
with CHOP's data retention policy (A-3-9). 
All print data will be housed in locked filing cabinets with restricted access at the Roberts 
Center for Pediatric Research at CHOP. At the end of the study, signed consent forms will 
be housed in locked filing cabinets separate from the ID coded data. All data that are 
transported to and from the school buildings and the research offices will be transported in 
HIPAA-compliant lockable bags. Families and school staff will be informed that research 
data are confidential and cannot be shared with participants; research data will not become 
part of the student’s educational record. All data that are analyzed and presented will be de-
identified. 
8.4 
Regulatory and Ethical Considerations 
8.4.1 Data and Safety Monitoring Plan 
The PI (Dr. Power) and Co-PIs (Drs. Nissley-Tsiopinis and Mautone) assume overall 
responsibility for monitoring the integrity of data collection and the safety of the 
interventions. The investigative team, which will most often meet monthly, will oversee all 
aspects of the study, monitor progress in meeting recruitment goals, and address 
methodological issues as they arise. The PI (Dr. Thomas Power) will chair this team. 
Members of the investigative team will include the Co-PIs (Drs. Jenelle Nissley-Tsiopinis 
and Jennifer Mautone) and Co-Investigators (Drs. Abbas Jawad, Russell Localio, Zuleyha 
Cidav, and Richard Gallagher). Dr. Howard Abikoff will be a consultant to this team. The 
research staff will attend these meetings. The study will include three core areas, which 
have been designed to ensure the study achieves its goals and data are collected in an 
unbiased manner. The Intervention Core, directed by Dr. Nissley-Tsiopinis, will address all 
intervention training, supervision, and implementation activities. This team, including the 
post-doctoral fellows and Drs. Gallagher and Abikoff, will most often meet weekly (although 
Drs. Gallagher and Abikoff will attend less frequently). The Evaluation Core, directed by 
Dr. Mautone, will address all data collection, management, and analytic activities. This 
team, including Drs. Power, Jawad, Localio, and Cidav, as well as the research staff, will 
most often meet bi-weekly (although Drs. Power, Jawad, Localio, and Cidav will attend less 
frequently). The School Engagement Core, directed by Dr. Power, will focus on recruiting 
schools and maintaining their engagement throughout the study. This team, including the 
Co-PIs and fellows, will most often meet on a monthly basis. 
Safety of Student Participants: Student participants will be under the care of a school 
partner who is supported by a consultant/coach (study team trainer) for the duration of their 
participation in the study. The consultant/coach will have the support of a licensed 
psychologist. School partners will monitor students’ behavior and response to the 
intervention through communication with them. School partners will closely monitor 
participants throughout the course of the study. In all cases, if a school partner or study 
team member has any concern about a student’s emotional state at any point, immediate 
action will be taken to provide appropriate care. If a family is interested in other treatments, 
we will work with them to identify appropriate referrals in the community. 
8.4.2 Risk Assessment 
Risks are not greater than minimal. There are no known physical or legal risks to 
participating in the study interventions.  
The following steps will be taken to protect against risk: First, all study personnel and all 
school-based personnel who will be involved in participant recruitment will receive initial 

 
 
 
 
 
 
31 
training and ongoing supervision in areas related to ethical conduct, confidentiality 
protection, and other topics of human participant protection.  
Second, only identified school personnel will make initial contacts with parents so as to 
protect parents/students from being known to the investigators prior to agreeing to 
participate in the study. Paper records will be stored in a locked file cabinet with restricted 
access at the Roberts Center for Pediatric Research.  
Third, students, teachers, school partners, and parents will be told that they do not have to 
answer any question that makes them feel uncomfortable.  
Fourth, careful monitoring of family conflict and teacher stress and the provision of 
psychological consultation if families or teachers become destabilized will minimize the risk 
of the student, parent, teacher, and family-school interventions.  
Fifth, school partners, families and teachers will be informed that when information about 
the study is disseminated, no information that could identify the student, family, or school 
will be included.  
Finally, parents, teachers, school partners, and students will also be informed that 
participation is voluntary. If they choose to take part in this study, they may stop at any time 
during the study. If they choose not to take part in the study, there will be no negative 
impact on their educational services or health care services provided by CHOP (students 
and families) or employment with the participating school districts (teachers and school 
partners). 
8.4.3 Potential Benefits of Trial Participation 
This study will contribute to be available interventions that schools have to address 
organizational challenges of students by determining the efficacy of the school-based 
version of a very effective clinic-based intervention, the Organizational Skills Training 
intervention. This will improve schools’ ability to improve organization, time management 
and planning skills among students in grades 3 to 5, before they face the increased 
demands of middle school. There is a lack of such interventions for students in late 
elementary school in spite of the increased organizational expectations and independence 
at these ages. Families and teachers participating in the intervention are likely to benefit 
from the targeted interventions to improve organizational and academic functioning.  
8.5 
Risk-Benefit Assessment 
The risks associated with this study are minimal and generally no greater than the risks of 
receiving care in the community. 
8.6 
Informed Consent/Assent and HIPAA Authorization 
8.6.1 Waiver of Consent for Student Screening 
A waiver of consent has been obtained for school personnel to screen students.  The 
screening procedures noted in section 3.1.1 and 4.1 involves no more than minimal risk to 
the student. The screening is conducted by school personnel involved in the existing care of 
the student and support and management of his/her school-related challenges.  The 
process of screening students or identifying those struggling with OTMP skills in an effort to 
better support them will become part of school standards. No contact information about 
students or families collected as part of screening will be released to the study team without 

 
 
 
 
 
 
32 
parental permission/expressed interest in this study. Screening students for participation in 
this study does not adversely affect their rights and welfare, nor could they practicably be 
identified for this beneficial program without an identified OTMP skill deficit.  
8.6.2 Consent for Student/Parent/Legal Guardian (and Caregiver if applicable) 
Dyads 
After a student is identified and meets study criteria, the school partner will contact the 
family to gauge interest in the study. If families are interested, the school partner will ask 
permission to share family contact information (phone and email address) with the CHOP 
research team. If the family agrees, then a member of the research team will contact the 
family to explain the study and obtain written informed consent from the parent/legal 
guardian and assent from the student. If the family provides consent, a member of the 
research team will inform the student’s teacher of the family’s enrollment in the project.  The 
family and teacher will be informed that they have the right to withdraw participation in the 
study at any time. 
If another adult caregiver (other than a parent/legal guardian) is a primary caregiver of the 
child and supports the child with schoolwork and communication with the school, he/she 
may be enrolled as a research participant (with permission from the parent/legal guardian). 
This adult would only be consenting for his/her own participation in the research study. This 
adult could not consent for the student’s participation in the research study as that is 
needed from the parent/legal guardian. The caregiver’s role as a research participant would 
include completion of a demographic form, completion of outcomes measures, and 
participation in parent meetings which may be audio recorded. 
Study procedures as well as potential risks, benefits and treatment alternatives will be 
described to families at the time participation in the study intervention is sought. No student 
will be asked to participate if demonstrably unwilling, even if his or her parent wishes it. 
Students and their parents will be clearly informed of the voluntary and confidential nature 
of their participation, that treatment services will be provided in the school setting, and of 
their right to terminate their participation at any time without penalty.  Ample opportunity will 
be provided for them to ask any questions they may have of study team.  If the family 
agrees to participate, the consent form will be signed. The PI will retain copies of the signed 
consent and assent forms, and parents will be given a copy of these forms (either hard-
copy or provided electronically thru e-mail).   
If the study team has exhausted all possible ways to meet a parent for the consent process 
in-person and it is just not feasible, the study team member will discuss the ICF with the 
parent over the phone (or a web-based HIPAA compliant video conference platform 
provided by CHOP) and answer any questions they may have about the study.  Afterward, 
if the parent/student is interested in participating, the parent may return a copy of the signed 
consent form to the team member via fax or mail/email.   
Written informed consent may also be obtained electronically through REDCap. The 
parent/legal guardian would receive a link to a secure REDCap portal in which they will be 
asked to enter their name, their child’s name, and the date to indicate their consent. The 
provision of the parent/legal guardian name and child’s name will associate the informed 
consent document with the participant. The REDCap portal will contain the complete 
informed consent document with the exact same text as the paper consent copy. The study 
team will email a copy of the completed electronic consent form to the family, with the 
instruction to either save or print a copy of this form. These electronically signed consent 

 
 
 
 
 
 
33 
forms will be printed out from REDCap and stored with paper consent forms in locked filing 
cabinets in the Roberts Center for Pediatric Research. 
Electronic signature for an informed consent document for caregivers may also be obtained 
via the procedure detailed above if it is not possible to meet with the caregiver in person or 
obtain via email/fax. In this case, the caregiver will receive a link to a secure REDCap portal 
in which he/she will be asked to enter his/her name and the date to indicate his/her 
consent. 
Once parental consent is obtained/documented via fax/email or REDCap, student assent 
will be obtained either in-person by a study team member in the school, via the phone or 
thru a web-based HIPAA complaint video conference software provided by CHOP.  No 
study procedures will take place in the time between obtaining documentation of consent 
from the parent/legal guardian and obtaining student assent.   
Students or families who are in need of treatment, but do not qualify for this study or decide 
not to participate will be provided with appropriate treatment referrals, in collaboration with 
the school partner. 
8.6.3 Verbal Consent for School Partners and Teachers in the Intervention 
Condition 
Consent for the participation of school partners and teachers in the intervention condition of 
this study will be obtained verbally. Teachers will be provided with an information sheet 
either in-person, via email or via a REDCap link, outlining what their participation will entail 
(completion of questionnaires and implementation of /participation in recorded intervention 
sessions).  A consent letter will be provided either in-person, via email or via a REDCap link 
to school partners that outlines their participation. Teachers and school partners will be 
given the same opportunity as families to ask questions and make an informed decision 
regarding their involvement.  If it is not possible to have an in-person meeting with a teacher 
and/or school partner, a direct email to the teacher/school partner will provide contact 
information (phone/email) of the study team should they have any questions/concerns. 
Consent will be obtained by study team members, which will include Co-Investigators, Post-
Doctoral Fellows, Research Coordinators, Research Assistants, and other research team 
members.  Refusal to participate will not affect their employment at the participating school 
or their relationship with CHOP.  
 
8.6.4 Verbal Consent for School Partners and Teachers in the TAU Control 
Condition 
Consent for the participation of school partners and teachers in the TAU condition of this 
study will be obtained verbally. Teachers will be provided with an information sheet either 
in-person, via email or via a REDCap link, outlining what their participation will entail 
(completion of questionnaires).  A consent letter will be provided either in-person, via email 
or via a REDCap link to school partners that outlines their participation. Teachers and 
school partners will be given the same opportunity as families to ask questions and make 
an informed decision regarding their involvement.  If it is not possible to have an in-person 
meeting with a teacher and/or school partner, a direct email to the teacher/school partner 
will provide contact information (phone/email) of the study team should they have any 
questions/concerns. Consent will be obtained by Study Team Members, which will include 
Co-Investigators, Post-Doctoral Fellows, and other study team members.  Refusal to 

 
 
 
 
 
 
34 
participate will not affect their employment at the participating school or their relationship 
with CHOP. 
 
8.6.5 Verbal Consent for Trainers 
Trainers are study team members as well as secondary research subjects. Trainers will be 
provided with an information sheet outlining what their participation, as a research subject, 
will entail – completion of demographic questionnaire, use of audio recording data of 
consultation and coaching sessions with school partner for research purposes, and use of 
fidelity checklist data for research purposes. All of these procedures are detailed in the prior 
protocol sections. 
 
Informed Consent of trainers will be obtained verbally. Trainers are employed at CHOP and 
will not be paid for their participation as a secondary research participant. A waiver of 
documentation of consent is being requested for these participants. Verbal consent will be 
documented internally by the study team. A study team member other than a principal 
investigator will obtain verbal consent to prevent coercion.  
 
Given that these participants are research study team members providing a service as a 
part of this study, the audio recording and completion of fidelity checklists will not be 
voluntary. Completion of fidelity checklists and audio recording is a widely accepted, 
standard practice in the delivery of a behavioral intervention to monitor adherence to an 
intervention manual. These checklists and recordings will be used in the clinical supervision 
of trainers when applicable. 
 
The use of the fidelity checklist data and audio recordings for research purposes (beyond 
use in clinical supervision) will be voluntary. Completion of the demographic form for 
research purposes will also be voluntary. Participants will be given time to ask questions 
and make an informed decision regarding their completion of the demographic 
questionnaire and use of the “data” from the fidelity checklists and audio recordings for 
research purposes. The fidelity checklists, audio recordings, and demographic form (used 
for research purposes) will not have a negative impact on the trainer’s employability at 
CHOP. If a trainer declines participation as a secondary research participant, the fidelity 
checklists and audio recordings will ONLY be used for purposes of clinical supervision. This 
data would not be analyzed for research purposes. 
 
8.7 
Payment to Subjects/Families 
 
Parent/Legal Guardian/Caregiver Stipends. All parents/legal guardians/caregivers 
completing measures will be given a stipend of $30 for completing assessment forms at 
each time point. Forms will be collected at four time points: baseline, post treatment, 5-
month follow-up and 12-month follow-up.  
 
Student Compensation. Student participants will receive small prizes (valued at $2 or 
less) for actively participating in study sessions and for completion of measures at four time 
points: baseline, post-treatment, 5-month follow-up and 12-month follow-up. 
 
Teacher Stipends. Teachers of participating students will be given a stipend of $30 per 
student for completing assessment forms at each study assessment time point. Forms will 
be collected from all participants at baseline, post-treatment, 5-month follow-up, and 12-
month follow up. 

 
 
 
 
 
 
35 
 
School Staff Buyout Time. For their work collaborating with us in conducting the OST-S 
groups, school partners’ time will be bought out so that the school can pay for replacement 
staff during this time. Our budget calculations assume that for each OST-S group, a school 
partner will work with us 4 hours a week during the 8 weeks of the OST-S group, running 
two group sessions a week, preparing for the group, consulting with teachers and parents 
and meeting with study team trainers for consultation and coaching. In addition, we are 
assuming that each year they run groups, school staff will spend up to 8 hours in training 
during the weeks prior to running the first of the two groups. We have also allocated 4 hours 
per group for both OST-S and TAU groups to compensate the time that they spend 
assisting in the eligibility assessment and consent process (contacting families).  
 
School Partner Stipends. In addition to school staff buy-out, school partners in both 
conditions will be compensated $50 for their effort is assisting with student recruitment of 
two OST-S groups (up to 4 students each) (contacting families, collecting referral forms 
from teachers, and collaborating with CHOP staff). The stipend will be provided to the 
school partner each year after the eligible students are enrolled for that particular school 
year. If two school partners assist with the recruitment of students each school partner will 
receive $25 for assistance in recruiting one OST-S group (up to 4 students). 
 
In addition, a stipend of $25 will be provided to the school partners in both conditions at 
each of the 4 data collection time points to compensate them for assisting CHOP staff in 
collecting data from teachers, parents, and students within the school per OST-S group. 
This often requires additional time and effort on behalf of the school partner to coordinate 
student and teacher schedules in collaboration with CHOP staff. The stipend will be 
provided to the school partner after all data from a time point for the OST-S group has been 
collected (i.e. baseline, post-treatment, 5 Month, and 12 Month.) 
 
For school partners who are in a school assigned to the OST-S Condition only, school 
partners will be compensated $50 per group at two different times during the delivery of the 
OST-S intervention (mid-intervention and at the end of the intervention). This compensation 
is for the assistance of the school partner for data collection for research purposes that 
occurs during the OST-S groups. 
 
School partners will also be reimbursed (nontaxable) for travel expenses in the case that 
they have to travel to a location (other than their own school) for the initial in-service training 
as described above in Section 3.1.2 
 
Stipends for all participants will be issued on an electronic bankcard that functions like a 
debit card. Participants will be informed that their personal information to register the card 
will be shared with the bank institution. 
 
Trainers will not be compensated for their role as a secondary research participant. 
 
9 
PUBLICATION 
We will disseminate information to researchers and practitioners in school psychology, 
school mental health, special education, and clinical child psychology through conference 
presentations and publications in peer-reviewed journals. Conferences targeted include 
National Association of School Psychologists, Council for Exceptional Children, Association 

 
 
 
 
 
 
36 
for Behavioral and Cognitive Therapies, and Advancing School Mental Health. Journals to 
target include Journal of School Psychology, School Psychology Review, School Mental 
Health, Advances in School Mental Health Promotion, Exceptional Children, and Journal of 
Special Education. Further, the investigators are frequently asked to present to school 
districts. We will highlight the results of this study in these presentations. In addition, a 
summary of study results will be posted on the “Resources” section of the CHOP ADHD 
Center website, as well as on the NYU Child Study Center “About Our Kids” website. Lastly, 
in collaboration with CHOP Public Relations, we will publicize the results to parents, 
teachers, and intervention providers through press releases and notifications on the CHOP 
Facebook page and Twitter feed. 
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