Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 2
Phase: NA
Conditions: Sleep Disturbance, Sleep Deprivation, Sleep
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
  
Title: 
Implementing evidence-based behavioral sleep intervention in 
urban primary care: Aim 2 
Short Title 
Aim 2 Sleep Intervention 
eIRB Number 
19-016482 
Protocol Date: 
January 2, 2019 
Amendment 1 Date: October 21, 2019 
Amendment 3 Date: January 2, 2020 
Amendment 2 Date: December 5, 2019 
Amendment 4 Date: January 8, 2020 
Sponsor 
 Eunice Kennedy Shriver National Institute of Child Health and Human Development 
 1 Center Drive, Bethesda, MD 20892 
USA 
Study Principal Investigator 
Ariel A. Williamson, Ph.D. 
Roberts Center for Pediatric Research, Room 8202 
Philadelphia, PA 19046 
Phone 267-425-1301 
email: williamsoa@email.chop.edu  
 
 

  
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms ............................................................................. iv 
Abstract .................................................................................................................................. v 
Table 1: Schedule of Study Procedures .............................................................................. vi 
Figure 1: Study Diagram ..................................................................................................... vii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION..................................... 1 
1.3 
RELEVANT LITERATURE AND DATA ..................................................................................................... 1 
1.4 
COMPLIANCE STATEMENT .................................................................................................................... 2 
2 
STUDY OBJECTIVES .............................................................................................................................. 3 
2.1 
PRIMARY OBJECTIVE (OR AIM)............................................................................................................. 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 3 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN.................................................................................................. 3 
3.1.1 
Screening Phase .............................................................................................................................. 3 
3.1.2 
Study Intervention Phase ................................................................................................................. 5 
3.1.3 
Follow-up Phase .............................................................................................................................. 5 
3.2 
ALLOCATION TO INTERVENTION GROUPS AND BLINDING .................................................................... 6 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 6 
3.3.1 
Duration of Study Participation ...................................................................................................... 6 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 6 
3.4 
STUDY POPULATION ............................................................................................................................. 6 
3.4.1 
Inclusion Criteria ............................................................................................................................ 6 
3.4.2 
Exclusion Criteria ........................................................................................................................... 6 
4 
STUDY PROCEDURES ............................................................................................................................ 7 
4.1 
SCREENING PHASE ................................................................................................................................ 7 
4.2 
BASELINE ASSESSMENT (PRE-INTERVENTION) ..................................................................................... 7 
4.3 
STUDY TREATMENT PHASE .................................................................................................................. 7 
4.3.1 
Procedures for training Sleep Well! interventionists ...................................................................... 8 
4.4 
FOLLOW-UP PHASE (POST-INTERVENTION) .......................................................................................... 8 
4.5 
UNSCHEDULED VISITS .......................................................................................................................... 9 
4.6 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................. 9 
4.7 
EARLY TERMINATION STUDY VISIT ..................................................................................................... 9 
5 
STUDY EVALUATIONS AND MEASUREMENTS.............................................................................. 9 
5.1 
SCREENING MEASURES......................................................................................................................... 9 
5.1.1 
Medical Record Review ................................................................................................................... 9 
5.1.2 
Eligibility Screening Questionnaire .............................................................................................. 10 
5.2 
MEASURES OF TREATMENT FEASIBILITY AND ACCEPTABILITY (PRIMARY OUTCOMES) .................... 10 
5.3 
DEMOGRAPHIC AND CHILD SLEEP MEASURES (SECONDARY OUTCOMES) ......................................... 11 
5.4 
SAFETY EVALUATION ......................................................................................................................... 12 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 12 
6.1 
PRIMARY ENDPOINTS ......................................................................................................................... 12 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 12 
6.3 
CONTROL OF BIAS AND CONFOUNDING .............................................................................................. 12 
6.4 
STATISTICAL METHODS ...................................................................................................................... 12 
6.5 
SAMPLE SIZE AND POWER .................................................................................................................. 13 

 
 
 
 
 
 
 
 
iii
7 
SAFETY MANAGEMENT ..................................................................................................................... 13 
7.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 13 
7.2 
ADVERSE EVENT REPORTING ............................................................................................................. 13 
8 
STUDY ADMINISTRATION ................................................................................................................. 14 
8.1 
TREATMENT ASSIGNMENT METHODS ................................................................................................. 14 
8.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 14 
8.3 
CONFIDENTIALITY .............................................................................................................................. 15 
8.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 16 
8.4.1 
Data and Safety Monitoring Plan.................................................................................................. 16 
8.4.2 
Risk Assessment ............................................................................................................................. 16 
8.4.3 
Potential Benefits of Trial Participation ....................................................................................... 17 
8.4.4 
Risk-Benefit Assessment ................................................................................................................ 17 
8.5 
RECRUITMENT STRATEGY .................................................................................................................. 18 
8.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 18 
8.6.1 
Waiver of HIPAA Authorization to Screen Medical Records ........................................................ 18 
8.6.2 
Alteration of HIPAA Authorization for Screening ......................................................................... 18 
8.6.3 
Combined Informed Consent-Authorization of HIPAA for Study Procedures .............................. 18 
8.6.4 
Waiver of Assent ............................................................................................................................ 19 
8.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 19 
8.7.1 
Payments to caregivers for time, effort and inconvenience (i.e. compensation) ........................... 19 
8.7.2 
Gifts ............................................................................................................................................... 20 
9 
PUBLICATION ........................................................................................................................................ 20 
10 
REFERENCES ................................................................................................................................. 20 
 

  
 
 
 
 
 
 
 
iv 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
 
Adverse Event 
BCSQ 
 
Brief Child Sleep Questionnaire 
BMI 
 
Body Mass Index 
DSMB 
 
Data Safety and Monitoring Board 
IRB 
 
Institutional Review Board 
EMR 
 
Electronic Medical Record 
OSA 
 
Obstructive Sleep Apnea 
PHI 
 
Protected Health Information 
PI 
 
Principal Investigator 
REC 
 
Recruitment and Enhancement Core 
REDCap 
 
Research Electronic Data Capture 
SES 
 
Socio-Economic Status 
WCV 
 
Well Child Visit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
v
ABSTRACT 
Context:  (Background) 
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers 
and preschoolers and disproportionately impact lower socioeconomic status (SES) children. 
Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-
SES children or in primary care, an accessible service delivery setting. 
Objectives:  
The primary objective of this study is to determine the whether the Sleep Well! behavioral 
sleep intervention is feasible and acceptable to families. We will also examine the direction 
and magnitude of change in child sleep from pre-intervention to post-intervention. 
Study Design:  
This is a preliminary open trial of the Sleep Well! program with pre-intervention and post-
intervention assessments. 
Setting/Participants: 
Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from 3 
CHOP urban primary care sites (South Philadelphia, Cobbs Creek, Karabots). A maximum 
of 20 caregiver-child dyads will participate in the intervention.  
Study Interventions and Measures:  
Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have 
a caregiver-reported sleep problem or who are not getting enough sleep. The intervention 
includes evidence-based behavioral sleep approaches and strategies to engage and empower 
families. The primary outcomes for this open trial are feasibility (number of caregivers 
recruited, engaged, and retained in intervention; participant intervention attendance rate) and 
caregiver acceptability, assessed via a questionnaire and qualitative post-intervention 
interview. Secondary outcomes are the direction and magnitude in any pre- to post-
intervention change in child sleep.

 
page vi 
  
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES 
* = Completed at each treatment session and phone follow-up 
** = Optional; offered to all families who can complete baseline measures in-person. 
 
 
 
Procedure 
Screening/ 
Eligibility 
Pre-
intervention 
(baseline) 
Intervention 
Phase 
Post-
intervention 
Measures to Determine Eligibility 
Screening eligibility 
measure 
Caregiver-
reported 
X 
 
 
 
Measures of Treatment Feasibility and Acceptability  
Screening rate 
Study team-
documented 
X 
X 
 
X 
Recruitment rate 
Study team-
documented 
 
X 
 
X 
Retention rate 
Study-team 
documented 
 
X 
X 
X 
Intervention usability 
Study-team 
rated 
 
 
 
X 
Family engagement* 
Student-team 
documented 
 
 
X 
 
Intervention adherence* 
Study-team 
rated 
 
 
X 
 
Intervention fidelity* 
Study-team 
rated 
 
 
X 
 
Treatment acceptability: 
Treatment Evaluation 
Inventory—Short Form 
Caregiver-
reported 
 
 
 
X 
Treatment acceptability: 
Caregiver interview 
Caregiver-
reported 
 
 
 
X 
Assessment process 
Study-team 
documented 
 
X 
 
X 
Demographic and Child Sleep Measures 
Child demographic 
information 
Study team- 
abstracted from 
EMR 
 
X 
 
 
Caregiver demographic 
and family information 
Caregiver-
reported 
 
X 
 
 
Previous service use  
Caregiver-
reported 
 
X 
 
 
Brief Child Sleep 
Questionnaire 
Caregiver-
reported 
 
X 
 
X 
Daily sleep diary (7 
days) 
Caregiver-
reported 
 
X 
 
X 
Actiwatch (objective 
sleep monitor, 7 days)** 
Caregiver-
reported 
 
X 
 
X 

 
page vii 
  
 
 
 
FIGURE 1: STUDY DIAGRAM 
 
 
 
 
Referral from provider 
or patient (via flyer; 
email, or phone call)  
Phone screening for 
eligibility   
Screen 
failure or 
decline   
Written or 
electronically obtained 
(via REDCap) consent   
Baseline assessment 
(pre-intervention)   
Sleep Well! 
Intervention phase (2-3 
sessions + mobile 
contact)   
Post-intervention 
assessment   
0-3 weeks post-enrollment 
4-7-week intervention phase 
1-2 weeks post-intervention  

 
  
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Behavioral sleep problems, including insomnia and insufficient sleep, are associated with 
adverse physical,1 neurobehavioral,2,3 and social-emotional outcomes.4 Sleep problems 
impact 20-30% of young children5 and disproportionately impact lower-SES children.6-8 
There is little research on behavioral sleep interventions with lower-SES youth, and no 
studies have examined these interventions in primary care, an accessible setting. This project 
will the preliminary feasibility and acceptability of a behavioral sleep intervention for lower-
SES toddlers and preschoolers that is implemented in primary care. 
1.2 Name and Description of Investigational Product or Intervention 
Sleep Well!, a behavioral sleep intervention for toddlers and preschoolers, is being tested. 
The program includes standard behavioral sleep treatment approaches (caregiver education 
about healthy sleep habits; development of bedtime routine and sleep schedule; behavioral 
management of bedtime tantrums) with adaptations (see 1.3, below) for the target population 
(lower-SES caregivers) and context (pediatric primary care). 
1.3 Relevant Literature and Data 
Treating early childhood behavioral sleep problems is a key strategy for health 
promotion. Given the rapid neurobehavioral growth in toddlers and preschoolers,9 early 
childhood sleep problems may be especially detrimental. Early behavioral sleep problems 
predict concurrent and subsequent neurobehavioral (inattention; poor response inhibition)2-4 
and social-emotional10-12 problems, which can impair school outcomes.13,14 
 
Behavioral sleep problems are more prevalent in lower-socioeconomic status (SES) 
children.6,8,15 Behavioral sleep problems including pediatric insomnia (bedtime problems; 
night awakenings) and insufficient sleep are found in 20-30% of young children.16,17 Lower-
SES children show greater insomnia symptoms,7,15,18 shorter sleep duration, and worse sleep 
quality,3,6,8 even when controlling for other factors such as child race/ethnicity.7,18,19  
 
Although there are robust behavioral treatments for child sleep problems, studies rarely 
examine these treatments in lower-SES children with sleep problems.17,20,21 Brief 
interventions result in improvements in child sleep and behavior.22,23 Intervention content 
generally involves caregiver education about child sleep needs and healthy habits and 
implementing behavioral interventions, such as a consistent bedtime routine and sleep 
schedule, parental limit-setting, and reducing caregiver presence in the child’s bedroom at 
bedtime.17,20,24 Two studies have tested sleep health promotion for lower-SES children without 
sleep problems.25,26 A randomized trial with Head Start families26 found that one session of 
sleep education and a 2-week classroom curriculum resulted in increased preschooler sleep 
duration. We25 randomly assigned lower-SES children receiving a bed from a charity program 
to sleep education or a dental hygiene control, and found reductions in electronic items in the 
bedroom and increased child sleep duration in the sleep education condition.  
 

 
  
 
 
 
2
Behavioral sleep treatments have not been implemented in primary care. Primary care is 
an accessible and widely used service setting,27,28 especially in early childhood when there is 
increased need for well child visits and vaccinations.29 Receiving care in this setting may be 
more feasible for lower-SES families, who may lack access to specialty care.30-32 However, 
sleep problems are under-treated in primary care,27,33,34 and there is a nationwide shortage of 
behavioral sleep specialty care providers.35 The 2015 NIH and Sleep Research Society 
Workshop emphasized the need to translate evidence-based sleep interventions into practice 
settings.36 During the past 20 years, there has been a major emphasis on integrating 
behavioral health services into primary practice.28 To be responsive to this important 
practice shift, which has incorporated behavioral health clinicians into primary care, research 
is needed to identify how evidence-based interventions can be implemented in an 
integrated primary care context.37  
 
Adaptations to behavioral sleep intervention are needed for effective implementation in 
urban primary care. Previous research38 indicates a high need to adapt the content and 
service delivery methods of early childhood sleep interventions for a lower-SES sample and 
for implementation in the primary care context. Content adaptations include developing 
intervention materials for lower health literacy and education in lower-SES caregivers.39 Shift-
work and single parenthood, which are both common in lower-SES families, are each linked 
to increased parenting stress,40-43 which can make intervention components such as consistent 
bedtime routines difficult to implement.7 Other intervention components, such as reducing 
parent presence in the bedroom, may also need adaptation to accommodate socio-cultural 
variation in beliefs about sleep18,44 and increased bed- and room-sharing in lower-SES 
families.45 Other modifications may be needed, such as tailoring parenting strategies for 
mothers with depressed mood, as previous studies15,46,47 show that caregiver depression and 
child sleep problems are significantly associated across different levels of SES. 
 
Service delivery method adaptations include enhanced engagement, empowerment, and 
retention strategies may be needed, as attrition is common in lower-SES families facing 
multiple stressors (e.g., housing instability, childcare and transportation issues).48-52 
Additionally, pretreatment motivational strategies53 to increase engagement may be needed. 
Supplemental methods to provide content to families, such as via text messages, may also be 
appropriate. A trauma-informed approach may also need to be integrated due to high rates of 
violence exposure in lower-SES contexts.54-56  
 
1.4 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46 and the Good Clinical Practice: 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, and will report unanticipated problems involving risks to subjects or others in 
accordance with The Children’s Hospital of Philadelphia IRB Policies and Procedures and all 

 
  
 
 
 
3
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.  
2 
STUDY OBJECTIVES 
The purpose of the study is to test the preliminary feasibility and acceptability of a behavioral 
sleep intervention for lower-SES toddlers and preschoolers that is implemented in primary 
care. 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to determine the whether the behavioral sleep 
intervention is feasible and acceptable to families.  
2.2 Secondary Objectives (or Aim) 
The secondary objectives are to: 
• Examine the magnitude and direction of change in child sleep from pre- to post 
intervention. 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This is a small open pilot trial of Sleep Well!, a behavioral sleep program for toddlers and 
preschoolers that will be implemented at 3 of the CHOP urban primary care sites. Following 
referral, potentially eligible families will be screened by phone for intervention eligibility. 
Eligible and interested participants will be consented and scheduled for a pre-intervention 
(baseline) assessment occurring 0-3 weeks post-enrollment. The intervention consists of 2-3 
in-person sessions with periodic phone check-ins over a 4- to 7-week period. The post-
intervention assessment will occur 1-2 weeks post-intervention (see Figure 1, above). 
Outcomes related to intervention feasibility and acceptability will be assessed throughout the 
duration of the study period (see Table 1, above). Caregiver participants will complete 
baseline demographic information and ratings of their child’s sleep. Actigraph devices to 
objectively measure sleep will also be offered as an optional assessment. At post-intervention, 
caregiver participants will also provide ratings of their child’s sleep and participate in a 
qualitative interview to provide intervention content and delivery feedback. 
3.1.1 Screening Phase 
Potential participants will be recruited for study eligibility screening through multiple 
methods. 
First, providers (physicians, nurses, social workers, and psychologists) practicing at the South 
Philadelphia, Cobbs Creek, and Karabots primary care locations will identify potentially 
eligible families of young children with sleep problems for this study. The study team will 
also post a flyer for participants (see below and uploaded recruitment document) in providers’ 
office to remind them of the study and to encourage referrals.  This flyer will also be emailed 
to all of the providers. A smartphrase in Epic (see uploaded recruitment document) will be 
made available to providers practicing at these sites to facilitate recruitment and to provide 

 
  
 
 
 
4
families with information. Families who have sleep concerns and are potentially eligible will 
be asked if they would be interested in participating in an intervention program to improve 
child sleep. The providers will then provide the child’s name and either the date of birth and/or 
medical record number (MRN) of interested families to the study team, or provide the 
smartphrase to families in the After Visit Summary. 
Second, the study team will also identify possible participants by reviewing providers’ 
schedules prior to the date of the visit for basic eligibility criteria, and will contact the possible 
participant by telephone prior to the clinic visit. 
Third, the study team will also use printed flyers and tear pads, which will be posted in the 
providers’ waiting rooms, will be handed out to families, and will be displayed for potential 
families to take. 
Fourth, we have requested approval to use data collected as part of IRB 18-015041 on patient 
and provider perceptions of early childhood sleep problems.  This study was conducted by the 
principal investigator of this study, Dr. Ariel Williamson. Dr. Williamson will identify 
potentially eligible participants from IRB 18-015041 and notify the current study team of the 
patient name and MRN. The current study team will then contact these potentially eligible 
participants for recruitment in the current study by telephone using the screening procedure 
and methods identified below. 
Fifth, the Recruitment Enhancement Core (REC) will provide in assistance with recruitment 
plan development and may assist in identifying and contacting potential participants using the 
CRU, the CHOP Recruitment Registry, social media and internal communication resources. 
Please see the REC e-mail uploaded with this protocol for further information. The REC also 
engages community partners and facilitates outreach on behalf of the research Institute and 
CHOP research studies. Any recruitment materials distributed by REC, such as tear pads and 
recruitment flyers, will first be submitted to the IRB for review and approval prior to use. Of 
note, we have included the REC e-mail, tear pads, and recruitment flyers with this submission. 
Any additional recruitment materials, such as social media posts, will be submitted to the IRB 
for review prior to any use of these materials. 
For these methods we are requesting a waiver of HIPAA authorization to screen medical 
records in the EHR to ensure that families that are contacted for the study meet basic 
eligibility criteria available in the child’s medical record. 
For potentially eligible families, the study team will contact families by telephone and, for 
interested families, screen them for the study using inclusion/exclusion criteria and an 
associated eligibility screening survey, and schedule eligible and interested families for 
informed consent procedures. The study team is also requesting an alteration of 
documentation of HIPAA authorization to screen given that the study team is located in 
the Roberts building and will not have in-person contact with the families at the primary care 
sites. It would therefore not be feasible to obtain written documentation of HIPAA 
authorization for screening from these families. In addition, this method will reduce any 
burden to participants in traveling to complete in-person eligibility screening. 

 
  
 
 
 
5
The phone screening will include requesting that parents/legal guardians respond to questions 
to determine whether exclusion criteria are present. If families are eligible, they will be 
scheduled for a study visit at their child’s CHOP primary care practice to obtain written 
consent for the main study and collect baseline data. If families are unable to meet in-person 
for baseline procedures, they will be provided the option to complete electronic informed 
consent procedures via REDCap (see below). During the screening phone call, families will 
be informed of their choice to participate or not. If families decide not to participate, they will 
be referred to the CHOP Sleep Center, consistent with the current standard of care for 
behavioral sleep problems. 
Given that the CHOP urban primary care sites see approximately 49,600 children per year, 
we believe that we will be able to recruit a sufficient number of participants to meet the goals 
for this objective. In addition, this recruitment strategy has been discussed with the primary 
care sites for this study, and has been approved by the Pediatric Research Consortium. 
3.1.2 Study Intervention Phase 
Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally 
comprised of healthy sleep advice and tested in the context of a sleep health education 
campaign for impoverished children.25 Based on our preliminary research regarding the need 
for sleep intervention in primary care,38 we have expanded the intervention to more 
comprehensively address poor sleep health behaviors (e.g., use of electronics at bedtime; 
inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia 
(difficulty falling and staying asleep; the need for caregiver presence at bedtime) and 
insufficient sleep in toddlers and preschoolers who are living in disadvantaged contexts. 
Intervention components are based on effective pediatric behavioral sleep treatments.21,22,24,57  
Adaptations to the program content and delivery have been made based on preliminary results 
from our previous study (IRB 18-015041) with primary care providers in the target urban 
primary care context and caregivers of young children with sleep problems who are reflective 
of the target intervention population. For example, interventionists will use strategies to 
engage with and empower families, such as motivational interviewing and collaborative 
problem-solving.53 In-person session content will be reinforced via phone calls from 
interventionists. We will also send families intervention session appointment reminders and 
information about intervention content (e.g., reminders to follow a bedtime routine), using 
Twilio, which is integrated with REDCap. No PHI will be transmitted via text message, and 
families will be asked to contact the study team or interventionist by phone if they have any 
questions or concerns during the study assessments or intervention phase. Consistent with 
standards of clinical care for behavioral health services in the CHOP primary care network, 
sessions will be scheduled in the electronic health record, with progress notes for in-person 
visits and intervention-related phone calls also documented in the electronic health record.  
3.1.3 Follow-up Phase 
A follow-up assessment will occur with families either by phone or in-person, pending 
family availability, 1-2 weeks after the last contact with the Sleep Well! interventionist. The 
follow-up assessment will include caregiver-complete questionnaires and a brief qualitative 
interview. The follow-up assessment will be conducted by a research team member. 

 
  
 
 
 
6
3.2 Allocation to Intervention Groups and Blinding 
All participants will be allocated to the intervention condition, as this is a non-randomized, 
open trial. Blinding is not applicable. 
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per participant will be up to 3 months, to accommodate families needing 
to reschedule any assessments or intervention sessions. After screening and, for eligible 
families, enrollment, a baseline assessment will occur within 3 weeks. The enrolled family 
will then participate in the Sleep Well! intervention over the course of 4-7 weeks. The 
follow-up assessment will occur 1-2 weeks after the end of the intervention phase.   
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
This study will be conducted at the 3 CHOP-affiliated urban primary care sites in 
Pennsylvania (South Philadelphia, Cobbs Creek, and Karabots). 
It is expected that 80 caregiver-child dyads (total screening N = 160) will be screened to 
meet the recruitment goal of enrolling 30 caregiver-child dyads (total enrollment N = 60). 
Based on our previous research with the target population (IRB 18-015041) and intervention 
attrition rates (20-30%) in similar urban primary care contexts,58 it is expected that of those 
80 caregiver-child dyads screened, 30 will be enrolled in the main study to produce 20 
evaluable caregiver-child dyads (total evaluable N = 40). 
3.4 Study Population 
3.4.1 Inclusion Criteria 
1) Parental/guardian permission (informed consent) 
2) Caregiver participant is the parent or legal guardian of the child subject  
3) Caregiver/legal guardian 18 years of age. 
4) Child between the ages of 1 and 5 years. 
5) Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep 
Questionnaire item59,60 included in an eligibility screening questionnaire (see below) or 
child meets American Academy of Sleep Medicine51 diagnostic criteria for either pediatric 
insomnia or insufficient sleep, assessed through an eligibility screening questionnaire. 
6) English-speaking. 
 
3.4.2 Exclusion Criteria 
1) Caregiver is not parent or legal guardian of child participant. 
2) Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder; 
Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the 
disorder or treatment of the disorder impact sleep.  
3) Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-
compliant with study schedules or procedures. 
 

 
  
 
 
 
7
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES 
4.1 Screening Phase 
Procedures for screening referred and potentially eligible participants are described in detail 
above (section 3.1.1). The screening phase will be completed by a study team member and 
will include: 
• EMR review by a study team member after potential participant referral 
• Phone screening using eligibility screening questionnaire (section 5.1.2), after 
completing verbal HIPAA authorization 
• Scheduling of informed consent and baseline assessment (completed in person or 
electronically) 
4.2 Baseline Assessment (Pre-Intervention) 
The baseline assessment will be conducted by a study team member and will be completed 
in person or electronically. It will include: 
• Informed consent 
• Abstraction of child demographic information 
• Caregiver completion of caregiver demographic and family information 
questionnaire, previous treatment questionnaire, and Brief Child Sleep Questionnaire 
• 7-day daily sleep diary questionnaire via text messages delivered via REDCap and 
its integration with Twilio 
• Actigraphy for families who are able to conduct the baseline assessment in person 
(optional)  
If a caregiver has difficulty completing measures independently, a research assistant will 
read the items and provide assistance as needed. If a caregiver is unable or unwilling to 
receive the 7-day diary via text messages, we will offer to (a) e-mail the daily diary to the 
caregiver for 7 days or (b) have a research assistant call the caregiver by phone to administer 
the daily diary verbally for 7 days, with the research assistant entering caregiver responses 
into a REDCap database. 
4.3 Study Treatment Phase 
Sleep Well! will be provided over approximately 4-7 weeks, to allow for families to 
reschedule sessions as needed, and will include 2-3 sessions, depending on family needs. 
Intervention sessions will typically last about an hour, but session length may vary. Content 
is delivered in a modular format based on family goals and the child’s sleep concern (e.g., 
using electronics before bedtime; an inconsistent bedtime routine; etc.). To ensure high-
quality care, intervention providers will receive regular supervision. Providers will also 
contact families by phone to (a) promote attendance, engagement,53 and implementation of 
Sleep Well! strategies, (b) assist in resolving barriers to treatment, and (c) guide families to 
community resources as needed. As noted above (3.1.2), text messages about the intervention 

 
  
 
 
 
8
will also be sent to families via Twilio and its integration with REDCap. For ethical reasons, 
families will be informed that they have the right not to participate in the study. If they choose 
not to participate, they will be referred to the CHOP Sleep Center for management of 
behavioral sleep problems, consistent with the current standard of care at CHOP.   
Intervention sessions will be audio-recorded to monitor fidelity. After each intervention 
session and intervention-related phone call, the interventionist will document which 
intervention contents were used using an intervention-specific fidelity checklist. The study 
interventionist will also document any feedback regarding the intervention as a method to 
assess intervention feasibility and usability.  
4.3.1 Procedures for training Sleep Well! interventionists 
The initial Sleep Well! provider for the first 1-4 families enrolled will be the PI, Dr. Ariel 
Williamson, a licensed psychologist who is also a Diplomat in Behavioral Sleep Medicine. 
Consultation and peer supervision related to intervention delivery will occur weekly with Dr. 
Williamson’s mentor, Dr. Jodi Mindell, Associate Director of the CHOP Sleep Center and 
Diplomat in Behavioral Sleep Medicine. Other study interventionists will be advanced 
clinical, counseling, school psychology or social work graduate students.  Dr. Williamson will 
provide each interventionist with approximately 4 hours of training prior to intervention. 
Interventionists will be trained to implement the treatment manual and attend to process 
variables, including establishing trust, listening actively, and re-directing tangential 
comments. Dr. Williamson will provide the interventionists with weekly supervision based on 
review of audio-recorded intervention sessions. 
4.4 Follow-up Phase (Post-Intervention) 
The follow-up assessment will be conducted by a study team member and will be completed 
in person or electronically (questionnaires) and via telephone (interview). It will include: 
• Caregiver completion of Treatment Evaluation Inventory-Short Form, Brief Child 
Sleep Questionnaire 
• Caregiver completion of Multicultural Therapy Competency Inventory- Client 
Version (MTCI-CV)  
• 7-day daily sleep diary questionnaire via text messages delivered via REDCap and 
its integration with Twilio 
• Audio-recorded caregiver interview on intervention content and acceptability 
• Actigraphy for families who completed actigraphy assessment at baseline 
If a caregiver has difficulty completing measures independently, a research assistant will 
read the items and provide assistance as needed. If a caregiver is unable or unwilling to 
receive the 7-day diary via text messages, we will offer to (a) e-mail the daily diary to the 
caregiver for 7 days or (b) have a research assistant call the caregiver by phone to administer 
the daily diary verbally for 7 days, with the research assistant entering caregiver responses 
into a REDCap database. 

 
  
 
 
 
9
4.5 Unscheduled Visits 
We do not anticipate any unscheduled visits, although unscheduled phone contact may occur 
with some participants (e.g., concern related to participant safety reported by caregiver or 
study interventionist; issue with actigraph). 
Participant safety concern. Please see sections 7 and 8.4.1 for information about safety 
monitoring throughout this study. 
Actigraph issue.  If there are any issues with the actigraph device, families will be 
encouraged to contact a member of the study team by phone. Any issues will be handled 
primarily via phone, although an in-person visit may occur if the family must be provided 
with a replacement actigraph. 
Other follow-up issue.  If caregiver-child dyads that participated in the study contact the 
study team by phone to request follow-up, any issues will be handled via phone by PI Dr. 
Ariel Williamson, without an in-person visit.  
4.6 Subject Completion/Withdrawal 
Caregiver-child dyads 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 the emergence of exclusionary 
criteria. Children will be withdrawn from the study if any exclusionary criteria emerge during 
the study. Child well-being will be monitored by the interventionists and the caregiver 
throughout the study. If any adverse events occur that require clinical intervention during the 
course of study participation, a PI or co-investigator who is a licensed clinician will conduct 
a risk and safety assessment and make clinically appropriate referrals. 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 a separate, coded REDCap database 
used to track study attrition and any adverse events. 
4.7 Early Termination Study Visit 
We will attempt to contact all participants who withdraw from the study during the 
intervention phase so that we may complete the follow-up (post-intervention) assessment 
with these participants and offer any clinical referrals if needed. 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening Measures 
5.1.1 Medical Record Review 
Medical record review for eligibility purposes and abstraction for child demographic data 
(baseline assessment, section 4.2, above) will occur for child participants and will include 
the following items. PHI marked with a * are entered into the separate, password-protected 
Study ID and MRN database in REDCap used for maintaining confidentiality and storing 
family contact information needed for screening, enrollment, intervention procedures, and 
follow-up. 

 
  
 
 
 
10
• Child name* 
• Age at time of enrollment 
• Sex 
• Race 
• Ethnicity 
• BMI 
• Current medications 
• Current diagnoses 
• Current problem list 
• Insurance at time of enrollment 
• All family addresses on file, including zip code* 
•  Caregiver names, e-mail addresses, and telephone numbers* 
 
5.1.2 Eligibility Screening Questionnaire 
Caregivers will be asked questions to identify whether dyads are eligibility for the study. 
These questions are related to child medical or neurodevelopmental conditions, medications, 
and the presence of child sleep problems.  
5.2 Measures of Treatment Feasibility and Acceptability (Primary Outcomes) 
• Screening rate (feasibility): The study team will track the number of potentially 
eligible participants screened of those referred per month. 
• Recruitment rate (feasibility): The study team will track the number of potentially 
eligible participants enrolled of those screened per month. 
• Retention rate (feasibility): The study team will track the number of caregiver-child 
dyad participants who complete all study procedures following enrollment. 
• Assessment process (feasibility): The study team will track the number of proportion 
of participants who complete all assessments (pre-intervention and post-intervention) 
that were planned. 
• Intervention usability (feasibility): Study interventionists will keep records of 
barriers to and facilitators of the intervention content and procedures. 
• Family engagement and adherence (feasibility): Study interventionists will keep 
records of family intervention attendance, including the number of sessions that the 
family attended, rescheduled, and no-showed, and the number of phone calls that 
families completed. Study interventionists will also keep records of families’ usage 
of intervention strategies, based on feedback from families in-session. 
• Intervention fidelity (feasibility): Intervention fidelity, or the extent to which the 
intervention is delivered as intended, will be assessed using the following two 
methods. 
1. Intervention sessions will be audio-recorded and coded by a study team 
member. This information will be provided to the PI/interventionist 
supervisor, Dr. Ariel Williamson, who will use the information in her 
supervision of study interventionists. Telephone contact between families and 
interventionists will not be recorded. 

 
  
 
 
 
11
2. Interventionists will complete fidelity checklists61 that include items 
corresponding to the core components of Sleep Well! and to process items, 
including establishing trust, listening attentively, and re-directing tangential 
comments.  
• Treatment acceptability:  Treatment acceptability will be assessed using the 
following two methods. 
1.  Caregivers will complete the Treatment Evaluation Inventory—Short 
Form,62 a widely used measure of treatment acceptability that has been 
adapted for the purposes of the Sleep Well! intervention. 
2. Caregivers will complete the Multicultural Therapy Competency Inventory- 
Client Version (MTCI-CV)63 to assess patient’s perceptions of the Sleep 
Well! therapist’s cultural sensitivity during discussions about safe sleep. 
3. Caregivers will complete an audio-recorded, open-ended qualitative 
interview (15-20 minutes) with questions related to aspects of the 
intervention that were helpful/unhelpful, how the intervention could be 
improved, and the acceptability of the measurement process (see interview 
guide uploaded with study measures). 
5.3 Demographic and Child Sleep Measures (Secondary Outcomes) 
• Child Demographic Information: Child demographic information will be abstracted 
from the EMR (see section 5.1.1). 
• Caregiver Demographic and Family Questionnaire: Caregivers will complete a 
caregiver and family demographic questionnaire at baseline. Child data will include 
CHOP primary care site where child receives care, whether the child attends 
daycare/preschool, and where the child typically sleeps. Caregiver/family data will 
include age, sex, race, ethnicity, highest educational level obtained, relationship to 
child, income, employment status, relationship status, number of times the family has 
moved in the last year, and information about children and adults living in the home.  
• Previous Service Use Form: At baseline, caregivers will complete a form related to 
any previous treatment for child sleep or behavior problems. 
• Brief Child Sleep Questionnaire (BCSQ): Caregivers will complete the BCSQ59,60 to 
report on child sleep habits (sleep time, total sleep durations, night wakings, aspects 
of the sleep environment, etc.) and the severity of any caregiver-perceived sleep 
problems. The BCSQ is appropriate for children ages 1-5 years and has shown good 
reliability and moderate correspondence with actigraphic recordings of child-sleep.60  
• 7-Day Daily Child Sleep Diary: Items drawn from the BCSQ will be used to track 
regularity in child bedtime routines, bedtime activities, and 24-hour sleep schedule 
over 7 days at baseline (pre-intervention) and follow-up (post-intervention). 
• Actigraphy: Objective child sleep will be assessed using a Philips Respironics, Inc., 
Actiwatch Spectrum,63 which is a water-resistant accelerometer device. Consistent 
with guidelines for the reliable and valid use of actigraph devices in children,64 
caregivers will be instructed to keep the actigraph on their child’s wrist continuously 
for the 7-day period at baseline and the 7-day period at follow-up, with the exception 
of bath time or swimming, to ensure that at least 5 days of data (to account for 2 days 
of missing data) are obtained.64 Caregivers will be asked to press an event marker at 
lights-off and lights-on. Actigraph data show an 85.1-88.6% agreement with 

 
  
 
 
 
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polysomnography, which is the gold standard for objectively assessing sleep.64 
Actigraph data will be analyzed using Philips Actiwatch software and scored using 
guidelines for young children.64 Actigraphs will generate daily total estimates of 
child sleep onset, offset, and sleep time variability. 
5.4 Safety Evaluation 
Participant safety will be monitored by adverse events throughout the study. Please see the 
Data Safety and Monitoring Plan (section 8.4.1) for further information.  
6 
 STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoints 
The primary endpoints are overall ratings of intervention feasibility and acceptability for 
specific outcomes.  
6.2 Secondary Endpoints 
Secondary endpoints include the magnitude and direction of change in child sleep. 
6.3 Control of Bias and Confounding 
As a convenience sample, our participants may differ in important ways from those who 
choose not to participate in the study, which will limit the generalizability of our findings. 
We will mention this as a limitation of our study in any publications. In addition, in order to 
ensure that the subjects recruited from the study sites are representative of primary care 
patients presenting to these sites, we will monitor the demographics of our samples from 
each site to the CHOP Pediatric Research Consortium data on the demographics of patients 
at each site and to the demographics of primary care providers.  Finally, although we will 
attempt to recruit subjects evenly throughout the study period, recruitment during different 
times of the year (i.e., various seasons) could potentially impact child sleep. We will note 
this as a limitation in any study publications.  
6.4 Statistical Methods 
I will examine the following quantitative feasibility and acceptability outcomes through the 
use of descriptive statistics, which include means for continuous variables and proportions for 
categorical variables.  
• Screening (number of caregiver-child dyads referred and screened/month) 
• Recruitment (number of caregiver-child dyads enrolled/month) 
• Retention (number of dyads who complete intervention condition of those enrolled) 
• Intervention usability (interventionist-rated perceptions of intervention manual and 
strategies) 
• Family engagement (number of intervention sessions/phone calls completed) 
• Intervention adherence (interventionist-rated checklist) 
• Intervention fidelity (a: interventionist self-reported checklist; b: coding of the 
implementation of audio-recorded intervention sessions) 
• Intervention acceptability (caregiver-rated TEI-SF and MTCI-CV) 

 
  
 
 
 
13
• Assessment process (number of planned assessments that are completed) 
 
I will examine the following quantitative child sleep-related outcomes drawn from the 
caregiver-rated BCSQ and, for families that have it, actigraphy, through descriptive statistics 
(means; proportions). I will also estimate within-group effect sizes (Cohen’s d) with 95% 
confidence intervals. Effect sizes will be estimated as the ratio of the mean within-person 
change scores (post-treatment minus pre-treatment) to the standard deviation of change scores. 
Cohen’s d values will be examined to identify the direction and magnitude of effects. 
• BCSQ: 
o Child total (24-hour) sleep duration 
o Child sleep onset latency 
o Child night awakenings 
o Child bedtime resistance 
o Child sleep problems 
 
• Actigraphy (for families who have opted to complete it) 
o Sleep onset and offset 
o Sleep time regularity 
 
Interview data analysis will utilize an integrated approach,65 with both a priori codes and 
grounded theory codes that emerge from the data. We will use QSR NVivo© software for 
interview data analysis. The study team will create a codebook from the first three transcripts. 
After establishing a stable codebook, all transcripts will be coded. Every fifth transcript will 
be double coded to generate an interrater reliability (Kappa) index. Coding disagreements will 
be resolved through discussion. We will examine each code to identify patterns in the data 
and key themes.  
 
6.5 Sample Size and Power 
This open clinical trial is not designed to have sufficient power to test the efficacy or 
significance of intervention effects. A power analysis was thus not appropriate. The sample 
size for this study was identified through a review of the literature on the testing of preliminary 
behavioral intervention development/adaptation66-68 and through discussion with my mentors 
and co-investigators Drs. Alexander Fiks, Jodi Mindell, and Thomas Power.  
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. 

 
  
 
 
 
14
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 
Randomization and blinding procedures are not applicable for this non-randomized, open 
trial. 
8.2 Data Collection and Management 
The data collection and management plan described below is consistent with CHOP Policy 
A-3-9: Acceptable Use of Technology Resources that defines the requirements for 
encryption and security of computer systems. 
Confidentiality: A separate, password-protected REDCap database will be used as a master 
list linking PHI and study ID numbers. This master list will contain the child name, MRN, 
and the contact information for the family (caregiver name, family address, phone number, 
e-mail addresses) for communicating with participants. This master list database will be 
accessible only to members of the study team. All paper consent forms will be stored 
separately, in locked filing cabinets in the Roberts Center for Pediatric Research. Any 
electronically completed consent forms will be entered by participants into a separate, 
password-protected REDCap database with consent documents only identified by child and 
caregiver names. These electronic consent forms will be printed out from REDCap and 
stored with paper consent forms in the same locked filing cabinets in the Roberts Center for 
Pediatric Research. 
Participants will complete study questionnaires by entering responses electronically and 
directly into REDCap databases. Daily sleep diary information will be administered to 
participants via Twilio and its integration with REDCap. The REDCap databases are 
password-protected, accessible only to members of the study team, and only contain subject 
ID numbers and questionnaire responses. 
Actigraphy data will be identified via unique participant ID. These coded data will be stored 
in a password-protected CHOP network drive accessible only to study team members for 
actigraphy analysis. Once data have been downloaded from the actigraph device, data on the 
actigraph will be destroyed. 
Intervention sessions will be audio-recorded in person for fidelity purposes. For the 
qualitative post-intervention interview, participants’ responses will be audio-recorded in 
person or by telephone. All audio files will also be password-protected and temporarily 
saved on the secure CHOP computer network drive. Transfer of audio files from the audio 
device to the secure CHOP computer network drive will occur via a flash drive that is 
encrypted and password-protected per CHOP IT standards. Once the audio file is transferred 
from the audio-recording device, it will be deleted from the flash drive and from the audio-
recording device. In the drive on the password-protected computer, audio files will be 
labeled according to participants’ unique study ID numbers, and no identifying information 

 
  
 
 
 
15
will be used to label the files. Audio files of the intervention sessions will be analyzed by 
study team members for the coding of fidelity. Audio files of the interviews will also be 
transcribed and checked for accuracy. All audio files will be retained for a minimum of 6 
years, consistent with CHOP Data Retention Policy A-3-9, after which point they will be 
destroyed. Audio recordings may be sent to an outside professional transcription agency, 
ACTS Document Management located in South Point, Ohio. All files are securely stored, 
transmitted, and encrypted. The agency will remove all identifying information from the 
transcripts and destroy their copy of the audio files after transcription is complete. 
Transcribed interview data will be coded using participants’ unique study ID numbers. Any 
interviewer field notes taken during the interview will be coded using only the participants’ 
unique study ID numbers, and stored in a locked filing cabinet in the Roberts Center for 
Pediatric Research until the point of transcription. Interviewer field notes will then be 
destroyed. The transcribed interview and interviewer field note data will be stored in the 
secure and password-protected CHOP network drive.  
Security: Copies of only coded data (i.e., with participant unique study ID, demographic 
information, questionnaire responses, the transcribed interview and interviewer field note 
data) will be downloaded from REDCap for data analysis purposes. These data will be 
stored on the secure CHOP network drive. No identifying data from the separate, password-
protected REDCap dataset that contains the master list linking the participants’ identifying 
information and their unique study ID number will be downloaded, and the database will 
only be accessible on the secure, password-protected REDCap server. As noted above, for 
audio files, transfer of files from the audio device to the password-protected computer will 
occur via an encrypted and password-protected CHOP flash drive, consistent with CHOP IT 
security procedures. Uploads of audio files to the ACTS Document Management site for 
transcription purposes will also be encrypted.  ACTS Document Management has been 
vetted by CHOP and is compliant with all CHOP technology transfer policies. 
Anonymization: All identifiers that are stored in the separate, password protected REDCap 
database master list and the separate, password protected REDCap electronic consent 
database will be retained for 6 years and then destroyed, consistent with CHOP policy. The 
coded data will be retained indefinitely through password-protected files on the secure 
research server and on the REDCap platform.  
8.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
CHOP institutional policies and HIPAA on subject privacy. The PI, members of the study 
team, and other site personnel will not use such data and records for any purpose other than 
conducting the study.  
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 
any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI 
limited to dates and zip codes).  

 
  
 
 
 
16
8.4 Regulatory and Ethical Considerations 
8.4.1 Data and Safety Monitoring Plan 
The PI, Dr. Ariel Williamson, and her co-Investigators and mentors Drs. Alexander Fiks, Jodi 
Mindell, and Thomas Power will maintain oversight over data integrity and subject safety. 
The co-Investigators and mentors have extensive experience conducting clinical trials of 
behavioral interventions with caregivers and children, and will mentor Dr. Williamson on all 
aspects of data safety and monitoring.  
Each member of the research team will be instructed about his or her responsibility to maintain 
data collection integrity and participant safety. Members of the study team meet weekly with 
the study coordinator and PI to monitor safety and will be in contact by phone during all data 
collection and intervention periods. In addition, the PI and the co-Investigators are licensed 
pediatric providers who are experienced in talking with individuals who are under stress due 
to mood concerns, child behavior concerns, or contextual issues (e.g., poverty, housing 
instability, work-related stress). In addition, we will work closely with the CHOP Office of 
Research Compliance to insure data collection integrity, the privacy of data, and participant 
safety, and to monitor procedural compliance. We will inform the IRB of serious adverse 
events (SAEs) in a timely manner. Other adverse events (AEs) will be reported annually.  
Additionally, a Data and Safety Monitoring Board (DSMB), comprised of a pediatric sleep 
provider, a pediatric psychologist, and a pediatric primary care provider who work internally 
at CHOP, will be appointed at the outset of this study, and this board will meet every 6 months 
and provide feedback to the research team. DSMB members have no conflicts of interest with 
the study team and are not involved in any study procedures. 
8.4.2 Risk Assessment 
Risks of participating in this study are not greater than minimal. There are no known 
physical or legal risks to participating in the study intervention. Potential risks are as 
follows: 
Families who are able to conduct the baseline assessment in person may choose to participate 
in an Actigraphy assessment. There are no risks with wearing an Actigraph, which is the size 
and shape of a small wristwatch, though some participants may consider it a minor 
inconvenience. 
Families may experience continued child sleep problems following the intervention phase. 
If families report continued child sleep concerns at post-intervention we will offer families a 
referral to the CHOP Sleep Center, which is the current standard of care for managing child 
sleep problems. 
Although we are not asking caregivers to report on any instances of child abuse or neglect, 
should a caregiver or child spontaneously disclose this information to us during the study 
procedures or intervention phase, we will file a Department of Human Services report in this 
regard. Based on standard behavioral health practices within the CHOP system, these 
procedures are likely to be effective in the case that additional behavioral health treatment 
and/or risk assessment are necessary.  

 
  
 
 
 
17
The study members responsible for data collection and intervention will offer participants an 
opportunity to reflect on their experience (i.e., ‘debrief’) after they have completed the study 
procedures/intervention. In the rare event that a participant necessitates psychological 
treatment due to adverse effects of study participation, or a caregiver spontaneously 
discloses low mood or other psychological concerns, the study team member will contact 
the PI by phone, and the PI will speak with the participant, provide behavioral health 
resources, and screen for any suicide/homicide risk in a manner consistent with routine 
behavioral health practice at CHOP. Resources to mitigate risk (crisis numbers; referral 
resources) will be provided to participants verbally. 
All information obtained during any of the risk assessment procedures described above will 
be used only for the purposes of determining appropriate follow-up care. Information about 
mandated child abuse reporting or concerns for the child’s safety will be documented in the 
child's medical record, and will not be stored with study data, or used for any study-related 
data analysis. It will not be stated in the medical record documentation that the child or 
caregiver are participating in a research study. For any caregiver-related risks (i.e., caregiver 
homicidal or suicidal risk), risk assessment information will be documented in a Note to File 
coded by the participant ID and will be stored separately from the consent form and in a 
separate REDCap database used for tracking purposes only. 
There is also the risk related to the potential loss of confidentiality.  All reasonable 
safeguards to secure the confidentiality of data will be taken by the study team (section 8.2).  
The risk of breach of privacy and confidentiality are greatly reduced by using password-
protected REDCap databases, storing data on secure CHOP computers and servers, and de-
identification of data when applicable.   
Additionally, a Certificate of Confidentiality (CoC) will be obtained to protect identifiable 
research information from forced disclosure. The CoC will allow all individuals who have 
access to research records to refuse to disclose identifying information on research participants 
in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, 
state, or local level. By protecting researchers and institutions from being compelled to 
disclose information that would identify research subjects, the CoC will help achieve the 
research objectives and promote participation in the study by assuring confidentiality and 
privacy to participants. 
 
8.4.3 Potential Benefits of Trial Participation 
Families in this study may learn information to manage their child’s sleep problems. 
Knowledge gained from this study will inform a larger pilot randomized trial of the Sleep 
Well! intervention. It is possible that families will not derive any direct benefits from study 
participation. 
8.4.4 Risk-Benefit Assessment 
The risks associated with this study are minimal and generally no greater than the risks of 
receiving the standard of care in the community (i.e., referral to the CHOP Sleep Center). 

 
  
 
 
 
18
8.5 Recruitment Strategy 
Potential participants will be recruited for study eligibility screening through multiple 
methods, including provider referral, review of well child visit schedules and related EMR 
data, study flyers and tear pads, recruitment emails to providers and via the REC, and 
participant information from a previous study (IRB 18-015041). Please see the detailed plan 
for study recruitment and screening described above in section 3.1.1. for further information. 
8.6 Informed Consent/Assent and HIPAA Authorization 
8.6.1 Waiver of HIPAA Authorization to Screen Medical Records 
We are requesting a waiver of HIPAA authorization to screen medical records in the 
EHR for children referred to the study or to identify potentially eligible participants via chart 
review. As described in section 3.1.1., this will ensure that families who are contacted 
appear to be eligible based on chart review.  
8.6.2 Alteration of HIPAA Authorization for Screening 
Members of the study team will be responsible for contacting referred, potentially eligible 
families to initiate the telephone screening for eligibility. Study members who contact 
families will introduce themselves as research team members of the Sleep Center and the 
Department of Child and Adolescent Psychiatry and Behavioral Sciences at CHOP. We are 
requesting an alteration of documentation of HIPAA authorization to screen. The 
eligibility screening procedure could not practicably be conducted without a waiver of HIPAA 
authorization, as the study team members contacting referred families are not located at the 
primary care sites. This method will also ensure that families do not have to travel to the 
primary care sites or the main hospital to undergo screening procedures. 
8.6.3 Combined Informed Consent-Authorization of HIPAA for Study Procedures 
Members of the study team will be responsible for obtaining informed consent for study 
procedures for all participants. For eligible families, informed consent using a combined 
consent-HIPAA authorization will occur either in person or electronically, via a secure 
REDCap portal, pending caregiver preferences and availability. Informed consent will be 
obtained from the child participant’s legal guardian. For families who agree to meet with the 
study team to perform the consent process in person, this meeting will take place in the waiting 
room of the primary care sites or at the CHOP Main Hospital, in spaces that are semi-private 
and far enough away from other patients in order to maintain privacy. If the waiting room at 
the primary care site is too crowded to maintain patient privacy, we will request to use a 
private room at each primary care site for the consent process. If informed consent is obtained 
electronically, the participant will receive a link to the 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 caregiver’s and child’s name will associate the consent document with 
the enrolled participant. The REDCap portal will contain the exact same information in the 
same format 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. See section 8.2 for information about secure maintenance of electronic consent data. 

 
  
 
 
 
19
For all consent procedures, families will be given unlimited time to decide their participation. 
Either in person or by phone with a member of the study team, families will be informed of 
the nature of this research, study procedures, and its potential benefits and possible risks. 
Families will be informed that they are free to decline to participate or to withdraw from the 
study, and that this will not impact any future medical care. Families will be asked to explain 
back to the investigators the nature of the study, study procedures, and risk and benefits of 
participants to assure their understanding. A copy of the completed consent form will be 
provided to participants for their records. For families completing the consent process 
electronically, we will print a copy of the completed consent from the secure REDCap portal 
and provide this to the family. 
8.6.4 Waiver of Assent 
A waiver of child assent is requested as all child participants will be between the ages of 
1 and 5 years. The capacity of children in this age group is so limited that they cannot 
reasonably be consulted about their assent and study participation. 
8.7 Payment to Subjects/Families 
8.7.1 Payments to caregivers for time, effort and inconvenience (i.e. compensation) 
The compensation for study participation will be provided to caregivers of the participating 
child as described below. All payment will be provided either in cash or by ClinCard (for 
those completing assessments electronically, without an in-person visit).  
• $20.00 (for those completing surveys electronically) for questionnaire completion at 
the baseline assessment. 
• $1.00 for each day that the caregiver completes the daily sleep diary over the 7-day 
baseline measurement period (7 days x $1.00 = $7.00 total) 
• For those participating in actigraphy: $2.00 for each day that the child wears the 
actigraph over the 7-day baseline measurement period (7 days x $2.00 = $14.00 
total) 
• $5.00 for having complete data (i.e., all measurement occasions complete, either 
diary only or diary + actigraphy) over the 7-day daily baseline measurement period. 
• $30.00 for questionnaire and interview completion at follow-up (post-intervention). 
• $1.00 for each day that the caregiver completes the daily sleep diary over the 7-day 
follow-up measurement period (7 days x $1.00 = $7.00 total) 
• For those participating in actigraphy: $2.00 for each day that the child wears the 
actigraph over the 7-day follow-up measurement period (7 days x $2.00 = $14.00 
total) 
• $5.00 for having complete data (i.e., all measurement occasions complete, either 
diary only or diary + actigraphy) over the 7-day daily follow-up measurement period. 
For the daily measures, providing subjects with daily incentives and additional 
compensation for complete data has been shown to increase measure adherence to ≥ 94%.69 
The total possible payment for adherence to all measurement strategies (actigraphy 
included) is $102.00.  

 
  
 
 
 
20
8.7.2 Gifts 
During Sleep Well! intervention participation, families may be provided with small stuffed 
animals or age-appropriate books to keep and use during their child’s bedtime routine.  
9 
PUBLICATION 
We intend to present the results of this project at national and international conferences and 
to publish project results in peer-reviewed journals. 
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Taveras EM, Rifas-Shiman SL, Bub KL, Gillman MW, Oken E. Prospective Study 
of Insufficient Sleep and Neurobehavioral Functioning among School-Age Children. 
Academic Pediatrics. 2017. 
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Hysing M, Sivertsen B, Garthus-Niegel S, Eberhard-Gran M. Pediatric sleep 
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Mindell JA, Sadeh A, Kwon R, Goh DY. Cross-cultural differences in the sleep of 
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