Determining Age Appropriateness of Children's Products and Toys: An Interagency Agreement With the Consumer Product Safety Commission
Phase: NA
Conditions: Healthy Volunteers Only
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

 
CNS IRB Protocol Template (1.12.16) 
 
 
 
NCT02544035  
 
Protocol Title 
Determining Age Appropriateness of Children's Products and Toys:   
An Interagency Agreement with the Consumer Product Safety Commission 
 
Abbreviated Title  
Children’s Products and Toys 
 
Protocol Number  
15-CH-N196 
 
Date of This Submission/Version  
11/15/23 
 
Principal Investigator 
Name, Degree 
Branch/Institute Bldg/Rm 
Phone 
E-mail 
Diane Putnick, Ph.D. 
Child and Family Research Section  
NICHD DIR 
6555 Rock Spring Dr, Suite 220 
301-496-6291 
putnickd@mail.nih.gov 
 
 
Lead Associate Investigator 
Name, Degree 
Branch/Institute Bldg/Rm 
Phone 
E-mail 
Melissa N. Richards, Ph.D. 
NICHD DIR, Child and Family Research Section  
6555 Rock Spring Dr, Suite 220 
301-496-6843 
melissa.richards@nih.gov 
 
Associate Investigators (list all) 
Name, Degree 
Branch/Institute Bldg/Rm 
Phone 
E-mail 
 
Todd D. Little, Ph.D. 
Professor, Educational Psychology at Texas Tech University 
Director, Institute for Measurement, Methodology, Analysis, and Policy 
Texas Tech University 
College of Education, 3008 18th Street 
Lubbock, TX 79409 
406-858-0363 
todd.d.little@ttu.edu 
 
Kyle M. Lang, Ph.D. 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 2 of 37 
 
 
Assistant Professor 
Department of Methodology and Statistics 
Tilburg University 
PO Box 90153 
5000 LE Tilburg 
The Netherlands 
+31 (0)13 466 2544 
K.M.Lang@uvt.nl 
 
Laura Bradley, B.A. 
Graduate Student 
Interdisciplinary Studies in Human Development 
University of Pennsylvania 
3101 Walnut Street 
Philadelphia, PA 19104 
715-891-1262 
laurapbr@gse.upenn.edu 
 
Marc H. Bornstein, Ph.D. 
NICHD DIR, Child and Family Research Section  
6555 Rock Spring Dr, Suite 220 
bornstem@mail.nih.gov 
301-496-6832 
 
Non-Investigator Research Staff (list all) 
Name, Degree 
Branch/Institute Bldg/Rm 
Phone 
E-mail 
 
Referral Contact  
Name, Degree 
Branch/Institute Bldg/Rm 
Phone 
E-mail 
Melissa N. Richards, Ph.D. 
NICHD DIR, Child and Family Research Section  
Rockledge II, Suite 8030   
301-496-6843 
melissa.richards@nih.gov 
 
Accountable Investigator 
Name, Degree 
Branch/Institute Bldg/Rm 
Phone 
E-mail 
Stephen Gilman, Sc.D. 
Chief, NICHD/DIPHR/SBSB 
6710B Rockledge Dr. 
301-435-8395 
gilmanse@nih.gov 
 
Medical Advisory Investigator  

 
 
 
 
C N S I R B Pr ot oc ol Te m plate ( 2. 5. 1 5)  
  
 
 
 
 
 
pa ge 3 of 3 7 
 
 
Na me, De gree  
Bra nc h/I nstit u te  Bl d g/ R m   
P h o ne   
E- mail  
N ot a p plica ble 
 
H u m a n Rese arc h Pr ot ecti o ns Pr o gr a m I n vesti g at or a n d St aff Tr ai ni n g: 
Bef ore t he pr ot oc ol is s u b mitte d t o P T M S, t he researc h t ea m will ha ve c o m plete d all 
re q uire d H u m a n Researc h Pr otecti o ns Pr o gra m Trai ni n g (i.e., CI TI, C R T). 
 
T ot al re q ueste d accr u al  
 
   ( 0) Patie nts       
   ( 7 2 0) Healt h y V ol u nteers    
  
  
C hil d 
p artici p a nts 
( a ges 6 m os- 1 2 
ye ars) 
Acc o m p a n yi n g 
p are nts ( at le ast 1 8 
ye ars of a ge) 
6- 1 1 m os 
6 0
 6 0
 
1 2- 1 8 m os ( 1- 1. 5 ye ars) 
6 0
 6 0
 
1 9- 3 5 m os ( 1. 5- 2 ye ars) 
6 0
 6 0
 
3 6- 7 1 m os ( 3- 5 ye ars) 
6 0
 6 0
 
7 2- 1 0 7 m os ( 6- 8 ye ars) 
6 0
 6 0
 
1 0 8- 1 4 4 m os ( 9- 1 2 ye ars) 
6 0
 6 0
 
 
3 6 0
 3 6 0
 
 T otal N u m ber of partici pa nts ( 3 6 0 + 3 6 0) = 7 2 0  
 
Pr oject Uses I o nizi n g R a di ati o n:   X N o   
 Yes (att ac h R S C/ R D R C d oc u me nt ati o n)  
   
 
Me dicall y-i n dicate d o nl y 
   
 
Researc h-relate d o nl y 
   
 
B ot h 
 
I N D/I D E 
 
 
  X  N o  
Yes ( att ac h F D A d oc u me nt ati o n) 
   
Dr u g/ De vice/ # _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
   
S p o ns or: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
D ur a ble P o wer of Att o r ne y     
X N o     
 Yes  
 
M ulti-i nstit uti o n al Pr oject 
 
X N o   
 
 
Yes
  
 
 
  
  
I nstit uti o n # 1 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _    F W A # _ _ _ _ _ _ _ _ _  
Date of I R B a p pr o val _ _ _ _ _ _ _ _ _ _ _ _ _ _ ( att ac h I R B d oc u me nt ati o n) 
 
  
  
I nstit uti o n # 2 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _    F W A # _ _ _ _ _ _ _ _ _  
Date of I R B a p pr o val _ _ _ _ _ _ _ _ _ _ _ _ _ _ ( att ac h I R B d oc u me nt ati o n) 
 
D at a a n d S afet y M o nit o ri n g B o ar d   X N o     Yes  

 
 
 
 
C N S I R B Pr ot oc ol Te m plate ( 2. 5. 1 5)  
  
 
 
 
 
 
pa ge 4 of 3 7 
 
 
 
Tec h n ol o g y Tr a nsfer A gree m e nt   
X N o    Yes  
A gree me nt t y pe a n d n u m be r _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ E x pirati o n Date _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
S a m ples are bei n g st ore d    
 
X N o   
 Yes  
 
Flesc h- Ki nc ai d re a di n g le vel of c o nse nt f o r m:  _ _ _ _ N/ A _ _ _ _ _ _ _ _  
 
 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 5 of 37 
 
 
Précis 
The proposed project is the outcome of an interagency agreement (IAG; #CPSC-I-14-
0016) between the Consumer Product Safety Commission (CPSC) of the United States 
and the Child and Family Research Section (CFRS) within NICHD DIR.  At the CPSC, 
the Division of Human Factors (ESHF) examines products and toys for U.S. children and 
determines the appropriate age of their potential users based on a set of Guidelines last 
revised in 2002.  Due to the outdated nature of the 2002 Guidelines, the CFRS is charged 
with revising this rulebook after conducting an empirical research project to inform these 
amendments.  The goal of the current study is to categorize traditional and contemporary 
children’s products and toys into age appropriate groups and use this information to 
rewrite the Guidelines for efficient CPSC use.  
  
Participants will be 360 parent-child dyads from 6 months to 12 years of age.   We will 
recruit equal numbers of boys and girls from each of the following six developmentally 
determined and CPSC approved age groups:  6-11 mos, 12-18 mos, 19-35 mos, 36-71 
mos (3-5 years), 72-107 mos (6-8 years), and 108-144 mos (9-12 years).  Participants will 
be tested at the CFRS once parental consent and child assent have been obtained.   
 
Each child will receive one of three counterbalanced children’s products or toys that are 
targeted to their age group from 6 of the 9 following categories: (1) Building or 
Construction (e.g., blocks, interlocking building materials), (2) Exploratory (e.g., clay, 
sand toys), (3) Games & Puzzles, (4) Instructional Toys (e.g., books, science kits), (5) 
Sports, Recreation, & Outdoor, (6) Imaginative Play (e.g., puppets, dolls, dress up 
materials), (7) Small Wheeled Vehicles (e.g., car toys), (8) Arts and Crafts, and (9) 
Musical Toys (e.g., musical instruments).  Children will also receive one of three 
(counterbalanced) children’s products or toys from each of the categories aimed at the 
age group below their age as well as another from each of the categories aimed at the age 
group older than their age. Each child will first play alone and then play with a parent.  
Different sets of toys will be presented when children switch from playing alone to 
playing in a dyad.    
 
Parents will provide information about their socioeconomic status and demographics.  
They will also complete the Vineland Adaptive Behavior Scales (i.e., an instrument 
assessing the child’s socialization, motor, communication, and daily living skills) and an 
age-appropriate instrument that assesses the child’s temperament.  They will provide 
information about toys that are already in their home.  Some parents may be invited to 
take part in a more in-depth qualitative focus group interview about children’s toys.  All 
play sessions will be video recorded and will be scored for relevant behaviors. 
 
We will examine differences in play with toys from the three age groups that are 
chronologically adjacent (i.e., to determine differences in outcomes for a given age group 
with age-appropriate toys compared to toys of the same category from the next youngest 
and next oldest age groupings).  Our outcome measures include the following: (1) 
Complexity of play, (2) Parts and features of toys used by the child, (3) Duration of time 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 6 of 37 
 
 
spent with each toy, (4) Preference for the toys, and (5) Number of times and duration the 
child solicits the parent’s involvement during play. 
 
This observational study of children fits well with the CFRS program of research and the 
mission of the NICHD DIR.  We will investigate children’s interactions with toys that 
surround children in their natural environment, as well as study how parents moderate 
child play behavior.  Observing and quantifying behaviors during play will allow us to 
have a richer understanding of social and cognitive growth during different stages of 
child development in the context of toy play with parents and will form an empirical 
basis for revising the 2002 CPSC Guidelines in light of changes in the last decade and a 
half in the toy industry. 
 
The cost impact for this project is minimal.  All necessary testing facilities are already 
available at the CFRS.  Funding for additional staff needed to work with participants, 
subject reimbursement, and supplies to carry out the project is allocated through the IAG.   
 
 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 7 of 37 
 
 
Table of Contents (update page numbers with each version) 
Introduction…………………………… 
  7 
Study Objectives……………………… 
12 
Subjects………………………………..  
13 
Study Design and Methods…………  
13 
Management of Data and Samples…… 
19 
Additional Considerations…………… 
20 
Risks and Discomforts………………….. 
20 
Subject Safety Monitoring…………….... 
20 
Outcome Measures……………………… 
21 
Statistical Analysis………………………. 
21 
Human Subjects Protection………………. 21 
Anticipated Benefit……………………….. 23 
Classification of Risk……………………… 23 
Consent Documents and Process………… 24 
Data and Safety Monitoring……………… 25 
Quality Assurance………………………… 25 
Reporting of Unanticipated Problems, 
Adverse Events, and Protocol Deviations... 26 
Alternatives to Participation……………… 26 
Privacy…………………………………… 26 
Confidentiality…………………………… 27 
Conflict of Interest………………………… 27 
Technology Transfer……………………… 28 
Research and Travel Compensation…… 
28 
References………………………………… 28 
 
List of Abbreviations 
 
ADD:  Attention Deficit Disorder 
 
ADHD:  Attention Deficit Hyperactivity Disorder  
ANCOVA:  Analysis of Covariance 
ASD:  Autism Spectrum Disorder 
CBQ: Children’s Behavior Questionnaire  
CFRS:  Child and Family Research Section 
CTSS:  Clinical Trials Survey System 
CPSC:  Consumer Product Safety Commission 
DIR:  Division of Intramural Research 
EATQ:  Early Adolescent Temperament Questionnaire 
ECBQ: Early Childhood Behavior Questionnaire  
HOME:  Home Observation for Measurement of the Environment Inventory  
IAG:  Interagency Agreement 
IBQ:  Infant Behavior Questionnaire 
KEPS:  Knowledge of Effective Parenting Scale 
KIDI:  Knowledge of Infant Development Inventory   

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 8 of 37 
 
 
PDD:  Pervasive Developmental Disorders 
PTQ:  Parent Toy Questionnaire 
RM-ANCOVA:  Repeated-Measures Analysis of Covariance 
TMCQ:  Temperament in Middle Childhood Questionnaire  
TQS:  Toy Quality Scale 
VABS:  Vineland Adaptive Behavior Scales 
 
1. Introduction  
Overview 
From building a tower of blocks, to playing “house” with a doll, to sharing a 
game of checkers with a friend, children’s play has been described historically as a 
“leading source of development” (Vygotsky, 1967, p. 6) during childhood and is 
consistently implicated as a crucial component of children’s healthy cognitive and social 
growth (Bergen, 2002; Ginsburg, 2007; Scarlett, 2005; Trawick-Smith & Dziurgot, 
2011).  For example, essential skills of abstraction and symbolism are acquired through 
play (Vygotsky, 1967), and play during preschool is linked to long-term mathematics 
achievement later in school (Wolfgang, Stannard, & Jones, 2001).  
 Much of the time that children devote to play is with toys and other child-
directed products.  Parents and other consumers spend substantial amounts on these items 
each year, with sales of toys and children’s products totaling $18.1 billion in 2014 (Toy 
Industry Association, 2014).  Moreover, this industry grows annually—revenues rose 4% 
between 2013 and 2014.   
With such a plethora of children’s products and toys available to U.S. consumers, 
how do American parents decide which toys are appropriate for their children?  Play 
progresses in complexity with child age.  As such, children’s product and toy needs 
during play are largely a function of their age and developmental stage.  A parent would 
not give a science kit to a 6-month-old, nor provide a rattle to a 10-year-old.  However, 
many toy decisions are not as clear cut.   
In addition, children’s play with toys is influenced by their play partners.  
Children’s play is more complex when playing with parents than when playing alone 
(Bornstein, Haynes, O’Reilly, & Painter, 1996; Bornstein, Haynes, Pascual, Painter, & 
Galperín, 1999, Cote & Bornstein, 2009; Damast, Tamis-LeMonda, & Bornstein, 1996).   
Children’s play with various types of toys and with a more advanced play partner 
across development is important from scholarly and theoretical perspectives as well as to 
policymakers and government stakeholders, such as the U.S. Consumer Product Safety 
Commission (CPSC).  In 1973, the CPSC was established to regulate consumer products, 
including toys, which may pose risks to U.S. consumers.  Before mechanical or chemical 
testing is performed on toys to identify health hazards, the Division of Human Factors 
(ESHF) first determines the appropriate age group of potential users. ESHF staff 
members currently consult a rulebook known as the Age Determination Guidelines 
(2002), which has become outdated in light of developments in the children’s products 
and toy industry over the last 15 years.  Due to the outdated nature of the 2002 
Guidelines, the CFRS is charged with revising this rulebook after conducting an 
empirical research project to inform these amendments.  The project we have proposed is 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 9 of 37 
 
 
the outcome of an interagency agreement (IAG; #CPSC-I-14-0016) between the 
Consumer Product Safety Commission (CPSC) of the United States and the Child and 
Family Research Section (CFRS) within NICHD DIR.   
The importance of understanding children’s play with children’s products and 
toys at different ages is clear, but very little recent research has systematically 
investigated play behavior interactions between child age and type of toy.  Additionally, 
parent-child dyadic play with toys across different age groups is understudied.   The aims 
of the current project are two-fold:  (1) to add to the current body of knowledge on 
children’s play with different categories of toys at different ages alone and with a parent 
and (2) to provide information to the Consumer Product Safety Commission about 
children’s play with toys in the form of a revision of the 2002 Age Determination 
Guidelines, which the CFR at NICHD will edit after gathering information from the 
empirical study.  Due to this partnership with the CPSC, the proposed NICHD study will 
have a significant impact on U.S. children, their families, and current practices of the 
CPSC.   
 
Children’s Play with Different Types of Toys 
During play, much of children’s time is spent with diverse products and toys, 
making these objects an integral part of children’s daytime activities (Glassy & Romano, 
2003).  The bulk of children’s toy play time involves constructing objects (Pellegrini & 
Gustafson, 2005) or manipulating these toys without any pretense involved (Gredlein & 
Bjorklund, 2005).  Although children’s products and toys are important elements of 
children’s play, basic research that rigorously and systematically investigates qualities of 
toys and documents the effects of these qualities on children’s play is surprisingly scant.  
Furthermore, existing research that touches on the topic is outdated and includes only a 
few age groups.   
Kimmerle and colleagues (1995) demonstrated that children begin to manipulate 
toys with increasing complexity between the ages of 7-13 months if the toy is 
lightweight, easy to grasp, and has moveable parts that are accessible to infants’ small 
fingers.  For example, children showed the most advanced sensorimotor play using a 
barbell with a rotary knob at one end and a noisemaker at the other.  Likewise, one 
extensive study examined the qualities of toys and the ways that infants played with toys 
between the ages of 3-12 months (Furby & Wilke, 1982).  Overall, the authors discovered 
that 12-month-olds preferred objects with movable pieces and parts that could fit together 
more than the 3-month-olds. McCall (1974) explored infant play behavior among 7 ½ to 
11-month-olds and discovered that infants were more likely to attend to toys that were 
“responsive”.  Responsiveness included plasticity (how easily the object could be 
changed in shape through manipulation) as well as sound potential (whether or not the 
object produced sounds when shaken).   
Responsiveness and detail of toys continues to hold importance later during 
childhood. Preschool children spent more time with a toy that provided random (instead 
of predictable) responses dependent on the child’s input (Schulz & Bonawitz, 2005).  
Furthermore, responsiveness afforded by interactive toys that ‘talk’ when a button is 
pressed can foster liking of the toy and rich engagement with it during play (Bergen & 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 10 of 37 
 
 
Davis, 2011; Kahn, Friedman, Pérez-Granados, & Freier, 2006), as well as enhanced 
learning from the toy (Calvert, Richards, & Kent, 2014).  Detail of toys is also important 
to preschoolers, as Robinson and Jackson (1987) found that 4-year-olds, regardless of 
their gender, played longer with toy cars that were more realistic in their detail (working 
doors, painted with racing stripes and bright colors) than with cars with less detail (no 
working doors, painted with a dull brown color).   
 
An Ecological Model of Play 
In addition to the types of toys with which children play, a multitude of other 
factors affects children’s play.  Bornstein (2006) proposed a model to outline the effects 
of these various elements on children’s play (see Figure 1).  The model illustrates that 
children’s play does not happen in a vacuum.  Rather, sociodemographics (e.g., 
socioeconomic status, cultural upbringing, schooling), characteristics of play partners 
(e.g., parent personality, parenting knowledge), and individual characteristics of the child 
(e.g., language, temperament, age) are interrelated and have profound effects on the ways 
in which children play.   
 
Figure 1.  Ecological Model of Play, taken from Bornstein (2006) 
 
 
The two primary independent variables that will be manipulated in the 
experimental design of the proposed study are children’s age and the absence or presence 
of a parent play partner.  The proposed project will also control for relevant aspects of 
children’s sociodemographic characteristics, partner individual characteristics, and the 
children’s individual characteristics by gathering information about those domains 
through surveys described in the methods section of this proposal. 
 
Children’s play differs with age.  Piaget (1962) long ago proposed three stages 
in the development of play—sensorimotor play, symbolic play, and games with rules, 
which still constitute a basic foundation for the progression of play throughout childhood.  
To build on Piaget’s stages, chronological age acts as an organizational framework for 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 11 of 37 
 
 
the following discussion of development of children’s play.  Our study of child play will 
extend from infancy (6 months) to middle childhood (12 years). 
Birth-2 years old.  During infancy and early toddlerhood, play entails 
manipulating objects for the purpose of exploring them (e.g., mouthing, fingering, hitting, 
shaking objects), as children examine the texture, shape, and functionality of toys 
(Kimerlee et al., 1995).  Piaget defined this class of play as sensorimotor play.  Although 
sensorimotor play nurtures cognitive and motor growth, it only lasts for a small part of 
childhood.   
When children engage in sensorimotor play, they perform circular actions, or the 
repetition of certain actions that are solitary and nonsocial (Piaget, 1962; Scarlett, 2005).  
These circular actions become more complex with increasing age through infancy.  
Between 4-8 months of age children discover that certain activities with objects are 
enjoyable and will repeat these actions (e.g., grabbing a rattle and shaking it).  When 
children are between 8-12 months old, they begin to use two objects at once (such as 
clapping two cups together) to play.  Finally, between 12-18 months, children engage in 
repetitive behaviors with objects and engage in trial and error, exploring new toys to see 
what types of new and interesting sounds and reactions they can create (Scarlett, 2005).     
Fenson and colleagues (1976) followed children’s toy play behaviors 
longitudinally between the ages of 7-20 months. Children in the earlier part of that age 
range (i.e., at 7 and 9 months old) tended to explore toys through touching, mouthing, 
shaking, and banging them.  However, between the ages of 13 and 20 months, more 
symbolic forms of play emerged (e.g., pretending to drink out of a cup in a tea set or eat 
something from a plate; Fenson et al., 1976).   
Ages 2-6.  Just as Fenson and colleagues (1976) discovered, as children approach 
the age of 2 years, they begin to engage in play that is more abstract in nature.  During 
this imaginary play, termed symbolic play by Piaget, a toy can represent a real-world 
object, and gestures can represent real-life actions.  During this play, the child is creating 
an “imaginative sphere” to express interpretations of the real world (Schousboe, 2013; p. 
14).    
Beginning around the age of 2 years, children may begin to engage in object 
substitution, e.g., using a toy milk bottle to feed a baby doll.  When children first begin to 
engage in object substitution, they need an object that is similar and resembles the real 
object before they are able to pretend with it (Elder & Pederson, 1978).  They also need 
to have seen another person perform that behavior, i.e., at this age, symbolic play is 
imitative (Scarlett, 2005).  Starting at about age 3, children are able to substitute objects 
for dissimilar objects in their play (e.g., pretending to brush hair with a rubber ball).  
Finally, starting around age 3½ years, children do not need toys to support pretend play.  
They are able to act as though an invisible object is in the play scene, when in reality, the 
object is not present (e.g., believe that a princess is in the room; Elder & Pederson, 1978; 
Lillard, 2015).  Around ages 4-5, storylines with loose narratives, fantastical characters, 
and scenes emerge (Scarlett, 2005).  Symbolic play becomes more complex throughout 
the preschool years and peaks in prevalence around 4 years of age, starting to decline 
around the age of 6-7 (Eckler & Weininger, 1989; Trawick-Smith, 1998; Lillard, 2015).   

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 12 of 37 
 
 
Ages 7-12 years.  Between 7-12 years of age, children begin to set their own a-
priori rules, deciding what is fair and just during play (Scarlett, 2005).  During this age 
range, children are not as reliant on pretense and symbolism in their play.  Instead, they 
engage in games that have rules and regulations such as basketball or board games 
(Piaget, 1962).  One illustrative qualitative study examined how boys played soccer 
together.  Winther-Lindqvist (2013) found that playing games with rules was an integral 
part of how boys socialized and formed a community with one another.  Furthermore, 
understanding rules, such as who would be the judge, gatekeeper, etc. during the game 
was an essential part of how they played with one another. 
It should be noted that during this age range, children’s games still often contain 
elements of pretense.  For example, games with rules, such as Dungeons and Dragons, 
require players to create fantastical characters who exist in imaginary worlds.  
Furthermore, symbolic play has been shown to continue until children are 11 years old 
(Smith & Lillard, 2012), and may occur in private settings away from observers to avoid 
the embarrassment of appearing too immature (Scarlett, 2005).  There are some benefits 
to continuing to engage in symbolic imaginary play in the elementary and middle school 
years.  For example, children may become better at controlling their emotions and 
improve their empathic understanding (Niec & Russ, 2002; Singer, 1994).   
 
Children’s play with adults.  Although children play alone, they often have play 
partners, such as parents, caregivers, siblings, and friends.  The effects of these 
companions on children’s play behavior are large (Bornstein, 2006).  During the early 
stages of life, parents and other adult caregivers are children’s primary playmates.  
Vygotsky (1967) recognized the importance of adults in children’s play, due to the 
adult’s ability to guide within the child’s zone of proximal development during play.  A 
task within the child’s zone of proximal development is one that the child has not yet 
mastered, but that becomes possible for him or her to achieve with the aid of a skilled 
other.  Vygotsky contended that, with the help of parents, children could advance in 
development through the use of scaffolding, or the careful guidance of adults during task 
execution (Wood, Bruner, & Ross, 1976).  Indeed, sensitive fathers and mothers who 
engage in scaffolding during playtime have beneficial effects on children’s subsequent 
cognitive development (Tamis-LeMonda, Shannon, Cabrera, & Lamb, 2004).   
Consistent with this idea, when playing with parents, children play at more 
sophisticated levels because parents often prompt them to engage in more complex 
behaviors (O’Reilly & Bornstein, 1993).  For example, when using a standard set of toys, 
children are more likely to engage in more sophisticated pretense play when collaborating 
with their mother than when playing alone (Bornstein et al., 1996; Bornstein et al., 1999, 
Cote & Bornstein, 2009; Damast et al., 1996).  In addition, non-parental adult play 
partners can scaffold increases in the child’s level of play sophistication (Bornstein, 
Haynes, Legler, O’Reilly, & Painter 1997; Kwak, Bornstein, & Putnick, 2008; Trawick-
Smith & Dziurgot, 2011).   
 
The Current Study 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 13 of 37 
 
 
The interplay among child age, toy type, and presence/absence of an adult play 
partner is complex, and adequate understanding of this interplay is lacking.  Most 
currently available research focuses on children of infant and preschool age, and less 
attention has been paid to children in the elementary and middle school years.  
Furthermore, experimental designs that systematically compare play with different toy 
types alone vs. with a parent across all stages of development do not exist.  Therefore, 
there are two main goals in the current study.  First, we aim to categorize traditional and 
contemporary children’s products and toys into age appropriate groups by observing 
children’s play alone and with a play partner to enrich our theoretical understanding of 
play and how toys and parents mediate child play.  Second, the information derived from 
our empirical study will be used in an applied setting to revise the CPSC’s 2002 Age 
Determination Guidelines for children’s products and toys as part of this interagency 
agreement with the CPSC. 
 
2. Study Objectives  
 
a.  Primary objectives 
The primary objective of the current observational study is to categorize traditional and 
contemporary children’s products and toys into age appropriate groups based on their 
intended use.  To do this, we will examine differences in child play among toys from the 
three chronologically adjacent age groups to determine the differences in play for a given 
age group with an age-appropriate toy in comparison with toys from the same toy 
category intended for the next youngest and the next oldest age groups.  
 
b. Secondary objectives  
There are three secondary objectives of this research project:   
(1)  To determine how play group type (i.e., play alone, play with parent) affects 
children’s play with toys. 
(2)  To determine how the qualities of toys differ depending on the 
manufacturer’s suggested age. 
(3)  To determine how parents gauge age appropriateness when making decisions 
about the types of products and toys to give to their children. 
 
3. Subjects 
 
a.  Description of study populations  
The participants in our study are healthy volunteers.  Parents and their children between 
the ages of 6 months to 12 years of age will be invited to participate.  All children will 
need consent from their parent or legal guardian, and children over the age of 4 will need 
to provide assent.  Our accrual ceiling is 360 parent-child dyads (720 participants total).  
If participants withdraw, they will be replaced.   
 
b.  Inclusion criteria 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 14 of 37 
 
 
All children between the ages of 6 months to 12 years of age who are typically 
developing and born of a full term pregnancy if under 24 months of age, healthy, and 
English speaking are eligible for inclusion in the study.  Typically developing children 
would not have any diagnosed congenital conditions, developmental delay or disability, 
dyslexia, PDD, ADD, ADHD, or ASD.  In addition, we will only enroll subjects if they 
are from a racial and ethnic group that is still needed to ensure the diversity and 
representative nature of our sample as set forth in the Planned Enrollment Form.  These 
are the initial screening criteria that will be used. 
 
c.  Exclusion criteria 
If the participants do not meet the inclusion criteria, they will not be included in the 
study.  Children who are deaf or blind will also need to be excluded from the study.  The 
Eligibility Checklist will be used by investigators at the time of screening for admission 
to the protocol and will list the inclusion criteria to determine the dyad’s eligibility.   
 
While we want to make this study as inclusive as possible, our goal is to understand toy 
play for typical American children in the time allotted by the CPSC using only the 
resources allocated in our budget.  Thus, the following bullet points explain why the 
following populations must be excluded from our study: 
• Children outside of the 6 month-12 year age range:  These years cover early life and 
are the ages of interest for children’s play and are of central significance to the 
Consumer Product Safety Commission’s goals. 
• Families not fluent in English:  Fluency in English is essential for parents to be 
able to fill out surveys.  Families also need to be fluent in English so that they can 
comprehend verbal directions given by the experimenter during the testing 
session.  If we included people who were not fluent in English, we would need 
many additional staff members who speak the multitude of languages of the 
diverse population of the Washington, D.C metro area to work with participants 
during the testing session and code the videos after the testing session is complete. 
• Children who are sick, not typically developing, born premature (if they are under 
24 months of age), blind, or deaf:  We must recruit a healthy sample of typically 
developing children born in a full term pregnancy (if they are under 24 months of 
age) who are not blind or deaf for this project to remove any potential confounds 
that atypical conditions may have on children’s play. Typically developing 
children would not have any diagnosed congenital conditions, developmental 
delay or disability, dyslexia, PDD, ADD, ADHD, or ASD.  Including other 
populations such as deaf or blind children would require a different experimental 
set up, stimulus toys, and resources (i.e., someone who could convert our surveys 
to American Sign Language or Braille and could code the videos for the parent 
child behaviors during those sessions).   

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 15 of 37 
 
 
• Children who are not adding to the ethnic and racial diversity of the sample:  The 
goal of our study is to recruit a sample of subjects who are racially and ethnically 
diverse.  By making this diverse sample a priority, we hope that our results will be 
applicable to the diverse populations residing within the United States.  To keep 
with this goal of a diverse and representative sample of children, we may have to 
exclude some families if we have already reached the quota of families from that 
particular racial or ethnic group. 
4. Study Design and Methods 
 
a. 
Study overview  
Participants will be children aged 6 months to 12 years and their parents.  Participants 
will receive children’s products or toys to play with during an hour play session.  Based 
on the manufacturer’s suggested age, some products will be geared towards children who 
are younger, some will be geared toward children their own age, and others will be aimed 
at older children.  Each child will first play alone and then play with a parent.  Different 
sets of toys will be presented when children switch from playing alone to playing in a 
dyad.  The play sessions will be videorecorded.  Video records will subsequently be 
scored for children’s play with the toys.   
 
Participation in this project will take roughly 1-2 hours for the play session of the visit 
and approximately 1 additional hour for the parent to complete accompanying relevant 
questionnaires, which can be done at home. Participation in the study requires one visit to 
the CFRS lab. 
 
This research is social and behavioral in nature, and the visits are considered outpatient.  
Participants will be tested at the CFRS laboratory in Bethesda, MD.   
 
Subjects who participate in this study are not required to participate in other protocols. 
 
b. Recruitment 
Subjects will be recruited through the following methods: 
 
(1) Birth records:  We will purchase lists of local addresses and phone numbers of 
families with children. This recruitment procedure has been used in CFRS studies 
previously approved by the NICHD IRB (Study # 88-CH-0032; Study # 02-CH-
0278).  If we have only the family’s mailing address, a short letter or postcard 
describing the study will be mailed to each family, with an invitation to call or 
email the lab to learn more.  If the family’s telephone number is available, we also 
may directly call families, provide a short description of the study, and ask if they 
would like to participate in the project. 
 
(2) The local community:  We will contact authorized personnel in the community 
and ask for permission to post or circulate information.  We may contact: 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 16 of 37 
 
 
• Newspapers, magazines, local community publications 
 A short blurb of information with the CFRS contact information 
would be printed. 
• Neighborhood listservs, blogs, and online parenting communities on social 
networking sites such as Facebook 
 A short blurb of information with the CFRS contact information 
would be posted. 
• Schools, child care centers, and after-school programs 
 Directors may post flyers or place informational flyers or 
brochures in children’s backpacks or mailboxes to take home to 
their parents. 
• Coffee shops, libraries, recreation centers, and other places known to 
attract parents and their children. 
 Flyers with detachable CFRS contact information tabs would be 
posted. 
 (3)  Prior participants in CFRS studies:  Families who have previously 
participated in other approved CFRS studies (e.g., 04-CH-0250, 03-CH-0069) and 
have provided their phone numbers will be re-contacted with information about 
this new study and will be recruited for participation. 
 
(4)  NIH websites and recruitment hubs:  Those reading about the study on the 
Clinical Center website, the Clinical Center Facebook or Twitter, the OPR 
Listserv, the Clinical Center Newsletter, ClinicalTrials.gov, ResearchMatch, and 
the CFRS website and who contact the CFRS or the Clinical Center with interest 
in the study will be considered for participation. 
 
We anticipate that we will be able to recruit at a rate of 5 children per week.   
 
Screening  
We plan to have a telephone conversation with parents who express interest in the study. 
During the call, the study will be explained in detail, and parents will be encouraged to 
ask questions. For those who wish to participate, we will conduct a short interview to 
check their eligibility criteria (see the Intake Criteria checklist).  Parents who are eligible 
and interested in the study will receive the Informed Consent Form and surveys in the 
mail in paper format, which they will fill out and return to CFRS staff.  Surveys and 
consent forms may also be completed electronically on the Clinical Trials Survey System 
(CTSS). 
c. Study procedures 
Procedure 
Participants will be 720 parents and their children from 6 months to 12 years of age.   We 
will recruit children divided into the following six age groups:  
• 6-11 mos 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 17 of 37 
 
 
• 12-18 mos (1-1.5 years) 
• 19-35 mos (1.5-2 years) 
• 36-71 mos (3-5 years) 
• 72-107 mos (6-8 years) 
• 108-144 mos (9-12 years) 
Each child will first :   
o Play alone 
then 
o Play with parent 
 
 
Each child in each age group will receive children’s products and toys from 6 of the 9 
following categories: 
(1)  Construction toys (e.g., blocks, interlocking building materials) 
(2)  Exploratory toys (e.g., clay, sand toys) 
(3)  Games & Puzzles 
(4)  Instructional toys (e.g., books, science kits) 
(5)  Sports, Recreational, & Outdoor Equipment 
(6)  Imaginative play toys (e.g., puppets, dolls, dress up materials) 
(7)  Small Wheeled Vehicles (e.g., car toys) 
(8)  Arts & Crafts toys 
(9)  Musical toys (e.g., musical instruments) 
-  Prior to testing, all toys used in this project will be inspected for safety hazards by 
staff trained in conducting safety evaluations of toys for the Consumer Product 
Safety Commission. Toys will be inspected for small parts, mechanical hazards 
(cord length, magnet strength, etc.), lead, and phthalates. All small parts will be 
removed from toys for children under age 3, and toys will be replaced with similar 
ones if any mechanical hazards, lead, or phthalates are identified. 
-  There is a large body of research regarding children’s gravitation towards and play 
with sex-stereotyped toys (O’Brien & Huston, 1985; Caldera et al., 1989).  Although 
child gender is an important factor to consider when studying the qualities of toys, 
the current study will use gender neutral toys as stimuli in an attempt to eliminate 
any potential gender confound.  
 
The experimenters will select three representative target toys from each toy category.  
Target ages are determined by the manufacturer’s suggested age. 
• Children will be presented with one of three (counterbalanced) toys 
targeted for their age group from 6 of the 9 toy categories.  
• When presented, each target toy will be paired with two additional toys 
from the same toy category: one targeted to the age group just below and 
one from the age group just above the target toy. 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 18 of 37 
 
 
• Children will receive novel sets of toys when switching from playing 
alone to play with parent. 
 
To decrease the burden on parents and their children, reduce unplanned missingness, and 
increase data quality, we are using a 3-form planned missingness design.  Because of this 
design, parents and their children will only have to play with toys from 6 of the 9 
categories. 
 
Parents and their children will be offered to take a break from playing approximately 
every 15 minutes during the toy play session in the event that they are tired of playing 
with the toys.  In addition, to ease frustration that can occur when transitioning from one 
toy type to the next, we will give children and their parents a couple of minutes notice 
before the transition occurs.   
 
All play sessions will be video recorded. 
 
Measures and Surveys:  
The following questionnaires will be sent to the parent to complete before the scheduled 
visit with the child.  Parents can bring these documents with them to the scheduled visit 
or return them by mail.  Although the surveys are currently in paper format, for ease of 
completion, we may convert them to electronic format that parents can fill out online 
through CTSS. These questionnaires include the following:   
• Consent form and permission to use videorecorded data. 
• Basic demographics about the child/family/home life, measuring:  Number/ages 
of children at home, birth order, parental age, parental education, parental marital 
status, race/ethnicity, etc. (see Bornstein et al., 1996). 
• Hollingshead Four-Factor Index of Social Status (Hollingshead, 1975):  Measures 
SES of the family.  
• Vineland Adaptive Behavior Scales (VABS; Sparrow, Balla, & Cicchetti, 1984): 
Measures the child’s developmental level in a more sensitive way than by the 
rough proxy of age  
• Temperament through the use of validated scales for different age groups: Infant 
Behavior Questionnaire (IBQ), Early Childhood Behavior Questionnaire (ECBQ), 
Children’s Behavior Questionnaire (CBQ), Temperament in Middle Childhood 
Questionnaire (TMCQ), Early Adolescent Temperament Questionnaire (EATQ) 
(see Bornstein et al., 2015; Rothbart, 2007). 
• Social Desirability Scale, Short Form (Reynolds, 1982):  A questionnaire used 
during self-reporting to detect and control for possible social desirability bias. 
• Knowledge of Infant Development Inventory (KIDI) for children < 2; or the 
Knowledge of Effective Parenting Scale (KEPS) for children ≥ 2: The KIDI has 
been previously approved by the IRB in CFRS protocol (Study# 88-CH-0032; 
Study # 02-CH-0278). The KIDI and the KEPS are designed to assess knowledge 
of parental practices, developmental processes, and infant norms, areas that form 
a knowledge base that may influence and regulate parental behavior vis-a-vis an 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 19 of 37 
 
 
individual child (MacPhee, 1981; Morawska, Sanders, & Winter, 2007).  The 
KIDI is appropriate for use with parents with children up to 2 years old and the 
instrument is comprised of 75 items covering four areas:  Norms and Milestones, 
Principles (developmental processes), Parenting (strategies), and Health and 
Safety (guidelines).  The KEPS is appropriate for use with parents with children 
as young as 2 years old and is comprised of 28 items covering four areas:  
Promoting Development, Principles of Effective Parenting, Using Assertive 
Discipline, and Causes of Behavior Problems. 
• Knowledge of Play (see Tamis-LeMonda et al., 1994):  A questionnaire used to 
assess parent’s knowledge of children’s play, specifically, what types of play 
behaviors are more complex than others.   
• Parent Toy Questionnaire (PTQ):  Uses some new and some similar questions 
from a previous (2002) CPSC-sponsored study of toy play.  Parents would be 
asked:  “Where do you get information about toys?  Where do you buy your toys?   
What information do you gather about toys before purchasing them?  What is 
some information you wish that you had before purchasing toys?  
o Optional parent focus group:  If time and resources permit, we may 
invite a small number of parents to participate in a focus group 
conversation about toys. 
 The PTQ will ask parents to check a box if they are interested in 
this focus group opportunity.  We will only contact parents who 
have checked this box. 
 Topics discussed in the focus group will elaborate on the topics 
highlighted on the PTQ.  The focus group will give parents an 
opportunity to elaborate verbally on their thoughts about age 
appropriateness of children’s toys and how they make their toy 
purchasing decisions.  This mixed methods research can 
supplement the quantitative data that parents provide in the PTQ.   
 The focus group may take place at the CFRS or we may use a 
phone conference call for ease of scheduling. 
 
The following questionnaires will be completed at the end of the testing session. 
• Perceptions of child’s comfort during testing situation, as reported by (1) the 
parent and (2) the experimenter (Bornstein et al., 1999).  
• Questions adapted from the Home Observation for Measurement of the 
Environment Inventory (HOME; see Linver, Brooks-Gunn, Cabrera, 2004) to 
gather information about what toys are already at the child’s home and in the 
child’s play environment.  
• Additional questions about the toys and their features, including the toys that the 
child played with during the testing session and additional toys of interest to the 
CFRS and the CPSC. 
 
Child questions 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 20 of 37 
 
 
• For children over the age of 4, we will ask children questions to assess what they 
thought of each toy by asking: “How much did you like [toy]?  Why?” Children 
will respond to scaled items by pointing to a visual representation of a Likert-type 
scale in the form of smiley faces (adapted from Harter, 1982; Richards & Calvert, 
2015).  
• We will also ask the child whether or not she/he has played with the toys before. 
 
Video behavior coding 
Video records of the toy play session will be scored for certain qualitative and 
quantitative behaviors, including, but not limited to: 
• The Toy Quality Scale (TQS):  Qualities of the toy itself (i.e., are there moving 
parts, does the toy make noise, how soft is the toy? Is it a branded toy with a 
licensed character on it?).  This coding system is being developed in CFRS. 
• Parts and features of toys used by the child. 
• Duration of time child spends with each toy. 
• When playing with parent, how often, in what way, and for how long does the 
child solicit the parent’s involvement?  How often, in what way, and for how long 
does the parent solicit the child’s involvement? 
• Level of Play Complexity (taken from Bornstein et al., 1996; Cote & Bornstein, 
2009, Suizzo & Bornstein, 2006): 
(0) default (no play);  
(1) unitary functional activity (e.g., throw the ball);  
(2) inappropriate combinatorial activity (e.g., put the ball into a teacup): 
Was the toy used as intended or features of toy fully exploited? 
(3) appropriate combinatorial activity (e.g., put the cup on the saucer);  
(4) transitional play (e.g., put the telephone to the ear without speaking);  
(5) self-directed pretense (e.g., drink from a cup);  
(6) other-directed pretense (e.g., pretend to feed the doll);  
(7) sequential pretense (e.g., dial and speak into the telephone); and  
(8) substitution pretense (e.g., pretend the block is a telephone receiver 
and speak into it). 
 
Note that all of these procedures described above are solely for research purposes, not for 
medical or clinical evaluation or treatment.  Radiation is not used in this study. 
 
There are no follow-up visits associated with this study.   The study has no relations to 
any other existing protocol. 
 
d. End of participation 
Because this is a social and behavioral research project, transfer of care to assure 
continuity, the provision of additional medical care, and sharing information with health 
care providers is not applicable.  When the project is complete, parents may request a 
summary of the findings from the study.  However, all findings from the study will be 
anonymized. 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 21 of 37 
 
 
 
Experimenters will not provide individual-level survey information to participants.  This 
will aid in guarding against any possible negative feelings that could arise from families 
knowing their results (e.g., feeling inadequate as a parent because he or she did not score 
highly on the Knowledge of Effective Parenting Scale) or inappropriate use of the data by 
the family (e.g., using the score on the Vineland Adaptive Behavior Scale as part of a 
school entrance exam).  If parents request a video of their session, we will not distribute a 
copy to them until the study is over.  Parents must provide a written request for the video.  
We will not distribute the videos to parents until the completion of the study to guard 
against their sharing it with friends, neighbors, on social media, etc.  Other people who 
view the video through these outlets could potentially become participants in the study 
without our knowledge.  If these people ever do become participants, already having 
watched a video like this could confound their results and behaviors, weakening the 
scientific integrity of the study. 
   
5. 
Management of Data and Samples 
 
a. Storage 
Data will be stored according to NICHD and NIH policy.  We will not collect any 
specimens or samples.  All data will be stored permanently in an archival database by the 
National Institutes of Health.  They will be retained for analysis in perpetuity.  The 
Principal Investigator will maintain subjects’ records after completion of the study.   
 
In addition, data may be stored in a password-protected database via CTDB.  For 
statistical analyses, data will be de-identified according to the Privacy Act, and when 
possible, by all 18 HIPAA identifiers.  If a limited dataset is needed (for example to 
include dates), a user agreement will be executed.  Only investigators or designees 
authorized to use CTDB will have access to the data.   
 
The anonymity and rights of the study's participants and their families will be 
fully protected. The full proper names of participants will not appear on the video record 
or questionnaires, although it is possible that a child’s first name might be used during the 
video recorded play session. All data will be tallied and analyzed without reference to 
individual names. 
  
Child participants will be assigned ID numbers at the outset of the study, and the key 
linking the ID numbers with the participants’ identity, as well as digital video records of 
the children filmed during the testing session, will be kept in a locked filing cabinet in a 
locked room when no researchers are present at the CFRS laboratory.  ID numbers are 
linked with personal identifying information, and only the clinical site investigators or 
designees have access to it.  The linkage is critical to interpretation of the data, as data 
will be compared across subject groups.  No one other than members of the research team 
will have access to this linkage data without the explicit consent of the volunteer adult.   
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 22 of 37 
 
 
This protocol will be kept open as long as there is a possibility of future research use of 
the data.  When there is no longer a need, data will be archived by the investigator in 
compliance with the requirements for retention of research records, or after IRB approval, 
destroyed or transferred to another repository. 
 
Any loss or unanticipated destruction of data that would affect the scientific integrity of 
the study will be reported to the IRB as an unanticipated problem. 
 
b.  Data (if applicable: including genomic data) and sample sharing plan 
At this time, we do not have any approved collaborators, but anticipate this in the future. 
Other investigators (both intramural and extramural to the NIH) may wish to study these 
data. Before sharing the data approved outside collaborators, we will submit an 
amendment with specific information about the other investigators/institutions and what 
data/samples will be shared.  IRB approval will be sought prior to any sharing of data.   
 
The broad public sharing of data generated by this project is not possible until participant 
consents to share data publicly are obtained. Data generated by this study will be made 
available through vetted collaborations and IRB approvals in the interim.  This study will 
be registered on our NICHD Intramural website 
(https://science.nichd.nih.gov/confluence/display/cfr/Home) along with the above 
justification. 
 
Any use of this data by a secondary party after submission to a designated repository 
must be shared by that party according to the permissions granted by the original consent 
form of the study participants unless additional permissions are obtained. Secondary 
parties must adhere to the NIH Human Data Sharing guidelines for broad data sharing 
and to the limitations for use set forth by the Institutional Certification associated with 
this project. Access to identified data for secondary research will only be granted after 
IRB review or OHSRP clearance, as applicable.  
 
Any publications and presentations authored or co-authored using data generated by this 
project will clearly indicate where the data will be available and how to access it. The 
repository(s) and funding source will also be acknowledged in any publications and 
presentations.  
 
6. Additional Considerations 
 
a. 
Research with investigational drugs or devices 
This provision is not applicable to our research.  We will not be using investigational 
drugs or devices. 
 
b. Gene therapy 
This provision is not applicable to our research.  We will not be using gene therapy. 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 23 of 37 
 
 
7. Risks and Discomforts 
Participation in this study involves minimal risk.  The probability and magnitude of harm 
or discomfort anticipated with the research are not greater in and of themselves than those 
ordinarily encountered in daily life.  We will minimize risk by choosing stimulus toys 
that are approved as safe by the CPSC.  It is possible that while completing the 
questionnaires, participants may find that some questions touch on areas of personal 
sensitivity and may experience discomfort when answering the questionnaires.  Parents 
and children may decline to answer any question.  
 
All procedures are non-invasive. Previous work conducted in the CFRS reassures us that, 
while some parents may initially feel slightly self-conscious while being observed 
(perhaps more so when being filmed), in a short period of time they relax and enjoy being 
involved in a study that focuses on their child and his or her development. Parents will be 
assured that if their child becomes distressed by any procedure, the session will be 
interrupted and she will be allowed to soothe the child and resume any caregiving 
responsibilities. 
 
8. Subject Safety Monitoring 
We will monitor the play room and end the play session if a child engages in a potentially 
dangerous action.  Because this is social and behavioral research, we will not use toxicity 
tables, etc. for subject safety monitoring.  Participating in this study is voluntary, and 
participants may withdraw at any time without penalty.  At the time of the play session, 
we will ask each child if s/he would like to play with toys.  If a child says that they do not 
want to play, or decides in the middle of the study that they want to play no longer, the 
child will be allowed to withdraw without penalty.  Parents may also elect to stop their 
own or their child’s participation in the study at any time. 
 
9. Outcome Measures 
 
a. 
Primary outcome measures 
The primary study outcomes are the video-coded measures of age-appropriateness and 
play complexity.  We will examine differences in the mean scores of play among toys 
from the three age groups that are chronologically adjacent (i.e., the differences in 
outcomes for a given age group with the age-appropriate toy in comparison with toys 
from the same toy category just below and just above that age group). 
 
b. Secondary outcome measures 
Our other secondary outcome measures include the following: 
• Parts and features of toys used by the child 
• Duration of time child spends with each toy 
• Child preference for the toys based on child-report (smiley face Likert scale) 
• Number of times and duration of time the child solicits the parent’s or friend’s 
involvement during play 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 24 of 37 
 
 
10. Statistical Analysis 
 
a. 
Analysis of data/ study outcomes 
For our primary outcome measure, our independent variables will be the age group for 
which the toy is aimed (younger vs. age-appropriate vs. older; within-subject) and the age 
group of the child (6 groups; between-subject), and our dependent variables will be the 
video-coded measures of play.  The statistical methodology that we will use to analyze 
this question is a repeated-measures ANCOVA with up to five covariates.  Our five 
covariates include the following: (1) toy characteristics, (2) child temperament, (3) family 
socioeoconomic status, (4) child preferences for the toy, and (5) parenting knowledge.   
 
For our secondary outcome of interest (how children play alone vs. with parent), we will 
conduct another repeated-measures ANCOVA with condition (alone vs. with parent) and 
designated toy age (younger vs. age-appropriate vs. older) as within-subject factors and 
child age (6 groups) as a between-subject factor.  Again, our dependent variables will be 
the video-coded measures of play.  We will also use the same five covariates mentioned 
above:  (1) toy characteristics, (2) child temperament, (3) family socioeconomic status, 
(4) child preferences for the toys, and (5) parenting knowledge.     
 
Both of the repeated-measures ANCOVA designs will also be employed when we 
examine the dependent variables of secondary interest noted in section 9b, such as parts 
and features of toys used by the child, duration of time child spends with each toy, child 
preference for the toys based on child-report (smiley face Likert scale), and the number 
of times and duration of time the child solicits the parent’s involvement during play.  The 
independent variables mentioned above would remain the same.   
 
We do not have any planned interim analysis.  Our criteria for significance is alpha = .05.  
Due to the protocol’s design, unplanned missingness will be low.  Missing data 
procedures, such as Full Information Maximum Likelihood and Multiple Imputation, will 
be used.   
 
b.    Power analysis  
For our primary research question, a power analysis revealed that 360 parent child dyads 
split across 6 age groups and 3 within-subject designated toy ages (younger vs. age-
appropriate vs. older) is sufficient to detect a medium effect (f = .25) for between-subjects 
and within-subjects effects and their interactions in a RM-ANCOVA with 5 covariates 
(power = .80 and alpha = .05).   
 
For our secondary research question, a power analysis revealed that 360 parent child 
dyads split across 6 between-subject age groups, 2 within-subject conditions (alone vs. 
with parent), and 3 within-subject designated toy ages (younger vs. age-appropriate vs. 
older) is sufficient to detect a medium effect (f = .25) for within- and between-subject 
effects and their interactions in a RM-ANCOVA with 5 covariates (power = .80 and 
alpha = .05).   

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 25 of 37 
 
 
 
For both our primary and secondary research questions, our five covariates include the 
following: (1) toy characteristics, (2) child temperament, (3) family socioeoconomic 
status, (4) child preferences for the toys, and (5) parenting knowledge.  Subject dropouts 
will be replaced with other comparable subjects who complete the protocol.   
 
11. Human Subjects Protection 
 
a. 
Subject selection 
Participants of any race, ethnicity, sex, nationality, religion, and handedness may 
participate. Approximately equal numbers of male and female children will be recruited, 
and to the extent possible, the sample will be racially and ethnically diverse.   
 
However, we must exclude the following populations: 
• Children outside of the 6 month-12 year age range:  These years cover early life 
and are the ages of interest for children’s play and are of central significance to 
the Consumer Product Safety Commission’s goals. 
• Families not fluent in English:  Fluency in English is essential for parents to be 
able to fill out surveys.  Families also need to be fluent in English so that they can 
comprehend verbal directions given by the experimenter during the testing 
session.  If we included people who were not fluent in English, we would need 
many additional staff members who speak the multitude of languages of the 
diverse population of the Washington, D.C metro area to work with participants 
during the testing session and code the videos after the testing session is complete. 
• Children who are sick, not typically developing, born premature (if they are under 
24 months of age), blind, or deaf:  We must recruit a healthy sample of typically 
developing children born in a full term pregnancy (if they are under 24 months of 
age) who are not blind or deaf for this project to remove any potential confounds 
that atypical conditions may have on children’s play. Typically developing 
children would not have any diagnosed congenital conditions, developmental 
delay or disability, dyslexia, PDD, ADD, ADHD, or ASD.  Including other 
populations such as deaf or blind children would require a different experimental 
set up, stimulus toys, and resources (i.e., someone who could convert our surveys 
to American Sign Language or Braille and could code the videos for the parent 
child behaviors during those sessions).   
• Children who are not adding to the ethnic and racial diversity of the sample:  The 
goal of our study is to recruit a sample of subjects who are racially and ethnically 
diverse.  By making this diverse sample a priority, we hope that our results will be 
applicable to the diverse populations residing within the United States.  To keep 
with this goal of a diverse and representative sample of children, we may have to 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 26 of 37 
 
 
exclude some families if we have already reached the quota of families from that 
particular racial or ethnic group. 
b. Justification for inclusion of children  
The following project must include children because child behavior is at the heart of the 
research question for this project.  Without including a young subject population, we 
would not be able to provide the required information to the Consumer Product Safety 
Commission. 
 
c. 
Justification for inclusion of other vulnerable subjects AND/OR 
Justification for exclusion of other vulnerable subjects  
Not applicable. 
 
d.  Justification for sensitive procedures  
Not applicable—there are no sensitive procedures in this project. 
 
e. 
Safeguards for vulnerable populations and sensitive procedures  
Children are welcome to withdraw from the study at any time, and their confidentiality 
will be protected throughout the testing process. 
 
f. 
Qualifications of investigators 
Principal Investigator: Diane L. Putnick, Ph.D., NICHD 
has extensive research experience designing experiments, working with minors, 
collecting data, analyzing data, and writing research reports. 
 
 
 
Associate Investigators: 
Melissa N. Richards, Ph.D., NICHD 
 
 
 
 
Diane L. Putnick, Ph.D., NICHD 
 
 
 
 
Todd D. Little, Ph.D., Texas Tech University 
 
 
 
 
Kyle M. Lang, Ph.D., Tilburg University 
 
 
 
 
Laura Bradley, B.A., University of Pennsylvania 
 
 
 
 
Marc H. Bornstein, Ph.D., NICHD 
 
All Associate Investigators have extensive research 
experience designing experiments, working with minors, 
collecting data, analyzing data, and writing research 
reports. Dr. Little, Dr. Lang, and Dr. Bornstein’s protocol 
related duties will not include obtaining consent from 
patients.  They will only engage in analysis of de-identified 
data. 
 
Research Assistants and  
Data Collection Aides: 
Post-baccalaureate IRTA Research Assistants 
All IRTA Research Assistants have Bachelor’s 
degrees in psychology or other social science 
related fields and have prior experience working in 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 27 of 37 
 
 
a research laboratory.  IRTAs will be trained 
thoroughly in the methods of the protocol. 
 
Only the principal investigator and the associate investigators are eligible to obtain 
informed consent.   
 
The Principal Investigator has verified that all individuals working on this protocol 
required to take HRPP training under OHSRP SOP 25 (Training requirements for the 
NIH Human Research Protections Program) will have completed all required training 
before starting work on the protocol. 
 
12. Anticipated Benefit 
This study does not offer direct benefit to participants but will yield generalizable 
knowledge about how to categorize traditional and contemporary children’s products and 
toys into age appropriate groups.  The age determinations based on this research that are 
made by the CPSC have a large and generalizable impact on U.S. children, their families, 
and the current practices of toy manufacturers and the CPSC.  First, the changes made to 
the CPSC Guidelines based on the results of this study will have a large impact on how 
the CPSC determines the age appropriateness of children's products and toys.  In 
addition, manufacturers of children's products and toys adhere to the CPSC Guidelines 
when determining what target age to label on packages of their products.  Finally, U.S. 
Consumers of these goods are steered in their purchasing decisions of these products 
based on the age labels on the toys. 
 
13. Classification of Risk  (for the study as a whole) 
For the child participants, this project is classified under 45CFR46.404; it does not 
involve greater than minimal risk to children. The probability and magnitude of harm or 
discomfort anticipated with the research are not greater in and of themselves than those 
ordinarily encountered in daily life.  
 
For our adult (parent) participants, this study does not involve greater than minimal risk. 
It is possible that some participants may find that some of the questions touch on areas of 
personal sensitivity and experience discomfort.  Participants can decline to answer any 
question.  No invasive procedures or interventions are involved.    
 
d. 
Overall risk and benefit consideration 
The less than minimal risk involved in this project is reasonable in relation to anticipated 
benefit.  The benefit of this study lies in the extension of knowledge of how to effectively 
categorize children’s toys in the U.S. for parents into age appropriate categories, leading 
to a safer consumer market for children and their families. 
 
14. Consent Documents and Process 
 
a. 
Designation of those obtaining consent 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 28 of 37 
 
 
Study investigators designated as able to obtain consent in Section #11f above will obtain 
informed consent.  All study investigators obtaining informed consent will have 
completed the NIMH HSPU ‘Elements of Successful Informed Consent’ training.  Verbal 
or written assent will be obtained from minor subjects over age 4. 
 
b. Consent procedures  
Permission for participation of minors will be obtained from parents/legal guardians.  
Parents will have the opportunity to carefully review the written consent form and ask 
questions regarding the study prior to signing.  After the consent form has been filled out 
and parental permission is obtained, the parent and child may begin participation in the 
study.   
 
Permission from only one parent is being requested.  The permission of one parent is 
sufficient for compliance with 45 CFR 46.404, as the proposed research poses risk no 
greater than that ordinarily encountered in daily life or during the performance of routine 
physical or psychological examinations or tests (i.e., minimal risk).  
 
At the time of the play session, CFRS staff will also obtain assent from the children to 
ensure that they want to participate in the study as well.  Parents will be present during 
the assent process and will sign the bottom of the assent form to certify that they 
witnessed their child’s assent.  
 
Children between the ages of 4-5 will provide verbal assent.  Researchers will sign the 
form to certify that they received assent from the participant.  Language for verbal assent 
will be as follows:  
“We are doing this project because we want to know more about how kids play 
with toys.  If you join in, you will play with some toys.  My friend here is going to 
use a camera to make a video of you while you play with the toys.  Nobody will 
see the video except people who work with us, and we will keep the video private 
by putting it in a locked room.  Then, I will ask you some questions.  You might 
like playing with these toys, but you might not like it.  If you do not want to play 
with them, you do not have to.  We will get to learn about what kids like and how 
they think if you will help us.  You will also get to play with some toys.  If you do 
not want to play anymore, you do not have to.  Just tell me if you do not want to 
play anymore!  If you decide you want to stop, you can leave—I will not be upset.  
Anything that you say to me will be safe.  Do you have any questions?  Would 
you like to do this?”  
 
Children over the age of 6 will be read the same statement and will be asked to sign a 
written assent form to indicate their willingness to participate.   
 
c. 
Consent documents 
The consent form contains all required elements of information needed to understand the 
goals and procedures of the study and will use the language set forth in the NICHD 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 29 of 37 
 
 
consent form template  The information will be taken from this protocol, but worded in 
such a way that it is easy to understand at approximately an 8th grade reading level. 
 
As such, it will contain information about the following elements: 
Introduction, Purpose of The Study, Background, Study Population, Inclusion Criteria, 
Exclusion Criteria, Procedures, Risks, and Discomforts, Use of Stored Data, Anticipated 
Benefits, Right of Withdrawal, How Findings will be Shared with Participants, 
Alternatives to Participation, Confidentiality, Compensation, Policy Regarding Research-
Related Injuries, Conflict of Interest, and Problems or Questions. 
 
15. Data and Safety Monitoring 
 
a. 
Data and safety monitor 
Data and safety will be monitored by the Principal and Associate Investigators.  
Ultimately, the Principal Investigator is responsible for all aspects of the study.   
 
This protocol does not meet the criteria as outlined in the NIH HRPP SOP 17 for data to 
be submitted to a data safety monitoring committee, therefore, this project does not have 
a DSMB. 
 
b. Data and safety monitoring plan 
Participant safety will be monitored while playing with the toys; because this is not a 
clinical trial, we will not engage in planned interim analyses.   
 
Lead Associate Investigator Melissa Richards is responsible for coordinating data collection 
and will review the data for accuracy and completeness within 48 hours of each subject 
visit, including review of subject consent documents. An evaluation of subject 
recruitment, accrual, and retention as specified in the protocol will be ongoing. Review of 
literature and results of related studies will be assessed throughout the study for any 
impact on patient safety or ethical questions.   
 
c. 
Criteria for stopping the study or suspending enrollment or procedures 
In the event that the study is stopped or enrollment or procedures are suspended, a review 
will be completed by the principal and associate investigators to determine if research can 
resume. 
 
16. Quality Assurance 
 
a. Quality assurance monitor 
This research is social/behavioral in nature and minimal in risk and does not involve 
interventions or drugs.  Therefore, the people who will perform monitoring are the 
Principal and Associate Investigators, as well as the NICHD Quality Assurance Program. 
 
b. Quality assurance plan 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 30 of 37 
 
 
Oversight of monitoring will be performed by the NICHD Quality Assurance (QA) 
Program.  The NICHD Quality Assurance Program will perform random audits annually 
on at least 10% of actively accruing NICHD protocols (policy: 
https://science.nichd.nih.gov/confluence/display/ocd/Protocol+Navigation). 
 
17. Reporting of Unanticipated Problems, Adverse Events and Protocol Deviations 
The Principal Investigator is responsible for detecting, documenting, and reporting 
unanticipated problems, adverse events (AEs), including serious adverse events (SAEs), 
and deviations in accordance with NIH policy, IRB requirements, and federal regulations. 
Relatedness to the research of all serious adverse events will be determined by the PI in 
consultation with the Clinical Director (CD). 
 
All Unanticipated Problems (UP), Protocol Deviations (PD), deaths, and Adverse Events 
(AE) will be reported to the IRB or the Clinical Director (CD) using PTMS, in 
accordance with SOP 16. When PTMS is not available, the NIH Problem Report Form 
will be used. 
(https://federation.nih.gov/ohsr/nih/ohrdocs/NIH_Problem_Report_Form_Fillable_DDIR
_v1_6-11-13_508.pdf).   
 
Serious unanticipated problems and serious protocol deviations will be reported to the 
IRB and CD as soon as possible but not more than 7 days after the PI first learns of the 
event.  Non-serious UP’s will be reported to the IRB and CD, and non-serious PD’s to the 
IRB not more than 14 days after the PI first learns of the event.  Written reports will be 
submitted in PTMS.  Deaths will be reported to the CD within 7 days after the PI first 
learns of the event.  
 
An aggregated summary of all UP’s, PD’s, UADE’s, and AE’s will be reported to the 
IRB at the time of Continuing Review (CR). 
 
All IRB documentation can be found in PTMS. The Principal Investigator is responsible 
for maintaining IRB documentation, including records of all reviews of the study and 
submissions to the IRB. 
 
18. Alternatives to Participation OR Alternative Therapies  
Participants do not receive any treatment in this study or forego any treatment in order to 
participate in this study. The alternative, therefore, is not to participate. 
 
19. Privacy 
All research activities will be conducted in as private a setting as possible.  All research 
activities will be conducted by researchers who have been trained on the protocol of the 
project.   
 
All information collected in connection with this study is confidential. If CTSS is used, 
each participant will be provided with a unique password to access the website in order to 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 31 of 37 
 
 
complete the questionnaires. Online responses are identified with a randomly generated 
coded number, rather than with the name of the participant. Data will be stored 
permanently on the National Institute of Child Health and Human Development 
computerized database.  No one other than members of the research team will have 
access to the data without the explicit consent of the participant adult. 
 
We will do everything we can to keep outsiders from learning about families’ 
participation in this study.  To further help us protect their privacy, we will obtain a 
Certificate of Confidentiality from the United States Department of Health and Human 
Services (DHHS).  With this Certificate, we cannot be forced (for example by court order 
or subpoena) to disclose information that may identify subjects in any federal, state, local, 
civil, criminal, legislative, administrative, or other proceedings.  The researchers will use 
the Certificate to resist any demands for information that would identify participants, 
except to prevent serious harm to themselves or others. 
 
20. Confidentiality 
 
a. 
For research data and investigator medical records 
Child participants will be assigned ID numbers at the outset of the study.  The key linking 
the ID numbers with the participants’ identity and videos taken of the children will be 
kept in a locked filing cabinet in a room that is locked when unoccupied.   
 
Electronic data will be kept in password-protected computers and servers.  Only study 
investigators will have access to the samples and data. Data collected on paper will be de-
identified through the use of the ID number assigned to the participant at the outset of the 
study.  Data collected on paper will be entered into electronic spreadsheets.  All 
participant identifying data except for subject numbers will be removed from these 
spreadsheets.   
 
In addition, parents will have the option of indicating on the consent form whether or not 
they will allow the use of short video clips of themselves and their child at professional 
presentations and conferences.  Parents may contact us to change their preferences for the 
public use of these videos at any time, both during or after the study.   
 
Subject confidentiality will be maintained to the greatest extent possible.  Research 
results will be labeled using a unique code.  Publications will not include subject names 
nor will they contain personal identifying information. 
 
b. For stored samples 
Not applicable, we are not collecting any samples, only data. 
 
c. 
Special precautions  
Not applicable 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 32 of 37 
 
 
21. Conflict of Interest 
 
a.   Distribution of NIH guidelines 
NIH guidelines on conflict of interest have been distributed to all investigators.   
 
b.  Conflict of interest  
 There are no conflicts of interest to report. 
 
c.  Role of a commercial company or sponsor  
Not applicable; this study does not have a commercial company collaborator or sponsor. 
 
22. Technology Transfer 
Not applicable; there are no associated tech transfer agreements for this study.  
 
23. Research and Travel Compensation  
Volunteers will be compensated for time and research-related inconveniences.  Each 
parent-child dyad enrolled will be paid a total of $30 for participation in the study.   
 
If parents participate in the focus group, they will receive an additional $10 of payment 
for participating.  
 
Participants may elect to have the payment dispersed either through a check mailed to 
their home or directly deposited into their bank account.  In both circumstances, 
researchers will register the payment in the NIH Clinical Center Research Volunteer 
System (https://rvs.cc.nih.gov).  If participants elect to the have the payment directly 
deposited into their bank account, an additional form with the participants’ bank routing 
number will have to be completed through RVS.  Payment will be coordinated through 
Ms. Mandy Jawara, Program Coordinator, NIH Clinical Center Office of Patient 
Recruitment—Healthy Volunteer Program.  If parents would prefer to not fill out the 
form, they may call Mandy Jawara directly and provide her with this information over the 
phone.  Payment will be sent after the visit to the CFRS. 
 
Compensation will be prorated for parts completed if participants do not complete the 
entire study.   
 
24. References 
Bergen, D. (2002).  The role of pretend play in children's cognitive development.  Early 
Childhood Research and Practice, 4, 1-13. 
 
Bergen, D. & Davis, D. (2011).  Influences of technology-related playful activity and 
thought on moral development.  American Journal of Play, 4, 80-99. 
  
Bornstein, M.H. (2006).  On the significance of social relationships in the development of 
children's earliest symbolic play: An ecological perspective.  In A. Göncü & S. 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 33 of 37 
 
 
Gaskins (Eds.), Play and development: Evolutionary, sociocultural, and 
functional perspectives. The Jean Piaget symposium series (pp. 101-129). 
Mahwah, NJ: Lawrence Erlbaum Associates Publishers. 
 
Bornstein, M.H., Haynes, O.M., Legler, J.M., O’Reilly, A.W., & Painter, K.M. (1997).  
Symbolic play in childhood: Interpersonal and environmental context and 
stability.  Infant Behavior and Development, 20, 197-207. 
 
Bornstein, M. H., Haynes, O. M., O'Reilly, A. W., & Painter, K.  (1996). Solitary and 
collaborative pretense play in early childhood: Sources of individual variation in 
the development of representational competence.  Child Development, 67, 2910-
2929. 
 
Bornstein, M. H., Haynes, O. M., Pascual, L., Painter, K. M., & Galperín, C. (1999).  
Play in two societies:  Pervasiveness of process, specificity of structure.  Child 
Development, 70, 317-331. 
 
Bornstein, M.H., Putnick, D.L., Gartstein, M.A., Hahn, C.S., Auestad, N., & O’Connor, 
D.L. (2015).  Infant temperament: Stability by age, gender, birth order, term 
status, and socioeconomic status.  Child Development, Early View. 
 
Caldera, Y.M., Huston, A.C., & O’Brien, M. (1989).  Social interactions and play 
patterns of parents and toddlers with feminine, masculine, and neutral toys.  Child 
Development, 60, 70-76. 
 
Calvert, S.L., Richards, M.N., Kent, C.C. (2014). Personalized interactive characters for 
toddlers’ learning of seriation from a video presentation. Journal of Applied 
Developmental Psychology, 35, 148-155. 
 
Cote, L. R., & Bornstein, M. H. (2009).  Child and mother play in three U.S. cultural 
groups: Comparisons and associations. Journal of Family Psychology, 23, 355-
363. 
 
Damast, A.M., Tamis-LeMonda, C.S., & Bornstein, M.H. (1996).  Mother-child play: 
Sequential interactions and the relation between maternal beliefs and behaviors.  
Child Development, 67, 1752-1766. 
 
Eckler, J.A. & Weininger, O. (1989).  Structural parallels between pretend play and 
narratives.  Developmental Psychology, 25, 736-743. 
 
Elder, J.L. & Pederson, D.R. (1978).  Preschool children's use of objects in symbolic 
play.  Child Development, 49, 500-504. 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 34 of 37 
 
 
Fenson, L., Kagan, J. Kearsley, R.B., & Zelazo, P.R. (1976).   The developmental 
progression of manipulative play in the first two years.  Child Development, 47, 
232-236. 
  
Furby, L. & Wilke, M. (1982).  Some characteristics of infants’ preferred toys.  The 
Journal of Genetic Psychology, 140, 207-219. 
 
Ginsburg, K.R. (2007).  The importance of play in promoting healthy child development 
and maintaining strong parent-child bonds.  Pediatrics, 119, 182-191.  
 
Glassy, D. & Romano, J. (2003).  Selecting appropriate toys for young children: The 
pediatrician’s role.  Pediatrics, 111, 911-913. 
 
Gredlein, J. M., & Bjorklund, D. F. (2005). Sex differences in young children’s use of 
tools in a problem-solving task. Human Nature, 16, 211–232. 
 
Harter, S. (1982).  The Perceived Competence Scale for Children.  Child Development, 
53, 87-97. 
 
Hollingshead, AB. (1975).  The four-factor index of social status. Yale University: 
Unpublished manuscript. 
 
Howes, C. (1987).  Social competence with peers in young children:  Developmental 
sequences.  Developmental Review, 7, 252-272. 
 
Kahn, P.H., Friedman, B.  Perez-Granados, D.R., & Freier, N.G. (2006).  Robotic pets in 
the lives of preschool children.  Interaction Studies, 7, 405–436. 
 
Kimmerle, M., Mick, L.A., & Michel, G.F. (1995).  Bimanual role differentiated toy play 
during infancy. Infant Behavior & Development, 18, 299-307. 
 
Kwak, K., Bornstein, M.H., & Putnick, D.L. (2008).  Child and mother play in South 
Korea:  A longitudinal study across the second year of life.  Psychologia, 51, 14-
27. 
 
Lillard, A.S. (2015).  The development of play.  In R.M. Lerner (Ed.), The Handbook of 
Child Psychology and Developmental Science (pp. 425-468).  Hoboken, NJ:  John 
Wiley & Sons , Inc.      
 
Linver, M.R., Brooks-Gunn, J., & Cabrera, N. (2004).  The Home Observation for 
Measurement of the Environment (HOME) Inventory:  The derivation of 
conceptually designed subscales.  Parenting:  Science and Practice, 4, 99-114. 
 
MacPhee, D., Benson, J.B., & Bullock, D. (1986). Influences on Maternal Self 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 35 of 37 
 
 
Perceptions.  Poster presented at the Biennial International Conference on Infant 
Studies, Los Angeles, CA. 
 
McCall, R.B. (1974).  Exploratory manipulation and play in the human infant.  
Monographs of the Society for Research in Child Development, 39, 1-88. 
 
Morawska, A., Sanders, M. R., & Winter, L. (2007). The knowledge of effective 
parenting scale. Brisbane, QLD: The School of Psychology, The University of 
Queensland. 
 
Niec, L. N., & Russ, S. (2002). Children’s internal representations, empathy, and fantasy 
play: A validity study of the SCORS-Q. Psychological Assessment, 14, 331–338. 
 
O’Brien, M. & Huston, A.C. (1985).  Activity level and sex-stereotyped toy choice in 
toddler boys and girls.  The Journal of Genetic Psychology, 146, 527-533. 
 
O'Reilly, A. W., & Bornstein, M. H. (1993). Caregiver-child interaction in play.  In M. H. 
Bornstein & A. W. O'Reilly (Eds.), The Role of Play in the Development of 
Thought (pp. 55-66).  San Francisco: Jossey-Bass. 
 
Pellegrini, A. D., & Gustafson, K. (2005). Boys’ and girls’ uses of objects for 
exploration, play, and tools in early childhood. In A. Pellegrini & P. Smith (Eds.), 
The nature of play: Great apes and humans (pp. 113–138). New York, NY: 
Guilford Press 
 
Piaget, J. (1962). Play, dreams, and imitation in childhood. New York: Norton. 
 
Reynolds, W.M. (1982). Development of reliable and valid short forms of the Marlowe-
Crowne Social Desirability Scale. Journal of Clinical Psychology, 38, 119-125. 
 
Richards, M.N. & Calvert, S.L. (2015).  Measuring Young Children's Parasocial 
Relationships:  Creating a Child Self-Report Survey.  Poster to be presented at the 
Association for Psychological Science Annual Convention. 
 
Robinson, C.C. & Jackson, R. (1987).  The effects of varying toy detail within a 
prototypical play object on the solitary pretend play of preschool children.  
Journal of Applied Developmental Psychology, 8, 209-220. 
 
Rothbart, M.K.  (2007). Temperament, development and personality. Current Directions 
in Psychological Science, 16, 207-212. 
 
Rubin, K.H., Watson, K.S., & Jambor, T.W. (1978).  Free-play behaviors in preschool 
and kindergarten children.  Child Development, 49, 534-536. 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 36 of 37 
 
 
Scarlett, W.G. (2005).  Children’s Play.  Thousand Oaks, CA:  SAGE Publications, Inc.   
 
Schousboe, I. (2013).  The structure of fantasy play and its implications for good and evil 
games.  In D. Winther-Lindqvist & I. Schousboe (Eds.), Children’s Play and 
Development:  Cultural-historical Perspectives (pp. 13-27).  Dordrecht:  Springer. 
 
Schulz, L., & Bonawitz, E. (2007). Serious fun: Preschoolers engage in more exploratory 
play when evidence is confounded. Developmental Psychology, 43, 1045–1050. 
 
Shure, M.B. (1963).  Psychological ecology of a nursery school.  Child Development, 34, 
979-992. 
 
Singer, J. L. (1994). Imaginative play and adaptive development. In J. H. Goldstein (Ed.), 
Toys, play, and child development (pp. 6–26). Cambridge, UK: Cambridge 
University Press. 
 
Smith, E.D., & Lillard, A.S. (2012).  Play on:  Retrospective reports of the persistence of 
pretend play into middle childhood.  Journal of Cognition and Development, 13, 
524-549. 
 
Sparrow, S.S., Balla, D.A., & Cicchetti, D.V. (1984).  Vineland Adaptive Behavior 
Scales survey form manual (Interview edition) American Guidance Service; 
Circle Pines, MN. 
 
Suizzo, M.-A., & Bornstein, M. H. (2006). French and European American child-mother 
play: Culture and gender considerations. International Journal of Behavioral 
Development, 30, 498-508. 
 
Tamis-LeMonda, C.S., Shannon, J.D., Cabrera, N.J., & Lamb, M.E. (2004).  Fathers and 
mothers at play with their 2- and 3-year-olds: Contributions to language and 
cognitive development.  Child Development, 75, 1806-1820. 
 
Tamis-LeMonda, C.S., Damast, A.M., & Bornstein, M.H. (1994).  What do mothers 
know about the nature of play?  Infant Behavior and Development, 17, 341-345. 
 
Teti, D.M., Bond, L.A., & Gibbs, E.D. (1988).   Mothers, fathers, and siblings: A 
comparison of play styles and their influence upon infant cognitive level.  
International Journal of Behavioral Development, 11, 415-432. 
 
Toy Industry Association (2014).  Annual Sales Data.  Retrieved from 
http://www.toyassociation.org/TIA/Industry_Facts/salesdata/IndustryFacts/Sales_
Data/Sales_Data.aspx?hkey=6381a73a-ce46-4caf-8bc1-
72b99567df1e#.VTFwciHBzRY 
 

 
 
 
 
CNS IRB Protocol Template (2.5.15) 
 
 
 
 
 
 
page 37 of 37 
 
 
Trawick-Smith, J. & Dzuirgot, T. (2011).  “Good-fit” teacher-child play interactions and 
subsequent autonomous play in preschool.  Early Childhood Research Quarterly, 
26, 110-123. 
  
Trawick-Smith, J. (1998).  A qualitative analysis of metaplay in the preschool years.  
Early Childhood Research Quarterly, 14, 433-452.   
 
Vygotsky, L.S. (1967).  Play and its role in the mental development of the child.  Soviet 
Psychology, 5, 6-18. 
 
Winther-Lindqvist, D. (2013).  Playing with social identities:  Play in the everyday life of 
a peer group in day care.  In D. Winther-Lindqvist & I. Schousboe (Eds.), 
Children’s Play and Development:  Cultural-historical Perspectives (pp. 29-54).  
Dordrecht:  Springer. 
 
Wolfgang, C.H., Stannard, L.L., & Jones, I. (2001).  Play performance among 
preschoolers as a predictor of later school achievement in mathematics. Journal of 
Research in Childhood Education, 15, 173-180. 
 
Wood, D., Bruner, J.S., & Ross, G. (1976).  The role of tutoring in problem solving.  
Journal of Child Psychology and Psychiatry, 17, 89-100.