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Determining Age Appropriateness of Children's Products and Toys

Determining Age Appropriateness of Children's Products and Toys: An Interagency Agreement With the Consumer Product Safety Commission

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02544035
Enrollment
486
Registered
2015-09-09
Start date
2015-09-05
Completion date
2017-08-31
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers Only

Keywords

Childhood Growth and Development, Development

Brief summary

Background: Play during childhood is an important part of healthy development, and children can learn many things when they play. Much of the time that children spend playing is with toys. However, children at different ages need different types of toys to engage in healthy play. Understanding children s play with toys is important to the National Institute of Child Health and Human Development (NICHD), and to the U.S. Consumer Product Safety Commission (CPSC). The CPSC rates toys that are currently available in the United States for children for age appropriateness. NICHD will share the findings of this study with CPSC to aid in their toy rating process. Objective: To categorize traditional and contemporary children s products and toys into age appropriate groups. Eligibility: Healthy children 6 months to 12 years old. Their parents. Design: Participants will be screened with a phone call with the parents. Participants will complete surveys online or on paper, and by phone. These will ask about demographic facts, behavior, thoughts on parenting and toys, and child development. Participants will have 1 study visit. The child will play with toys by himself or herself. Then they will play with their parent. A researcher will observe. The sessions will be videotaped. Children will share their thoughts about the toys by pointing at a smiley face scale. Parents will fill out a short survey. Then can choose to participate in a 1-hour focus group.

Detailed description

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 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.

Interventions

OTHERType of Toy

Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;

OTHERPlay Partner

Each child will first play alone then play with parent.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: 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.

Exclusion criteria

* 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 exclude some families if we have already reached the quota of families from that particular racial or ethnic group.

Design outcomes

Primary

MeasureTime frameDescription
Utilization of Toy1 hour play sessionChildren's play with each of the toys was categorized as fully utilized (1) or not fully utilized (0) according to the intended use of each toy

Secondary

MeasureTime frameDescription
Played With Toy1 hour play sessionWe constructed a variable to indicate whether the child played with the toy (1) or did not play with the toy (0).
Duration of Toy Play1 hour play sessionDuration of time child plays with each toy
Preference for the Toy - Child-report1 hour play sessionChild preference for the toys based on child-report
Solicits to Parent Involvement1 hour play sessionNumber of times child solicits parent involvement

Countries

United States

Participant flow

Participants by arm

ArmCount
12-18 Month-old Toy Type
12-18 month-olds (1-1.5 year olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;
60
19-35 Month-old Toy Type
19-35 month-olds (1.5-2 year-olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;
61
36-71 Month-old Toy Type
36-71 month-olds (3-5 year-olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;
62
72-107 Month-old Toy Type
72-107 month-olds (6-8 year-olds) Type of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;
60
12-18 Month-old Play Partner
12-18 month-olds (1-1.5 year olds) Play Partner: Each child will first play alone then play with parent.
60
19-35 Month-old Play Partner
19-35 month-olds (1.5-2 year olds) Play Partner: Each child will first play alone then play with parent.
61
36-71 Month-old Play Partner
36-71 month-olds (1.5-2 year olds) Play Partner: Each child will first play alone then play with parent.
62
72-107 Month-old Play Partner
72-107 month-olds (6-8 year-olds) Play Partner: Each child will first play alone then play with parent.
60
Total486

Baseline characteristics

Characteristic12-18 Month-old Toy Type19-35 Month-old Toy Type36-71 Month-old Toy Type72-107 Month-old Toy Type12-18 Month-old Play Partner19-35 Month-old Play Partner36-71 Month-old Play Partner72-107 Month-old Play PartnerTotal
Age, Continuous15.34 months
STANDARD_DEVIATION 2.02
26.88 months
STANDARD_DEVIATION 4.96
54.16 months
STANDARD_DEVIATION 10.77
89.52 months
STANDARD_DEVIATION 11.42
15.34 months
STANDARD_DEVIATION 2.02
26.88 months
STANDARD_DEVIATION 4.96
54.16 months
STANDARD_DEVIATION 10.77
89.52 months
STANDARD_DEVIATION 11.42
46.46 months
STANDARD_DEVIATION 29.66
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants3 Participants6 Participants8 Participants5 Participants3 Participants6 Participants8 Participants44 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
55 Participants58 Participants56 Participants52 Participants55 Participants58 Participants56 Participants52 Participants442 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants8 Participants4 Participants4 Participants4 Participants8 Participants4 Participants4 Participants40 Participants
Race (NIH/OMB)
Black or African American
4 Participants5 Participants4 Participants8 Participants4 Participants5 Participants4 Participants8 Participants42 Participants
Race (NIH/OMB)
More than one race
12 Participants7 Participants12 Participants12 Participants12 Participants7 Participants12 Participants12 Participants86 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
40 Participants41 Participants42 Participants36 Participants40 Participants41 Participants42 Participants36 Participants318 Participants
Region of Enrollment
United States
60 participants61 participants62 participants60 participants60 participants61 participants62 participants60 participants486 participants
Sex: Female, Male
Female
26 Participants33 Participants31 Participants28 Participants26 Participants33 Participants31 Participants28 Participants236 Participants
Sex: Female, Male
Male
34 Participants28 Participants31 Participants32 Participants34 Participants28 Participants31 Participants32 Participants250 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 610 / 620 / 600 / 600 / 610 / 620 / 60
other
Total, other adverse events
0 / 600 / 610 / 620 / 600 / 600 / 610 / 620 / 60
serious
Total, serious adverse events
0 / 600 / 610 / 620 / 600 / 600 / 610 / 620 / 60

Outcome results

Primary

Utilization of Toy

Children's play with each of the toys was categorized as fully utilized (1) or not fully utilized (0) according to the intended use of each toy

Time frame: 1 hour play session

Population: Child age by toy age appropriateness

ArmMeasureValue (NUMBER)
12-18 Month-old Toy TypeUtilization of Toy.45 Proportion
19-35 Month-old Toy TypeUtilization of Toy.49 Proportion
36-71 Month-old Toy TypeUtilization of Toy.50 Proportion
72-107 Month-old Toy TypeUtilization of Toy.53 Proportion
Secondary

Duration of Toy Play

Duration of time child plays with each toy

Time frame: 1 hour play session

Secondary

Played With Toy

We constructed a variable to indicate whether the child played with the toy (1) or did not play with the toy (0).

Time frame: 1 hour play session

ArmMeasureValue (NUMBER)
12-18 Month-old Toy TypePlayed With Toy.67 Proportion
19-35 Month-old Toy TypePlayed With Toy.61 Proportion
36-71 Month-old Toy TypePlayed With Toy.62 Proportion
72-107 Month-old Toy TypePlayed With Toy.65 Proportion
Secondary

Preference for the Toy - Child-report

Child preference for the toys based on child-report

Time frame: 1 hour play session

Secondary

Solicits to Parent Involvement

Number of times child solicits parent involvement

Time frame: 1 hour play session

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026