Clinical trial NCT02544035: Determining Age Appropriateness of Children's Products and Toys
Official title: Determining Age Appropriateness of Children's Products and Toys: An Interagency Agreement With the Consumer Product Safety Commission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers Only
Keywords: Childhood Growth and Development
Development
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2015-09-09
Enrollment: 486
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Utilization of Toy
timeFrame: 1 hour play session
Secondary outcomes:
measure: Played With Toy
timeFrame: 1 hour play session
measure: Duration of Toy Play
timeFrame: 1 hour play session
measure: Preference for the Toy - Child-report
timeFrame: 1 hour play session
measure: Solicits to Parent Involvement
timeFrame: 1 hour play session
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Child Health and Human Development (NICHD)
state: Maryland
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Diane L Putnick, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bornstein MH, Haynes OM, O'Reilly AW, Painter KM. Solitary and collaborative pretense play in early childhood: sources of individual variation in the development of representational competence. Child Dev. 1996 Dec;67(6):2910-29.
citation: Richards MN, Putnick DL, Bradley LP, Lang KM, Little TD, Suwalsky JTD, Bornstein MH. Children's Utilization of Toys is Moderated by Age-Appropriateness, Toy Category, and Child Age. Appl Dev Sci. 2022;26(1):192-205. doi: 10.1080/10888691.2020.1760868. Epub 2020 May 19.
citation: Richards MN, Putnick DL, Bornstein MH. Toy Buying Today: Considerations, Information Seeking, and Thoughts about Manufacturer Suggested Age. J Appl Dev Psychol. 2020 May-Jun;68:101134. doi: 10.1016/j.appdev.2020.101134. Epub 2020 Apr 8.