NCT02544035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

December 5, 2023

Completed
Last Updated

December 5, 2023

Status Verified

April 30, 2021

Enrollment Period

2 years

First QC Date

September 5, 2015

Results QC Date

June 21, 2022

Last Update Submit

November 16, 2023

Conditions

Keywords

Childhood Growth and DevelopmentDevelopment

Outcome Measures

Primary Outcomes (1)

  • 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

    1 hour play session

Secondary Outcomes (4)

  • Played With Toy

    1 hour play session

  • Duration of Toy Play

    1 hour play session

  • Preference for the Toy - Child-report

    1 hour play session

  • Solicits to Parent Involvement

    1 hour play session

Study Arms (8)

36-71 month-old Play Partner

EXPERIMENTAL

36-71 month-olds (1.5-2 year olds)

Other: Play Partner

72-107 month-old Play Partner

EXPERIMENTAL

72-107 month-olds (6-8 year-olds)

Other: Play Partner

12-18 month-old Toy Type

EXPERIMENTAL

12-18 month-olds (1-1.5 year olds)

Other: Type of Toy

19-35 month-old Toy Type

EXPERIMENTAL

19-35 month-olds (1.5-2 year-olds)

Other: Type of Toy

36-71 month-old Toy Type

EXPERIMENTAL

36-71 month-olds (3-5 year-olds)

Other: Type of Toy

72-107 month-old Toy Type

EXPERIMENTAL

72-107 month-olds (6-8 year-olds)

Other: Type of Toy

12-18 month-old Play Partner

EXPERIMENTAL

12-18 month-olds (1-1.5 year olds)

Other: Play Partner

19-35 month-old Play Partner

EXPERIMENTAL

19-35 month-olds (1.5-2 year olds)

Other: Play Partner

Interventions

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;

12-18 month-old Toy Type19-35 month-old Toy Type36-71 month-old Toy Type72-107 month-old Toy Type

Each child will first play alone then play with parent.

12-18 month-old Play Partner19-35 month-old Play Partner36-71 month-old Play Partner72-107 month-old Play Partner

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 9071765BACKGROUND
  • 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.

  • 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.

Results Point of Contact

Title
Dr. Diane Putnick
Organization
National Institute of Child Health and Human Development

Study Officials

  • Diane L Putnick, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2015

First Posted

September 9, 2015

Study Start

September 5, 2015

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

December 5, 2023

Results First Posted

December 5, 2023

Record last verified: 2021-04-30

Locations