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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02544035
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Only Other: Type of Toy Other: Play Partner (Either parent or friend) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 532 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Determining Age Appropriateness of Children's Products and Toys: An Interagency Agreement With the Consumer Product Safety Commission
Study Start Date : September 5, 2015
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Arm Intervention/treatment
Experimental: 1
6-11 month-olds
Other: 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; one targeted to the age group just below and one from the age group just above the target toy.

Experimental: 10
36-71 month-olds (1.5-2 year olds)
Other: Play Partner (Either parent or friend)
For children ages 6 months-5 years, each child will first play alone then play with parent. For children ages 6-12 years, each child will first play alone then play with a friend.

Experimental: 11
72-107 month-olds (6-8 year-olds)
Other: Play Partner (Either parent or friend)
For children ages 6 months-5 years, each child will first play alone then play with parent. For children ages 6-12 years, each child will first play alone then play with a friend.

Experimental: 12
108-144 month-olds (9-12 year-olds)
Other: Play Partner (Either parent or friend)
For children ages 6 months-5 years, each child will first play alone then play with parent. For children ages 6-12 years, each child will first play alone then play with a friend.

Experimental: 2
12-18 month-olds (1-1.5 year olds)
Other: 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; one targeted to the age group just below and one from the age group just above the target toy.

Experimental: 3
19-35 month-olds (1.5-2 year-olds)
Other: 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; one targeted to the age group just below and one from the age group just above the target toy.

Experimental: 4
36-71 month-olds (3-5 year-olds)
Other: 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; one targeted to the age group just below and one from the age group just above the target toy.

Experimental: 5
72-107 month-olds (6-8 year-olds)
Other: 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; one targeted to the age group just below and one from the age group just above the target toy.

Experimental: 6
108-144 month-olds (9-12 year-olds)
Other: 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; one targeted to the age group just below and one from the age group just above the target toy.

Experimental: 7
6-11 month-olds
Other: Play Partner (Either parent or friend)
For children ages 6 months-5 years, each child will first play alone then play with parent. For children ages 6-12 years, each child will first play alone then play with a friend.

Experimental: 8
12-18 month-olds (1-1.5 year olds)
Other: Play Partner (Either parent or friend)
For children ages 6 months-5 years, each child will first play alone then play with parent. For children ages 6-12 years, each child will first play alone then play with a friend.

Experimental: 9
19-35 month-olds (1.5-2 year olds)
Other: Play Partner (Either parent or friend)
For children ages 6 months-5 years, each child will first play alone then play with parent. For children ages 6-12 years, each child will first play alone then play with a friend.




Primary Outcome Measures :
  1. The primary study outcome is the video-coded measures of play complexity. We will examine differences in the mean scores of play complexity by the type of toy the child receives. [ Time Frame: 1 hour play session ]

Secondary Outcome Measures :
  1. Parts and features of toys used by the child [ Time Frame: 1 hour play session ]
  2. Duration of time child spends with each toy [ Time Frame: 1 hour play session ]
  3. Child preference for the toys based on child-report (smiley face Likert scale) [ Time Frame: 1 hour play session ]
  4. Number of times child solicits parent or friend involvement [ Time Frame: 1 hour play session ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544035


Locations
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United States, Maryland
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Charlene Hendricks, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications:
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT02544035     History of Changes
Other Study ID Numbers: 999915196
15-CH-N196
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: August 27, 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Childhood Growth and Development
Development