N/A
N=486
Determining Age Appropriateness of Children's Products and Toys
Healthy Volunteers Only
Bottom Line
View on ClinicalTrials.gov: NCT02544035 ↗Enrolled (actual)
486
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Utilization of Toy — .45; .49; .50; .53 Proportion
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Type of Toy (Other); Play Partner (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Utilization of Toy |
.45; .49; .50; .53 | — |
| SECONDARY Played With Toy |
.67; .61; .62; .65 | — |
| SECONDARY Duration of Toy Play |
— | — |
| SECONDARY Preference for the Toy - Child-report |
— | — |
| SECONDARY Solicits to Parent Involvement |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02544035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.