Trial Outcomes & Findings for Determining Age Appropriateness of Children's Products and Toys (NCT NCT02544035)
NCT ID: NCT02544035
Last Updated: 2023-12-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
486 participants
Primary outcome timeframe
1 hour play session
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
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;
|
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;
|
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;
|
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;
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
62
|
60
|
60
|
61
|
62
|
60
|
|
Overall Study
COMPLETED
|
60
|
61
|
62
|
60
|
60
|
61
|
62
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determining Age Appropriateness of Children's Products and Toys
Baseline characteristics by cohort
| Measure |
12-18 Month-old Toy Type
n=60 Participants
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;
|
19-35 Month-old Toy Type
n=61 Participants
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;
|
36-71 Month-old Toy Type
n=62 Participants
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;
|
72-107 Month-old Toy Type
n=60 Participants
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;
|
12-18 Month-old Play Partner
n=60 Participants
12-18 month-olds (1-1.5 year olds)
Play Partner: Each child will first play alone then play with parent.
|
19-35 Month-old Play Partner
n=61 Participants
19-35 month-olds (1.5-2 year olds)
Play Partner: Each child will first play alone then play with parent.
|
36-71 Month-old Play Partner
n=62 Participants
36-71 month-olds (1.5-2 year olds)
Play Partner: Each child will first play alone then play with parent.
|
72-107 Month-old Play Partner
n=60 Participants
72-107 month-olds (6-8 year-olds)
Play Partner: Each child will first play alone then play with parent.
|
Total
n=486 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.34 months
STANDARD_DEVIATION 2.02 • n=5 Participants
|
26.88 months
STANDARD_DEVIATION 4.96 • n=7 Participants
|
54.16 months
STANDARD_DEVIATION 10.77 • n=5 Participants
|
89.52 months
STANDARD_DEVIATION 11.42 • n=4 Participants
|
15.34 months
STANDARD_DEVIATION 2.02 • n=21 Participants
|
26.88 months
STANDARD_DEVIATION 4.96 • n=8 Participants
|
54.16 months
STANDARD_DEVIATION 10.77 • n=8 Participants
|
89.52 months
STANDARD_DEVIATION 11.42 • n=24 Participants
|
46.46 months
STANDARD_DEVIATION 29.66 • n=42 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
236 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
250 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
44 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
52 Participants
n=24 Participants
|
442 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
40 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
318 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
86 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
61 participants
n=7 Participants
|
62 participants
n=5 Participants
|
60 participants
n=4 Participants
|
60 participants
n=21 Participants
|
61 participants
n=8 Participants
|
62 participants
n=8 Participants
|
60 participants
n=24 Participants
|
486 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 1 hour play sessionPopulation: Child age by toy age appropriateness
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
Outcome measures
| Measure |
12-18 Month-old Toy Type
n=60 Participants
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;
|
19-35 Month-old Toy Type
n=61 Participants
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;
|
36-71 Month-old Toy Type
n=62 Participants
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;
|
72-107 Month-old Toy Type
n=60 Participants
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;
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Utilization of Toy
|
.45 Proportion
|
.49 Proportion
|
.50 Proportion
|
.53 Proportion
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour play sessionWe constructed a variable to indicate whether the child played with the toy (1) or did not play with the toy (0).
Outcome measures
| Measure |
12-18 Month-old Toy Type
n=60 Participants
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;
|
19-35 Month-old Toy Type
n=61 Participants
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;
|
36-71 Month-old Toy Type
n=62 Participants
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;
|
72-107 Month-old Toy Type
n=60 Participants
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;
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Played With Toy
|
.67 Proportion
|
.61 Proportion
|
.62 Proportion
|
.65 Proportion
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 hour play sessionDuration of time child plays with each toy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour play sessionChild preference for the toys based on child-report
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour play sessionNumber of times child solicits parent involvement
Outcome measures
Outcome data not reported
Adverse Events
12-18 Month-old Toy Type
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
19-35 Month-old Toy Type
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
36-71 Month-old Toy Type
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
72-107 Month-old Toy Type
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12-18 Month-old Play Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
19-35 Month-old Play Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
36-71 Month-old Play Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
72-107 Month-old Play Partner
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Diane Putnick
National Institute of Child Health and Human Development
Phone: 301-496-6291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place