Trial Outcomes & Findings for Infant and Parent Shared Book Reading (NCT NCT04337372)
NCT ID: NCT04337372
Last Updated: 2025-02-06
Results Overview
Infant visual attention was measured for all 3 conditions using head mounted eye-tracking. Duration of visual attention (total duration of infant visual fixations greater than 100 ms each, to the book during shared book reading) was measured within a spatial window of the scene. Proportations of visual attention to the book were calculated by dividing attention duration to the book by the total task duration
COMPLETED
NA
146 participants
Day 1
2025-02-06
Participant Flow
Recruitment and study participation occurred between January 2022 and December 2023 in a research laboratory. Infant participants and their parents came in for two visits within one week, and were not followed up with beyond that.
Participant milestones
| Measure |
6 Month Olds
6 month olds infants completed the a book reading intervention. A parent and their infant read a short book in the laboratory. Books included three labeling conditions expected to elicit different levels of attention.
|
9 Month Olds
9 month olds infants completed the a book reading intervention. A parent and their infant read a short book in the laboratory. Books included three labeling conditions expected to elicit different levels of attention.
|
12 Month Olds
12 month olds infants completed the a book reading intervention. A parent and their infant read a short book in the laboratory. Books included three labeling conditions expected to elicit different levels of attention.
|
Adults: Parents of Infants
Data from parents of infants were collected for the joint attention and EEG synchrony task and combined with infant data for analysis. Parent data was not examined separately.
|
|---|---|---|---|---|
|
Day 1: Eye-tracking Measures
STARTED
|
21
|
26
|
26
|
73
|
|
Day 1: Eye-tracking Measures
COMPLETED
|
20
|
23
|
17
|
60
|
|
Day 1: Eye-tracking Measures
NOT COMPLETED
|
1
|
3
|
9
|
13
|
|
Day 2: EEG Measures
STARTED
|
21
|
26
|
26
|
73
|
|
Day 2: EEG Measures
COMPLETED
|
15
|
17
|
19
|
51
|
|
Day 2: EEG Measures
NOT COMPLETED
|
6
|
9
|
7
|
22
|
Reasons for withdrawal
| Measure |
6 Month Olds
6 month olds infants completed the a book reading intervention. A parent and their infant read a short book in the laboratory. Books included three labeling conditions expected to elicit different levels of attention.
|
9 Month Olds
9 month olds infants completed the a book reading intervention. A parent and their infant read a short book in the laboratory. Books included three labeling conditions expected to elicit different levels of attention.
|
12 Month Olds
12 month olds infants completed the a book reading intervention. A parent and their infant read a short book in the laboratory. Books included three labeling conditions expected to elicit different levels of attention.
|
Adults: Parents of Infants
Data from parents of infants were collected for the joint attention and EEG synchrony task and combined with infant data for analysis. Parent data was not examined separately.
|
|---|---|---|---|---|
|
Day 1: Eye-tracking Measures
Protocol Violation
|
1
|
3
|
7
|
11
|
|
Day 1: Eye-tracking Measures
Equipment Failure
|
0
|
0
|
2
|
2
|
|
Day 2: EEG Measures
Lost to Follow-up
|
0
|
3
|
2
|
5
|
|
Day 2: EEG Measures
Protocol Violation
|
6
|
6
|
5
|
17
|
Baseline Characteristics
73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
Baseline characteristics by cohort
| Measure |
Infants
n=73 Participants
Infants included three groups, 6-month-olds, 9-month-olds, and 12-month-olds.
|
Parents
n=73 Participants
One parent of each infant was included in the dyadic data analysis.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Infants · <=18 years
|
73 Participants
n=5 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
0 Participants
n=7 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
73 Participants
n=5 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
|
Age, Categorical
Infants · Between 18 and 65 years
|
0 Participants
n=5 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
73 Participants
n=7 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
73 Participants
n=5 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
|
Age, Categorical
Infants · >=65 years
|
0 Participants
n=5 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
0 Participants
n=7 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
0 Participants
n=5 Participants • 73 infants and their parents (n=146) were recruited. Each dyad (parent-infant) completed shared book reading with books that contain each of the 3 manipulations (individual, category, no label).
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: One infant was excluded due to equipment failure, 9 infants excluded due to unwillingness to wear the eye-tracking equipment, and 2 excluded for test dates falling outside the 28 day age group exclusion window.
Infant visual attention was measured for all 3 conditions using head mounted eye-tracking. Duration of visual attention (total duration of infant visual fixations greater than 100 ms each, to the book during shared book reading) was measured within a spatial window of the scene. Proportations of visual attention to the book were calculated by dividing attention duration to the book by the total task duration
Outcome measures
| Measure |
Effects of Shared Book Reading: Effect of Labels 6 Month Olds
n=20 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 6 month olds.
|
Effects of Shared Book Reading: Labels 9 Month Olds
n=21 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 9 month olds.
|
Effects of Shared Book Reading: Labeling 12 Month Olds
n=18 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 12 month olds.
|
|---|---|---|---|
|
Infant Visual Attention
Individual
|
.533 Proportion of Visual Attention Duration
Standard Deviation .206
|
.358 Proportion of Visual Attention Duration
Standard Deviation .157
|
.377 Proportion of Visual Attention Duration
Standard Deviation .252
|
|
Infant Visual Attention
Category
|
.544 Proportion of Visual Attention Duration
Standard Deviation .236
|
.300 Proportion of Visual Attention Duration
Standard Deviation .168
|
.351 Proportion of Visual Attention Duration
Standard Deviation .226
|
|
Infant Visual Attention
No Label
|
.472 Proportion of Visual Attention Duration
Standard Deviation .222
|
.257 Proportion of Visual Attention Duration
Standard Deviation .174
|
.404 Proportion of Visual Attention Duration
Standard Deviation .207
|
PRIMARY outcome
Timeframe: On Day 2Population: Two dyads were excluded for technical issues during EEG recording, and 5 dyads who completed visit one but did not have EEG data collected.
To examine the extent to which infant EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition and age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions by age group.
Outcome measures
| Measure |
Effects of Shared Book Reading: Effect of Labels 6 Month Olds
n=15 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 6 month olds.
|
Effects of Shared Book Reading: Labels 9 Month Olds
n=17 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 9 month olds.
|
Effects of Shared Book Reading: Labeling 12 Month Olds
n=19 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 12 month olds.
|
|---|---|---|---|
|
Infant EEG Steady-state Evoked Potential Frequency Tagging Power
Individual
|
7.270 Signal to Noise Ratio
Standard Deviation .856
|
7.506 Signal to Noise Ratio
Standard Deviation .642
|
7.392 Signal to Noise Ratio
Standard Deviation .639
|
|
Infant EEG Steady-state Evoked Potential Frequency Tagging Power
Category
|
7.298 Signal to Noise Ratio
Standard Deviation .606
|
7.583 Signal to Noise Ratio
Standard Deviation .670
|
7.108 Signal to Noise Ratio
Standard Deviation .603
|
|
Infant EEG Steady-state Evoked Potential Frequency Tagging Power
No Label
|
7.256 Signal to Noise Ratio
Standard Deviation .879
|
7.449 Signal to Noise Ratio
Standard Deviation .728
|
7.612 Signal to Noise Ratio
Standard Deviation .570
|
SECONDARY outcome
Timeframe: On Day 2Population: The data represent the number of dyads (infant plus 1 parent) analyzed. Dyads were excluded for technical issues during EEG recording and 5 dyads were excluded because they completed visit 1 but did not have EEG data collected for Visit 2.
Infant and parent EEG synchrony (as a dyad) was quantified and compared across conditions. We used a phase-locking index to quantify EEG dyadic synchrony across conditions. The phase-locking index measures the extent to which the parent and infant oscillatory response is in the same phase across time. This index is bounded between 0 and 1, with 1 being perfect synchrony.
Outcome measures
| Measure |
Effects of Shared Book Reading: Effect of Labels 6 Month Olds
n=15 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 6 month olds.
|
Effects of Shared Book Reading: Labels 9 Month Olds
n=17 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 9 month olds.
|
Effects of Shared Book Reading: Labeling 12 Month Olds
n=19 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 12 month olds.
|
|---|---|---|---|
|
Infant and Parent EEG Synchrony
Individual Label
|
.478 Phase Locking Index
Standard Deviation .053
|
.484 Phase Locking Index
Standard Deviation .048
|
.461 Phase Locking Index
Standard Deviation .037
|
|
Infant and Parent EEG Synchrony
Categorical Label
|
.471 Phase Locking Index
Standard Deviation .048
|
.488 Phase Locking Index
Standard Deviation .043
|
.474 Phase Locking Index
Standard Deviation .034
|
|
Infant and Parent EEG Synchrony
No Label
|
.471 Phase Locking Index
Standard Deviation .063
|
.480 Phase Locking Index
Standard Deviation .043
|
.480 Phase Locking Index
Standard Deviation .034
|
SECONDARY outcome
Timeframe: On Day 1Population: The data represent the number of dyads analyzed. 60 dyads (27 Female Infants, 33 Male Infants; 47 Female caregivers; 13 Male Caregivers) were included in the final sample. The final sample included dyads with 20 6-month infants, 23 9-month infants, and 17 12-month infants.
Parent and infant visual attention (as a dyad) was measured across conditions using dual parent and infant head mounted eye-tracking. Duration of joint attention (periods of overlap of parent and infant visual fixations to the book during shared book reading) was measured within a spatial window of the scene. Proportions of joint attention were calculated by dividing joint attention duration by the total task duration.
Outcome measures
| Measure |
Effects of Shared Book Reading: Effect of Labels 6 Month Olds
n=20 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 6 month olds.
|
Effects of Shared Book Reading: Labels 9 Month Olds
n=23 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 9 month olds.
|
Effects of Shared Book Reading: Labeling 12 Month Olds
n=17 Participants
Proportions of visual attention to the book were calculated by dividing attention duration to the book by the total task duration for the 12 month olds.
|
|---|---|---|---|
|
Parent-Infant Visual Joint Attention
Individual
|
.356 Joint Attention Proportion Mean
Standard Deviation .170
|
.262 Joint Attention Proportion Mean
Standard Deviation .145
|
.286 Joint Attention Proportion Mean
Standard Deviation .219
|
|
Parent-Infant Visual Joint Attention
Category
|
.409 Joint Attention Proportion Mean
Standard Deviation .210
|
.222 Joint Attention Proportion Mean
Standard Deviation .150
|
.276 Joint Attention Proportion Mean
Standard Deviation .198
|
|
Parent-Infant Visual Joint Attention
No Label
|
.323 Joint Attention Proportion Mean
Standard Deviation .176
|
.180 Joint Attention Proportion Mean
Standard Deviation .167
|
.254 Joint Attention Proportion Mean
Standard Deviation .179
|
Adverse Events
Effects of Shared Book Reading
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place