Language Development, Literacy
Conditions
Keywords
Digital literacy, Reading
Brief summary
This study evaluates the effects of digital versus standard literacy promotion, as well as dialogic language behaviors and reading comprehension among infants when comparing the use of e-books to standard board books. Around half of the participants will receive standard board books at the 6, 9, and 12 month well visits, while the other half will receive digital e-books.
Detailed description
This study has three main objectives. The first is to test the effects of digital versus standard literacy promotion by way of a randomized controlled trial design. The second aim is to explore the reading behaviors and reading activities between parents and their infants when comparing the use of e-books to standard board books. The third aim is to identify themes regarding dialogical reading behaviors among parents participating in the video sub-study. Participants will be stratified by clinic site and randomized to receive literacy promotion using 1) standard early reader board books or 2) digital electronic early reader e-books. We will recruit and consent one hundred eligible parent-infant dyads, with the infant being between 5 and 7 months of age at enrollment. In this intervention, parent-infant dyads randomized to the digital arm will receive developmentally appropriate e-books. Those randomized to the standard arm will receive developmentally appropriate board books. Participants will receive either the e-book or board book at the time of their 6, 9 and 12 month well visits. In addition to the books, parent-infant dyads in both arms will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework. The main outcome will be differences in Bayley-3 Composite scores between groups. Secondary aims include differences in StimQ Reading Subscale Scores and Edinburgh Postnatal Depression Scale Scores between groups.
Interventions
BEHAVIORALDigital/E-Book Arm
Promotion of early reader digital e-book reading
BEHAVIORALStandard/Board Book Arm
Promotion of early reader board book reading
Sponsors
Vanguard Strong Start for Kids Program
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Eligible participants will be stratified by site and randomized 1:1
Eligibility
Sex/Gender
ALL
Age
5 Months to 7 Months
Healthy volunteers
Yes
Inclusion criteria
* English or Spanish speaking * Parents ≥ 15 years of age at start of study * Child born ≥ 35 weeks estimated gestational age * Child 5 to 7 months * Medicaid Insurance * Access to a smart phone and/or tablet
Exclusion criteria
* Child has neurodevelopmental disabilities or congenital malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Second Study visit (approximately one month after child is age-eligible for 12 month well child visit) | Evaluation of the infant's cognitive, language and motor development using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Results were reported as composites of cognitive, language, and motor scores, where data were continuous variables on a scale with a normal distribution of 95%. The composite scores are scaled to a metric with a mean of 100 and a standard deviation of 15, and range from 40-160. A composite score above 77.5 is considered developmentally average and a composite score below 77.5 is considered a developmental concern. Data were described using mean and standard deviation. Significance was considered at a level of 0.05. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| StimQ READ Subscale Change Score | 1 month after the 6, 9, and 12 month well visits | Differences in StimQ READ Subscale scores collected approximately 1 month after the 6, 9, and 12 month well visits. Reading activity is measured using the StimQ READ subscale. This contains yes/no questions reflecting access to books, frequency of shared reading, and variety of books read in homes of young children, ages 5 to 36 months. The StimQ-Infant READ subscale is for use with infants 5-12 months of age and the StimQ-Toddler READ subscale is used with toddlers 12-36 months of age. The StimQ Infant and Toddler Read Subscales include a point scale for measuring cognitive stimulation resulting from the reading activity. Scores for the StimQ-Infant READ scale range from 0-15 with higher scores (greater number values) reflective of higher reading exposure. Scores for the StimQ-Toddler READ scale range from 0-19 with higher scores (greater number values) reflective of higher reading exposure. |
| Frequency of Parent-Reported Board Book Reading | 1 month | Frequency of board book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often. |
| Frequency of E-Book Reading | 1 month | Frequency of e-book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often. |
| Frequency of Television Viewing | 1 month | Frequency of television viewing in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often. |
| Frequency of Board Book Reading | 4 months | Frequency of board book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard/Board Book Arm Parent-infant dyads randomized to the standard/board book arm will receive developmentally appropriate early reader board books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.
Standard/Board books: Promotion of early reader board book reading | 54 |
| Digital/E-Book Arm Parent-infant dyads randomized to the digital/e-book arm will receive developmentally appropriate e-books at the time of their infant's 6, 9, and 12 month well visits. In addition to the books, parent-infant dyads will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.
Digital/E-books: Promotion of early reader digital e-book reading | 48 |
| Total | 102 |
Baseline characteristics
| Characteristic | Standard/Board Book Arm | Digital/E-Book Arm | Total |
|---|---|---|---|
| Age, Continuous Father's Age | 31.4 years STANDARD_DEVIATION 7.9 | 32.3 years STANDARD_DEVIATION 6.4 | 32.0 years STANDARD_DEVIATION 7.3 |
| Age, Continuous Mother's Age | 28.0 years STANDARD_DEVIATION 5.1 | 29.6 years STANDARD_DEVIATION 6.2 | 28.7 years STANDARD_DEVIATION 5.7 |
| Age, Customized Infant Age | 6.1 months STANDARD_DEVIATION 0.4 | 6.2 months STANDARD_DEVIATION 0.38 | 6.2 months STANDARD_DEVIATION 0.39 |
| Annual Household Income $0 - $24,999 | 23 Participants | 19 Participants | 42 Participants |
| Annual Household Income $25,000 - $49,999 | 24 Participants | 19 Participants | 43 Participants |
| Annual Household Income $50,000+ | 7 Participants | 9 Participants | 16 Participants |
| Level of Education College/Post College Degree | 20 Participants | 12 Participants | 32 Participants |
| Level of Education High School/GED | 13 Participants | 19 Participants | 32 Participants |
| Level of Education Some College | 20 Participants | 15 Participants | 35 Participants |
| Level of Education Some High School | 1 Participants | 2 Participants | 3 Participants |
| Marital Status Married/Living Together as if Married | 31 Participants | 30 Participants | 61 Participants |
| Marital Status Separated/Divorced | 2 Participants | 1 Participants | 3 Participants |
| Marital Status Single/Never Married | 21 Participants | 17 Participants | 38 Participants |
| Number of Other Adults in the Household | 1.2 Adults STANDARD_DEVIATION 0.9 | 1.5 Adults STANDARD_DEVIATION 0.9 | 1.3 Adults STANDARD_DEVIATION 0.9 |
| Number of Other Children in the Household | 1.2 Children STANDARD_DEVIATION 1 | 1.0 Children STANDARD_DEVIATION 1.1 | 1.2 Children STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized African American | 22 Participants | 23 Participants | 45 Participants |
| Race/Ethnicity, Customized Caucasian | 25 Participants | 17 Participants | 42 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Female | 29 Participants | 23 Participants | 52 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 49 |
| other Total, other adverse events | 2 / 55 | 1 / 49 |
| serious Total, serious adverse events | 0 / 55 | 0 / 49 |
Outcome results
Primary
Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old)
Evaluation of the infant's cognitive, language and motor development using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Results were reported as composites of cognitive, language, and motor scores, where data were continuous variables on a scale with a normal distribution of 95%. The composite scores are scaled to a metric with a mean of 100 and a standard deviation of 15, and range from 40-160. A composite score above 77.5 is considered developmentally average and a composite score below 77.5 is considered a developmental concern. Data were described using mean and standard deviation. Significance was considered at a level of 0.05.
Time frame: Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard/Board Book Arm | Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Cognitive Composite Score | 98.8 score on a scale | Standard Deviation 10.5 |
| Standard/Board Book Arm | Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Language Composite Score | 89.7 score on a scale | Standard Deviation 10.3 |
| Standard/Board Book Arm | Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Motor Composite Score | 94.8 score on a scale | Standard Deviation 9.4 |
| Digital/E-Book Arm | Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Cognitive Composite Score | 99.6 score on a scale | Standard Deviation 11.9 |
| Digital/E-Book Arm | Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Language Composite Score | 85.7 score on a scale | Standard Deviation 11.2 |
| Digital/E-Book Arm | Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) | Motor Composite Score | 97.4 score on a scale | Standard Deviation 9.4 |
Comparison: Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Armsp-value: 0.7635t-test, 2 sided
Comparison: Language Composite Scores between infants 12-18 months old in the Standard and Digital Armsp-value: 0.0996t-test, 2 sided
Comparison: Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Armsp-value: 0.2291t-test, 2 sided
Secondary
Frequency of Board Book Reading
Frequency of board book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 4 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of Board Book Reading | Very Often/Often | 33 Participants |
| Standard/Board Book Arm | Frequency of Board Book Reading | Rarely/Never | 18 Participants |
| Digital/E-Book Arm | Frequency of Board Book Reading | Rarely/Never | 21 Participants |
| Digital/E-Book Arm | Frequency of Board Book Reading | Very Often/Often | 23 Participants |
p-value: 0.219Chi-squared
Secondary
Frequency of Board Book Reading
Frequency of board book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 7 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of Board Book Reading | Very Often/Often | 31 Participants |
| Standard/Board Book Arm | Frequency of Board Book Reading | Rarely/Never | 13 Participants |
| Digital/E-Book Arm | Frequency of Board Book Reading | Very Often/Often | 23 Participants |
| Digital/E-Book Arm | Frequency of Board Book Reading | Rarely/Never | 14 Participants |
p-value: 0.43Chi-squared
Secondary
Frequency of E-Book Reading
Frequency of e-book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 7 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of E-Book Reading | Very Often/Often | 10 Participants |
| Standard/Board Book Arm | Frequency of E-Book Reading | Rarely/Never | 34 Participants |
| Digital/E-Book Arm | Frequency of E-Book Reading | Very Often/Often | 24 Participants |
| Digital/E-Book Arm | Frequency of E-Book Reading | Rarely/Never | 13 Participants |
p-value: <0.001Chi-squared
Secondary
Frequency of E-Book Reading
Frequency of e-book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 4 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of E-Book Reading | Very Often/Often | 7 Participants |
| Standard/Board Book Arm | Frequency of E-Book Reading | Rarely/Never | 44 Participants |
| Digital/E-Book Arm | Frequency of E-Book Reading | Very Often/Often | 26 Participants |
| Digital/E-Book Arm | Frequency of E-Book Reading | Rarely/Never | 18 Participants |
p-value: <0.001Chi-squared
Secondary
Frequency of E-Book Reading
Frequency of e-book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 1 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of E-Book Reading | Very Often/Often | 6 Participants |
| Standard/Board Book Arm | Frequency of E-Book Reading | Rarely/Never | 46 Participants |
| Digital/E-Book Arm | Frequency of E-Book Reading | Very Often/Often | 33 Participants |
| Digital/E-Book Arm | Frequency of E-Book Reading | Rarely/Never | 12 Participants |
p-value: <0.001Chi-squared
Secondary
Frequency of Parent-Reported Board Book Reading
Frequency of board book reading in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 1 month
Population: 3 participants in the DLP arm dropped out prior to completion of 1 month study visit.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of Parent-Reported Board Book Reading | Very Often/Often | 35 Participants |
| Standard/Board Book Arm | Frequency of Parent-Reported Board Book Reading | Rarely/Never | 17 Participants |
| Digital/E-Book Arm | Frequency of Parent-Reported Board Book Reading | Very Often/Often | 25 Participants |
| Digital/E-Book Arm | Frequency of Parent-Reported Board Book Reading | Rarely/Never | 20 Participants |
p-value: 0.235Chi-squared
Secondary
Frequency of Television Viewing
Frequency of television viewing in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 1 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of Television Viewing | Very Often/Often | 17 Participants |
| Standard/Board Book Arm | Frequency of Television Viewing | Rarely/Never | 35 Participants |
| Digital/E-Book Arm | Frequency of Television Viewing | Very Often/Often | 17 Participants |
| Digital/E-Book Arm | Frequency of Television Viewing | Rarely/Never | 28 Participants |
p-value: 0.601Chi-squared
Secondary
Frequency of Television Viewing
Frequency of television viewing in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 4 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of Television Viewing | Very Often/Often | 18 Participants |
| Standard/Board Book Arm | Frequency of Television Viewing | Rarely/Never | 33 Participants |
| Digital/E-Book Arm | Frequency of Television Viewing | Very Often/Often | 18 Participants |
| Digital/E-Book Arm | Frequency of Television Viewing | Rarely/Never | 26 Participants |
p-value: 0.574Chi-squared
Secondary
Frequency of Television Viewing
Frequency of television viewing in the prior two weeks. Parents reported frequency as very often, often, rarely, never. Very often and often categories were combined and rarely and never categories were combined. We report number in each arm who report very often/often.
Time frame: 7 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard/Board Book Arm | Frequency of Television Viewing | Very Often/Often | 17 Participants |
| Standard/Board Book Arm | Frequency of Television Viewing | Rarely/Never | 27 Participants |
| Digital/E-Book Arm | Frequency of Television Viewing | Very Often/Often | 15 Participants |
| Digital/E-Book Arm | Frequency of Television Viewing | Rarely/Never | 22 Participants |
p-value: 0.861Chi-squared
Secondary
StimQ READ Subscale Change Score
Differences in StimQ READ Subscale scores collected approximately 1 month after the 6, 9, and 12 month well visits. Reading activity is measured using the StimQ READ subscale. This contains yes/no questions reflecting access to books, frequency of shared reading, and variety of books read in homes of young children, ages 5 to 36 months. The StimQ-Infant READ subscale is for use with infants 5-12 months of age and the StimQ-Toddler READ subscale is used with toddlers 12-36 months of age. The StimQ Infant and Toddler Read Subscales include a point scale for measuring cognitive stimulation resulting from the reading activity. Scores for the StimQ-Infant READ scale range from 0-15 with higher scores (greater number values) reflective of higher reading exposure. Scores for the StimQ-Toddler READ scale range from 0-19 with higher scores (greater number values) reflective of higher reading exposure.
Time frame: 1 month after the 6, 9, and 12 month well visits
Population: The variation in number analyzed per row is reflective of participants who had incomplete measures at different study time-points which prevented analysis of their \[missing\] scores since the analysis is a comparison of scores at different study time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard/Board Book Arm | StimQ READ Subscale Change Score | Difference in StimQ scores at 7 and 10 months | 0.4 units on a scale | Standard Deviation 4.9 |
| Standard/Board Book Arm | StimQ READ Subscale Change Score | Difference in StimQ scores at 10 and 13 months | 3.5 units on a scale | Standard Deviation 2.3 |
| Standard/Board Book Arm | StimQ READ Subscale Change Score | Difference in StimQ scores at 7 and 13 months | 4.3 units on a scale | Standard Deviation 3.5 |
| Digital/E-Book Arm | StimQ READ Subscale Change Score | Difference in StimQ scores at 7 and 10 months | 2.9 units on a scale | Standard Deviation 5.4 |
| Digital/E-Book Arm | StimQ READ Subscale Change Score | Difference in StimQ scores at 10 and 13 months | 2.9 units on a scale | Standard Deviation 4.5 |
| Digital/E-Book Arm | StimQ READ Subscale Change Score | Difference in StimQ scores at 7 and 13 months | 4.9 units on a scale | Standard Deviation 4.3 |
Comparison: StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book armp-value: 0.018t-test, 2 sided
Comparison: StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book armp-value: 0.4144t-test, 2 sided
Comparison: StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book armp-value: 0.4251t-test, 2 sided
Post Hoc
Feasibility of Literacy Promotion
Proportion of participants in each arm who received books and literacy promotion counseling at well visits and completed all study visits.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard/Board Book Arm | Feasibility of Literacy Promotion | 44 Participants |
| Digital/E-Book Arm | Feasibility of Literacy Promotion | 37 Participants |