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| Name | Class |
|---|---|
| Vanguard Strong Start for Kids Program | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard/Board Book Arm | Active Comparator | 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. |
|
| Digital/E-Book Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital/E-Book Arm | Behavioral | Promotion of early reader digital e-book reading |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Second Study visit (approximately one month after child is age-eligible for 12 month well child visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Guevara | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34022425 | Derived | Guevara JP, Erkoboni D, Gerdes M, Winston S, Sands D, Rogers K, Haecker T, Jimenez ME, Mendelsohn AL. Promoting Early Literacy Using Digital Devices: A Pilot Randomized Controlled Trial. Acad Pediatr. 2021 Aug;21(6):1001-1008. doi: 10.1016/j.acap.2021.05.013. Epub 2021 May 19. |
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Following completion of all analyses, data will be de-identified and made available for other investigators.
12 months after publication of all relevant papers
De-identified only
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 1 Months |
| |||||||||||||
| 4 Months |
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| 7 Months |
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Of the 104 enrolled, 102 were randomized to either study arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Second Study visit (approximately one month after child is age-eligible for 12 month well child visit) |
|
Adverse Events were monitored throughout study completion, approximately 1 year 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breach of Confidentiality | Social circumstances | Non-systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Guevara | The Children's Hospital of Phiadelphia | 215-590-1130 | Guevara@email.chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 | Nov 4, 2020 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D000067010 | Literacy |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
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Eligible participants will be stratified by site and randomized 1:1
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| Standard/Board Book Arm |
| Behavioral |
Promotion of early reader board book reading |
|
| 1 month after the 6, 9, and 12 month well visits |
| 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. | 1 month |
| 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. | 1 month |
| 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. | 1 month |
| 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. | 4 months |
| 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. | 4 months |
| 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. | 4 months |
| 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. | 7 months |
| 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. | 7 months |
| 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. | 7 months |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Mean | Standard Deviation | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Level of Education | Count of Participants | Participants |
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| Annual Household Income | Count of Participants | Participants |
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| Number of Other Adults in the Household | Mean | Standard Deviation | Adults |
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| Number of Other Children in the Household | Mean | Standard Deviation | Children |
|
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
| OG001 | 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 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month after the 6, 9, and 12 month well visits |
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| 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. | 3 participants in the DLP arm dropped out prior to completion of 1 month study visit. | Posted | Count of Participants | Participants | 1 month |
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| 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. | Posted | Count of Participants | Participants | 1 month |
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| 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. | Posted | Count of Participants | Participants | 1 month |
|
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| 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. | Posted | Count of Participants | Participants | 4 months |
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| 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. | Posted | Count of Participants | Participants | 4 months |
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| 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. | Posted | Count of Participants | Participants | 4 months |
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| 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. | Posted | Count of Participants | Participants | 7 months |
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| 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. | Posted | Count of Participants | Participants | 7 months |
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| 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. | Posted | Count of Participants | Participants | 7 months |
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| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 2 |
| 55 |
| EG001 | 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 | 0 | 49 | 0 | 49 | 1 | 49 |
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| Difference in StimQ scores at 10 and 13 months |
|
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| Difference in StimQ scores at 7 and 13 months |
|
|
| t-test, 2 sided |
| .4144 |
| Equivalence |
0.05 |
| StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm | t-test, 2 sided | .4251 | Equivalence | 0.05 |