Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2017-04-19
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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 Book Arm
Promotion of early reader board book reading
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-Book Arm
Promotion of early reader digital e-book reading
Interventions
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Digital/E-Book Arm
Promotion of early reader digital e-book reading
Standard/Board Book Arm
Promotion of early reader board book reading
Eligibility Criteria
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Inclusion Criteria
* 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
5 Months
7 Months
ALL
Yes
Sponsors
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Vanguard Strong Start for Kids Program
UNKNOWN
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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James Guevara
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-013524
Identifier Type: -
Identifier Source: org_study_id