Digital Literacy Promotion
DLP
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2017
CompletedStudy Start
First participant enrolled
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
November 20, 2019
CompletedNovember 5, 2020
November 1, 2020
1.7 years
April 17, 2017
February 1, 2019
November 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (10)
StimQ READ Subscale Change Score
1 month after the 6, 9, and 12 month well visits
Frequency of Parent-Reported Board Book Reading
1 month
Frequency of E-Book Reading
1 month
Frequency of Television Viewing
1 month
Frequency of Board Book Reading
4 months
- +5 more secondary outcomes
Study Arms (2)
Standard/Board Book Arm
ACTIVE COMPARATORParent-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
EXPERIMENTALParent-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.
Interventions
Promotion of early reader board book reading
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Child has neurodevelopmental disabilities or congenital malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 34022425DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. We were not able to control for use of digital devices by participants in the board book arm, which may affect home reading environment outcomes 2. Pilot study and small sample size and small power may affect significance of outcome measures
Results Point of Contact
- Title
- Dr. James Guevara
- Organization
- The Children's Hospital of Phiadelphia
Study Officials
- PRINCIPAL INVESTIGATOR
James Guevara
Children's Hospital of Philadelphia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 20, 2017
Study Start
April 19, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
November 5, 2020
Results First Posted
November 20, 2019
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 12 months after publication of all relevant papers
- Access Criteria
- De-identified only
Following completion of all analyses, data will be de-identified and made available for other investigators.