Clinical trial NCT03121365: Digital Literacy Promotion
Official title: Digital Literacy Promotion Among Medicaid Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Literacy
Keywords: Digital literacy
Reading
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Vanguard Strong Start for Kids Program
First posted: 2017-04-20
Enrollment: 104
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be stratified by site and randomized 1:1
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old)
timeFrame: Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)
Secondary outcomes:
measure: StimQ READ Subscale Change Score
timeFrame: 1 month after the 6, 9, and 12 month well visits
measure: Frequency of Parent-Reported Board Book Reading
timeFrame: 1 month
measure: Frequency of E-Book Reading
timeFrame: 1 month
measure: Frequency of Television Viewing
timeFrame: 1 month
measure: Frequency of Board Book Reading
timeFrame: 4 months
measure: Frequency of E-Book Reading
timeFrame: 4 months
measure: Frequency of Television Viewing
timeFrame: 4 months
measure: Frequency of Board Book Reading
timeFrame: 7 months
measure: Frequency of E-Book Reading
timeFrame: 7 months
measure: Frequency of Television Viewing
timeFrame: 7 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James Guevara
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.