Digital Literacy Promotion (DLP)

• ClinicalTrials.gov Identifier: NCT03121365
• Recruitment Status: Completed
• First Posted: April 20, 2017
• Results First Posted: November 20, 2019
• Last Update Posted: November 5, 2020
• Sponsor: Children's Hospital of Philadelphia
• Collaborator: Vanguard Strong Start for Kids Program
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Language Development; Literacy	Behavioral: Digital/E-Book Arm; Behavioral: Standard/Board Book Arm	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Eligible participants will be stratified by site and randomized 1:1
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Digital Literacy Promotion Among Medicaid Children
• Actual Study Start Date: April 19, 2017
• Actual Primary Completion Date: December 31, 2018
• Actual Study Completion Date: December 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Behavioral: Standard/Board Book Arm; Promotion of early reader board book reading
Experimental: 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.	Behavioral: Digital/E-Book Arm; Promotion of early reader digital e-book reading

Outcome Measures

Primary Outcome Measures :

1. Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) [ Time Frame: 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 Outcome Measures :

1. StimQ READ Subscale Change Score [ Time Frame: 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.

2. Frequency of Parent-Reported Board Book Reading [ Time Frame: 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.
3. Frequency of E-Book Reading [ Time Frame: 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.
4. Frequency of Television Viewing [ Time Frame: 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.
5. Frequency of Board Book Reading [ Time Frame: 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.
6. Frequency of E-Book Reading [ Time Frame: 4 months ]
   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. Frequency of Television Viewing [ Time Frame: 4 months ]
   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.
8. Frequency of Board Book Reading [ Time Frame: 7 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.
9. Frequency of E-Book Reading [ Time Frame: 7 months ]
   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.
10. Frequency of Television Viewing [ Time Frame: 7 months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 5 Months to 7 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

Vanguard Strong Start for Kids Program

Investigators

• Principal Investigator: James Guevara; Children's Hospital of Philadelphia

  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:

Study Protocol and Statistical Analysis Plan  [PDF] August 10, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT03121365
• Other Study ID Numbers: 16-013524
• First Posted: April 20, 2017
• Results First Posted: November 20, 2019
• Last Update Posted: November 5, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Following completion of all analyses, data will be de-identified and made available for other investigators.
• Supporting Materials: Study Protocol
• Time Frame: 12 months after publication of all relevant papers
• Access Criteria: De-identified only

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital of Philadelphia:

Digital literacy; Reading