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Completed

NCT Number: NCT03121365

Digital Literacy Promotion

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.

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Key information

Age range

5 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital/E-Book Arm

Behavioral

Promotion of early reader digital e-book reading

Standard/Board Book Arm

Behavioral

Promotion of early reader board book reading

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Vanguard Strong Start for Kids Program

Registry information

Official study title

Digital Literacy Promotion Among Medicaid Children

Acronym: DLP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2017
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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