- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03121365
Digital Literacy Promotion (DLP)
Digital Literacy Promotion Among Medicaid Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
Promotion of early reader digital e-book reading
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1 month after the 6, 9, and 12 month well visits
|
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.
|
1 month
|
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.
|
1 month
|
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.
|
1 month
|
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.
|
4 months
|
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.
|
4 months
|
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.
|
4 months
|
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.
|
7 months
|
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.
|
7 months
|
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.
|
7 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James Guevara, Children's Hospital of Philadelphia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16-013524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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