Digital Literacy Promotion (DLP)

November 4, 2020 updated by: Children's Hospital of Philadelphia

Digital Literacy Promotion Among Medicaid Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vanguard Strong Start for Kids Program

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Guevara, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-013524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Following completion of all analyses, data will be de-identified and made available for other investigators.

IPD Sharing Time Frame

12 months after publication of all relevant papers

IPD Sharing Access Criteria

De-identified only

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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