Trial Outcomes & Findings for Digital Literacy Promotion (NCT NCT03121365)

Last Updated: 2020-11-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

104 participants

Primary outcome timeframe

Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)

Results posted on

2020-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	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. Standard/Board books: Promotion of early reader board book reading	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. Digital/E-books: Promotion of early reader digital e-book reading
Baseline STARTED	55	49
Baseline COMPLETED	54	48
Baseline NOT COMPLETED	1	1
1 Months STARTED	54	48
1 Months COMPLETED	52	45
1 Months NOT COMPLETED	2	3
4 Months STARTED	54	45
4 Months COMPLETED	51	44
4 Months NOT COMPLETED	3	1
7 Months STARTED	54	45
7 Months COMPLETED	44	37
7 Months NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Digital Literacy Promotion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard/Board Book Arm n=54 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=48 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading	Total n=102 Participants Total of all reporting groups
Age, Continuous Mother's Age	28.0 years STANDARD_DEVIATION 5.1 • n=5 Participants	29.6 years STANDARD_DEVIATION 6.2 • n=7 Participants	28.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Age, Continuous Father's Age	31.4 years STANDARD_DEVIATION 7.9 • n=5 Participants	32.3 years STANDARD_DEVIATION 6.4 • n=7 Participants	32.0 years STANDARD_DEVIATION 7.3 • n=5 Participants
Age, Customized Infant Age	6.1 months STANDARD_DEVIATION 0.40 • n=5 Participants	6.2 months STANDARD_DEVIATION 0.38 • n=7 Participants	6.2 months STANDARD_DEVIATION 0.39 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized African American	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Marital Status Single/Never Married	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Marital Status Separated/Divorced	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Marital Status Married/Living Together as if Married	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Level of Education Some High School	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Level of Education High School/GED	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Level of Education Some College	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Level of Education College/Post College Degree	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Annual Household Income $0 - $24,999	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Annual Household Income $25,000 - $49,999	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Annual Household Income $50,000+	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Number of Other Adults in the Household	1.2 Adults STANDARD_DEVIATION 0.9 • n=5 Participants	1.5 Adults STANDARD_DEVIATION 0.9 • n=7 Participants	1.3 Adults STANDARD_DEVIATION 0.9 • n=5 Participants
Number of Other Children in the Household	1.2 Children STANDARD_DEVIATION 1.0 • n=5 Participants	1.0 Children STANDARD_DEVIATION 1.1 • n=7 Participants	1.2 Children STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=43 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=37 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) Cognitive Composite Score	98.8 score on a scale Standard Deviation 10.5	99.6 score on a scale Standard Deviation 11.9
Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) Language Composite Score	89.7 score on a scale Standard Deviation 10.3	85.7 score on a scale Standard Deviation 11.2
Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old) Motor Composite Score	94.8 score on a scale Standard Deviation 9.4	97.4 score on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: 1 month after the 6, 9, and 12 month well visits

Population: The variation in number analyzed per row is reflective of participants who had incomplete measures at different study time-points which prevented analysis of their \[missing\] scores since the analysis is a comparison of scores at different study time-points.

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.

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=52 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=44 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
StimQ READ Subscale Change Score Difference in StimQ scores at 7 and 10 months	0.4 units on a scale Standard Deviation 4.9	2.9 units on a scale Standard Deviation 5.4
StimQ READ Subscale Change Score Difference in StimQ scores at 10 and 13 months	3.5 units on a scale Standard Deviation 2.3	2.9 units on a scale Standard Deviation 4.5
StimQ READ Subscale Change Score Difference in StimQ scores at 7 and 13 months	4.3 units on a scale Standard Deviation 3.5	4.9 units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: 1 month

Population: 3 participants in the DLP arm dropped out prior to completion of 1 month study visit.

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.

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=52 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=45 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of Parent-Reported Board Book Reading Very Often/Often	35 Participants	25 Participants
Frequency of Parent-Reported Board Book Reading Rarely/Never	17 Participants	20 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=52 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=45 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of E-Book Reading Very Often/Often	6 Participants	33 Participants
Frequency of E-Book Reading Rarely/Never	46 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=52 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=45 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of Television Viewing Very Often/Often	17 Participants	17 Participants
Frequency of Television Viewing Rarely/Never	35 Participants	28 Participants

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=51 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=44 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of Board Book Reading Very Often/Often	33 Participants	23 Participants
Frequency of Board Book Reading Rarely/Never	18 Participants	21 Participants

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=51 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=44 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of E-Book Reading Very Often/Often	7 Participants	26 Participants
Frequency of E-Book Reading Rarely/Never	44 Participants	18 Participants

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=51 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=44 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of Television Viewing Very Often/Often	18 Participants	18 Participants
Frequency of Television Viewing Rarely/Never	33 Participants	26 Participants

SECONDARY outcome

Timeframe: 7 months

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=44 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=37 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of Board Book Reading Very Often/Often	31 Participants	23 Participants
Frequency of Board Book Reading Rarely/Never	13 Participants	14 Participants

SECONDARY outcome

Timeframe: 7 months

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=44 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=37 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of E-Book Reading Very Often/Often	10 Participants	24 Participants
Frequency of E-Book Reading Rarely/Never	34 Participants	13 Participants

SECONDARY outcome

Timeframe: 7 months

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=44 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=37 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Frequency of Television Viewing Very Often/Often	17 Participants	15 Participants
Frequency of Television Viewing Rarely/Never	27 Participants	22 Participants

POST_HOC outcome

Timeframe: 6 months

Proportion of participants in each arm who received books and literacy promotion counseling at well visits and completed all study visits.

Outcome measures

Outcome measures
Measure	Standard/Board Book Arm n=54 Participants 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=48 Participants 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. Digital/E-books: Promotion of early reader digital e-book reading
Feasibility of Literacy Promotion	44 Participants	37 Participants

Adverse Events

Standard/Board Book Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Digital/E-Book Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard/Board Book Arm n=55 participants at risk 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. Standard/Board books: Promotion of early reader board book reading	Digital/E-Book Arm n=49 participants at risk 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. Digital/E-books: Promotion of early reader digital e-book reading
Social circumstances Breach of Confidentiality	3.6% 2/55 • Number of events 2 • Adverse Events were monitored throughout study completion, approximately 1 year 8 months	2.0% 1/49 • Number of events 1 • Adverse Events were monitored throughout study completion, approximately 1 year 8 months

Additional Information

Dr. James Guevara

The Children's Hospital of Phiadelphia

Phone: 215-590-1130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place