Trial Outcomes & Findings for Early Literacy Promotion Intervention (NCT NCT02713659)

Last Updated: 2019-09-09

Results Overview

The Preschool Language Scale-5th Edition (PLS) is a validated measure of expressive and receptive language function among children from birth through 7 years of age and is available in Spanish and English. PLS-5 provides three norm-referenced standard scores: Auditory Comprehension (AC) standard score, Expressive Communication (EC) standard score, and Total Language (TL) composite score. The scores are on a normalized standard score scale that has a mean of 100 and a standard deviation of 15 with scores ranging from 0-200. Higher scores represent better language development..

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Change in PLS scores from 6 to 24 months of age

Results posted on

2019-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Early Literacy Promotion Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Standard Literacy Promotion Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
Baseline STARTED	60	60
Baseline COMPLETED	60	60
Baseline NOT COMPLETED	0	0
6 Month Study Visit STARTED	60	60
6 Month Study Visit COMPLETED	53	47
6 Month Study Visit NOT COMPLETED	7	13
12 Month Study Visit STARTED	57	55
12 Month Study Visit COMPLETED	54	52
12 Month Study Visit NOT COMPLETED	3	3
18 Month Study Visit STARTED	58	53
18 Month Study Visit COMPLETED	50	50
18 Month Study Visit NOT COMPLETED	8	3
24 Month Study Visit STARTED	57	52
24 Month Study Visit COMPLETED	49	44
24 Month Study Visit NOT COMPLETED	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Numbers in columns may not sum to overall totals due to missing data.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Change in PLS scores from 6 to 24 months of age

Outcome measures

Outcome measures
Measure	Early Literacy Promotion n=49 Participants Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Standard Literacy Promotion n=44 Participants Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
Change in Preschool Language Scale-5th Edition Score Difference in Auditory Standard Score	-8.2 score on a scale Standard Deviation 18.4	-9.0 score on a scale Standard Deviation 16.5
Change in Preschool Language Scale-5th Edition Score Difference in Expressive Standard Score	-3.9 score on a scale Standard Deviation 15.6	-2.0 score on a scale Standard Deviation 10.5
Change in Preschool Language Scale-5th Edition Score Difference in Total Standard Score	-5.9 score on a scale Standard Deviation 16.3	-3.3 score on a scale Standard Deviation 19.0

SECONDARY outcome

Timeframe: Change in StimQ score from 6 to 24 months of age

Population: One participant only completed the StimQ survey at 24 months, therefore this number includes that participant. However, they are not counted in the total number of participants who completed the 24-month study visit because they did not complete the rest of the study visit surveys.

Reading activity is measured using the StimQ Read Subscale, a subscale scale of the overall StimQ that measures the home reading environment among young children ages 5 to 36 months, and is available in Spanish and English. The Read Subscale of the StimQ-I is used for infants 5-12 months old and contains 12 questions, while the Read Subscale of the StimQ-T is used for children aged 12-36 months old and contains 11 questions. Scores range from 0-19 with higher scores representing better home reading environments.

Outcome measures

Outcome measures
Measure	Early Literacy Promotion n=49 Participants Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Standard Literacy Promotion n=45 Participants Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
Change in StimQ Score	2.4 Scores on a Scale Standard Deviation 3.2	2.8 Scores on a Scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Birth to 6 months of age

Immunizations and well child visit data will be collected from electronic health records to measure impact of ELP intervention on health services use.

Outcome measures

Outcome measures
Measure	Early Literacy Promotion n=57 Participants Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Standard Literacy Promotion n=54 Participants Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
Health Services Utilization Well Child Visits Up to Date	32 Participants	40 Participants
Health Services Utilization Vaccinations Up to Date	44 Participants	36 Participants

Adverse Events

Early Literacy Promotion

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard Literacy Promotion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Early Literacy Promotion n=60 participants at risk Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Standard Literacy Promotion n=60 participants at risk Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.
General disorders Mortality	1.7% 1/60 • Number of events 1 • The All-Cause Mortality Adverse Event for each participant over the 24-month period of participation.	0.00% 0/60 • The All-Cause Mortality Adverse Event for each participant over the 24-month period of participation.

Other adverse events

Adverse event data not reported

Additional Information

Dr. James Guevara

The Children's Hospital of Philadelphia

Phone: 215-590-1130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Early Literacy Promotion n=60 Participants Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Standard Literacy Promotion n=60 Participants Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, this group will receive standard literacy promotion and will attend study visits every six months until age 2.	Total n=120 Participants Total of all reporting groups
Age, Continuous Mother's Age	25.4 years STANDARD_DEVIATION 5.2 • n=60 Participants • Numbers in columns may not sum to overall totals due to missing data.	25.3 years STANDARD_DEVIATION 5.2 • n=60 Participants • Numbers in columns may not sum to overall totals due to missing data.	25.4 years STANDARD_DEVIATION 5.2 • n=120 Participants • Numbers in columns may not sum to overall totals due to missing data.
Age, Continuous Father's Age	28.2 years STANDARD_DEVIATION 6.4 • n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	28.7 years STANDARD_DEVIATION 7.0 • n=57 Participants • Numbers in columns may not sum to overall totals due to missing data.	28.4 years STANDARD_DEVIATION 6.7 • n=116 Participants • Numbers in columns may not sum to overall totals due to missing data.
Age, Continuous	5.4 Infant Age (Days) STANDARD_DEVIATION 2.1 • n=60 Participants	5.6 Infant Age (Days) STANDARD_DEVIATION 2.3 • n=60 Participants	5.5 Infant Age (Days) STANDARD_DEVIATION 2.2 • n=120 Participants
Sex: Female, Male Child Gender · Female	32 Participants n=60 Participants	34 Participants n=60 Participants	66 Participants n=120 Participants
Sex: Female, Male Child Gender · Male	28 Participants n=60 Participants	26 Participants n=60 Participants	54 Participants n=120 Participants
Race/Ethnicity, Customized Race · African American	57 Participants n=60 Participants	46 Participants n=60 Participants	103 Participants n=120 Participants
Race/Ethnicity, Customized Race · White	0 Participants n=60 Participants	2 Participants n=60 Participants	2 Participants n=120 Participants
Race/Ethnicity, Customized Race · Hispanic	2 Participants n=60 Participants	4 Participants n=60 Participants	6 Participants n=120 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=60 Participants	8 Participants n=60 Participants	9 Participants n=120 Participants
Marital Status Single	40 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	39 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	79 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Marital Status Married/Living Together as if Married	17 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	20 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	37 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Marital Status Seperated/Divorced	2 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	0 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	2 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Annual Household Income $0 - $24,000	47 Participants n=58 Participants • Numbers in columns may not sum to overall totals due to missing data.	48 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	95 Participants n=117 Participants • Numbers in columns may not sum to overall totals due to missing data.
Annual Household Income $25,000 - $49,000	11 Participants n=58 Participants • Numbers in columns may not sum to overall totals due to missing data.	11 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	22 Participants n=117 Participants • Numbers in columns may not sum to overall totals due to missing data.
Education Level Some High School	11 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	9 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	20 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Education Level High School/GED	27 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	24 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	51 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Education Level Some College	18 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	23 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	41 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Education Level College/Post College Degree	3 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	3 Participants n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	6 Participants n=118 Participants • Numbers in columns may not sum to overall totals due to missing data.
Number of Other Adults in the Household	1.3 people STANDARD_DEVIATION 1.1 • n=60 Participants • Numbers in columns may not sum to overall totals due to missing data.	1.2 people STANDARD_DEVIATION 0.6 • n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	1.3 people STANDARD_DEVIATION 0.9 • n=119 Participants • Numbers in columns may not sum to overall totals due to missing data.
Number of Other Children in the Household	1.2 children STANDARD_DEVIATION 1.2 • n=60 Participants • Numbers in columns may not sum to overall totals due to missing data.	1.0 children STANDARD_DEVIATION 1.2 • n=59 Participants • Numbers in columns may not sum to overall totals due to missing data.	1.1 children STANDARD_DEVIATION 1.2 • n=119 Participants • Numbers in columns may not sum to overall totals due to missing data.