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Early Literacy Promotion Intervention

Early Literacy Promotion Among Poor Urban Children in Philadelphia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02713659
Acronym
ELPI
Enrollment
120
Registered
2016-03-21
Start date
2016-03-31
Completion date
2018-12-31
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

Literacy, Child Development, Reading

Brief summary

This study is testing the effects of early literacy promotion compared to standard literacy promotion at The Children's Hospital of Philadelphia. Eligible participants and their families will be consented and randomly assigned into either a standard literacy program or an early literacy program. Standard literacy will consist of the receipt of books and reading promotion beginning at 6 months of age, while early literacy will consist of the receipt of books and reading promotion beginning in the newborn period. In both groups, participants will receive weekly text messages until the child is 6 months old (the text messages will either about reading or safety) and have follow-up study visits at 6, 12, 18, and 24 months. The study will examine the effects of the intervention on language development and reading behaviors.

Detailed description

Poor urban children are at an increased risk for language and cognitive delays. Such delays can lead to poor school readiness and disparities in educational outcomes when compared to children from middle and upper income strata. Reach Out and Read (ROR), a national program which promotes parent-child reading activities for children 6 months through 5 years of age at pediatric well child visits, has been shown to improve at-risk children's expressive and receptive language development. However, poor children who participate in ROR still demonstrate language outcomes that are below national averages. It isn't clear whether early literacy promotion, i.e. promotion of parent-child reading prior to six months of age, is more effective than standard literacy promotion and can further improve poor children's language and cognitive outcomes. Therefore, this study will test the effectiveness of early literacy promotion compared to standard literacy promotion among poor at-risk children. Children with Medicaid insurance who are under 1 month of age, were born at least 35 weeks gestation, whose mothers speak English or Spanish and are 15 years of age and older, and are without any neurodevelopmental disabilities will be eligible to participate. One to two urban practices affiliated with The Children's Hospital of Philadelphia (CHOP) who have implemented ROR as standard practice will be recruited to participate. One hundred twenty eligible children attending participating practices will be recruited to participate and consented, stratified by practice site, and randomized to receive early literacy promotion or standard literacy promotion. Early literacy promotion will consist of the provision of developmentally appropriate books selected specifically for well visits starting from one month of age to six months; discussion of the importance of reading, talking, and singing by pediatric clinicians; and text message reminders to parents concerning early literacy and daily reading. Standard literacy promotion will consist of the Reach Out and Read Program with provision of developmentally appropriate books at all well visits from six months of age onward and promotion of reading, talking, and singing activities by pediatric clinicians. Mothers will complete study measures consisting of demographic characteristics, postpartum depression symptoms, health literacy, and adverse childhood experiences at enrollment, and mothers and children will complete measures of reading activity (Stim-Q) at 6, 12, 18, and 24 months of age and child expressive and receptive language development (Preschool Language Scale) at 6 and 24 months of age. Differences in child language outcomes will be assessed using intention-to-treat. Results of this study will be disseminated to key stakeholders through peer-reviewed manuscripts, reports, social media, and evidence-to-action briefs prepared by Policylab at the Children's Hospital of Philadelphia. Study findings will be of importance to the Annie E. Casey Foundation's Read! By 4th in Philadelphia and other community Grade-Level Reading Campaigns, the Clinton Foundation's Too Small to Fail initiative to advance early brain development, and Great Start Collaborative's Early to Read campaign.

Interventions

BEHAVIORALEarly 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, both groups will receive standard literacy promotion and will attend study visits every six months until age 2.

BEHAVIORALStandard 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, both groups will receive standard literacy promotion and will attend study visits every six months until age 2.

Sponsors

William Penn Foundation
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. English or Spanish speaking 2. Mothers 15 years of age or older at the start of the study 3. Child born ≥ 35 weeks estimated gestational age (EGA) 4. Child less than 4 weeks old at enrollment 5. Child with Medicaid Insurance

Exclusion criteria

1. Child born premature \< 35 weeks EGA 2. Children with neurodevelopmental disabilities or congenital malformation at increased risk of language delays

Design outcomes

Primary

MeasureTime frameDescription
Change in Preschool Language Scale-5th Edition ScoreChange in PLS scores from 6 to 24 months of ageThe 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..

Secondary

MeasureTime frameDescription
Change in StimQ ScoreChange in StimQ score from 6 to 24 months of ageReading 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.
Health Services UtilizationBirth to 6 months of ageImmunizations and well child visit data will be collected from electronic health records to measure impact of ELP intervention on health services use.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
60
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.
60
Total120

Baseline characteristics

CharacteristicEarly Literacy PromotionStandard Literacy PromotionTotal
Age, Continuous
Father's Age
28.2 years
STANDARD_DEVIATION 6.4
28.7 years
STANDARD_DEVIATION 7
28.4 years
STANDARD_DEVIATION 6.7
Age, Continuous
Mother's Age
25.4 years
STANDARD_DEVIATION 5.2
25.3 years
STANDARD_DEVIATION 5.2
25.4 years
STANDARD_DEVIATION 5.2
Age, Continuous5.4 Infant Age (Days)
STANDARD_DEVIATION 2.1
5.6 Infant Age (Days)
STANDARD_DEVIATION 2.3
5.5 Infant Age (Days)
STANDARD_DEVIATION 2.2
Annual Household Income
$0 - $24,000
47 Participants48 Participants95 Participants
Annual Household Income
$25,000 - $49,000
11 Participants11 Participants22 Participants
Education Level
College/Post College Degree
3 Participants3 Participants6 Participants
Education Level
High School/GED
27 Participants24 Participants51 Participants
Education Level
Some College
18 Participants23 Participants41 Participants
Education Level
Some High School
11 Participants9 Participants20 Participants
Marital Status
Married/Living Together as if Married
17 Participants20 Participants37 Participants
Marital Status
Seperated/Divorced
2 Participants0 Participants2 Participants
Marital Status
Single
40 Participants39 Participants79 Participants
Number of Other Adults in the Household1.3 people
STANDARD_DEVIATION 1.1
1.2 people
STANDARD_DEVIATION 0.6
1.3 people
STANDARD_DEVIATION 0.9
Number of Other Children in the Household1.2 children
STANDARD_DEVIATION 1.2
1.0 children
STANDARD_DEVIATION 1.2
1.1 children
STANDARD_DEVIATION 1.2
Race/Ethnicity, Customized
Race
African American
57 Participants46 Participants103 Participants
Race/Ethnicity, Customized
Race
Hispanic
2 Participants4 Participants6 Participants
Race/Ethnicity, Customized
Race
Other
1 Participants8 Participants9 Participants
Race/Ethnicity, Customized
Race
White
0 Participants2 Participants2 Participants
Sex: Female, Male
Child Gender
Female
32 Participants34 Participants66 Participants
Sex: Female, Male
Child Gender
Male
28 Participants26 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 600 / 60
other
Total, other adverse events
0 / 600 / 60
serious
Total, serious adverse events
1 / 600 / 60

Outcome results

Primary

Change in Preschool Language Scale-5th Edition Score

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..

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

ArmMeasureGroupValue (MEAN)Dispersion
Early Literacy PromotionChange in Preschool Language Scale-5th Edition ScoreDifference in Auditory Standard Score-8.2 score on a scaleStandard Deviation 18.4
Early Literacy PromotionChange in Preschool Language Scale-5th Edition ScoreDifference in Expressive Standard Score-3.9 score on a scaleStandard Deviation 15.6
Early Literacy PromotionChange in Preschool Language Scale-5th Edition ScoreDifference in Total Standard Score-5.9 score on a scaleStandard Deviation 16.3
Standard Literacy PromotionChange in Preschool Language Scale-5th Edition ScoreDifference in Auditory Standard Score-9.0 score on a scaleStandard Deviation 16.5
Standard Literacy PromotionChange in Preschool Language Scale-5th Edition ScoreDifference in Expressive Standard Score-2.0 score on a scaleStandard Deviation 10.5
Standard Literacy PromotionChange in Preschool Language Scale-5th Edition ScoreDifference in Total Standard Score-3.3 score on a scaleStandard Deviation 19
Comparison: Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy armp-value: 0.85t-test, 2 sided
Comparison: Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy armp-value: 0.53t-test, 2 sided
Comparison: Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy armp-value: 0.49t-test, 2 sided
Secondary

Change in StimQ Score

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Early Literacy PromotionChange in StimQ Score2.4 Scores on a ScaleStandard Deviation 3.2
Standard Literacy PromotionChange in StimQ Score2.8 Scores on a ScaleStandard Deviation 4
Comparison: Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy armp-value: 0.57t-test, 2 sided
Secondary

Health Services Utilization

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

Time frame: Birth to 6 months of age

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Early Literacy PromotionHealth Services UtilizationWell Child Visits Up to Date32 Participants
Early Literacy PromotionHealth Services UtilizationVaccinations Up to Date44 Participants
Standard Literacy PromotionHealth Services UtilizationWell Child Visits Up to Date40 Participants
Standard Literacy PromotionHealth Services UtilizationVaccinations Up to Date36 Participants
Comparison: Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of agep-value: 0.23Chi-squared
Comparison: Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of agep-value: 0.71Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026