Clinical trial NCT02713659: Early Literacy Promotion Intervention
Official title: Early Literacy Promotion Among Poor Urban Children in Philadelphia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Literacy
Child Development
Reading
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: William Penn Foundation
First posted: 2016-03-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Preschool Language Scale-5th Edition Score
timeFrame: Change in PLS scores from 6 to 24 months of age
Secondary outcomes:
measure: Change in StimQ Score
timeFrame: Change in StimQ score from 6 to 24 months of age
measure: Health Services Utilization
timeFrame: Birth to 6 months of age
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James P Guevara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: