N/A N=120 Randomized Single-blind Treatment

Early Literacy Promotion Intervention

Child Development

Bottom Line

View on ClinicalTrials.gov: NCT02713659 ↗

Enrolled (actual)

120

Serious AEs

0.8%

Results posted

Sep 2019

Primary outcome: Primary: Change in Preschool Language Scale-5th Edition Score — -8.2; -9.0; -3.9; -2.0 score on a scale — p=0.85

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Early Literacy Promotion (Behavioral); Standard Literacy Promotion (Behavioral)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: Female
Sponsor: Children's Hospital of Philadelphia
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Preschool Language Scale-5th Edition Score	-8.2; -9.0; -3.9; -2.0; -5.9; -3.3	0.85
SECONDARY Change in StimQ Score	2.4; 2.8	0.57
SECONDARY Health Services Utilization	32; 40; 44; 36	0.23

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02713659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.