Early Literacy Promotion Intervention

NCT02713659 | Completed Results

• 1 other identifier: IRB 15-012507
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

Literacy; Child Development; Reading

Outcome Measures

Primary Outcomes (1)

• 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..

  Change in PLS scores from 6 to 24 months of age

Secondary Outcomes (2)

• Change in StimQ Score

  Change in StimQ score from 6 to 24 months of age

• Health Services Utilization

  Birth to 6 months of age

Study Arms (2)

Early Literacy Promotion

EXPERIMENTAL

Parents and children randomized to the Early Literacy Promotion arm.

Behavioral: Early Literacy Promotion

Standard Literacy Promotion

ACTIVE COMPARATOR

Parents and children randomized to the Standard Literacy Promotion arm.

Behavioral: Standard Literacy Promotion

Interventions

Early Literacy Promotion BEHAVIORAL

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.

Early Literacy Promotion

Standard Literacy Promotion BEHAVIORAL

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.

Standard Literacy Promotion

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• William Penn Foundation: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Guevara JP, Erkoboni D, Gerdes M, Winston S, Sands D, Rogers K, Haecker T, Jimenez ME, Mendelsohn AL. Effects of Early Literacy Promotion on Child Language Development and Home Reading Environment: A Randomized Controlled Trial. J Pediatr X. 2020 May 11;2:100020. doi: 10.1016/j.ympdx.2020.100020. eCollection 2020 Spring.

  PMID: 37332625 DERIVED

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Limitations and Caveats

1. Study setting and demographics may not be generalizable to other sites. 2. Participating families in the SLP arm with older children may have been exposed to the ROR program already, likely initiating shared reading prior to 6 months of age.

Results Point of Contact

• Title: Dr. James Guevara
• Organization: The Children's Hospital of Philadelphia

guevara@email.chop.edu

215-590-1130

Study Officials

• James P Guevara, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 21, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after publication of all relevant papers
• Access Criteria: De-identified only

Locations

US (1)