Promoting Caregiver Implementation of an Effective Early Learning Intervention

NCT06275815 | Recruiting

• 1 other identifier: R01DC020958
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to examine the impact of a caregiver-implemented shared reading program, Sit Together and Read (STAR), on children ages 4 to 5 with developmental language disorder. The main questions it aims to answer are:

• how much STAR impacts children's literacy skills in the short-term and long-term--up to two-years after completing STAR.
• how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement STAR at its intended frequency of sessions per week. Caregiver participants will be assigned to either a control group or one of three STAR groups. Children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years. Researchers will determine the short term and long term impacts of STAR compared to the control group. Researchers will compare the three STAR conditions to see if the rewards or encouragement helped parents to follow through with completing more STAR sessions.

Conditions

Developmental Language Disorder; Reading; Difficult

Keywords

Randomized Control Trial; Print Knowledge; Reading Outcomes; literacy; behavior-change strategies; early literacy

Outcome Measures

Primary Outcomes (5)

• Preschool Word and Print Awareness (PWPA)

  Standardized criterion-referenced measure of children's knowledge of 15 basic print concepts

  Pretest before intervention and post-test immediately following intervention

• Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing

  PALS-Preschool is a scientifically-based phonological awareness and literacy screening and progress measure that assesses preschoolers' developing knowledge of important literacy fundamentals. The assessment reflects skills that are predictive of future reading success. We administer two subtests that measures name writing ability and upper-case and lower-case alphabet recognition.

  Pretest before intervention and post-test immediately following intervention

• The Reading House (THR)

  A direct screening tool developed for use with pediatricians that allows a variety of providers to identify children who may be at risk for reading difficulties. It is a direct, book-based screener grounded in the concept of emergent literacy. TRH assessment examines 1) print knowledge, 2) alphabet knowledge, 3) letter-sound knowledge, 4) phonological awareness, 5) vocabulary, and 6) emergent writing.

  Pretest before intervention and post-test immediately following intervention

• Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification

  We administer two subtests of the norm referenced, standardized WJ-IV, Word Attack and Letter-Word Identification. Measure of child literacy and reading skill. We will explore avenues for data reduction, including use of a latent-variable modeling strategy.

  Completed at all assessing timepoints. Pretest, immediate post-test, 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.

• Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension

  We administer two subtests of the norm referenced, standardized WJ-IV, Spelling and Passage Comprehension. Measure of child literacy and reading skill

  6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.

Study Arms (4)

Untreated Control

NO INTERVENTION

Caregivers read to child as usual over 15 week period.

STAR Only

EXPERIMENTAL

Typical implementation of Sit Together and Read (STAR)

Other: Sit Together and Read (STAR)

STAR + Reward

EXPERIMENTAL

Typical implementation of Sit Together and Read (STAR) plus additional small monetary incentives for caregivers

Other: Sit Together and Read (STAR); Behavioral: Monetary Reward

STAR + text encouragement

EXPERIMENTAL

Typical implementation of Sit Together and Read (STAR) plus caregivers receive encouraging text messages

Other: Sit Together and Read (STAR); Behavioral: Text Encouragement

Interventions

Sit Together and Read (STAR) OTHER

Sit Together and Read (STAR) features an explicit, systematic sequence of 15 objectives that target four dimensions of print knowledge: print organization, print meaning, letters, and words. These objectives are explicitly targeted in the context of repeated adult-child shared reading sessions and are systematically cycled over an intervention period so the child has repeated opportunities for acquiring the targeted print objectives. STAR is a manualized 15-week intervention.

Also known as: STAR Read-Aloud Practices, Read-Aloud Practices

STAR + Reward; STAR + text encouragement; STAR Only

Monetary Reward BEHAVIORAL

Caregiver receives a monetary reward of $0.50 for each session logged (up to 60 sessions) and audio-recording completed (up to 15 audio recordings).

STAR + Reward

Text Encouragement BEHAVIORAL

Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.

Also known as: SMS Messaging

STAR + text encouragement

Eligibility Criteria

• Age: 48 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• receiving or on waitlist for speech services
• primary complaint of impaired language skills
• receptive, expressive, or mixed language disorder
• primarily communicates in English

You may not qualify if:

• No known additional diagnoses causal of developmental language disorder including
• autism spectrum disorder
• hearing loss
• severe intellectual disability
• Is not attending or has completed Kindergarten

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (2)

Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy

Columbus, Ohio, 43201, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders; Dyslexia; Literacy

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Specific Learning Disorder; Learning Disabilities; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Laura M Justice, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer M Bostic, MA

CONTACT

614-292-5715; bostic.18@osu.edu

Laura M Justice, PhD

CONTACT

614-292-1045; justice.57@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 23, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (2)