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Active, not recruitingNCT06275815Updated Nov 3, 2026

Promoting Caregiver Implementation of an Effective Early Learning Intervention

An interventional study of Sit Together and Read (STAR) and Monetary Reward in Developmental Language Disorder and Reading; Difficult, sponsored by Ohio State University. Active, not recruiting at 2 sites in United States. Open to participants aged 48 Months to 71 Months. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Ohio State University · Not applicable, Interventional, and Prevention

Updated Nov 3, 2026Now Active, not recruitingGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
48 Months to 71 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Developmental Language Disorder
  • Reading; Difficult

Keywords

  • Randomized Control Trial
  • Print Knowledge
  • Reading Outcomes
  • literacy
  • behavior-change strategies
  • early literacy
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's planned enrollment of 320 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Months to 71 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. No known additional diagnoses causal of developmental language disorder including

    1. autism spectrum disorder
    2. hearing loss
    3. severe intellectual disability
  2. Is not attending or has completed Kindergarten
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
320 participants (estimated)

Study arms

  • No intervention
    Untreated Control

    Caregivers read to child as usual over 15 week period.

  • Experimental
    STAR Only

    Typical implementation of Sit Together and Read (STAR)

    Other: Sit Together and Read (STAR)

  • Experimental
    STAR + Reward

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

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

  • Experimental
    STAR + text encouragement

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

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

Interventions

  • OtherSit Together and Read (STAR)

    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

  • BehavioralMonetary Reward

    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).

  • BehavioralText Encouragement

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

    Also known as: SMS Messaging

06

What researchers measure

Primary outcomes

  1. Preschool Word and Print Awareness (PWPA)

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

    Time frame: Pretest before intervention and post-test immediately following intervention

  2. 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.

    Time frame: Pretest before intervention and post-test immediately following intervention

  3. 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.

    Time frame: Pretest before intervention and post-test immediately following intervention

  4. 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.

    Time frame: 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.

  5. 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

    Time frame: 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.

07

Study locations

2 sites
  • Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
    Columbus, Ohio 43201, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jul 2028, 51 months after the start.

Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 51 months is above that.

Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2024
First posted
Feb 23, 2024
StartActual
Apr 10, 2024
Primary completionEst.
Jul 31, 2028
CompletionEst.
Jul 31, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06275815
Responsible party
Sponsor
First posted
Feb 23, 2024
Start date
Apr 10, 2024
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Laura M Justice, PhD
principal investigator · Ohio State University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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