NCT06275815 · Ohio State University
Promoting Caregiver Implementation of an Effective Early Learning Intervention
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Sit 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.
BEHAVIORAL
Monetary 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).
BEHAVIORAL
Text Encouragement
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
Primary outcome measures
Preschool Word and Print Awareness (PWPA)
Time frame: Pretest before intervention and post-test immediately following intervention
Standardized criterion-referenced measure of children's knowledge of 15 basic print concepts
Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing
Time frame: Pretest before intervention and post-test immediately following intervention
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.
The Reading House (THR)
Time frame: Pretest before intervention and post-test immediately following intervention
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.
Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification
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.
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.
Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension
Time frame: 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.
We administer two subtests of the norm referenced, standardized WJ-IV, Spelling and Passage Comprehension. Measure of child literacy and reading skill
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Columbus, Ohio
Collaborators
Nationwide Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations