Developmental Language DisorderNCT06275815
Promoting Caregiver Implementation of an Effective Early Learning Intervention
A study testing Sit Together and Read (STAR), Monetary Reward and Text Encouragement in people with Developmental Language Disorder and Reading; Difficult, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 71 months
- Conditions the study is for
- Developmental Language Disorder, Reading; Difficult
- What is being tested?
- Sit Together and Read (STAR), Monetary Reward and Text Encouragement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- receiving or on waitlist for speech services
- primary complaint of impaired language skills
- receptive, expressive, or mixed language disorder
- primarily communicates in English
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
Columbus, Ohio, 43201
Jennifer M Bostic, MA, 614-292-5715, bostic.18@osu.edu
Laura M Justice, PhD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Jamie B Boster, PhD, 614-722-8756, jamie.boster@nationwidechildrens.org
Jamie B Boster, PhD, CCC-SLP
About this study
Official title: Promoting Caregiver Implementation of an Effective Early Learning Intervention: Sit Together and Read (STAR)
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.
Read more
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.
- Being tested
- Sit Together and Read (STAR), Monetary Reward, Text Encouragement
- Keywords
- Randomized Control Trial, Print Knowledge, Reading Outcomes, literacy, behavior-change strategies, early literacy
- Medical subject headings
- Language Development Disorders, Dyslexia, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sit Together and Read (STAR)Other
Also called STAR Read-Aloud Practices, Read-Aloud Practices
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.
Monetary RewardBehavioural
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).
Text EncouragementBehavioural
Also called SMS Messaging
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Sit Together and Read (STAR) |
| STAR + Reward | Experimental | Typical implementation of Sit Together and Read (STAR) plus additional small monetary incentives for caregivers Receives: 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 Receives: Other: Sit Together and Read (STAR); Behavioral: Text Encouragement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool Word and Print Awareness (PWPA)
Standardized criterion-referenced measure of children's knowledge of 15 basic print concepts
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start10 Apr 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Laura M Justice, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275815
- Sponsor's protocol ID
- R01DC020958
- Status last verified
- Sep 2025
- First submitted
- 29 Jan 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Caregiver Implementation of an Effective Early Learning Intervention: Sit Together and Read (STAR)
- ClinicalTrials.gov ID
- NCT06275815
- Acronym / sponsor ID
- R01DC020958
- Keywords
- Randomized Control Trial, Print Knowledge, Reading Outcomes, literacy, behavior-change strategies, early literacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Untreated Control | No intervention | –Caregivers read to child as usual over 15 week period. |
| STAR Only | Experimental | Other: Sit Together and Read (STAR)Typical implementation of Sit Together and Read (STAR) |
| STAR + Reward | Experimental | Other: Sit Together and Read (STAR), Behavioral: Monetary RewardTypical implementation of Sit Together and Read (STAR) plus additional small monetary incentives for caregivers |
| STAR + text encouragement | Experimental | Other: Sit Together and Read (STAR), Behavioral: Text EncouragementTypical implementation of Sit Together and Read (STAR) plus caregivers receive encouraging text messages |
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- receiving or on waitlist for speech services
- primary complaint of impaired language skills
- receptive, expressive, or mixed language disorder
- primarily communicates in English
Key exclusion criteria (5 listed)
- No known additional diagnoses causal of developmental language disorder including
- Is not attending or has completed Kindergarten
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sit Together and Read (STAR)Also: STAR Read-Aloud Practices, Read-Aloud PracticesSit 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. | Other | STAR + Reward, STAR + text encouragement, STAR Only |
| Monetary RewardCaregiver receives a monetary reward of $0.50 for each session logged (up to 60 sessions) and audio-recording completed (up to 15 audio recordings). | Behavioural | STAR + Reward |
| Text EncouragementAlso: SMS MessagingCaregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention. | Behavioural | STAR + text encouragement |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura M Justice, PhD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sit Together and Read (STAR), Monetary Reward and Text Encouragement in people with Developmental Language Disorder and Reading; Difficult, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer M Bostic, MA (614-292-5715, bostic.18@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preschool Word and Print Awareness (PWPA) (time frame: Pretest before intervention and post-test immediately following intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.