- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06275815
Promoting Caregiver Implementation of an Effective Early Learning Intervention
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer M Bostic, MA
- Phone Number: 614-292-5715
- Email: bostic.18@osu.edu
Study Contact Backup
- Name: Laura M Justice, PhD
- Phone Number: 614-292-1045
- Email: justice.57@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Jamie B Boster, PhD
- Phone Number: 614-722-8756
- Email: jamie.boster@nationwidechildrens.org
-
Principal Investigator:
- Jamie B Boster, PhD, CCC-SLP
-
Columbus, Ohio, United States, 43201
- Recruiting
- Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
-
Contact:
- Jennifer M Bostic, MA
- Phone Number: 614-292-5715
- Email: bostic.18@osu.edu
-
Principal Investigator:
- Laura M Justice, PhD
-
Sub-Investigator:
- Rebecca Dore, PhD
-
Sub-Investigator:
- Hui Jiang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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)
|
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.
Other Names:
|
|
Experimental: STAR + Reward
Typical implementation of Sit Together and Read (STAR) plus additional small monetary incentives for caregivers
|
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.
Other Names:
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).
|
|
Experimental: STAR + text encouragement
Typical implementation of Sit Together and Read (STAR) plus caregivers receive encouraging text messages
|
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.
Other Names:
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Pretest before intervention and post-test immediately following intervention
|
|
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.
|
Pretest before intervention and post-test immediately following intervention
|
|
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.
|
Pretest before intervention and post-test immediately following intervention
|
|
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.
|
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
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
|
6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura M Justice, PhD, Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Specific Learning Disorder
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Communication Disorders
- Language Disorders
- Learning Disabilities
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Communication
- Dyslexia
- Language Development Disorders
- Literacy
Other Study ID Numbers
- R01DC020958 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Developmental Language Disorder
-
University of IoanninaDOTSOFT SA - GR; TELEGLOBAL LP - GR; Region of Epirus (Regional Operational Programme... and other collaboratorsCompletedDevelopmental Articulation Disorder | Developmental Language Disorders | Speech Disorder | Neurodevelopmental Disorder (Diagnosis)Greece
-
University College CorkNational University of Ireland, Galway, IrelandNot yet recruitingDevelopmental Language Disorder and Language Impairment | DeprivationIreland
-
Ohio UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingDevelopmental Language DisordersUnited States
-
Purdue UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingDevelopmental Language Disorder and Language Impairment | Language Development | Specific Language ImpairmentUnited States
-
Heidelberg UniversityUnknownLanguage Delay | Developmental Language DisordersGermany
-
University of Sao PauloCompletedDevelopmental Language DisordersBrazil
-
Nanyang Technological UniversityCompletedDevelopmental Language Disorder and Language Impairment | Anxiety Disorders and SymptomsSingapore
-
Russian Academy of Medical SciencesCompletedAutism Spectrum Disorder | Language Delay | Language; Developmental Disorder, Expressive | Language; Developmental Disorder, Receptive | Attention Deficit-Hyperactivity Disorder | Speech Disorders in ChildrenRussian Federation
-
Centre Hospitalier Universitaire de la RéunionCompletedLanguage Disorders in Children | Learning; Developmental DisorderRéunion
-
Université Catholique de LouvainNot yet recruitingUnderstanding the Predictive Factors and the Neurocognitive Basis of Developmental Language DisorderLanguage Development | Developmental Language DisordersBelgium
Clinical Trials on Sit Together and Read (STAR)
-
Ohio State UniversityCompleted
-
Sherine TambyrajaOhio State UniversityCompleted
-
University of WashingtonRecruitingAnxiety | Parent-Child Relations | LiteracyUnited States
-
American University of Beirut Medical CenterTerminated
-
Boston Children's HospitalGLMA: Health Professionals Advancing LGBTQ+ EqualityCompletedReproductive HealthUnited States
-
University of WashingtonAlzheimer's AssociationCompletedDementia | Alzheimer DiseaseUnited States
-
University of NottinghamCompletedSedentary BehaviorUnited Kingdom
-
Hamilton Health Sciences CorporationOntario Ministry of Health and Long Term CareUnknownCerebrovascular AccidentCanada
-
Auburn UniversityCompletedBody CompositionUnited States