Promoting Caregiver Implementation of an Effective Early Learning Intervention

Developmental Language Disorder Clinical Trial

Official title:

Promoting Caregiver Implementation of an Effective Early Learning Intervention: Sit Together and Read (STAR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275815
• Other study ID #: R01DC020958
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: Ohio State University
• Contact: Jennifer M Bostic, MA
• Phone: 614-292-5715
• Email: bostic.18[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 71 Months

Eligibility

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:

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

Related Conditions & MeSH terms

• Developmental Language Disorder
• Language Development Disorders
• Language Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.