Clinical trial NCT06275815: Promoting Caregiver Implementation of an Effective Early Learning Intervention
Official title: Promoting Caregiver Implementation of an Effective Early Learning Intervention: Sit Together and Read (STAR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Language Disorder
Reading; Difficult
Keywords: Randomized Control Trial
Print Knowledge
Reading Outcomes
literacy
behavior-change strategies
early literacy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2024-02-23
Enrollment: 320
Sex: ALL
Minimum age (years): 48
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Preschool Word and Print Awareness (PWPA)
timeFrame: Pretest before intervention and post-test immediately following intervention
measure: Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing
timeFrame: Pretest before intervention and post-test immediately following intervention
measure: The Reading House (THR)
timeFrame: Pretest before intervention and post-test immediately following intervention
measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification
timeFrame: 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.
measure: Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension
timeFrame: 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Laura M Justice, PhD
role: PRINCIPAL_INVESTIGATOR
References: