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Recruiting NCT06275815

Promoting Caregiver Implementation of an Effective Early Learning Intervention

No phase Interventional Developmental Language Disorder Reading; Difficult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sit Together and Read (STAR), Monetary Reward, Text Encouragement.
Who it may be relevant to
Registry conditions: Developmental Language Disorder, Reading; Difficult. Basic parameters: 48 months — 71 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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]
  • Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing [Time frame: Pretest before intervention and post-test immediately following intervention]
  • The Reading House (THR) [Time frame: 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.]
  • 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.]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy — Columbus
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT06275815 · R01DC020958

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗