- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06275815
Promuovere l'implementazione da parte del caregiver di un efficace intervento di apprendimento precoce
Promuovere l'implementazione da parte dei caregiver di un efficace intervento di apprendimento precoce: sedersi insieme e leggere (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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ohio
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Columbus, Ohio, Stati Uniti, 43205
- Nationwide Children's Hospital
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Columbus, Ohio, Stati Uniti, 43201
- Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
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Is not attending or has completed Kindergarten
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Untreated Control
Caregivers read to child as usual over 15 week period. |
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Sperimentale: 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.
Altri nomi:
|
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Sperimentale: 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.
Altri nomi:
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). |
|
Sperimentale: 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.
Altri nomi:
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Preschool Word and Print Awareness (PWPA)
Lasso di tempo: 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
|
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Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing
Lasso di tempo: Pretest before intervention and post-test immediately following intervention
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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
|
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The Reading House (THR)
Lasso di tempo: 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
|
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Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification
Lasso di tempo: 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.
|
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Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Laura M Justice, PhD, Ohio State University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbo Specifico dell'Apprendimento
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Disordini mentali
- Manifestazioni neurocomportamentali
- Disturbi del neurosviluppo
- Disturbi della comunicazione
- Disturbi del linguaggio
- Difficoltà di apprendimento
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Comunicazione
- Dislessia
- Disturbi dello sviluppo del linguaggio
- Alfabetizzazione
Altri numeri di identificazione dello studio
- R01DC020958 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
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