- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT06275815
Podpora pečovatelů při zavádění efektivní intervence v raném učení
Podpora pečovatele při zavádění efektivní intervence v raném učení: sedněte si a čtěte (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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43205
- Nationwide Children's Hospital
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Columbus, Ohio, Spojené státy, 43201
- Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Untreated Control
Caregivers read to child as usual over 15 week period. |
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Experimentální: 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.
Ostatní jména:
|
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Experimentální: 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.
Ostatní jména:
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). |
|
Experimentální: 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.
Ostatní jména:
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Preschool Word and Print Awareness (PWPA)
Časové okno: Pretest before intervention and post-test immediately following intervention
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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
Časové okno: 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
|
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The Reading House (THR)
Časové okno: 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
Časové okno: 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
Časové okno: 6 month follow-up, 12 month follow-up, 18 month follow-up, 24 month follow up.
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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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Laura M Justice, PhD, Ohio State University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Specifická porucha učení
- Neurologické projevy
- Nemoci nervového systému
- Duševní poruchy
- Neurobehaviorální projevy
- Neurologické vývojové poruchy
- Poruchy komunikace
- Poruchy jazyka
- Poruchy učení
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Sdělení
- Dyslexie
- Poruchy vývoje jazyka
- Gramotnost
Další identifikační čísla studie
- R01DC020958 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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