- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06275815
Fremme omsorgsgivers implementering av en effektiv tidlig læringsintervensjon
Fremme omsorgspersonens implementering av en effektiv tidlig læringsintervensjon: Sit Together and Read (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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43205
- Nationwide Children's Hospital
-
Columbus, Ohio, Forente stater, 43201
- Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Untreated Control
Caregivers read to child as usual over 15 week period. |
|
|
Eksperimentell: 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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
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). |
|
Eksperimentell: 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.
Andre navn:
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Preschool Word and Print Awareness (PWPA)
Tidsramme: 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
|
|
Phonological Awareness Literacy Screening (PALS): Alphabet Knowledge and Name Writing
Tidsramme: 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
|
|
The Reading House (THR)
Tidsramme: 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
|
|
Woodcock Johnson Test of Achievement- IV (WJ-IV): Word Attack and Letter-Word Identification
Tidsramme: 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.
|
|
Woodcock Johnson Test of Achievement- IV (WJ-IV): Spelling, Passage Comprehension
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Laura M Justice, PhD, Ohio State University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Spesifikk læringsforstyrrelse
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Nevroatferdsmanifestasjoner
- Nevroutviklingsforstyrrelser
- Kommunikasjonsforstyrrelser
- Språkforstyrrelser
- Lærevansker
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Kommunikasjon
- Dysleksi
- Språkutviklingsforstyrrelser
- Leseferdighet
Andre studie-ID-numre
- R01DC020958 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .