- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06275815
Promovendo a implementação pelo cuidador de uma intervenção eficaz de aprendizagem precoce
Promovendo a implementação pelo cuidador de uma intervenção eficaz de aprendizagem precoce: sentar juntos e ler (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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ohio
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Columbus, Ohio, Estados Unidos, 43205
- Nationwide Children's Hospital
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Columbus, Ohio, Estados Unidos, 43201
- Schoenbaum Family Center; Crane Center for Early Childhood Research and Policy
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Untreated Control
Caregivers read to child as usual over 15 week period. |
|
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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). |
|
Experimental: 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.
Outros nomes:
Caregiver receives three tailored encouraging text messages specific to each week of the Sit Together and Read intervention.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Preschool Word and Print Awareness (PWPA)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Laura M Justice, PhD, Ohio State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtorno Específico de Aprendizagem
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Manifestações Neurocomportamentais
- Distúrbios do Neurodesenvolvimento
- Distúrbios da Comunicação
- Distúrbios de Linguagem
- Dificuldades de aprendizagem
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Comunicação
- Dislexia
- Distúrbios do Desenvolvimento da Linguagem
- Alfabetização
Outros números de identificação do estudo
- R01DC020958 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
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