Book Sharing for Toddlers With Clefts

Обзор

Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups.

Вмешательства

• Поведенческое Book-Sharing for Toddlers with Clefts (BOOST)
  BOOST is a dialogic book-sharing intervention. Topics covered include strategies to increase the frequency of shared reading, child engagement and involvement in reading, and strategies to promote language development. Handouts will be shared during the sessions (using the Zoom share screen feature) and sent to families to summarize the content. Parents will record and securely upload shared reading videos during the intervention period. The research team will send prompts for these video upload

Первичные конечные точки

• Expressive One Word Picture Vocabulary Test-Fourth Edition [Срок оценки: End of study (At least 8 weeks after the end of the intervention period)]
• Receptive One Word Picture Vocabulary Test-Fourth Edition [Срок оценки: End of study (At least 8 weeks after the end of the intervention period)]
• Child Language Sample [Срок оценки: End of study (At least 8 weeks after the end of the intervention period)]
• MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test [Срок оценки: Baseline and at end of study (at least 8 weeks after the end of the intervention period)]

Вторичные конечные точки (1)

• Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants [Срок оценки: Baseline and at end of study (at least 8 weeks after the end of the intervention period)]

Критерии участия

Критерии включения

• A child's parent or primary caregiver provides a signed and dated informed consent form and permission for their child to participate.
• A child's parent is willing to comply with all study procedures and be available for the duration of the study.
• Child is between the ages of 20 to 32 months at the time of enrollment.
• Child has been diagnosed with isolated cleft palate, with or without cleft lip.
• Child has received palate repair surgery.
• The family's preferred language is English or Spanish.
• The family has access to a smartphone or similar device (e.g., tablets) capable of recording and sending videos.

Критерии исключения

• Diagnosed genetic condition associated with developmental delay (e.g., 22q11 deletion).
• The child has a diagnosis of autism spectrum disorder
• The child has a tracheostomy tube
• Child delivered < 32 weeks' gestation.
• Child in state custody or foster care.
• Child with significant sensory impairment (blindness, sensorineural hearing loss).
• The caregiver speaks a language other than English or Spanish
• The caregiver does not own a smartphone or similar device capable of recording/sending video

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Seattle Children's Hospital — Seattle

Идентификаторы

NCT: NCT06338319 · 23-048-E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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