Book Sharing for Toddlers With Clefts
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Expressive One Word Picture Vocabulary Test-Fourth Edition
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Months 至 32 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Expressive One Word Picture Vocabulary Test-Fourth Edition
时间窗: End of study (At least 8 weeks after the end of the intervention period)
Standardized, clinician-administered measure of expressive language. Possible raw scores range from 0 to 190, with higher scores indicating better expressive language
Child Language Sample
时间窗: End of study (At least 8 weeks after the end of the intervention period)
Observational measure to assess child expressive language. We will obtain a count of the number of clear and intelligible utterances, the number of unique words used, and mean length of utterance. Higher scores indicate better child language skills.
MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test
时间窗: Baseline and at end of study (at least 8 weeks after the end of the intervention period)
Parent report measure of children's expressive language. Raw scores range from 0 to 50, with higher scores indicating better expressive language.
Receptive One Word Picture Vocabulary Test-Fourth Edition
时间窗: End of study (At least 8 weeks after the end of the intervention period)
Standardized, clinician-administered measure of receptive language. Raw scores range from 0 to 190, with higher scores indicating better receptive language.
次要结局
- Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants(Baseline and at end of study (at least 8 weeks after the end of the intervention period))