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临床试验/NCT03121365
NCT03121365已完成不适用

Digital Literacy Promotion Among Medicaid Children

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old)

研究概览

简要总结

This study evaluates the effects of digital versus standard literacy promotion, as well as dialogic language behaviors and reading comprehension among infants when comparing the use of e-books to standard board books. Around half of the participants will receive standard board books at the 6, 9, and 12 month well visits, while the other half will receive digital e-books.

详细描述

This study has three main objectives. The first is to test the effects of digital versus standard literacy promotion by way of a randomized controlled trial design. The second aim is to explore the reading behaviors and reading activities between parents and their infants when comparing the use of e-books to standard board books. The third aim is to identify themes regarding dialogical reading behaviors among parents participating in the video sub-study.

Participants will be stratified by clinic site and randomized to receive literacy promotion using 1) standard early reader board books or 2) digital electronic early reader e-books. We will recruit and consent one hundred eligible parent-infant dyads, with the infant being between 5 and 7 months of age at enrollment.

In this intervention, parent-infant dyads randomized to the digital arm will receive developmentally appropriate e-books. Those randomized to the standard arm will receive developmentally appropriate board books. Participants will receive either the e-book or board book at the time of their 6, 9 and 12 month well visits. In addition to the books, parent-infant dyads in both arms will be provided information on the importance of early parent-child reading activity by pediatric clinicians using the Reach Out and Read framework.

The main outcome will be differences in Bayley-3 Composite scores between groups. Secondary aims include differences in StimQ Reading Subscale Scores and Edinburgh Postnatal Depression Scale Scores between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Months 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • English or Spanish speaking
  • Parents ≥ 15 years of age at start of study
  • Child born ≥ 35 weeks estimated gestational age
  • Child 5 to 7 months
  • Medicaid Insurance
  • Access to a smart phone and/or tablet

排除标准

  • Child has neurodevelopmental disabilities or congenital malformation

结局指标

主要结局

Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old)

时间窗: Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)

Evaluation of the infant's cognitive, language and motor development using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Results were reported as composites of cognitive, language, and motor scores, where data were continuous variables on a scale with a normal distribution of 95%. The composite scores are scaled to a metric with a mean of 100 and a standard deviation of 15, and range from 40-160. A composite score above 77.5 is considered developmentally average and a composite score below 77.5 is considered a developmental concern. Data were described using mean and standard deviation. Significance was considered at a level of 0.05.

次要结局

  • Frequency of Board Book Reading(7 months)
  • StimQ READ Subscale Change Score(1 month after the 6, 9, and 12 month well visits)
  • Frequency of Parent-Reported Board Book Reading(1 month)
  • Frequency of E-Book Reading(7 months)
  • Frequency of Television Viewing(7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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