Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention
研究概览
简要总结
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:
Will the TWMB program increase the time a caregiver talks to their infant?
Participants will:
- Come to at least four well-child checkups
- Receive the TWMB program from the provider during the checkups
- Record their conversations with their infant before they receive the program and after they receive the program four times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For this study, each child-caregiver dyad will consist of:
- •A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
- •The child of the above caregiver for whom the WCC visits are conducted.
- •A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:
- •Be the age of majority, or older, as defined by the state of residency.
- •Able to complete study measures in English.
- •Have the legal authority to consent to participate for themselves and to consent on behalf of their child.
- •To proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.
- •A potential child participant must meet all the following inclusion criteria to be enrolled in the study:
- •Receive WCC at a participating clinic from a participating provider.
- •Be zero to nine months (+ 0-30 days) old at enrollment.
- •Was born at full term (> 37 weeks gestation).
- •Was born in a singleton birth (i.e., was the only child delivered during the birth).
排除标准
- 未提供
研究组 & 干预措施
Talk With Me Baby
干预措施: Talk with Me Baby (Behavioral)
结局指标
主要结局
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention
时间窗: 12 months
Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention
时间窗: 12 months
次要结局
未报告次要终点