跳至主要内容
临床试验/NCT04031326
NCT04031326已完成不适用

Feasibility and Effectiveness of LENA Home in the Every Child Succeeds Home Visiting Program

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年4月1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
31
试验地点
2
主要终点
Change in Absolute Word Count

研究概览

简要总结

This study evaluates feasibility and efficacy of adding the LENA Home program to the standard Every Child Succeeds (ECS) home visiting curriculum. Half of the participants will receive the standard ECS curriculum during normally scheduled home visits, while the other half will receive this plus LENA Home.

详细描述

Every Child Succeeds is a program that uses home visiting as a preventive strategy to support low income families in providing stimulating, safe, and nurturing environments for their young children. Most families in home visiting have experienced adversity in their lives, and had inadequate parenting role models as they grew up. Home visitors visit families during pregnancy through the child reaching three years of age, providing information, teaching, and resources to help parents provide the best possible start for their children.

LENA Home is a 13-week curriculum designed to add an early-language focus to existing home visiting or parent education programs for children ages birth to three. It employs LENA wearable audio recorder technology and targeted content to help parents and other caregivers increase interactive talk. There are 13 weekly one-on-one sessions, including modules on parent-child reading and increasing verbal interaction during typical home activities. Sessions include videos, practical techniques, and feedback from LENA recordings via intuitive reports to help parents talk more with their children. LENA Home reports provide data on adult words spoken to the child (AWC) and conversational turns (CTC). LENA Home has been shown to increase interactive talk and child language ability and informs parents how much they are talking with their children in an objective way.

Upon completion of the study, we will have more information regarding whether (1) LENA Home can be successfully integrated into existing home visiting programs (feasibility), (2) children exposed to LENA have larger vocabularies than those who do not receive the intervention, (3) mothers using LENA engage in more literacy-promoting behaviors relative to controls, and (4) LENA improves parent-child interactions (utility).

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 (Participant)

入排标准

年龄范围
6 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • enrollment in the Every Child Succeeds home visiting program,
  • child age between 6- and 9-months old,
  • English-speaking household,
  • child gestation of at least 32 weeks,
  • child has no known neurobehavioral/genetic syndrome or brain injury likely to cause language delay,
  • maternal age at least 15 years old.

排除标准

  • Not meeting the above criteria.

结局指标

主要结局

Change in Absolute Word Count

时间窗: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)

The LENA Home recording device measures Absolute Word Count (AWC) over an approximately 13-hour recording period at each recording. This outcome will involve change in AWC between baseline and a Midpoint assessment (approximately 6-7 weeks) and Endpoint (13-weeks).

Change in Conversational Turns Count

时间窗: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)

The LENA Home recording device measures Conversational Turns Count (CTC) over an approximately 13-hour recording period at each recording. This outcome will involve change in CTC between baseline and a Midpoint assessment (approximately 6-7 weeks) and Endpoint (13-weeks).

Change in LENA Snapshot Language Assessment Score

时间窗: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)

The LENA Developmental Snapshot is a questionnaire that provides parents with an

次要结局

  • Change in SPEAK (parenting mindset) score(Baseline and Endpoint (13 weeks))
  • Change in ScreenQ-I/T (screen-based media use)(Difference in score between Baseline and Endpoint (13 weeks))
  • Change in DialogPR-I/T (shared reading quality) Score(Baseline and Endpoint (13 weeks).)
  • Change in StimQ-I (home cognitive environment)(Baseline and Endpoint (13 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Randomized Trial of LENA Home in A Home Visiting... | 临床试验