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临床试验/NCT01459848
NCT01459848已完成不适用

A Randomized Controlled Trial of Block Play vs Dvd Viewing

Seattle Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
salivary cortisol

研究概览

简要总结

The investigators will do an experiment where 9-12 month old infants are randomized to 30 minutes of block play or 30 minutes of watching a baby DVD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
9 Months 至 12 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •9-12 months of age

排除标准

  • 未提供

研究组 & 干预措施

block play

Active Comparator

30 minutes of block play with parent

干预措施: block play (Behavioral)

baby dvd

Experimental

watch baby dvd with parent

干预措施: baby dvd (Behavioral)

结局指标

主要结局

salivary cortisol

时间窗: 40 minutes post baseline

Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis

salivary cortisol

时间窗: Baseline

Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis.

salivary cortisol

时间窗: 10 minutes post baseline

Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis

salivary cortisol

时间窗: 20 minutes post baseline

Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis

salivary cortisol

时间窗: 30 minutes post baseline

Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitri Christakis

Professor

Seattle Children's Hospital

研究点 (1)

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