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临床试验/NCT01573793
NCT01573793Unknown不适用

Promoting Optimal Parenting

Seattle Children's Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Language ENvironment Analysis System (LENA)

研究概览

简要总结

The purpose of this study is to determine if providing parenting education materials delivered in different ways during the first 30 months of a child's life will increase child-parent attachment and promote mother-child interaction, if certain types of strategies improve cognitive, language, and emotional development in infants and toddlers, and if our way of delivering these materials is cost-effective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 23 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •English-speaking
  • •18-23 year-old first-time mother of a healthy newborn

排除标准

  • •Anything other than above

研究组 & 干预措施

Intervention

Active Comparator

Will receive parenting educational materials hypothesized to enhance emotional and cognitive development

干预措施: Parenting Education (Behavioral)

Control

Sham Comparator

Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development

干预措施: Control Group - Safety Materials (Behavioral)

结局指标

主要结局

Language ENvironment Analysis System (LENA)

时间窗: 6/18/30 months - tracking changes throughout study

Adaptive Behavior Assessment System, Second Edition (ABAS-II)

时间窗: Month 12/24/36/42 - tracking changes throughout study

Brief Infant Sleep Questionnaire(BISQ)

时间窗: Month 12/24 - tracking changes throughout study

Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)

时间窗: Month 24/42 - tracking changes throughout study

MacArthur Communicative Development Inventory- Short Form (CDI)

时间窗: Month 24/42 - tracking changes throughout study

Children's Sleep Habits Questionnaire (CSHQ)

时间窗: Month 36/42 - tracking changes throughout study

Devereux Early Childhood Assessment-Clinical Form (DECA-C)

时间窗: Month 24/36/42 - tracking changes throughout study

Devereux Early Childhood Assessment- Infant/Toddler (DECA-I/T)

时间窗: Month 12

Family Resource Scale (FRS)

时间窗: Baseline

MARLOWE-CROWNE

时间窗: Baseline

Maternal Emotional Styles Questionnaire (MESQ)

时间窗: Month 36

Patient Health Questionnaire 2 (PHQ-2)

时间窗: Baseline and Month 12/24/36/42 - tracking changes throughout study

Preschool Language Scale-5 (PLS-5)

时间窗: Month 36

Parenting Sense of Competence-Efficacy(PSOC)

时间窗: Baseline and Months 12/24/36/42 - tracking changes throughout study

Social competence subscale of the Social Competence and Behavior Evaluation(SCBE)

时间窗: Months 36/42 - tracking changes throughout study

(Strange Situation Procedure) SSP

时间窗: Month 15

Nursing Child Assessment Teaching Scale (NCATS)

时间窗: Months 15/36 - tracking changes throughout study

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

Investigator

Seattle Children's Hospital

研究点 (1)

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