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临床试验/NCT00212576
NCT00212576已完成不适用

Promoting Early School Readiness in Primary Health Care

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 675 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
675
试验地点
1
主要终点
Discipline assessed using the Discipline Survey

研究概览

简要总结

This project will measure the degree to which parenting programs based in pediatric primary care can be effective in promoting language development and school readiness in at-risk young children.

The study is a randomized controlled trial in which two different primary care-based parenting programs will be compared to a control group in a population that is at risk on the basis of poverty. The two programs represent varying levels of low intensity, but each has the same goals: enhancing parent-child interaction in order to improve language, cognitive and social-emotional development and ultimately promote school readiness and school performance.

One program is called the "Video Interaction Project". While waiting to see the primary care provider for well child care, the family meets with a child development specialist, who videotapes the parent and infant interacting together. The videotape is then rewound and watched together by the parent (and infant!) and child development specialist. This leads to a discussion about child development, infant cues and parenting, with the child development specialist building on observed strengths in the interaction. In addition, families are provided with parenting pamphlets developed for the project, and with inexpensive developmentally stimulating toys.

The other program is called the "ASQ-Building Blocks Project". This project employs a public health approach to facilitate parental engagement in child development. Families are sent monthly newsletters that focus on child development, infant cues and parenting; included with each newsletter is an inexpensive, developmentally stimulating toy. In addition, families periodically receive Ages and Stages Questionnaires, which they complete and mail back to the program. Based on the questionnaires, the program determines whether the infant has screened positive for possible developmental delay and provides this information to both the family and the primary care provider.

This study will test 2 hypotheses:

  1. Primary care based parenting interventions can impact parent-child interaction, early child development and school readiness.
  2. Interventions of differing intensity will have impacts of differing magnitude depending on the risk level of the family.

详细描述

This project will measure the degree to which parenting programs based in pediatric primary care can be effective in promoting language development and school readiness in at-risk young children. The study will represent a collaboration between the Department of Pediatrics at New York University School of Medicine - Bellevue Hospital Center, the Medical and Health Research Association of New York City, Inc., and the Center for Research on Culture, Development and Education at New York University Steinhardt School of Education. Initial funding was provided by NICHD for 4 years. NICHD provided 5 additional years of competing renewal funding beginning in July, 2010.

The study is a randomized controlled trial in which two different primary care-based parenting programs will be compared to a control group in a population that is at risk on the basis of poverty. The two programs represent varying levels of low intensity, but each has the same goals: enhancing parent-child interaction in order to improve language, cognitive and social-emotional development and ultimately promote school readiness and school performance.

One program is called the "Video Interaction Project". While waiting to see the primary care provider for well child care, the family meets with a child development specialist, who videotapes the parent and infant interacting together. The videotape is then rewound and watched together by the parent and child development specialist. This leads to a discussion about child development, infant cues and parenting, with the child development specialist building on observed strengths in the interaction. In addition, families are provided with parenting pamphlets developed for the project, and with inexpensive developmentally stimulating toys.

The other program is called the "ASQ-Building Blocks Project". This project employs a public health approach to facilitate parental engagement in child development. Families are sent monthly newsletters that focus on child development, infant cues and parenting; included with each newsletter is an inexpensive, developmentally stimulating toy. In addition, families periodically receive Ages and Stages Questionnaires, which they complete and mail back to the program. Based on the questionnaires, the program determines whether the infant has screened positive for possible developmental delay and provides this information to both the family and the primary care provider.

The study will take place at Bellevue Hospital Center, a public hospital serving low socioeconomic status families from throughout New York City. Infant-mother dyads will be enrolled during the postpartum period and followed through age 2 years. Periodic assessments will be performed of parent-child interaction and child developmental outcome.

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
35 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intention to receive primary care in the well-child clinic (FCC or newborn clinic) at Bellevue Hospital Center.
  • Intention to remain in the New York City area for at least 3 years.
  • Primary caregiver's language is English or Spanish.
  • Birthweight 2000gm or higher
  • Gestational age 35 weeks or higher

排除标准

  • Significant newborn medical complication
  • Significant congenital anomaly or syndrome

结局指标

主要结局

Discipline assessed using the Discipline Survey

时间窗: 6, 14, 24, 36, 54 mos and in 1st grade

Discipline mediates effects of poverty on social-emotional outcomes (Gershoff, 2007), and attitudes about discipline practices form early in children's lives (Socolar, 1996).

Stress related to interactions and lack of warmth will be assessed using The Parenting Stress Index - Short Form (PSI)

时间窗: 6, 14, 24, 36, 54 mos and in 1st grade

Stress related to interactions and lack of warmth mediate effects of poverty on emotional outcomes.

Woodcock-Johnson III Tests of Cognitive Abilities

时间窗: 14, 24, and 36 mos

Will be used to estimate child's cognitive. Four sub-tests will be used: Verbal comprehension (VC) assesses the comprehension knowledge Cattell-Horn-Carroll cognitive factor (Gc); Memory for Words and Auditory Working Memory assess the short term memory CHC factor (Gsm); Visual Matching measures the CHC processing speed factor (Gs).

Bayley Scales of Infant and Toddler Development

时间窗: 14, 24, and 36 mos

Will assess cognitive development

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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