跳至主要内容
临床试验/NCT00110292
NCT00110292Unknown1 期

An RCT of a Low-Intensity Intervention to Reduce Delay

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2002年3月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
600
试验地点
4

研究概览

简要总结

This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.

详细描述

This study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. The intervention is based on a public health/primary care partnership and combines mailed parent-completed Ages & Stages Questionnaires (ASQ), a monthly mailed age-paced parenting newsletter (Building Blocks) and corresponding developmental toys (BB), and a Reach Out and Read (ROR) physician-based distribution of children's books.

Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQ/BB+ROR group, an ROR-only group, or a no intervention control group. Outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to Early Intervention programs. Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single

入排标准

年龄范围
4 Months 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Attend participating pediatric clinic (serving poor, largely black, and Hispanic communities)
  • Family with child 4 to 7 months of age at enrollment
  • English- or Spanish-speaking

排除标准

  • Developmental delay
  • Eligible for Early Intervention program

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (4)

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