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临床试验/NCT00970853
NCT00970853已完成3 期

The MOM Program Continuation - 8 Year Follow-up

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2009年3月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
187
试验地点
1
主要终点
Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)

研究概览

简要总结

Study measures will evaluate cognitive, academic, and behavioral outcomes for the children, school services received, and caregiver stress and depression. The main study outcome measures include cognitive status, school functioning, and behavior. Long-term outcomes will be studied in attempt to verify the 33 and 60 month significant differences found in school participation and behavior between the intervention and control groups.

详细描述

This study examines 8-year follow-up results from The MOM Program, a randomized controlled trial (RCT) of a mixed professional home visiting program to promote positive developmental outcomes among children in poverty. The earlier study found significant differences in both school participation and behavior among the intervention group at ages 33 and 60 months of age. Families from the original MOM Program RCT that provide informed consent will be eligible for the study when the children are 8 years of age.

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
94 Months 至 98 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Families from the original MOM RCT that participated in the 60 month evaluation
  • •Able to return to Philadelphia area for testing
  • •Parental/guardian informed consent and child assent

排除标准

  • •Children unable to complete testing due to sensory, physical, or other deficits, as determined by clinical review by study psychologist
  • •Caregivers unwilling to authorize the release of school information
  • •Non-English speaking

研究组 & 干预措施

Control

Active Comparator

Control group

干预措施: Control (Other)

MOM Program home visiting

Experimental

Mixed professional support home visiting program.

干预措施: MOM Program home visiting (Behavioral)

结局指标

主要结局

Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)

时间窗: 8 years post original enrollment in study

The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).

次要结局

  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading(8 years from study entry)
  • Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math(8 years from study entry)
  • Child Behavior Checklist (CBCL), Internalizing(8 years from study entry)
  • Child Behavior Checklist (CBCL), Externalizing(8 years from study entry)
  • Child Behavior Checklist (CBCL),Total Problems(8 years from study entry)
  • Teacher Rating Form (TRF), Internalizing(8 years from study entry)
  • Teacher Rating Form (TRF), Externalizing(8 years from study entry)
  • Teacher Rating Form (TRF), Total Problems(8 years from study entry)

研究者

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

Jerilynn Radcliffe

PI

Children's Hospital of Philadelphia

研究点 (1)

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