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临床试验/NCT00218751
NCT00218751已完成2 期

Promoting Child Mental Health: RCT of Home Visiting

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 1,122 人开始时间: 2000年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
1,122
试验地点
2
主要终点
Child cognitive development, behavior, and health

研究概览

简要总结

This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.

详细描述

Hawaii's Healthy Start Program (HSP) is a well-respected home visiting program for families at risk for abuse of their newborn children. The program incorporates early identification of at-risk families. Each family then begins receiving long-term home visitations. The home visiting component aims to promote child health and development and to prevent child abuse by improving family functioning and parenting. Home visitors are trained paraprofessionals working under professional supervision. The program includes both direct services and referrals to community resources. Direct services include providing emotional support to parents, encouraging them to seek needed professional help, teaching parents about child development, and role-modeling parenting skills and problem-solving techniques. In a previous study, at-risk families were randomly assigned to either HSP or no intervention. Evaluations were conducted at the time of the child's birth and at ages 1, 2, and 3 in order to assess the home environment and the development and well-being of the child. This study is a continuation study. Participants will include the original families from the previous study, as well as a new group of families who are not at risk for child abuse. By interviewing and observing these two groups of families, this study will evaluate the effectiveness of HSP in promoting children's mental health, cognitive and social-emotional development, and academic achievement in the first years of school.

All families will be evaluated on a yearly basis when the child is in 1st, 2nd, and 3rd grade. Interviews will be conducted with the parents, children, and teachers. Parent interviews will focus on family functioning, including mental health of the parents, parenting attitudes and behaviors, quality of the home environment, and any domestic violence or substance abuse that occurred. In addition, the child's health and development, as well as use of any community resources will be assessed. Interviews with the children and teachers will focus on assessing the child's behavior and emotional well-being. The family's home environment, the interaction between the parents and children, and the children's classroom behavior will be observed. Each child will also undergo developmental testing. All measurements will be collected at each yearly visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Families in the Oahu community who delivered newborns between November 1994 and November 1995
  • If enrolled in the control group, must not have been previously enrolled in Hawaii's Healthy Start Program

排除标准

  • Insufficient understanding of English

结局指标

主要结局

Child cognitive development, behavior, and health

时间窗: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

Child social-emotional development

时间窗: At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year

Child depression

时间窗: At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years

次要结局

  • Family functioning(At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
  • Parent functioning and stress levels(At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
  • Substantiated reports of child abuse(At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)

研究者

申办方类型
Other

研究点 (2)

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