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Building Healthy Children (BHC)

2020年3月17日 更新者:Sheree Toth、University of Rochester

Building Health Children: Randomized Controlled Trial (RCT) Evaluation

This study will evaluate the effectiveness of providing a combination of evidence-based behavioral health treatments for mothers who gave birth to their first child prior to the age of 21 and who meet eligibility requirements and their children on prevention of child maltreatment and promotion of positive socioemotional development.

研究概览

详细说明

Building Healthy Children is a collaboration of social service and health care agencies, each providing evidence-based services to intervention families in a seamless package. Low-income parents who gave birth to their first child when they were under 21 and who were not involved in the child welfare system were targeted as an at-risk group for whom home visitation services would offer optimal preventive and cost-efficiency outcomes. Services include Interpersonal Psychotherapy [IPT] for maternal depression and Child Parent Psychotherapy [CPP] for maternal-child relationship development and trauma treatment, and Parents As Teachers [PAT]. Families are provided a tiered complement of BHC services based upon risk and current need.

Case management and outreach services are key to assure family engagement and full program participation. An assigned community outreach worker provides a consistent, nurturing relationship that helps retain families in the program and readies parents for the evidence-based treatments, movement towards goals, and behavior change. Outreach workers help to stabilize families and ensure compliance with medical appointments and recommended care.

Most importantly, BHC home-based services are integrated with primary care practices: pediatric, family medicine, and federally qualified neighborhood health center. These comprehensive services are compared with a screening and referral only group in a randomized design. Integration with the child's medical home is an all-inclusive approach to improve child health and well-being and to achieve desired program outcomes.

研究类型

介入性

注册 (实际的)

1852

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Rochester、New York、美国、14608
        • Mt. Hope Family Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 23年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Participants will include patients drawn from Strong Pediatrics, Anthony Jordan Health Center, Rochester General Hospital, or Highland Family Medicine
  • residents of Monroe County,
  • Temporary Assistance for Needy Families (TANF) eligible,
  • are neither currently active nor have had an indicated CPS report,
  • have a mother who is or was under 21 at the birth of her first child, and
  • has a maximum of two children under the age of three.

Exclusion Criteria:

  • Children who have indicated Child Protective reports or who are in foster care at the time of recruitment
  • Any children or mothers who are not able to complete the research protocol also will be excluded.
  • Potential subjects suffering from extreme medical or psychiatric conditions (such as severe brain injury or psychosis) or serious cognitive impairments (such as mental retardation) that would render them incapable of completing research measures validly will be excluded.
  • Mothers with thought disorder, severe depression or suicidality requiring hospitalization, severely limited intellectual functioning (IQ less than 70), and current maternal incarceration.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Comprehensive preventive services
Combined comprehensive services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
其他名称:
  • Parents as Teachers Home visitation
  • Child-Parent Psychotherapy
  • 人际心理治疗
  • Outreach support
有源比较器:Screening and referral
Annual screening and referral for services as needed

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevention of indicated Child Protective Services (CPS) reports, including change over time
大体时间:Baseline and child's age of 12, 24, 36, 48, and 60 months
Prevention of indicated Child Protective Services (CPS) reports on mothers and their children
Baseline and child's age of 12, 24, 36, 48, and 60 months

次要结果测量

结果测量
措施说明
大体时间
Reduction in family risks over time
大体时间:Baseline and child's age of 12, 24, 36, 48, and 60 months
Changes in family risks, including maternal depression, domestic violence exposure, health outcomes, and family stability
Baseline and child's age of 12, 24, 36, 48, and 60 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sheree L Toth, Ph.D.、University of Rochester

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2007年8月1日

初级完成 (实际的)

2019年8月1日

研究完成 (实际的)

2019年8月1日

研究注册日期

首次提交

2013年6月21日

首先提交符合 QC 标准的

2013年6月25日

首次发布 (估计)

2013年6月28日

研究记录更新

最后更新发布 (实际的)

2020年3月19日

上次提交的符合 QC 标准的更新

2020年3月17日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • BHC-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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