跳至主要内容
临床试验/NCT01888809
NCT01888809已完成不适用

Building Health Children: Randomized Controlled Trial (RCT) Evaluation

University of Rochester2 个研究点 分布在 1 个国家目标入组 1,852 人开始时间: 2007年8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
1,852
试验地点
2
主要终点
Prevention of indicated Child Protective Services (CPS) reports, including change over time

研究概览

简要总结

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.

详细描述

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
12 Years 至 23 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Prevention of indicated Child Protective Services (CPS) reports, including change over time

时间窗: 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

次要结局

  • Reduction in family risks over time(Baseline and child's age of 12, 24, 36, 48, and 60 months)

研究者

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

Sheree Toth

Professor

University of Rochester

研究点 (2)

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