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临床试验/NCT03199326
NCT03199326已完成不适用

Collaborative Care for Infants at Risk

University of Utah2 个研究点 分布在 1 个国家目标入组 468 人开始时间: 2017年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
468
试验地点
2
主要终点
Infant Health Related Quality of Life

研究概览

简要总结

This study evaluates the feasibility, acceptability, and impact of a collaborative care practice for infants investigated by state Child Protective Services (CPS) for suspected maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of life, as well as the frequent contact of infants with health care providers in the first year of life, the investigators will conduct a RCT to measure the impact of a collaborative practice model linking CPS caseworkers with primary health care providers during an investigation for suspected infant maltreatment. With this trial, the investigators will ask (3a) Can a collaborative practice model improve parent-reported infant health-related quality of life 6 months following child welfare involvement for suspected infant maltreatment? and (3b) Does a collaborative practice model impact repeat child welfare involvement for suspected child maltreatment over 6 months?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Surveys will be collected without knowledge of intervention assignment

入排标准

年龄范围
0 Days 至 364 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Less than 12 months of age at referral
  • Involved in a child welfare investigation for suspected maltreatment
  • Investigation occurring in Utah DCFS Salt Lake Valley or Western regions

排除标准

  • For the primary and selected secondary outcomes,
  • Caregiver with primary spoken language other than English or Spanish,
  • CPS caseworkers not yet randomized to a practice arm
  • Infants in out-of-home placement at the time of referral or case closure,
  • Infants suffering fatal maltreatment
  • Prior investigation of an infant in a household during study timeframe (e.g., twins, infant siblings, and repeat referrals will be excluded).
  • For other secondary outcomes related to CPS outcomes, language exclusion will not be considered.

结局指标

主要结局

Infant Health Related Quality of Life

时间窗: Change from baseline to 6 months following CPS case closure

Difference in Change in Infant Health Related Quality of Life based on practice arm

次要结局

  • Parent Perception of Child Welfare and Child Health Care(at baseline (child welfare) and at 6 months (child health care))
  • Repeat Child Welfare Involvement(6 months after CPS case closure)

研究者

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

Kristine Campbell

Associate Professor, Pediatrics

University of Utah

研究点 (2)

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