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临床试验/NCT04438161
NCT04438161进行中(未招募)不适用

Identification of Newborns at High Risk for the Occurrence of Preventable Child Maltreatment: Phase 3 of Project 3 in the Overall Center for Innovation in Child Maltreatment Policy, Research, and Training (CICM), a Capstone Centers Grant.

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2021年1月26日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
105
试验地点
2
主要终点
Child Maltreatment

研究概览

简要总结

Childhood Maltreatment (CM) has highly deleterious effects on human development and is a preventable known cause of enduring psychopathology in the United States. Infants and young children are at particularly high risk for physical harm from abuse and neglect, comprising over 60% of all child maltreatment fatalities. An increasing number of studies point to the ability to target prevention of CM by estimating individual specific risk at the time of birth, on the basis of readily-accessible data elements of birth records. This clinical trial is a randomized controlled trial embedded within a prospective longitudinal study, in which families of infants recruited prenatally or in the newborn period are randomized to an enhanced level of engagement in resource navigation, which we refer to as Personalized Education Regarding Clinical and Community Supports (PERCCS). The enhancement involves keying recommendations for evidence-informed interventions for the prevention of CM to established risk factors for ascertained within a family.

The parent longitudinal cohort study involves enrollment of a diverse population of families of newborns (prenatally or in the immediate postnatal period) for the purpose of ascertaining sociodemographic, psychological (eg. parental stress) and family psychiatric risk factors for (a) child maltreatment (b) unmet service needs, and (c) adverse behavioral outcomes of the children. Families are contacted quarterly to track acquisition of support services that are relevant to the prevention of child maltreatment. At age 18 months early childhood behavioral outcomes are ascertained, biomaterials collected, and official-report child maltreatment records from the State of Missouri are individually cross-matched with identifiers of the children and their parents.

Two major outcomes are examined:

The first is whether the engagement protocol results in a higher level of acquisition and active participation in recommended preventive intervention services by the families (including home visitation, parental mental health care, evidence-based parenting education, and others delineated in Table 1, see below).

The second is the rate of child maltreatment (CM) ascertained in official Missouri state administrative records for which individual informed consent to individually-cross reference is obtained by the families in the course of their enrollment in the parent longitudinal study.

详细描述

Sample: The sample will be recruited from the Washington University School of Medicine Obstetrical Service within the Barnes Jewish Christian (BJC) Health System, on which there are over 3000 Missouri childbirths per year, serving an urban population of families that are disproportionately affected by poverty. Fifty-five per cent of patients report a family income less than $20,000, 65% of the mothers are unemployed, and the majority of the newborns are on Medicaid or are Medicaid-eligible. In preliminary screening efforts, over one third of the mothers reported their own childhood histories of maltreatment, and approximately one half score in the clinical range for depressive symptomatology.

Methods: A schematic summarizing study enrollment, participant randomization, and ascertainment of outcomes is provided in Figure 1.

Study Approach and Design: N=400 families are in the process of being enrolled in the parent longitudinal study. Among those who fall in an elevated risk category (upper 50% of the sample for total count of established risk factors) we will randomize 150 families 2:1 to Personalized Education Regarding Clinical and Community Supports (PERCCS) versus Usual Care. Risk counts are calculated by the total number of established predictors of risk for CM (itemized in Table 1) ascertained from birth records and: i) a screen for maternal depression, ii) a screen for maternal childhood trauma, and iii) a screen for active intimate partner violence. Utilization of community-based evidence-informed support services will be ascertained at baseline and quarterly thereafter for all study participants. Official-report Child Maltreatment data from Missouri state administrative data will be individually linked with participant research records when the children reach 18 months of age.

PERCCS involves i) a review with the mother of all family CM risks ascertained in the context of their own individual screening ii) recommendations of community and clinical interventions which substantively respond to those risks and are available to the subject (on the basis of each individual subject's zip code, insurance, and eligibility for the interventions), collectively the personalized family resource plan, iii) facilitation of contact between the subject and the respective provider agencies to initiate enrollment; and iv) authorization for the research team to share the personalized risk profile and support recommendations with the infant's outpatient primary care provider.

The community and clinical supports responsive to specific risk factors are listed in Table 1, which summarizes the array of evidence-informed preventions that will be presented to the families, and the correspondence with each to specific CM risks ascertained within a family. Table 2 depicts the set of scripts which are used by the study team to standardize all aspects of the review of endorsed risks, their potential adverse effects on parenting, and the opportunities for mitigation through evidence-informed intervention.

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 (Participant)

盲法说明

Single (study personnel blind to intervention allocation status)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be Missouri residents
  • 18 years of age or older
  • Engaged in the BJC Healthcare Obstetrics or Newborn Services

排除标准

  • Participants who are not Missouri residents
  • Under the age of 18 years
  • Not engaged in the BJC Healthcare Obstetrics or Newborn Services.

结局指标

主要结局

Child Maltreatment

时间窗: Not more than 18 months postpartum

Rate of official reports of child maltreatment, ascertained from records of the Missouri Department of Social Services at age 18 months. Child Maltreatment (number of cases of child abuse and neglect) as measured by official state administrative records

Service Utilization

时间窗: Not more than 18 months postpartum

Proportion of evidence-informed services indicated by risk profiles of all families within group acquired over the course of follow-up.

次要结局

未报告次要终点

研究者

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

Mini Tandon

Professor of Child and Adolescent Psychiatry

Washington University School of Medicine

研究点 (2)

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