At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating PERCCS: Personalized Education Regarding Clinical and Community Supports for A. Longitudinal Cohort n=400 and B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention. Completed, enrolled 399 participants across 1 site.
Signals
Detailed Summary
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 was a small 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 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.
Study Details
Timeline
Arms & Interventions
Low risk natural history study (planned was n=250\*; actual n=174). Of the 174, 105 families consented to the RCT \*Participants who consented to the RCT were randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" birth record risk counts (planned n=105l; actual n=78) families for child maltreatment or "low risk" counts (planned n=45; actual n=27) families.
High risk families in prospective longitudinal study of newborns (planned n=150\*; actual n=225). A total of 150 families were planned and a final 105 families consented to the RCT \*Participants were randomized 2:1 PERCCS:Control, and the randomization in successive sets of three families who fall in either "high risk" birth record risk counts (planned n=105; actual n=78) families for child maltreatment or "low risk" counts (planned n=45; actual n=27) families. Participants in this arm will be randomized to: 1. PERCCS (see attached figure and table for details) 2. Care as Usual
Interventions
A brief follow-up to the screening provided to 50% of the consented families (randomly assigned) that links their specific familial risks to community interventions.