Study to Understand Risk and Resilience Opportunity for Newborns After Delivery

A. Longitudinal Cohort n=400, B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention

Child maltreatment, preventative intervention, case management, newborn, infancy

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.

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: Consent was in three phases to reduce burden on mothers. A total of N=400 families were the target for recruitment in the parent longitudinal study. The consent period was delayed by the onset of COVID and switching to virtual recruitment. A total of 399 were consented during phase I which included a limited screen and match to birth records. Phase II included the full risk screen with referrals. Phase III consent was conducted from the Phase II consents for for nested RCT on a rolling basis. Among those who fall in an elevated risk category (or 3+ risks) or lower category (under 3) we planned to randomize 150 families 2:1 to Personalized Education Regarding Clinical and Community Supports (PERCCS) versus Usual Care. The total final recruitment was 105 (78 from the higher risk count group and 27 from the lower risk count group). Risk counts for phase III assignment were calculated by the total number of established predictors of risk for CM ascertained from birth records. Utilization of community-based evidence-informed support services were ascertained at baseline and quarterly thereafter for all study participants. PERCCS responded to the full array of risks present in Table 1. 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. All participants will receive care as usual, including the provision of a summary document itemizing key community supports for families of infants, a continuously-updated local community resource handbook, a published parenting guide, and opportunity to enroll free-of-charge in a virtual parenting education and developmental surveillance program, babynavigator.com. Key Measures: The Utilization of Community Services (UCS) is a survey that will be used to ascertain engagement of families in community supports and interventions, including tracking of both frequency and duration. This survey is completed at the time of study enrollment to establish a baseline, and quarterly thereafter until the completion of the study when a child reaches 18 months of age. State Records: The second primary outcome, rate of child maltreatment, will rely on official state records from the State of Missouri Department of Social Services. Participants are aware that accessing service records or CM report data are retrospective when acquired and do not pose any risk or liability to them nor can it impact services received. Planned Statistical Analyses: I. Intent-to-treat analysis of impact of PERCCS on service utilization. We will calculate the total proportion of evidence-informed services indicated by risk profiles of all families within each group (the intervention group and the control group) and compare the groups using chi square analysis. II. Intent-to-treat analysis of the impact of PERCCS on the occurrence of child maltreatment. We compared the rate of official-report abuse/neglect between the groups using chi square analysis. III. (Secondary) We planned to conduct logistic regression analysis simultaneously examining the effects of risk count and service access on official report child maltreatment outcome, but the final sample size precluded multivariate assessment.

United States