PERCCS for Newborn Health

(SURROuND Trial)

Overseen By Mackenzie Hynes, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Non-Missouri residents, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

105 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PERCCS: Personalized Education Regarding Clinical and Community Supports for newborn health?

Research shows that personalized education methods, like the parent information binder and patient-centric web methods, help parents of newborns, especially in stressful environments like NICUs, by providing tailored information and support. This approach empowers parents to be active participants in their child's care, which can improve outcomes. ^{1 2 3 4 5}

How is the PERCCS treatment different from other treatments for newborn health?

PERCCS is unique because it focuses on personalized education and support for parents, using technology to provide tailored information and resources about newborn health, which is different from traditional treatments that may not offer such personalized and accessible support. ^{1 3 4 6 7}

What is the purpose of this trial?

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.

Research Team

Mini Tandon, DO

Principal Investigator

Faculty

Eligibility Criteria

This trial is for Missouri residents who are at least 18 years old and using BJC Healthcare Obstetrics or Newborn Services. It's not open to those under 18, non-residents, or people not engaged with these specific healthcare services.

Inclusion Criteria

Participants must be Missouri residents

Participants must be engaged in the BJC Healthcare Obstetrics or Newborn Services

Exclusion Criteria

Participants who are not Missouri residents

Participants not engaged in the BJC Healthcare Obstetrics or Newborn Services.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Families are enrolled and baseline data on sociodemographic, psychological, and family psychiatric risk factors are collected

4 weeks

1 visit (in-person)

Intervention and Monitoring

Families receive Personalized Education Regarding Clinical and Community Supports (PERCCS) or usual care, with quarterly monitoring of service utilization and child maltreatment risk factors

18 months

Quarterly visits (virtual or in-person)

Follow-up

Participants are monitored for child maltreatment outcomes and service utilization until the child reaches 18 months of age

4 weeks

Treatment Details

Interventions

• PERCCS: Personalized Education Regarding Clinical and Community Supports

Trial Overview The study tests an enhanced support program called PERCCS (Personalized Education Regarding Clinical and Community Supports) aimed at preventing child maltreatment by providing families with targeted interventions based on risk factors identified at birth.

Participant Groups

Group I: High Risk Experimental Treatment 1 Intervention

High risk families in prospective longitudinal study of newborns (n=150\*). \*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" counts (n=105) families for child maltreatment or "low risk" counts (n=45) families. Participants in this arm will be randomized to: 1. PERCCS (see attached figure and table for details) 2. Care as Usual

Group II: Low Risk Active Control 1 Intervention

Low risk natural history study (n=250\*) \*Participants will be randomized 2:1 PERCCS:Control, and the randomization will be within successive sets of three families who fall in either "high risk" counts (n=105) families for child maltreatment or "low risk" counts (n=45) families.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Regionalized perinatal education. [2013]

2. France pubmed.ncbi.nlm.nih.gov

[Follow-up network for newborns with a handicap risk: experience of the Pays-de-la-Loire network]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Patient engagement practice within perinatal eHealth: A scoping review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Personalized case driven parental education informatics in the NICU. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Parent information binder: individualizing education for parents of preterm infants. [2004]

6. Australia pubmed.ncbi.nlm.nih.gov

Online healthy lifestyle support in the perinatal period: what do women want and do they use it? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Digital peer-to-peer information seeking and sharing: Opportunities for education and collaboration in newborn screening. [2021]