PERCCS for Newborn Health

(SURROuND Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent child maltreatment by offering personalized support to families with newborns. It helps families access resources like mental health care and parenting education based on specific needs and risks identified at birth. Participants include families engaged with BJC Healthcare in Missouri. The trial divides them into groups, with some receiving enhanced support through PERCCS (Personalized Education Regarding Clinical and Community Supports) and others receiving standard care. This comparison seeks to determine which approach better prevents child maltreatment and improves family engagement in services. As an unphased trial, it provides families the opportunity to contribute to important research that could shape future support systems for newborns and their families.

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 prior data suggests that the PERCCS protocol is safe for newborns and their families?

Research indicates limited specific information about the safety of the PERCCS program. This program aims to enhance family involvement and connect families with resources to prevent child abuse. It provides personalized education and support, particularly to high-risk families, to prevent abuse and neglect.

Previous studies on primary care methods for preventing child abuse have shown mixed results regarding benefits and risks. The U.S. Preventive Services Task Force (USPSTF) has stated that evidence is insufficient to clearly determine the safety and effectiveness of these methods. However, as the PERCCS program is a supportive service rather than a medical treatment, it generally poses a low risk of negative effects.

PERCCS aims to improve children's well-being by linking families with preventive services, typically including home visits, parenting education, and mental health support, which are generally safe and well-received. However, each family's experience may vary based on their specific situation and the services they receive.

In summary, while direct evidence on the safety of PERCCS itself is lacking, supportive programs like it are usually considered low risk. Participants can expect a focus on education and support rather than medical treatment, typically ensuring a safer experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PERCCS approach because it offers a unique, personalized method to support newborn health, especially for families at high risk for child maltreatment. Unlike traditional care that may take a one-size-fits-all approach, PERCCS tailors education and resources to meet the specific needs of each family, connecting them with relevant clinical and community supports. This personalized strategy aims to proactively address potential risk factors, providing targeted assistance to improve outcomes for both parents and newborns.

What evidence suggests that PERCCS is effective for preventing child maltreatment?

Research has shown that personalized education and community support can help prevent child abuse. In this trial, the PERCCS program, which participants may receive, focuses on providing customized resources to high-risk families. Studies indicate that activities like home visits, mental health support, and parenting education can lead to positive results. For instance, one study found that these methods moderately reduced reported cases of child abuse. Programs offering customized resources to high-risk families have shown promise in increasing family involvement with preventive services. While research continues, these methods rely on the idea that providing the right support at the right time can make a difference. ^{1 2 6 7 8}

Who Is on the Research Team?

Mini Tandon, DO

Principal Investigator

Faculty

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pa.gov pa.gov/agencies/education/programs-and-services/instruction/early-learning/family-support-programs

Pennsylvania Evidence-Based Home Visiting & Family ... EBHV is a prevention and intervention strategy that connects pregnant caregivers and new caregivers with nurses, mental health clinicians, parent educators, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4171685/

Prevention of Child Maltreatment - PMC Pediatricians can prevent child maltreatment by providing guidance, screening risk factors, referring to community programs, and advocating for policies.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0145213424002357

The effectiveness of interventions to prevent and reduce ... Across all interventions, based on 11 meta-analyses, they found an overall pooled effect size of d = 0.27 for outcomes based on officially reported child ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2816230

Primary Care Interventions to Prevent Child Maltreatment ... The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of primary care interventions to prevent child ...

5. childtrends.org childtrends.org/publications/identifying-the-effectiveness-of-policies-that-may-prevent-child-maltreatment-among-infants-and-toddlers

Identifying the Effectiveness of Policies That May Prevent ... This brief summarizes the Measuring Up project's efforts to identify policies that are theorized to help reduce child maltreatment rates for children from ...

6. aifs.gov.au aifs.gov.au/resources/policy-and-practice-papers/risk-and-protective-factors-child-abuse-and-neglect

Risk and protective factors for child abuse and neglect This paper provides an overview of the risk and protective factors for child abuse and neglect in families.

7. ldh.la.gov ldh.la.gov/

Louisiana Department of Health: Home Through Project M.O.M., LDH aims to reduce pregnancy‑associated opioid overdose deaths by 80% within three years and protect infants from loss or foster care ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145213424000851

Protective role of informal social support and early ... Aligned with past evidence stating that the youngest children are the most vulnerable to maltreatment, more than half (321,164) (51.93 %) of reported child ...