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NCT04438161 · ClinicalTrials.gov registry record · NA
Study to Understand Risk and Resilience Opportunity for Newborns After Delivery
A NA study of A. Longitudinal Cohort n=400 and B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention, sponsored by Washington University School of Medicine.
- Active
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT04438161 is a NA study of A. Longitudinal Cohort n=400 and B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 105 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04438161, a NA study of A. Longitudinal Cohort n=400 and B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study 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 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 se
Conditions Studied
Interventions
- BEHAVIORAL PERCCS: Personalized Education Regarding Clinical and Community Supports
Study Locations (1)
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2026-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04438161
The ClinicalTrials.gov registry entry for NCT04438161 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with A. Longitudinal Cohort n=400 appearing as the primary indexed condition, and to 1 intervention - of which PERCCS: Personalized Education Regarding Clinical and Community Supports is the first listed.
NCT04438161 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04438161 about?
NCT04438161 is a clinical study titled "Study to Understand Risk and Resilience Opportunity for Newborns After Delivery". 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 maltr...
What is the current status of trial NCT04438161?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 105 participants. The study started on 2021-01-26. Estimated completion is 2026-03-01.
What conditions does trial NCT04438161 study?
This clinical trial studies the following conditions: A. Longitudinal Cohort n=400, B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention.
What interventions are being tested in trial NCT04438161?
The interventions under investigation include: PERCCS: Personalized Education Regarding Clinical and Community Supports (BEHAVIORAL).
Who is sponsoring clinical trial NCT04438161?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04438161 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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A. Longitudinal Cohort n=400
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B. Lower Risk (n=45) and Higher Risk (n=105) Randomized 2:1 to PERCCS Intervention
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Missouri
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