Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active 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.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Mean number of evidence-informed services indicated by risk profiles of all families within group acquired over the course of follow-up.
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 |
What the registry record for NCT04438161 still lists
NCT04438161 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04438161's enrollment target sits among peer trials
105 834th of 2000 higher than 1,165 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03372317 · 105 participants
Tau PET in Imaging and Cognition: Healthy Adults From 55-90
- NCT04253964 · 105 participants · Phase 2
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
- NCT04742452 · 105 participants · NA
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
- NCT04875429 · 105 participants · NA
Zenith® Fenestrated+ Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI