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Improving Behavioral Health for Caregivers and Children After Pediatric Injury
NCT06856057 · View on ClinicalTrials.gov ↗
Study Summary
Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).
Conditions Studied
Interventions
- BEHAVIORAL Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
Study Locations (4)
California
- Children's Hospital Los Angeles — Los Angeles
Kentucky
- Kentucky Children's Hospital — Lexington
Michigan
- C.S. Mott Children's Hospital — Ann Arbor
Texas
- Children's Memorial Hermann Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2025-05-28 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06856057
The ClinicalTrials.gov registry entry for NCT06856057 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 348 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with PTSD appearing as the primary indexed condition, and to 1 intervention — of which Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06856057 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Kentucky, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06856057 about?
NCT06856057 is a clinical study titled "Improving Behavioral Health for Caregivers and Children After Pediatric Injury". Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recov...
What is the current status of trial NCT06856057?
This trial is currently recruiting. It is a NA study. The enrollment target is 348 participants. The study started on 2025-05-28. Estimated completion is 2028-08-31.
What conditions does trial NCT06856057 study?
This clinical trial studies the following conditions: PTSD, Quality of Life, Depression Not Otherwise Specified, Child Externalizing Behavior. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06856057?
The interventions under investigation include: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06856057?
This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06856057 being conducted?
This trial has 4 study locations across California, Kentucky, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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