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NCT06856057 · ClinicalTrials.gov registry record · NA
Improving Behavioral Health for Caregivers and Children After Pediatric Injury
A NA study of PTSD and Quality of Life, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 348
- Enrollment target
- 4
- Study locations
NCT06856057: Recruiting NA study of PTSD and Quality of Life, sponsored by Medical University of South Carolina.
NCT06856057 is a NA study of PTSD and Quality of Life that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 348 participants, above the 300-participant average among 154 other PTSD trials with a reported enrollment target (16% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06856057, a NA study of PTSD and Quality of Life, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 348 participants
- Enrollment target
- 4
- Study locations
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).
Primary Outcome
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the Pe
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 |
What NCT06856057 shows while recruiting
NCT06856057 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, above the 300-participant average among 154 other PTSD trials with a reported enrollment target (16% higher).
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.
NCT06856057 reports a single indexed study location in California, Kentucky, Michigan.
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.
What interventions are being tested in trial NCT06856057?
The interventions under investigation include: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06856057?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06856057's enrollment target sits among peer trials
348 14th of 154 higher than 141 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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.
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