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NCT05086757 · ClinicalTrials.gov registry record · NA
Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors
A NA study of Post Traumatic Stress Disorder and Adolescents, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT05086757: Recruiting NA study of Post Traumatic Stress Disorder and Adolescents, sponsored by Medical University of South Carolina.
NCT05086757 is a NA study of Post Traumatic Stress Disorder and Adolescents that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 300 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05086757, a NA study of Post Traumatic Stress Disorder and Adolescents, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42%), deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. The investigators partnered with three accredited Level I and II pediatric trauma centers to conduct a multi-site hybrid 1 effectiveness-implementation trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which the Trauma Resilience and Recovery Program (TRRP), a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care, promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. Directly in line with NICHD's Pediatric Trauma and Critical Illness Research and Training (PTCIB) Strategic Research and Training agenda, this study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.
Primary Outcome
The CPSS is a 26-item measure to assess PTSD diagnostic criteria and severity in youth. Responses are assessed using a 4-point Likert scale and a cutoff score of 31 can be used for identifying a probable PTSD diagnosis in children.
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Usual Care
- BEHAVIORAL TRRP
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-08-30 |
| Phase | NA |
What NCT05086757 shows while recruiting
NCT05086757 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT05086757 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05086757 about?
NCT05086757 is a clinical study titled "Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors". Pediatric traumatic injury (i.e., injury of sudden onset and severity requiring immediate attention) is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression (affecting between 19-42...
What is the current status of trial NCT05086757?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-07-01. Estimated completion is 2027-08-30.
What conditions does trial NCT05086757 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Adolescents, Traumatic Injury, Technology.
What interventions are being tested in trial NCT05086757?
The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), TRRP (BEHAVIORAL).
Who is sponsoring clinical trial NCT05086757?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05086757 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05086757's enrollment target sits among peer trials
300 28th of 262 higher than 230 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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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