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NCT00451282 · ClinicalTrials.gov registry record · Phase 3
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
A Phase 3 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
NCT00451282: Completed Phase 3 study, sponsored by Children's Hospital of Philadelphia.
NCT00451282 is a Phase 3 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 290 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00451282, a Phase 3 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
Study Summary
This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide preliminary data concerning cost-effectiveness of the intervention. The core study hypotheses are that children receiving the intervention will (1) have lower severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2) show greater adherence to discharge instructions and better health-related quality of life at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury, compared to those receiving usual care.
Primary Outcome
The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomizatio
Interventions
- BEHAVIORAL stepped preventive care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00451282 record still lists
NCT00451282 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which stepped preventive care is the first listed.
NCT00451282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00451282 about?
NCT00451282 is a clinical study titled "Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury". This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide pre...
What is the current status of trial NCT00451282?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2007-04. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00451282?
The interventions under investigation include: stepped preventive care (BEHAVIORAL).
Who is sponsoring clinical trial NCT00451282?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00451282's enrollment target sits among peer trials
290 1171st of 2000 higher than 828 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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