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NCT00844896 · ClinicalTrials.gov registry record · NA
Intervention to Reduce Stress in 0-5 Year Olds With Burns
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT00844896: Completed NA study, sponsored by Massachusetts General Hospital.
NCT00844896 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00844896, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
The objectives of this study are to test and validate a simple, feasible intervention to reduce pediatric burn traumatic stress in 0-5 year old children and their parents. We have refined and implemented an early post-burn psychosocial assessment and intervention for stress reduction for young children and their parents based on the "DEF" Protocol (Distress, Emotional Support, Family) from NCTSN's 'Pediatric Medical Toolkit for Health Care Providers,' and a burn specific version of the COPE (Creating Opportunities for Parent Empowerment)intervention. It is hypothesized that the combined DEF + COPE Intervention will be simple to implement and use under both experimental and real world conditions. The proof of the latter hypothesis will be that staff at Shriners Hospitals for Children-Boston will willingly incorporate it into routine care by the end of the project. We will evaluate, using an RCT design, the DEF + COPE Intervention by comparing outcomes for subjects who are randomly assigned to receive it with outcomes for subjects who are assigned to receive the DEF Intervention only. It is hypothesized that children in the DEF + COPE Intervention Group will show significantly greater decreases over time in pain and anxiety ratings, heart rate, PTSD total symptom scores and physiological symptom scores (such as heart rate and heart rate variability from baseline to follow up) than will children in the DEF-only group. Similarly, it is hypothesized that parents assigned to the DEF + COPE group will show significantly decreased scores on the Stanford PTSD measure.
Primary Outcome
Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up
Interventions
- BEHAVIORAL DEF-only
- BEHAVIORAL DEF + COPE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-08 |
| Phase | NA |
What the finished NCT00844896 record still lists
NCT00844896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which DEF-only is the first listed.
NCT00844896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00844896 about?
NCT00844896 is a clinical study titled "Intervention to Reduce Stress in 0-5 Year Olds With Burns". The objectives of this study are to test and validate a simple, feasible intervention to reduce pediatric burn traumatic stress in 0-5 year old children and their parents. We have refined and implemented an early post-burn psychosocial assessment and intervention for stress reduction for young chil...
What is the current status of trial NCT00844896?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2008-05. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00844896?
The interventions under investigation include: DEF-only (BEHAVIORAL), DEF + COPE (BEHAVIORAL).
Who is sponsoring clinical trial NCT00844896?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00844896's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 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
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