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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • BEHAVIORAL DEF-only
  • BEHAVIORAL DEF + COPE

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2008-05
Est. Completion 2010-08
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT00844896

The ClinicalTrials.gov registry entry for NCT00844896 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which DEF-only is the first listed.

NCT00844896 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.