Intervention to Reduce Stress in 0-5 Year Olds With Burns

Completed · Not applicable

Conditions studied: Stress, Psychological, Post-Traumatic Stress Disorder, Major Injury

In brief

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.

Key facts

Study ID

NCT00844896

Run by

Massachusetts General Hospital

People needed

57

Starts

2008-05-01

Expected to finish

2010-08-01

Last updated by the study team

2014-10-16

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All children between the ages of 0 to 5.9 years of age who are admitted to Shriners Hospitals for Children - Boston for an acute burn or reconstructive surgery
• Parent(s) or legal guardian is English- or Spanish-speaking
• Medical clinicians deem their patients appropriate candidates

You may not qualify if…

• Children whose primary physicians or nurses think that their patient or parent should not be approached for the study due to high levels of stress, criminal or child protective service involvement
• Children whose parents the Chief of Staff or his designee does not believe should be approached for study because they have not consented in general to a participation in research studies during their child's hospitalization
• Children who are so gravely ill that their parents do not wish to talk
• The parents of initially excluded children may be approached for the study later in the child's hospital stay if any of these rule outs abate (most typically when a child is no longer critically ill).

Where it is running

• Shriners Hospitals for Children — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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