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N/A N=57 Randomized Double-blind Supportive Care

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

Stress, Psychological · Post-Traumatic Stress Disorder · Major Injury

Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months — -4.9; -4.5 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DEF-only (Behavioral); DEF + COPE (Behavioral)
Age
Pediatric
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Aug 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months
-4.9; -4.5
PRIMARY
Change From Baseline in Pediatric Symptom Checklist at Six Months
2.9; 1.0
PRIMARY
Change From Baseline in Parenting Stress Index at Six Months
7.1; -3.3
PRIMARY
Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month
0.8; 0.7
PRIMARY
Change From Baseline in PTSD Semi-Structured Interview at Six Months
-1.7; -1.5
PRIMARY
Change From Baseline in Hospital Emotional Support Form From Six Months
1.1; 2.0
PRIMARY
Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months
-9.6; 13.8
PRIMARY
DEF Participation
29; 28
PRIMARY
Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.
-0.2

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00844896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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