RCT Intervention to Reduce Stress in 0-5 Year Olds With Burns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pediatric Symptom Checklist at Six Months
Study Overview
Brief 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.
Detailed Description
Despite their clear vulnerability and demonstrated need, preschool children and their families have been the subject of very little research on traumatic stress following all types of injuries including burns (Stoddard & Saxe, 2001). This lack of research is even more critical in an age in which tragic and traumatic events are increasing in frequency and severity.
Early identification of young burn survivors who also have elevated heart rates, high levels of pain and/or exhibit other symptoms of PTSD may help to prevent the development of later psychopathology. If assessment of stress is improved, then early interventions may be designed to prevent or reduce the later emergence of PTSD including phobias and associated symptoms. As of this time, however, no early interventions are available for very young burned children.
The intervention is driven by the findings of our previous study of 1-4 year olds that suggested that the child's PTSD symptoms could be reduced by improved pain and anxiety control and by reduced parental PTSD. The current study aims to advance the science of prevention of pathological stress responses in preschool children and their parents, strengthen both child and parent resilience after burn trauma and its treatments, and provide interventions for the children with posttraumatic symptoms such as re-experiencing, hyperarousal, avoidance, insomnia, nightmares, or regressions in social abilities like smiling and/or vocalization.
Our goal is not only to set up an intervention that will be effective in reducing stress for young children with burns and their families, we also want to assure that the intervention is feasible and sustainable for implementation in Shriners Hospital Boston, other Shriners Hospitals, and other Level I Pediatric Burn Centers after the end of this project.
The models for intervention are:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
DEF-only
Distress Emotional Support and Family Assessment Treatment
Intervention: DEF-only (Behavioral)
DEF + COPE
Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
Intervention: DEF + COPE (Behavioral)
Outcomes
Primary Outcomes
Change From Baseline in Pediatric Symptom Checklist at Six Months
Time Frame: Baseline and six month follow-up
Pediatric Symptom Checklist is an 18-item psychosocial checklist in which symptoms are rated from 0 (never) to 2 (often) and the last question is rated as yes or no (0 or 1). Items are summed and the score can range from 0-35, with a higher score indicative of more symptoms and a worse outcome. Change in scores were observed from baseline to six month follow-up
DEF Participation
Time Frame: Baseline
Outcomes in this measure were quantified by the number of participants in either intervention (DEF-only or COPE+DEF). During the study, DEF intervention was part of the standard of care for all patients at Shriners Hospitals for Children-Boston and thus every participant in this study had been evaluated using DEF to determine distress, emotional and family support.
Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.
Time Frame: baseline and six month follow-up
Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (5-18 Year Old Version) is a 3-item questionnaire with scores ranging from 0-18. A higher score is indicative of worse outcomes. Used for five year olds in the study. Change in scores were observed from baseline to six month follow-up.
Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months
Time Frame: Baseline and six month follow-up
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
Change From Baseline in Parenting Stress Index at Six Months
Time Frame: Baseline and six month follow-up
Parenting Stress Index is a 12-item parent-rated questionnaire which employs a 1-5 Likert scale. Scores range from 12-60, with a lower score indicative of worse outcomes and a cutoff of 15. Change in scores were observed from baseline to six month follow-up.
Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month
Time Frame: Baseline and six month follow-up
Child Stress Reaction Checklist Short Form is a 9-item parent-rated checklist. Scores range from 0-18 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up
Change From Baseline in PTSD Semi-Structured Interview at Six Months
Time Frame: Baseline and six-month follow-up
Posttraumatic Stress Disorder Semi-Structured Interview is based on DSM-IV criteria, with a higher score indicative of increased symptoms of PTSD. The total rating was scored from 19 questions in three clusters of symptoms, with a score range of 0-38. Change in scores were observed from baseline to six month follow-up.
Change From Baseline in Hospital Emotional Support Form From Six Months
Time Frame: Baseline and six-month follow-up
Hospital Emotional Support Form is a 12-question form that rates parents/caregivers need for in-hospital emotional support. Scores range from 11-24, with a lower score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.
Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months
Time Frame: Baseline and six-month follow-up
Stanford Acute Stress Reaction Questionnaire is a 31-question self-report measure for acute stress in parents. Scores range from 0-155 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.
Secondary Outcomes
No secondary outcomes reported
Investigators
Frederick J. Stoddard, MD
Principal Investigator
Massachusetts General Hospital