Intervention to Reduce Stress in 0-5 Year Olds With Burns
|First Received Date ICMJE||February 12, 2009|
|Last Updated Date||February 13, 2009|
|Start Date ICMJE||May 2008|
|Estimated Primary Completion Date||December 2009 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00844896 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Intervention to Reduce Stress in 0-5 Year Olds With Burns|
|Official Title ICMJE||RCT 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 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.
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:
- COPE (Creating Opportunities for Parent Empowerment)
The psychosocial intervention which holds the greatest promise as a treatment for young burned children and their families is the COPE (Creating Opportunities for Parent Empowerment) program. COPE was designed to be implemented in a tertiary care center with seriously ill children. It has been shown in more than a dozen studies to significantly reduce symptoms of stress in both children and their parents. In one study, Melnyk et al (2004) delivered the COPE program with audiotapes and matching written information, and a parent-child workbook that helped implement the audiotaped information. It focused on increasing: 1) parents' knowledge and understanding the range of behaviors and emotions that young children typically display during and after hospitalization and 2) direct parent participation in their children's' emotional and physical care. In collaboration with COPE's senior author, B. M. Melnyk, the COPE intervention and materials will be tailored for a population of young burned children at SBH Boston.
Melnyk and her colleagues (2004; 1997; 2006) developed COPE as a "theory-based educational-behavioral program that consists of two types of educational information: (a) child behavioral information that teaches parents about the most typical emotions and behavioral responses that young children manifest as they cope with illness or trauma and hospitalization, and (b) parental role information that provides parents with suggestions regarding how they can best help their children to cope with the hospital experience" (Melnyk, Feinstein, Alpert-Gillis et al., 2006, p. 475). The COPE program was developed to target two major stressors that parents experience when their children are hospitalized: 1) their children's emotions, behaviors, and physical characteristics and 2) the loss of the parental role/control. COPE also contains a behavioral component to help parents to carry out the recommendations provided to them in the educational information.
There are now three versions of the COPE program: (a) COPE for parents of young hospitalized children, 1 to 7 years of age, (b) COPE: PICU for parents of 2 to 7-year- old critically ill young children, and (c) COPE: NICU for parents of low-birth-weight (LBW) premature infants. Each of these versions of the COPE program is essentially self-administered to parents via audio tapes and activity workbooks, generally in three brief (15 minute) sessions over a two day period during a pediatric hospitalization. Examples of workbook activities are teaching their children about how to express their feelings through play with their children and reading the Jenny's Wish book (i.e., a story about a small child who copes successfully with a critical care hospitalization). The suggested administration times are: 6-16 hours after admission to PICU, 2-16 hours after transfer to general pediatric unit, and 2-3 days after discharge from hospital.
Multiple studies have shown the validity of COPE (Melnyk, 1994, 1995; Melnyk et al., 2004; Melnyk et al., 2001; Melnyk et al., 1997; Melnyk, Feinstein, & Fairbanks, 2006; Melnyk & Feinstein, 2001; Melnyk, Feinstein, Alpert-Gillis et al., 2006; Vulcan & Nikulich-Barrett, 1988). The 2004 paper describes an RCT design with 174 mother-child dyads that showed significant reductions in parental and child symptoms of stress at six and twelve months after the intervention.
- The Pediatric Medical Traumatic Stress Toolkit for Health Care Providers
The Pediatric Medical Traumatic Stress Toolkit for Health Care Providers provides another way to reduce unnecessary stress in medically ill children. Created by the National Child Traumatic Stress Network ("National Child Traumatic Stress Network (NCTSN) Toolkit for Health Care Providers,"; Stuber, Schneider, Kassam-Adams, Kazak, & Saxe, 2006), the Toolkit is another innovation that could provide a platform not only for identifying children and families who are most in need of the COPE intervention but also for interventions not addressed by COPE like finding additional parental support, providing additional pain, anxiety, or depression medication for children or parents, or designing more targeted interventions for children and families whose stress levels may be lower overall but high only in certain areas.
The Toolkit contains a protocol called 'D-E-F' that helps clinicians to assess medically traumatized children and their families and to plan specific interventions for them. The idea of the Toolkit is that after the standard ABC's (Airways, Breathing, Circulation) of medical problems have been dealt with, clinicians should attend to the next most important issues, the 'DEF's of problems. The DEF acronym stands for Distress, Emotional Support, and Family Functioning. As described later in this proposal, the DEF protocol will be the basis for the initial assessment and clinical intervention recommendations provided by child psychiatry staff as part of a new program being developed at SBH Boston. The Toolkit contains handouts to help parents understand the stresses their medically ill children are facing and to help their children to cope with them as well as an overarching framework for mental health and medical clinicians to use in assessing and intervening to minimize post traumatic stress reactions.
The Toolkit materials are designed primarily for hospital-based heath care providers like physicians and nurses, and for parents. The Toolkit promotes "trauma-informed practice of pediatric health care in hospital settings across the continuum of care… - e.g., from emergency care, to the ICU, to specialized inpatient units, to general pediatrics". The NCTSN Toolkit for Health Care Providers provides an overarching framework for healthcare workers to use for both assessment and intervention for PTSD in children and parents.
Working within the NCTSN, many medical and psychosocial professionals, including Drs. Saxe and Stoddard, spent several years formulating this approach to working with children who have injuries and medically related traumas (Stuber et al., 2006). The Toolkit was released in late 2004 and although it shows a great deal of promise, it has yet to be validated and applied as a part of routine clinical care. The proposed project will be the first to empirically test it as a part of an intervention strategy.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Enrolling by invitation|
|Estimated Enrollment ICMJE||50|
|Estimated Completion Date||December 2009|
|Estimated Primary Completion Date||December 2009 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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).
|Ages||up to 5 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00844896|
|Other Study ID Numbers ICMJE||SHC Grant No. 8894|
|Has Data Monitoring Committee||No|
|Responsible Party||Frederick J. Stoddard Jr., M.D., Massachusetts General Hospital|
|Study Sponsor ICMJE||Massachusetts General Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Massachusetts General Hospital|
|Verification Date||February 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP