Ignite Creation Date:
2024-05-05 @ 9:14 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00844896
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2009-02-12
Brief Title:
Intervention to Reduce Stress in 0-5 Year Olds With Burns
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
RCT Intervention to Reduce Stress in 0-5 Year Olds With Burns
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NCTSNs Pediatric Medical Toolkit for Health Care Providers and a burn specific version of the COPE Creating Opportunities for Parent Empowermentintervention
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
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 NCTSNs Pediatric Medical Toolkit for Health Care Providers and a burn specific version of the COPE Creating Opportunities for Parent Empowermentintervention
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 andor 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 childs 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 andor 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 childrens emotional and physical care In collaboration with COPEs senior author B M Melnyk the COPE intervention and materials will be tailored for a population of young burned children at Shriners Hospitals for Children-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 childrens emotions behaviors and physical characteristics and 2 the loss of the parental rolecontrol 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 Jennys Wish book ie 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 ABCs Airways Breathing Circulation of medical problems have been dealt with clinicians should attend to the next most important issues the DEFs 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 - eg 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
Early identification of young burn survivors who also have elevated heart rates high levels of pain andor 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 childs 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 andor 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 childrens emotional and physical care In collaboration with COPEs senior author B M Melnyk the COPE intervention and materials will be tailored for a population of young burned children at Shriners Hospitals for Children-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 childrens emotions behaviors and physical characteristics and 2 the loss of the parental rolecontrol 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 Jennys Wish book ie 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 ABCs Airways Breathing Circulation of medical problems have been dealt with clinicians should attend to the next most important issues the DEFs 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 - eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None