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

Purpose

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.

Condition	Intervention
Pathological Stress Post-Traumatic Stress Disorder Burn Trauma	Other: DEF (Distress, Emotional Support, Family) Other: DEF + COPE

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	RCT Intervention to Reduce Stress in 0-5 Year Olds With Burns

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Burns Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
Pediatric Symptom Checklist (17-item) [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
Parenting Stress Index (12-item) [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
Child Stress Disorder Checklist (9-item) [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
Posttraumatic Stress Disorder Semi-Structured Interview [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
Hospital Emotional Support Form [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
Stanford Acute Stress Reaction Questionnaire [ Time Frame: Baseline and six-month follow-up ] [ Designated as safety issue: No ]
DEF ratings of distress, emotional support and family functioning contained in patients' charts [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DEF-only	Other: DEF (Distress, Emotional Support, Family) The DEF protocol is from the National Child Traumatic Stress Network (NCTSN). DEF provides a sequential methodology for clinicians to assess medically traumatized children and their families and to plan specific interventions for them. In the present study, the DEF intervention is both a generalized approach taught to all Shriners Hospitals for Children (SHC)- Boston clinical staff, and for those participants of the present study, consists of an optional meeting with a member of the SHC Psychiatry Department. During this meeting, parents will have the chance to review any areas of pain, anxiety, or support that came up during their interviews or any other areas of concern about their child or his/her hospitalization that they wish to raise. Other Name: Psychosocial Intervention
DEF + COPE	Other: DEF + COPE All enrolled participants will be offered the chance to meet with a psychiatric clinician for the DEF component of the intervention. For those assigned to receive COPE (Creating Opportunities for Parent Empowerment), parents will receive one of two versions of the materials: one for children less than one year old, and one for children ages 1-5 years. The COPE program was adapted for children with burns and developed to target major stressors that parents experience when their children are hospitalized, such as the loss of parental control. COPE also contains a behavioral component to help parents to carry out the recommendations provided to them. Each of these versions of the COPE program is essentially self-administered to parents via audio tapes and activity workbooks. Other Name: Psychosocial Intervention

Arms

Assigned Interventions

DEF-only

Other: DEF (Distress, Emotional Support, Family)

The DEF protocol is from the National Child Traumatic Stress Network (NCTSN). DEF provides a sequential methodology for clinicians to assess medically traumatized children and their families and to plan specific interventions for them.

In the present study, the DEF intervention is both a generalized approach taught to all Shriners Hospitals for Children (SHC)- Boston clinical staff, and for those participants of the present study, consists of an optional meeting with a member of the SHC Psychiatry Department. During this meeting, parents will have the chance to review any areas of pain, anxiety, or support that came up during their interviews or any other areas of concern about their child or his/her hospitalization that they wish to raise.

Other Name: Psychosocial Intervention

DEF + COPE

Other: DEF + COPE

All enrolled participants will be offered the chance to meet with a psychiatric clinician for the DEF component of the intervention.

For those assigned to receive COPE (Creating Opportunities for Parent Empowerment), parents will receive one of two versions of the materials: one for children less than one year old, and one for children ages 1-5 years. The COPE program was adapted for children with burns and developed to target major stressors that parents experience when their children are hospitalized, such as the loss of parental control. COPE also contains a behavioral component to help parents to carry out the recommendations provided to them. Each of these versions of the COPE program is essentially self-administered to parents via audio tapes and activity workbooks.

Other Name: Psychosocial Intervention

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844896

Locations

United States, Massachusetts
Shriners Hospitals for Children
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Frederick J Stoddard Jr., MD

Massachusetts General Hospital

More Information

Publications:

Stoddard FJ, Saxe G, Ronfeldt H, Drake JE, Burns J, Edgren C, Sheridan R. Acute stress symptoms in young children with burns. J Am Acad Child Adolesc Psychiatry. 2006 Jan;45(1):87-93.

Stoddard FJ, Ronfeldt H, Kagan J, Drake JE, Snidman N, Murphy JM, Saxe G, Burns J, Sheridan RL. Young burned children: the course of acute stress and physiological and behavioral responses. Am J Psychiatry. 2006 Jun;163(6):1084-90.

Drake JE, Stoddard FJ Jr, Murphy JM, Ronfeldt H, Snidman N, Kagan J, Saxe G, Sheridan R. Trauma severity influences acute stress in young burned children. J Burn Care Res. 2006 Mar-Apr;27(2):174-82.

Stuber ML, Schneider S, Kassam-Adams N, Kazak AE, Saxe G. The medical traumatic stress toolkit. CNS Spectr. 2006 Feb;11(2):137-42.

Melnyk BM, Alpert-Gillis L, Feinstein NF, Crean HF, Johnson J, Fairbanks E, Small L, Rubenstein J, Slota M, Corbo-Richert B. Creating opportunities for parent empowerment: program effects on the mental health/coping outcomes of critically ill young children and their mothers. Pediatrics. 2004 Jun;113(6):e597-607.

Stoddard FJ, Saxe G. Ten-year research review of physical injuries. J Am Acad Child Adolesc Psychiatry. 2001 Oct;40(10):1128-45. Review.

Responsible Party:	Frederick J. Stoddard Jr., M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00844896 History of Changes
Other Study ID Numbers:	SHC Grant No. 8894
Study First Received:	February 12, 2009
Last Updated:	February 13, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Pathological stress & PTSD in preschool children & parents
Child and parent resilience after burn trauma

Additional relevant MeSH terms:

Burns
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

Wounds and Injuries
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013