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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00844896
First received: February 12, 2009
Last updated: February 13, 2009
Last verified: February 2009
  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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 29, 2014