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

NCT00844896 | Completed Results

• 1 other identifier: SHC Grant No. 8894
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Post-Traumatic Stress Disorder; Major Injury

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months

  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

  Baseline and six month follow-up

• Change From Baseline in Pediatric Symptom Checklist at Six Months

  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

  Baseline and six month follow-up

• Change From Baseline in Parenting Stress Index at Six Months

  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.

  Baseline and six month follow-up

• Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month

  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

  Baseline and six month follow-up

• Change From Baseline in PTSD Semi-Structured Interview at Six Months

  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.

  Baseline and six-month follow-up

• Change From Baseline in Hospital Emotional Support Form From Six Months

  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.

  Baseline and six-month follow-up

• Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months

  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.

  Baseline and six-month follow-up

• DEF Participation

  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.

  Baseline

• Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.

  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.

  baseline and six month follow-up

Study Arms (2)

DEF-only

ACTIVE COMPARATOR

Distress Emotional Support and Family Assessment Treatment

Behavioral: DEF-only

DEF + COPE

EXPERIMENTAL

Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment

Behavioral: DEF + COPE

Interventions

DEF-only BEHAVIORAL

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.

Also known as: Psychosocial Intervention

DEF-only

DEF + COPE BEHAVIORAL

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.

Also known as: Psychosocial Intervention

DEF + COPE

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Shriners Hospitals for Children

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• 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. doi: 10.1097/01.chi.0000184934.71917.3a.

  PMID: 16327585 BACKGROUND

• 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. doi: 10.1176/ajp.2006.163.6.1084.

  PMID: 16741210 BACKGROUND

• 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. doi: 10.1097/01.BCR.0000202618.51001.69.

  PMID: 16566561 BACKGROUND

• Stuber ML, Schneider S, Kassam-Adams N, Kazak AE, Saxe G. The medical traumatic stress toolkit. CNS Spectr. 2006 Feb;11(2):137-42. doi: 10.1017/s1092852900010671.

  PMID: 16520691 BACKGROUND

• 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. doi: 10.1542/peds.113.6.e597.

  PMID: 15173543 BACKGROUND

• Stoddard FJ, Saxe G. Ten-year research review of physical injuries. J Am Acad Child Adolesc Psychiatry. 2001 Oct;40(10):1128-45. doi: 10.1097/00004583-200110000-00007.

  PMID: 11589526 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological; Stress Disorders, Post-Traumatic

Interventions

Psychosocial Intervention; butyl phosphorotrithioate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Frederick J. Stoddard Jr., M.D.,
• Organization: Massachusetts General Hospital

fstoddard@partners.org

(617) 371-4762

Study Officials

• Frederick J Stoddard Jr., MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 16, 2009
• Study Start: May 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 16, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

US (1)