Trial record 7 of 137 for:    Open Studies | "Burns"

Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial (EPICAP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University Children's Hospital, Zurich
Sponsor:
Information provided by (Responsible Party):
Markus A. Landolt, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT02088814
First received: March 12, 2014
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Background: Unintentional injuries in preschoolers are frequent. Many accidents meet criteria for a psychotraumatic event as defined by the DSM-IV. It is therefore not surprising that previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma, such as road traffic or burn accidents. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children. While important components of successful early interventions have been identified in school-age children, evidence is completely lacking for younger children, especially for those below the age of 4 years.

Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries. Also, the effectiveness of an early screening measure in identyfing children with high risk for psychological follow-up problems shall be studied.

Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention includes the following components: psychoeducation on child and parental PTSS, promotion of adaptive strategies to manage child and parental distress, construction of a parental trauma narrative, promotion of strategies that increase parental capacity and enhance parent-child relationship. The intervention consists of two face-to-face sessions with the parents (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.


Condition Intervention
Burns
Behavioral: 'EPICAP'

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • PTSD Semi-structured Interview and Observational Record for Infants and Young Children (PTSDSSI; Scheeringa & Zeanah, 2005) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The PTSDSSI is an examiner-based interview that is conducted with the child's primary caregiver. The measure assesses all of the DSM-IV PTSD criteria, i.e. exposure to a traumatic stressor (criterion A), symptoms of re-experiencing (symptom cluster B), symptoms of avoidance and numbing (symptom cluster C), symptoms of hyperarousal (symptom cluster D), duration of symptoms (criterion E), and functional impairment (criterion F).


Secondary Outcome Measures:
  • Child Behavior Checklist 11⁄2-5 (CBCL; Achenbach & Rescorla, 2000) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This is a highly standardized, widely used and well validated 100-item parent-report measure for children ages 1.5 to 5 years.3 Caregivers have to report the extent to which they agree with statements on a 3-point Likert scale ranging from 1 (not true) to 3 (very true). The questionnaire yields scores for two broad-band sca- les (internalizing and externalizing behavior problems), and an overall total behavioral problems score.

  • TNO-AZL Preschool Children Quality of Life Questionnaire (TAPQOL; Fekkes et al., 2000). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The TAPQOL is a 43-item multidimensional instrument that yields sum scores for physical, emotional, social, and cognitive functioning by parent report. Also, an overall sum score indicating general HRQoL can be computed. The TAPQOL can be applied to children of 9 months to 6 years of age. It has good construct, criterion, and concurrent validity and a good internal consistency.


Estimated Enrollment: 124
Study Start Date: April 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 'EPICAP'
Secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills
Behavioral: 'EPICAP'
standardized, secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills
Other Name: 'EPICAP'
No Intervention: Medical treatment as usual
Medical treatment of burn injuries as usual

Detailed Description:

Background: Unintentional injuries in preschoolers are frequent. Many accidents meet criteria for a psychotraumatic event as defined by the DSM-IV. It is therefore not surprising that previous studies have found considerable rates of posttraumatic stress disorder (PTSD) or clinically relevant posttraumatic stress symptoms (PTSS) in preschoolers with injuries following accidental trauma, such as road traffic or burn accidents. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children. While important components of successful early interventions have been identified in school-age children, evidence is completely lacking for younger children, especially for those below the age of 4 years.

Aims: The proposed study aims at examining the effect of a newly developed, standardized early psychological intervention in reducing posttraumatic maladjustment and in enhancing health-related quality of life in children ages 1 to 4 years with acute burn injuries. Also, the effectiveness of an early screening measure in identyfing children with high risk for psychological follow-up problems shall be studied.

Method: The study is designed as a randomized controlled trial within a stepped procedure. First, eligible children will be screened 5 to 7 days post injury by means of a standardized measure for their risk of developing PTSS. After a baseline assessment, children at risk will then be randomly allocated to either a control group (standard medical care) or an intervention group. Participants of the intervention group will be provided with the standardized "EPICAP 1-4" intervention which uses established cognitive-behavioral techniques and is directed to the parents. The intervention includes the following components: psychoeducation on child and parental PTSS, promotion of adaptive strategies to manage child and parental distress, construction of a parental trauma narrative, promotion of strategies that increase parental capacity and enhance parent-child relationship. The intervention consists of two face-to-face sessions with the parents (at baseline and 1 week later) and a follow-up call or short follow-up face-to-face meeting (6 weeks after the first session). Blinded follow- up assessments with standardized parent report measures will be conducted at 3 and 6 months post injury. The primary outcome measures are child PTSD and PTSS, secondary outcome measures include child behavior and health-related quality of life. In addition, a variety of socio-demographic, medical and parental variables will be assessed as co-variates. Children screened as low-risk will be reassessed only at 6 months to make sure that the screening procedure is valid.

  Eligibility

Ages Eligible for Study:   1 Year to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 1- 4 years
  • Acute burn injury
  • Treatment at University Children's Hospital Zurich

Exclusion Criteria:

  • severe comorbid head injury in the child (Glasgow Coma Scale < 9)
  • expected initial stay in the pediatric intensive care unit for more than a week
  • burn injury due to suspected or substantiated child abuse
  • any previous evidence of cognitive impairment or pervasive developmental disorder in the child
  • insufficient command of the German language in both parents
  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: NCT02088814

Contacts
Contact: Markus A. Landolt, PhD +41 44 266 73 96 markus.landolt@kispi.uzh.ch
Contact: Ann-Christin Haag, M.Sc. +41 44 266 71 11 ann-christin.haag@kispi.uzh.ch

Locations
Switzerland
University Children's Hospital Not yet recruiting
Zurich, Switzerland, 8032
Contact: Markus A. Landolt, PhD    +41 44 266 73 96    markus.landolt@kispi.uzh.ch   
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Principal Investigator: Markus A. Landolt, PhD University Children's Hospital, Zurich
  More Information

No publications provided

Responsible Party: Markus A. Landolt, Prof. Markus Landolt, PhD, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02088814     History of Changes
Other Study ID Numbers: 100014_149158
Study First Received: March 12, 2014
Last Updated: March 13, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Children's Hospital, Zurich:
posttraumatic stress
burns
injuries
children

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014