COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088814
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Markus A. Landolt, University Children's Hospital, Zurich

Brief Summary:

Background: 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. In consequence, secondary preventive efforts (early interventions) should be undertaken to minimize such long-term deleterious consequences in children.

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.

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 consists of two face-to-face sessions (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 or disease Intervention/treatment Phase
Burns Behavioral: 'EPICAP' Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Posttraumatic Stress Symptoms in Young Children With Burns: a Randomized Controlled Trial
Actual Study Start Date : April 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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

No Intervention: Medical treatment as usual
Medical treatment of burn injuries as usual



Primary Outcome Measures :
  1. DIPA PTSD Module [ Time Frame: 6 months ]
    The DIPA PTSD module is an interview of caregivers for children from nine months to six years old that assesses DSM-5 PTSD preschool criteria.


Secondary Outcome Measures :
  1. Child Behavior Checklist 11⁄2-5 (CBCL; Achenbach & Rescorla, 2000) [ Time Frame: 6 months ]
    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.

  2. TNO-AZL Preschool Children Quality of Life Questionnaire (TAPQOL; Fekkes et al., 2000). [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088814


Locations
Layout table for location information
Switzerland
University Children's Hospital
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
Layout table for investigator information
Principal Investigator: Markus A. Landolt, PhD University Children's Hospital, Zurich
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Markus A. Landolt, Prof. Markus Landolt, PhD, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT02088814    
Other Study ID Numbers: 100014_149158
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Markus A. Landolt, University Children's Hospital, Zurich:
posttraumatic stress
burns
injuries
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Burns
Wounds and Injuries