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

NCT02088814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-04-22

No results posted yet for this study

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.

Conditions

  • Burns

Interventions

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

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Markus A. Landolt, PhD · University Children's Hospital, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-11-30
Completion
2017-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088814 on ClinicalTrials.gov