Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events

Summary

Background: International studies have shown that a substantial number of children and adolescents are exposed to potentially traumatic events. Many of these children and adolescents, some of whom will experience posttraumatic stress disorder (PTSD), are submitted to health care departments shortly after exposure as the most common types of traumatic events are accidental injury, serious somatic illness or death of someone close. There has been some research on early psychological interventions for prevention and treatment of PTSD. However, very little research has examined the efficacy of trauma-informed practice among health care professionals (HCPs). The present trial aims to evaluate and compare trauma-informed health care with usual practice.

Methods/Design: The primary clinical question under investigation is the efficacy of an early, trauma-informed intervention for the prevention of PTSD in children and adolescents following exposure to a potentially traumatic event. The trail compares a standardized trauma-informed practice with usual care (no intervention) in health care departments receiving children and adolescents after exposure to determine if trauma-informed care is associated with a reduction in psychological outcome measures over time. Specifically, the investigators examine the efficacy of health care professional's active use of trauma-informed standards of action and a trauma training program for HCPs in the intervention group. The primary outcome will be a reduction in trauma, anxiety and depressive symptoms on self-reports in the active intervention compared to usual care.

Discussion: This trial will be the first controlled trial to examine a trauma-informed intervention carried out by HCPs. It will provide the first evidence on the efficacy of health care delivered by trauma-educated HCPs using trauma-informed standards of action. A successful implementation of this protocol will support the thesis that prevention of PTSD among children and adolescents benefits from a focus on the practice of HCPs. If efficacious, the results will be a call for future research to extend the investigation of interventions from psychological treatment to HCP-based care.

Conditions

• Posttraumatic Stress Disorder
• Depression
• Anxiety

Interventions

OTHER

Preventive intervention trauma-informed early intervention

Every department appoints 2-4 health care professionals as child welfare officers (CWOs) who will be responsible for carrying out the intervention at the department. Whenever a child or adolescent is present in the department a CWO will be send for. The intervention consists of four distinct elements: 1) A standardized plan of action for the appointed health care CWOs on how to conduct trauma-informed health care for children and their families shortly after exposure to a PTE, 2) a training program for CWOs on trauma-informed support and communication with children and their families, 3) a supervision program for the CWOs, and 4) three psychoeducational booklets for young children, older children, and parents. The booklets will be given to the families by the CWOs.

Sponsors & Collaborators

• The Egmont Foundation

  collaborator UNKNOWN

• Ramboll Group

  collaborator UNKNOWN

• Carolina Magdalene Maier

  lead OTHER

Principal Investigators

• Lasse P Michelsen, MA · Rigshospitalet, Denmark

• Ditte B Eriksen, LPsy · Rigshospitalet, Denmark

• Carolina M Maier, MSc · Rigshospitalet, Denmark

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-09-30

Completion

2016-12-31

Countries

• Denmark

Study Locations