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

NCT02299583 | Unknown DMC

• 1 other identifier: f-22834-02
• Study Type: interventional
• Target: 684
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prevention; early intervention; trauma-informed practice

Outcome Measures

Primary Outcomes (9)

• Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.)

  The child assessment will be administered with the Children's Revised Impact of Event Scale. The parent primary outcome measure will be assessed with the Impact of Event Scale.

  4 weeks after the traumatic event

• Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.)

  The child assessment will be administered with the Children's Revised Impact of Event Scale. The parent primary outcome measure will be assessed with the Impact of Event Scale.

  6 months after the traumatic event

• Change from baseline in severity of posttraumatic stress symptoms at 6 months (Children's Revised Impact of Event Scale.)

  The child assessment will be administered with the Children's Revised Impact of Event Scale. The parent primary outcome measure will be assessed with the Impact of Event Scale.

  4 weeks and 6 months after the traumatic event

• Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.)

  The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  4 weeks after the traumatic event

• Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.)

  The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  6 months after the traumatic event

• Change from baseline in severity of anxiety symptoms at 6 months (Revised Child Anxiety and Depression Scale.)

  The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  4 weeks and 6 months after the traumatic event

• Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)

  The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  4 weeks after the traumatic event

• Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)

  The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  6 months after the traumatic event

• Change from baseline in severity of depressive symptoms at 6 months (Revised Child Anxiety and Depression Scale.)

  The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  4 weeks and 6 months after the traumatic event

Secondary Outcomes (6)

• Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)

  4 weeks after the traumatic event

• Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)

  6 months after the traumatic event

• Change from baseline in social functioning of the family at 6 months (Crisis Support Scale and the WHO-Five Well-being Index.)

  4 weeks and 6 months after the traumatic event

• Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)

  4 weeks after the traumatic event

• Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)

  6 months after the traumatic event

Other Outcomes (4)

• The families' satisfaction with the intervention program (Intervention Satisfaction Questionnaire)

  4 weeks after traumatic event

• The families' relational coping skills (Relational Coping Questionnaire )

  4 weeks after the traumatic event

• The families' relational coping skills (Relational Coping Questionnaire )

  6 months after the traumatic event

Study Arms (2)

Preventive intervention

EXPERIMENTAL

In this arm HCPs will conduct a trauma-informed early intervention with children and families after exposure to potentially traumatic events (PTE).

Other: Preventive intervention trauma-informed early intervention

Control group

NO INTERVENTION

There will be no intervention in this arm. The outcome will show the efficiency of usual care.

Interventions

Preventive intervention trauma-informed early intervention OTHER

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.

Preventive intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 8 and 18 years
• Admission to hospital for accidental injury involving danger to life, serious injury or impairment
• Admission to hospital for acute illness involving danger to life, serious injury or impairment
• Sudden severe impairment of medical condition
• Admission of parent or sibling to hospital for accidental injury involving danger to life, serious injury or impairment
• Admission of parent or sibling to hospital for acute illness involving danger to life, serious injury or impairment
• Sudden severe impairment of parental or sibling medical condition
• Consent to participate in the study

You may not qualify if:

• Parent's Danish insufficient for questionnaire completion
• Developmental delay or mental retardation in the child
• Moderate to severe head injury or posttraumatic amnesia following the accident
• Injury due to physical or sexual abuse (intentional injury)

Sponsors & Collaborators

• Carolina Magdalene Maier: lead
• The Egmont Foundation: collaborator
• Ramboll Group: collaborator

Study Sites (1)

Hospitals of the Capitol Region of Denmark

Copenhagen, Denmark

RECRUITING

Related Publications (44)

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Lasse P Michelsen, MA

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Ditte B Eriksen, LPsy

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Carolina M Maier, MSc

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Central Study Contacts

Carolina M Maier, MSc

CONTACT

carolina.magdalene.maier@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: cand.scient.soc.

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 24, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

DK (1)