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

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ClinicalTrials.gov Identifier: NCT02299583
Recruitment Status : Unknown
Verified November 2014 by Carolina Magdalene Maier, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Collaborators:
The Egmont Foundation
Ramboll Group
Information provided by (Responsible Party):
Carolina Magdalene Maier, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Depression Anxiety Other: Preventive intervention trauma-informed early intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 684 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Protocol for a Controlled Trial of Early Intervention With Children and Adolescents Exposed to Nonrelational Traumatic Events Comparing Trauma-informed and Usual Health Care Practice
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preventive intervention
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
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.

No Intervention: Control group
There will be no intervention in this arm. The outcome will show the efficiency of usual care.



Primary Outcome Measures :
  1. Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.) [ Time Frame: 4 weeks after the traumatic event ]

    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.


  2. Severity of posttraumatic stress symptoms (Children's Revised Impact of Event Scale.) [ Time Frame: 6 months after the traumatic event ]

    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.


  3. Change from baseline in severity of posttraumatic stress symptoms at 6 months (Children's Revised Impact of Event Scale.) [ Time Frame: 4 weeks and 6 months after the traumatic event ]

    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. Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.) [ Time Frame: 4 weeks after the traumatic event ]
    The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  5. Severity of anxiety symptoms (Revised Child Anxiety and Depression Scale.) [ Time Frame: 6 months after the traumatic event ]
    The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  6. Change from baseline in severity of anxiety symptoms at 6 months (Revised Child Anxiety and Depression Scale.) [ Time Frame: 4 weeks and 6 months after the traumatic event ]
    The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  7. Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.) [ Time Frame: 4 weeks after the traumatic event ]
    The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  8. Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.) [ Time Frame: 6 months after the traumatic event ]
    The assessment will be administered with the Revised Child Anxiety and Depression Scale.

  9. Change from baseline in severity of depressive symptoms at 6 months (Revised Child Anxiety and Depression Scale.) [ Time Frame: 4 weeks and 6 months after the traumatic event ]
    The assessment will be administered with the Revised Child Anxiety and Depression Scale.


Secondary Outcome Measures :
  1. Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.) [ Time Frame: 4 weeks after the traumatic event ]
    The child assessment will be administered with the Crisis Support Scale. The parent secondary outcome measure will be assessed with the Crisis Support Scale and the WHO-Five Well-being Index.

  2. Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.) [ Time Frame: 6 months after the traumatic event ]
    The child assessment will be administered with the Crisis Support Scale. The parent secondary outcome measure will be assessed with the Crisis Support Scale and the WHO-Five Well-being Index.

  3. Change from baseline in social functioning of the family at 6 months (Crisis Support Scale and the WHO-Five Well-being Index.) [ Time Frame: 4 weeks and 6 months after the traumatic event ]
    The child assessment will be administered with the Crisis Support Scale. The parent secondary outcome measure will be assessed with the Crisis Support Scale and the WHO-Five Well-being Index.

  4. Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.) [ Time Frame: 4 weeks after the traumatic event ]

    The child assessment will be administered with the Children's Post-traumatic Cognitions Inventory.

    The parent secondary outcome measure will be assessed with the Post-traumatic Cognitions Inventory.


  5. Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.) [ Time Frame: 6 months after the traumatic event ]

    The child assessment will be administered with the Children's Post-traumatic Cognitions Inventory.

    The parent secondary outcome measure will be assessed with the Post-traumatic Cognitions Inventory.


  6. Change from baseline in cognitive coping skills of the children and their parents at 6 months ( Post-traumatic Cognitions Inventory.) [ Time Frame: 4 weeks and 6 months after the traumatic event ]

    The child assessment will be administered with the Children's Post-traumatic Cognitions Inventory.

    The parent secondary outcome measure will be assessed with the Post-traumatic Cognitions Inventory.



Other Outcome Measures:
  1. The families' satisfaction with the intervention program (Intervention Satisfaction Questionnaire) [ Time Frame: 4 weeks after traumatic event ]
    It will be measured through an author developed Intervention Satisfaction Questionnaire, completed by parents and children.

  2. The families' relational coping skills (Relational Coping Questionnaire ) [ Time Frame: 4 weeks after the traumatic event ]
    It will be measured through an author developed Relational Coping Questionnaire covering questions that are not included in the secondary outcome measures.

  3. The families' relational coping skills (Relational Coping Questionnaire ) [ Time Frame: 6 months after the traumatic event ]
    It will be measured through an author developed Relational Coping Questionnaire covering questions that are not included in the secondary outcome measures.

  4. Change from baseline in the families' relational coping skills at 6 months (Relational Coping Questionnaire ) [ Time Frame: 4 weeks and 6 months after the traumatic event ]
    It will be measured through an author developed Relational Coping Questionnaire covering questions that are not included in the secondary outcome measures.



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.


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT02299583


Contacts
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Contact: Carolina M Maier, MSc carolina.magdalene.maier@regionh.dk

Locations
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Denmark
Hospitals of the Capitol Region of Denmark Recruiting
Copenhagen, Denmark
Sponsors and Collaborators
Carolina Magdalene Maier
The Egmont Foundation
Ramboll Group
Investigators
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Principal Investigator: Lasse P Michelsen, MA Rigshospitalet, Denmark
Principal Investigator: Ditte B Eriksen, LPsy Rigshospitalet, Denmark
Study Director: Carolina M Maier, MSc Rigshospitalet, Denmark

Publications:
Jeggesen A, Gudmundsdóttir DB, Elklit A: Posttraumatic stress disorder in adolescent and Young adult survivors of childhood cancer. Nordic Psychology 2012, 64;4:291-302.
Kahana SY, Feeny NC, Youngstrom EA, Drotar D: Posttraumatic Stress in Youth Experiencing Illnesses and Injuries: An Exploratory Meta-Analysis. Traumatology 2006; 12; 148-161
Ko SJ, Ford JD, Kassam-Adams N, Berkowitz SJ, Wilson C, Wong M: Creating Trauma-Informed Systems: Child Welfare, Education, First Responders, Health Care, Juvenile Justice. Professional Psychology: Research and Practice 2008, 39;4:396-404
Steel W, Malchiodi, CA: Trauma-Informed Practices With Children and Adolescents. Routledge, New York 2012
Conners-Burrow NA, Kramer TL, Sigel BA, Helpenstill K, Sievers C, McKelvey L: Trauma-informed care training in a child welfare system: Moving it to the front line. Children and Youth Services Review 2013, 35;11:1830-1835
Kramer TL, Sigel BA, Conners-Burrow NA, Savary PE, Tempel A: A statewide introduction of trauma-informed care in a child welfare system. Children and Youth Services Review 2013, 35:19-24
Ford, JD, Blaustein, ME: Systemic Self-Regulation: A Framework for Trauma-Informed Services in Residential Juvenile Justice Programs. Journal of Family Violence 2013, 28;7:665-677

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Responsible Party: Carolina Magdalene Maier, cand.scient.soc., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02299583     History of Changes
Other Study ID Numbers: f-22834-02
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 2014
Keywords provided by Carolina Magdalene Maier, Rigshospitalet, Denmark:
prevention
early intervention
trauma-informed practice
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders