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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 684
- Locations
- 1
- Primary Endpoint
- Severity of depressive symptoms (Revised Child Anxiety and Depression Scale.)
Study Overview
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.
Detailed Description
Background
A significant number of children and adolescents have been exposed to potentially traumatic events (PTEs). American and Australian studies report a prevalence of about 20-25% of high magnitude traumatic events among adolescents. A Danish study of four Nordic countries found that 90 % of adolescents with a mean age of 14.5 years had been exposed to at least one low magnitude traumatic event.
A potentially traumatic event may be either relational such as sexual or physical abuse or nonrelational such as illness, motor vehicle accident or fire. The incidence of nonrelational trauma is very high in children and adolescents with accidental injuries being the largest cause of morbidity and mortality among children in the United States as well as in Denmark. Although many children and adolescents demonstrate great resilience or appear to be only briefly affected by nonrelational traumatic events a significant minority of young people will develop posttraumatic stress disorder (PTSD), posttraumatic stress symptoms (PTSSs) or other psychological difficulties following exposure to trauma.
Accidental injury is the most common type of trauma. Researchers report prevalence rates of PTSD among children and adolescents in road traffic accidents ranging from 6% to 35%. Rates of PTSSs (also termed subclinical, subthreshold or partial PTSD) range from 11% to 50%6-14. These rates are important since recent research has indicated only minor differences in terms of distress and impairment between children meeting full and partial criteria for PTSD.
The diagnosis of medical illness such as cancer or diabetes has also been shown to cause PTSD in some children and adolescents with prevalence rates of 5.4% for diabetes and of 10% to 18% for cancer. A recent meta-analysis of prevalence related to both injury and illness reported average prevalence rates of PTSD related to injury ranging from 0% to 37.5%, with a mean of 19.82%, and rates in ill youth ranging from 0% to 32%, with a mean of 12.04%.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Preventive intervention
In this arm HCPs will conduct a trauma-informed early intervention with children and families after exposure to potentially traumatic events (PTE).
Intervention: Preventive intervention trauma-informed early intervention (Other)
Control group
There will be no intervention in this arm. The outcome will show the efficiency of usual care.
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcomes
- Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)(6 months after the traumatic event)
- Change from baseline in cognitive coping skills of the children and their parents at 6 months ( Post-traumatic Cognitions Inventory.)(4 weeks and 6 months 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)
- Social functioning of the family (Crisis Support Scale and the WHO-Five Well-being Index.)(4 weeks after the traumatic event)
- Cognitive coping skills of the children and their parents ( Post-traumatic Cognitions Inventory.)(4 weeks after the traumatic event)
Investigators
Carolina Magdalene Maier
cand.scient.soc.
Rigshospitalet, Denmark