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

 Preventive interventions for children and adolescents

 Given the high prevalence rates of exposure and the likewise high prevalence rates of PTSD
 and PTSSs after PTEs there is a pressing need for preventive interventions that decrease the
 risk of PTSD. In a recent systematic review by Forman-Hoffman et al. (2013) of interventions
 for children exposed to nonrelational traumatic events 6 different interventions based
 exclusively on exposure were identified. These included trauma-focused cognitive-behavioural
 therapy child and family traumatic stress intervention (CFTSI), 2 different school
 interventions with elements of CBT, early psychological intervention and a propranolol study.
 The two latter studies found no improvement in outcomes, the remaining 4 interventions found
 some improvement with regards to PTSD, severity of PTSD and PTSSs.

 Another recent meta-analysis by Kramer (2011) reviewing early psychological interventions in
 children and adolescents after single trauma included seven studies (two of which reappeared
 in the above mentioned review). These included CFTSI, school-based interventions, early
 psychological interventions, and two interventions based exclusively on psychoeducational
 information provision. The authors concluded that intervention effects regarding PTSSs and
 PTSD were small or non-significant but found promising beneficial tendencies with regards to
 dissociation, anxiety and, to some extent, arousal.

 Overall, the empirical literature has not supported the effectiveness of early psychological
 interventions such as psychological debriefing and single-session psychological intervention
 on preventing PTSD and PTSSs in children. These results are consistent with a Cochrane review
 by Rose 2002 of the effects of psychological debriefing for preventing PTSD in adults.
 However, school-based and family-focused interventions, as well as stepped-procedure and
 multiple-session psychological interventions have shown promising results.

 In conclusion, the current outcomes of the empirical research suggest early interventions
 that include the following elements31: age-appropriate psychoeducation, the provision of
 individual coping skills, parental involvement, social support, risk-assessment, multiple
 sessions and trauma exposure.

 The modest results of early psychological interventions suggest a need for a broader
 perspective on preventive interventions for children and adolescents exposed to nonrelational
 trauma. Despite the variety of interventions evaluated by the studies included in the two
 cited reviews none of the studies focused on the practice of health care professionals. This
 study is the first to conduct a controlled trial of a standardized preventive intervention
 conducted by health care professionals. The intervention to be evaluated in this study
 includes all of the above mentioned empirically supported elements except multiple sessions
 and trauma exposure.

 Trauma-informed health care

 The concept of trauma-informed practice has been advocated by institutions and researchers in
 diverse areas such as psychology, mental health care, education, child welfare, first
 responders, juvenile justice, and health care. The main aim of trauma-informed practice is to
 create systematic approaches within these areas to develop evidence-based services that
 address the impact of trauma on the children they serve37. This study will provide evidence
 on the impact of the practice of HCPs on symptoms, coping and social functioning of children,
 adolescents and their families who have been exposed to nonrelational trauma. It investigates
 the effects of educating HCPs in trauma-informed practice and the effects of a standardized
 trauma-informed plan of action implemented in health care departments working with children
 and adolescents.

 Design of the trial

 This study is designed as a controlled trial with one active intervention and one comparison.
 The study will be conducted across 19 health care departments in 7 hospitals in the Capitol
 Region of Denmark. There will be two measurement occasions: one assessment 4 weeks after
 exposure and one follow-up 6 months after exposure. The trial will run over 18 months. During
 the first 12 months the intervention will run in 12 of the participating departments while
 the other 8 departments will function as a control group. During the last 6 months the
 intervention will run in all nineteen departments thus expanding the sample size of the
 intervention group. Since the intervention is carried out by health care professionals
 shortly after exposure, the children in the control group will not receive intervention at
 any point.

 Because the intervention investigated in this trial is conducted by HCPs as an integrated
 part of their general practice (as opposed to a specific treatment program), it was neither
 practically possible nor ethically sound to design the allocation of participants in the
 control and intervention group as a randomization of subjects. For this reason, the
 allocation was done, not on a subject level, but on the level of departments. This precluded
 an actual randomization of the trial. However, it should be noted that the allocation of the
 departments is done before the intervention and thus prior to the recruitment of
 participants. This means that the allocation of subjects was predetermined in advance of
 their admission to the hospital. This prevents some of the bias associated with the lack of
 randomization. In the allocation of departments the best possible match of patient groups was
 pursued.

 It is the hypotheses of this study that: The children and adolescents who receive the
 intervention, compared to participants in the control group, will demonstrate greater
 reduction in posttraumatic stress, anxiety and depressive symptoms and higher ratings on
 positive cognitive coping skills and social functioning.

 Sample Size and Power Calculation

 Given that this is the first trial to examine the effect of a trauma-informed intervention
 conducted by HCPs as part of their general health care practice, calculations of power were
 very limited. Furthermore, effect sizes from related trials such as early psychological
 interventions and interventions based on information provision have been small or
 non-significant. Given these limitations, however, calculations of power were conducted on
 the basis of the available evidence.

 Results from a study by Kenardy et al. (2008) on an information-provision intervention had an
 effect size of 0.63 (between groups) on child anxiety. In a similar study by Cox et al.
 (2010) effect size on child anxiety was 0.33. Based on the results from Cox et al. (2010) a
 power analysis revealed that 115 families per group (N = 230) will result in 80% power for
 detecting a significant difference between the intervention and the control group at the 5%
 significance level. However, with an estimated 25% attrition rate over the assessment time
 periods, a total of 290 families should be aimed at to be recruited for the study.

 Another power analysis was conducted to calculate the power given a specific sample size.
 This was done because the participating departments are required to include all eligible
 families presented to the departments during the intervention period. It was estimated that
 each department would receive two eligible participants per month. Because of the difference
 in size between the intervention group and the control this resulted in a sample size of 516
 for the intervention group and 168 for the control group (N = 684). With an estimated 25 %
 attrition rate these numbers amount to 387 for the intervention group and 126 for the control
 group (N = 513). A post hoc power calculation resulted in 94 % power with an effect size of
 0.33 and a 5 % significance level.

 Statistical Considerations

 Prior to statistical analysis of outcomes, the control group and the intervention group will
 be compared for pre-intervention equivalence on demographic information and type of PTE. If
 significant differences are identified, this will be taken into account by including these
 variables as covariates in outcome analyses. The outcome data will be analysed and reported
 in terms of statistical significance of difference between intervention and control group in
 change over time on outcome, clinical significance of the change, and effect sizes. The
 analysis will be performed by researchers who have not been involved in assessing eligibility
 of participants, collection of data or entering of data.

 Primary analysis will be undertaken on an intention-to-treat (ITT) basis, including all
 participants who have received intervention or have been registered to the control group,
 regardless of withdrawal from the study. The data will be analysed with a mixed effects
 model, which is able to include participants whose data may be partly missing. Analysis of
 covariance will be conducted with three pairs of outcome: 1) child and parent outcome, 2)
 symptom outcome and coping outcome, and 3) symptom outcome and social functioning outcome.
 Other outcomes such as demographics and types of PTE will be described.
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)