Building Resilience After Childhood Emergencies (BRACE)
Condition: Posttraumatic Stress Disorder
MeSH terms: Emergencies; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The investigators study seeks to evaluate the feasibility and efficacy of a parent-focused,
      early intervention to prevent the development of chronic PTSD for children admitted to the
      emergency department for an acute traumatic injury and their parents. Furthermore, the
      investigators will identify potential risk factors for the development of PTSD and factors
      that influence treatment response. Finally, the investigators will prospectively measure
      trajectories of parental and child responses to trauma and their interaction over time. This
      study will bring together a multidisciplinary team across two major research universities
      (Case Western Reserve University and Kent State University) and a large pediatric trauma
      center (Akron Children's Hospital) in an effort to reduce rates of PTSD in children following
      traumatic injury.
    

Detailed description: 
      Objectives:

      The proposed research study will evaluate the feasibility and efficacy of an early
      parent-focused intervention to prevent the development of PTSD for children admitted to the
      hospital after suffering a medical injury who are at-risk of developing PTSD. Children
      presenting to the ED with injuries sufficient to warrant admission to the hospital (see below
      for criteria for trauma admissions), who show risk for PTSD according to a standardized
      assessment and their parents will be approached to participate in the study. After
      consenting/assenting to participate in research, children and parents will be randomized to
      receive the study intervention or treatment as usual. The primary goal will be to measure
      differences between the study groups on PTSD diagnosis and severity at 1-. 3-, and 6-months
      post trauma, as well as differences in comorbid diagnoses (e.g., depression),
      global/scholastic functioning, and other domains targeted by the intervention (e.g., sleep
      quality, life stress, and social support). The secondary goal will be to measure the impact
      of parental/ family factors (e.g., parental pathology and family stressors) on children's
      trajectories of pathology and resilience. The final goal will be to identify salient changes
      in methylation levels for both parent and child after trauma and the relationship of those
      changes with the development of symptoms or maladaptive coping. The study will bring together
      a multidisciplinary team of medical and psychological professionals to build upon a growing
      literature supporting the use of targeted early interventions to prevent PTSD.

      Specific Aims and Hypotheses:

        1. Determine the preliminary efficacy of a parent-focused, early intervention to prevent
           the development of chronic PTSD and other trauma-related outcomes in children exposed to
           acute, traumatic injury, and their parents. Outcomes will be measured by child
           self-report, parental self-report, and parental report of the child at intake and
           follow-up assessments (1-, 3-, and 6-months post trauma). It is hypothesized that the
           treatment group (early intervention) will show significantly lower rates of PTSD
           symptoms and associated markers of psychological functioning and higher well-being at
           all follow-up assessments compared to the treatment as usual (TAU) group. Also, child
           and parent factors will predict the development of PTSD and treatment response. Finally,
           the slope of symptom change for parents and their children will be related across time
           in both groups, and that the slope of symptom change will be moderated by treatment
           group, with parents and children who received treatment showing greater reductions in
           symptoms over time.

        2. Evaluate the feasibility of a parent-focused, early intervention to prevent the
           development of chronic PTSD in children exposed to acute, traumatic injury. Feasibility
           will be determined by participant enrollment and dropout rates, as well as participant
           subjective ratings of satisfaction with their treatment. It is hypothesized that the
           intervention will be well-received by participants and that participant enrollment goals
           will be met.

        3. Understand the trajectory of epigenetics (through methylation levels) after a trauma and
           the relationship between methylation levels and psychological functioning for both
           parents and children. The investigators will also, investigate the impact of an early
           intervention on epigenetics in parents and children exposed to an acute injury.

      Study Design:

      The proposed study will utilize a longitudinal design to measure the effect of early
      intervention to prevent the development of PTSD symptoms in children (and their parents)
      exposed to acute traumatic injury. Parent/child dyads entering the study will have an initial
      assessment after admission to the hospital, within approximately 24-48 hours after the
      trauma. CHMCA follows recommendations of the American College of Surgeons Committee on Trauma
      in determining whether a patient's injuries are sufficient to necessitate a trauma admission.
      Criteria for activating a Trauma Team response are either physiologic (based on HR, blood
      pressure, mental status, etc) or anatomic (based on extent of identified injuries, such as
      presence of fractures, penetrating injuries of the torso/head, chest wall injuries, etc), or
      a combination of the two. Once a trauma team is called, patients are typically admitted for a
      minimum of 15 hours. As part of the trauma admission process, patients will be screened for
      PTSD severity using the STEPP. PTSD risk based on this measure is one of the inclusion
      criteria for this study.Those enrolled in the study will be assigned to 4 sessions of an
      early intervention or a treatment as usual group. Parent/child dyads will then be assessed
      again at 1 month, 3 months and 6 months post-trauma. The longitudinal design will allow for
      the prospective measurement of the effect of predictive factors on the development of PTSD
      and treatment response.
    

Intervention name(s): Building Resilience after Childhood Emergencies (BRACE)
Intervention type(s): Behavioral
Intervention description(s): See arm/group description for details regarding this intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention