Clinical trial NCT02898883: Building Resilience After Childhood Emergencies (BRACE)
Official title: Building Resilience After Childhood Emergencies (BRACE): A Randomized Trial Examining Efficacy and Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Akron Children's Hospital
name: Kent State University
First posted: 2016-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient must be between the ages of 8 and 13
* Patient must be admitted to the hospital as a trauma admission due to their traumatic injury
* Patient must be accompanied by a legal guardian
* Patient must meet threshold for risk of PTSD
* Both patient and parent must be fluent in English

Exclusion Criteria:

* Intellectual disability or brain damage
* Lower than a 14 on the Glasgow Coma Scale
* Patients who are not deemed sufficiently medically stable to participate by their designated attending physician
* Patients or parents who arrive at the ED intoxicated
* Patients who are not alert, oriented, coherent, or capable of responding to questions

Primary outcomes:
measure: UCLA Posttraumatic Stress Disorder Reaction Index (UCLA-PTSD-RI)
timeFrame: 1 month post baseline
measure: Posttraumatic Stress Disorder Checklist for Civilians (PCL)
timeFrame: 1 month post baseline
Secondary outcomes:
measure: Center for Epidemiological Studies -Depression for Children (CES-DC)
timeFrame: 1 month post baseline
measure: Center for Epidemiological Studies -Depression (CES-D)
timeFrame: 1 month post baseline
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron children's Hospital
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Mark Burton, MA
role: STUDY_DIRECTOR
References: