Akron children's Hospital
Akron, Ohio, 44308, United States
NCT Number: NCT02898883
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.
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Notify Me8 year–13 year
All sexes
Interventional
Not applicable
Akron, Ohio, 44308, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See arm/group description for details regarding this intervention
Time frame: 1 month post baseline
Child PTSD severity and diagnostic status
Time frame: 1 month post baseline
Parent PTSD severity and diagnostic status
Time frame: 1 month post baseline
Child depression severity and diagnostic status
Time frame: 1 month post baseline
Parent depression severity and diagnostic status
Case Western Reserve University
Other
Building Resilience After Childhood Emergencies (BRACE): A Randomized Trial Examining Efficacy and Feasibility
Acronym: BRACE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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