Building Resilience After Childhood Emergencies (BRACE): A Randomized Trial Examining Efficacy and Feasibility

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: