Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02898883 |
| Other study ID # |
BRACE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
August 2018 |
Study information
| Verified date |
August 2021 |
| Source |
Case Western Reserve University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
