- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02898883
Building Resilience After Childhood Emergencies (BRACE) (BRACE)
Building Resilience After Childhood Emergencies (BRACE): A Randomized Trial Examining Efficacy and Feasibility
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Akron, Ohio, United States, 44308
- Akron Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Early intervention Program The early intervention program (EIP) will consist of 4 sessions with one parent/guardian of the injured child and a clinical psychology graduate student therapist.
All sessions are one on one for one hour.
The first session will be conducted in the hospital within an average of 24- 48 hours after the traumatic event.
The subsequent three sessions will be conducted electronically via web-based video chat once per week.
In general, the EIP will utilize psychoeducation, skills implementation, and daily monitoring to facilitate communication regarding the traumatic event, maintain daily and sleep routines, increase child's access to social support and mitigate the impact of life stress.
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See arm/group description for details regarding this intervention
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No Intervention: Treatment as Usual (TAU)
As part of routine hospital protocol, all participants who screen positively for PTSD risk are provided with a packet of educational materials and potential referrals for behavioral healthcare.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UCLA Posttraumatic Stress Disorder Reaction Index (UCLA-PTSD-RI)
Time Frame: 1 month post baseline
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Child PTSD severity and diagnostic status
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1 month post baseline
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Posttraumatic Stress Disorder Checklist for Civilians (PCL)
Time Frame: 1 month post baseline
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Parent PTSD severity and diagnostic status
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1 month post baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiological Studies -Depression for Children (CES-DC)
Time Frame: 1 month post baseline
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Child depression severity and diagnostic status
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1 month post baseline
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Center for Epidemiological Studies -Depression (CES-D)
Time Frame: 1 month post baseline
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Parent depression severity and diagnostic status
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1 month post baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mark Burton, MA, Case Western Reserve University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRACE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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