Building Resilience After Childhood Emergencies (BRACE)

NCT02898883 | Completed

• 1 other identifier: BRACE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• UCLA Posttraumatic Stress Disorder Reaction Index (UCLA-PTSD-RI)

  Child PTSD severity and diagnostic status

  1 month post baseline

• Posttraumatic Stress Disorder Checklist for Civilians (PCL)

  Parent PTSD severity and diagnostic status

  1 month post baseline

Secondary Outcomes (2)

• Center for Epidemiological Studies -Depression for Children (CES-DC)

  1 month post baseline

• Center for Epidemiological Studies -Depression (CES-D)

  1 month post baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Building Resilience after Childhood Emergencies (BRACE)

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

Building Resilience after Childhood Emergencies (BRACE) BEHAVIORAL

See arm/group description for details regarding this intervention

Intervention group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Akron Children's Hospital: collaborator
• Kent State University: collaborator

Study Sites (1)

Akron children's Hospital

Akron, Ohio, 44308, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Mark Burton, MA

  Case Western Reserve University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 13, 2016
• Study Start: October 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)