Posttraumatic Stress DisorderBRACENCT02898883
Building Resilience After Childhood Emergencies (BRACE)
A study testing Building Resilience after Childhood Emergencies (BRACE) in people with Posttraumatic Stress Disorder, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Building Resilience after Childhood Emergencies (BRACE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Resilience After Childhood Emergencies (BRACE): A Randomized Trial Examining Efficacy and Feasibility
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Building Resilience after Childhood Emergencies (BRACE)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Resilience after Childhood Emergencies (BRACE)Behavioural
See arm/group description for details regarding this intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Posttraumatic Stress Disorder Reaction Index (UCLA-PTSD-RI)
Child PTSD severity and diagnostic status
Measured: 1 month post baseline
Posttraumatic Stress Disorder Checklist for Civilians (PCL)
Parent PTSD severity and diagnostic status
Measured: 1 month post baseline
Secondary outcomes (2)
Center for Epidemiological Studies -Depression for Children (CES-DC)
Child depression severity and diagnostic status
Measured: 1 month post baseline
Center for Epidemiological Studies -Depression (CES-D)
Parent depression severity and diagnostic status
Measured: 1 month post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Akron Children's Hospital, Kent State University
- Responsible party
- Principal investigator, Norah Feeny, Case Western Reserve University
- Investigators
- Mark Burton, MA, Study director, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898883
- Sponsor's protocol ID
- BRACE
- Acronym
- BRACE
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2016
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience After Childhood Emergencies (BRACE): A Randomized Trial Examining Efficacy and Feasibility
- ClinicalTrials.gov ID
- NCT02898883
- Acronym / sponsor ID
- BRACE / BRACE
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Akron Children's Hospital, Kent State University
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Building Resilience after Childhood Emergencies (BRACE)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. |
| 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. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Resilience after Childhood Emergencies (BRACE)See arm/group description for details regarding this intervention | Behavioural | Intervention group |
Primary outcome
UCLA Posttraumatic Stress Disorder Reaction Index (UCLA-PTSD-RI)
Time frame: 1 month post baseline
Child PTSD severity and diagnostic status
Posttraumatic Stress Disorder Checklist for Civilians (PCL)
Time frame: 1 month post baseline
Parent PTSD severity and diagnostic status
2 secondary outcomes
Center for Epidemiological Studies -Depression for Children (CES-DC)
Time frame: 1 month post baseline
Center for Epidemiological Studies -Depression (CES-D)
Time frame: 1 month post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Burton, MA study director
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Resilience after Childhood Emergencies (BRACE) in people with Posttraumatic Stress Disorder, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Posttraumatic Stress Disorder Reaction Index (UCLA-PTSD-RI) (time frame: 1 month post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.