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| Name | Class |
|---|---|
| Childress Institute for Pediatric Trauma | UNKNOWN |
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The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.
This study is a trial to determine if a caregiver-child dyadic screening and caregiver intervention with pediatric trauma patients reduces traumatic stress symptoms in both child and caregiver, and depressive symptoms in caregivers compared to the current standard of care. The purpose of the PACTS Intervention is to identify and address the needs of the caregiver and the child survivor who are at-risk for developing post-traumatic stress disorder and/or depression following traumatic injury of the child.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling | Experimental | Screening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization |
|
| Peritraumatic Distress Inventory (PDI) Tool - Standard of Care | Active Comparator | Screening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver Counseling for Childhood Traumatic Injury | Behavioral | Caregiver intervention will be provided by the counseling team that includes components of trauma narrative, psychoeducation, coping strategies, and resilience-building using, for burn patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kessler 6 Scores | Administered to the caregiver to screen for secondary Post Traumatic Stress Disorder (PTSD) - A six-item K6 screening scale for psychological distress - a short measure of non-specific psychological distress based on questions about the level of nervousness, agitation, psychological fatigue and depression - scores range from 10-50 with higher scores meaning a severe mental disorder | From baseline to Month 3 |
| Change in Patient Health Questionnaire - 9 (PHQ-9) Scores | Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression | From baseline to Month 3 |
| Change in Child and Adolescent Trauma Screen (CATS) Scores | Caregiver administered to caregiver to screen for PTSD in the child - The "Child and Adolescent Trauma Screen (CATS)" is a Diagnostic and Statistical Manual-5 (DSM-5) based checklist that includes 15 potentially traumatic events or series of events, the 20 posttraumatic stress symptoms (PTSS) and 5 impairment items. The younger child version conforms to the DSM-5 3-6 year old PTSD symptom criteria. The CATS can be administered as a self-report or as an interview. Interview may be preferable with younger children or youth with reading comprehension challenges. Scores ranging from 0-16+ with higher scores meaning more probability of Post Traumatic Stress Disorder (PTSD) | From baseline to Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liz White, MA, LCMHCS | Contact | 336-716-2801 | Elizabeth.B.White@Advocatehealth.org | |
| D'Ann Hershel | Contact | 336.716.1659 | Dann.Hershel@wfusm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Shilling, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care for Childhood Traumatic Injury | Behavioral | Control group receives the current standard of care provided by the counseling team |
|
| D001519 | Behavior |