Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
Location contact
Elizabeth Shilling, PhD
PRINCIPAL_INVESTIGATOR
Elizabeth White, MA, LCMHCS
CONTACT
NCT Number: NCT06366282
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.
Interested in participating?
Request Info1 year–6 year
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
Elizabeth Shilling, PhD
PRINCIPAL_INVESTIGATOR
Elizabeth White, MA, LCMHCS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Control group receives the current standard of care provided by the counseling team
Time frame: From baseline to Month 3
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
Time frame: From baseline to Month 3
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
Time frame: From baseline to Month 3
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)
Contact information is provided by the study sponsor or research team.
D'Ann Hershel
CONTACT
Liz White, MA, LCMHCS
CONTACT
Wake Forest University Health Sciences
Other
Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
Acronym: PACTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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