RecruitingRecruiting
Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
NCT06366282 · Wake Forest University Health Sciences
In plain English
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Official title
Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units
* English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR)
* Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.
Exclusion Criteria:
* Patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2024-11-26
Estimated completion: 2026-07
Last updated: 2026-04-06
Interventions
Behavioral: Caregiver Counseling for Childhood Traumatic InjuryBehavioral: Standard of Care for Childhood Traumatic Injury
Primary outcomes
- • Change in Kessler 6 Scores (From baseline to Month 3)
- • Change in Patient Health Questionnaire - 9 (PHQ-9) Scores (From baseline to Month 3)
- • Change in Child and Adolescent Trauma Screen (CATS) Scores (From baseline to Month 3)
Sponsor
Wake Forest University Health Sciences · other
With: Childress Institute for Pediatric Trauma
Contacts & investigators
ContactLiz White, MA, LCMHCS · contact · Elizabeth.B.White@Advocatehealth.org · 336-716-2801
ContactD'Ann Hershel · contact · Dann.Hershel@wfusm.edu · 336.716.1659
InvestigatorElizabeth Shilling, PhD · principal_investigator, Wake Forest University Health Sciences
All locations (1)
Wake Forest University Health SciencesRecruiting
Winston-Salem, North Carolina, United States