Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT06366282
- Status
- Recruiting
Conditions
- Traumatic Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 6 Years
- Healthy Volunteers
- Not accepted
Interventions
- Caregiver Counseling for Childhood Traumatic Injury — BEHAVIORALCaregiver intervention will be provided by the counseling team that includes components of trauma narrative, psychoeducation, coping strategies, and resilience-building using, for burn patients.
- Standard of Care for Childhood Traumatic Injury — BEHAVIORALControl group receives the current standard of care provided by the counseling team
Study Details
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.
Key Dates
- Start date
- Nov 26, 2024
- Status verified
- Apr 2026
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Peritraumatic Distress Inventory (PDI) Tool - Trauma CounselingScreening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization
- Active Comparator: Peritraumatic Distress Inventory (PDI) Tool - Standard of CareScreening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress
Primary Outcome Measure
Change in Kessler 6 Scores [ Time Frame: From baseline to Month 3 ]
Central Contacts
- Liz White, MA, LCMHCS336-716-2801
- D'Ann Hershel336.716.1659
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | Elizabeth Shilling, PhD (PRINCIPAL_INVESTIGATOR) |
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