Pediatric and Caregiver Traumatic Stress Intervention (PACTS) (PACTS)

Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Injury
• Intervention / Treatment: Behavioral: Caregiver Counseling for Childhood Traumatic Injury; Behavioral: Standard of Care for Childhood Traumatic Injury

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liz White, MA, LCMHCS; Phone Number: 336-716-2801; Email: Elizabeth.B.White@Advocatehealth.org
• Study Contact Backup: Name: D'Ann Hershel; Phone Number: 336.716.1659; Email: Dann.Hershel@wfusm.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Principal Investigator: Elizabeth Shilling, PhD
      • Contact: Elizabeth White, MA, LCMHCS; Phone Number: 336-716-2801; Email: Elizabeth.B.White@Advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling; Screening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization	Behavioral: Caregiver Counseling for Childhood Traumatic Injury; 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.
Active Comparator: Peritraumatic Distress Inventory (PDI) Tool - Standard of Care; Screening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress	Behavioral: Standard of Care for Childhood Traumatic Injury; Control group receives the current standard of care provided by the counseling team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Childress Institute for Pediatric Trauma
• Investigators: Principal Investigator: Elizabeth Shilling, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: depression; posttraumatic stress disorder; pediatric injury
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Depression; Wounds and Injuries; Stress Disorders, Post-Traumatic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00110030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No