Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

NCT06366282 | Recruiting

• 1 other identifier: IRB00110030
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Injury

Keywords

posttraumatic stress disorder; depression; pediatric injury

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

Behavioral: Caregiver Counseling for Childhood Traumatic Injury

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

Behavioral: Standard of Care for Childhood Traumatic Injury

Interventions

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.

Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling

Standard of Care for Childhood Traumatic Injury BEHAVIORAL

Control group receives the current standard of care provided by the counseling team

Peritraumatic Distress Inventory (PDI) Tool - Standard of Care

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Childress Institute for Pediatric Trauma: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic; Depression

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Elizabeth Shilling, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz White, MA, LCMHCS

CONTACT

336-716-2801; ebwhite@wakehealth.edu

D'Ann Hershel

CONTACT

336.716.1659; dhershel@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)