Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

Wake Forest University (WFU)

Status: Enrolling

Conditions: Traumatic Injury

Treatments: Behavioral: Standard of Care for Childhood Traumatic Injury; Behavioral: Caregiver Counseling for Childhood Traumatic Injury

Study type: Interventional

Funder types: Other

Identifiers

NCT06366282

IRB00110030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling

Experimental group

Description:

Screening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization

Treatment:

Behavioral: Caregiver Counseling for Childhood Traumatic Injury

Peritraumatic Distress Inventory (PDI) Tool - Standard of Care

Active Comparator group

Description:

Screening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress

Treatment:

Behavioral: Standard of Care for Childhood Traumatic Injury