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

This study, called PACTS, is looking at ways to help children and their caregivers cope after a child experiences a traumatic injury. Researchers want to see if a special type of caregiver counseling, called "Caregiver Counseling for Childhood Traumatic Injury," can reduce stress and depression symptoms in both the child and caregiver. This counseling includes talking about the trauma, learning about it, and building coping skills. You might be able to join if your child is between 1 and 6 years old, needs to stay in the hospital for an accidental injury (like a burn or dog bite), and you and your child screen positive for distress after the injury. The study will measure changes in stress and depression scores over three months to see if the counseling is helpful. The study is currently unclear on its recruitment status and plans to enroll 24 participants.

Study design
This is an interventional study comparing a new caregiver counseling approach to the standard care. It plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06366282

Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

Completed
NAAges 1–6InterventionalSupportive care
Wake Forest University Health Sciences
~13 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Caregiver Counseling for Childhood Traumatic InjuryStandard of Care for Childhood Traumatic Injury

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Kessler 6 Scores
Measured over From baseline to Month 3
+2 more outcomes measured
Traumatic Injury
1 sites across 1 states
North Carolina1
  • Elizabeth Shilling, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Change in Kessler 6 ScoresFrom baseline to Month 3

    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

  • Change in Patient Health Questionnaire - 9 (PHQ-9) ScoresFrom baseline to Month 3

    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

  • Change in Child and Adolescent Trauma Screen (CATS) ScoresFrom baseline to Month 3

    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)