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Not recruiting

PACTS

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06366282

Conditions

Traumatic Injury

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Not accepted

Interventions

Caregiver Counseling for Childhood Traumatic Injury

Standard of Care for Childhood Traumatic Injury

Study Details

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

Study ID

NCT06366282

Start date

Nov 26, 2024

Status verified date

Apr, 2026

Completion date

Jul 31, 2026

Primary completion date

Jul 31, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Not accepted

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 Design

Enrollment

13 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

Interventions

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.

Standard of Care for Childhood Traumatic Injury

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

Primary outcome measure

  • Change in Kessler 6 Scores [ Time Frame: From baseline to Month 3 ]
  • Change in Patient Health Questionnaire - 9 (PHQ-9) Scores [ Time Frame: From baseline to Month 3 ]
  • Change in Child and Adolescent Trauma Screen (CATS) Scores [ Time Frame: From baseline to Month 3 ]

Central Contacts and Locations

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 3, 2026

Last verified

Apr, 2026

Keywords

  • posttraumatic stress disorder
  • depression
  • pediatric injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.