Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling

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

Group Type EXPERIMENTAL

Caregiver Counseling for Childhood Traumatic Injury

Intervention Type 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 - Standard of Care

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

Group Type ACTIVE_COMPARATOR

Standard of Care for Childhood Traumatic Injury

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Standard of Care for Childhood Traumatic Injury

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No