Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
ConditionTraumatic Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Caregiver Counseling for Childhood Traumatic Injury
BehavioralCaregiver 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
BehavioralControl group receives the current standard of care provided by the counseling team
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Peritraumatic Distress Inventory (PDI) Tool - Trauma CounselingExperimental treatment 1 intervention
Group B: Peritraumatic Distress Inventory (PDI) Tool - Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From baseline to Month 32
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
Time frame
From baseline to Month 33
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)
Time frame
From baseline to Month 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Childress Institute for Pediatric Trauma
Collaborator
Source ClinicalTrials.gov