About this trial
One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
parent and child agree that the target event/index trauma occurred;
report of at least five symptoms of PTSD (1 from re-experiencing category or 1 from avoidance);
suicidal ideation does not exclude as long as there is no active plan/intent. Safety planning implemented and continued assessment for plan/intent;
children ages 7-12 and a legal guardian willing to participate;
Disqualifiers
Children with pervasive developmental disorders or Autism;
legal guardian or child with active psychosis;
any condition that may limit the legal guardian ability to understand CBT and the child's ability to follow instructions;
children who have unsupervised visitation with their perpetrator;
Trial design
Single group
Treatments tested in this trial
Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)
BehavioralThe SC-CBT-CT intervention in this study is a data driven, stakeholder-informed revision of SC-CBT-CT that incorporates Latino specific values and beliefs, that is, personalized SC-CBT-CT (pSC-CBT-CT). The intervention consists of two steps utilizing Cognitive Behavioral Therapy (CBT). Step one (Stepping Together for Children after Trauma, SC-CT) involves a caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy, and step two consists of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which utilizes gradual exposure. SC-CT includes three therapist-led caregiver-child meetings over 6-9 weeks, with brief weekly phone support (10-15 minutes) from the therapist to caregiver. During 11 home-based, caregiver-led meetings, the child and caregiver work together on therapeutic tasks (i.e., exposure tasks, a trauma narrative, and in-vivo exposure reminders) guided by an empirically supported activity book.
Treatment groups
Trial outcomes
Primary outcomes
Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index (RI) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (UCLA-RI-5) - Child Reported
Total score ranges from 0 to 73, with a higher score indicating worse symptoms.
Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported
Total score ranges from 0 to 73, with a higher score indicating worse symptoms.
Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C)
Total score ranges from 0 to 65, with a higher score indicating a worse outcome.
Secondary outcomes
Number of participants with a PTSD Diagnosis as Assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders Child and Adolescent Version (DIAMOND-KID) Clinical Interview
A PTSD diagnosis using the DIAMOND-KID Clinical Interview is indicated by answering "yes" to the presence of 4 types of PTSD symptoms.
Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore
Total score ranges from 0 to 111, with a higher score indicating greater symptom severity.
Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore
Total score ranges from 0 to 30, with a higher score indicating greater symptom severity.
Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale
Total score ranges from 0 (no illness) to 6 (extremely severe), with a higher score indicating a greater severity of trauma symptoms.
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
Texas Child Mental Health Care Consortium
Collaborator
Baylor College of Medicine
Collaborator
University of South Florida
Collaborator
University of Houston
Collaborator
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