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| Name | Class |
|---|---|
| Texas Child Mental Health Care Consortium | UNKNOWN |
| Baylor College of Medicine | OTHER |
| University of South Florida | OTHER |
| University of Houston |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) | Experimental | The 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, week 7, week 15 |
| 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. | baseline, week 7, week 15 |
| 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. | baseline, week 7, week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, week 7, week 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leslie K Taylor, PhD | Contact | 713-486-2728 | psyc.steppedcarecbt@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leslie K Taylor, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
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| OTHER |
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| 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. | baseline, week 15 |
| 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. | baseline, week 15 |
| 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. | baseline, week 7, week 15 |
| Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity/Improvement (CGI-S/I) Scale | Total score ranges from 0 to 7, with a higher score indicating a worse outcome. A score 1, 2 or 3 will be used to indicate treatment response. | baseline, week 7, week 15 |
| Parent Post-Traumatic Stress Syndrome (PTSS) as Assessed by the PTSD Checklist for DSM-5 (PCL-5) | Total score ranges from 0 to 80, with a higher score indicating a worse outcome. | baseline, week 15 |
| Parent Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9) | Total score ranges from 0 to 27, with a higher score indicating a worse outcome. | baseline, week 15 |
| Parent Anxiety as Assessed by the General Anxiety Disorder-7 (GAD-7) Scale | Total score ranges from 0 to 21, with a higher score indicating a worse outcome. | baseline, week 15 |
| Parent Stress as Assessed by the Perceived Stress Scale (PSS) | Scores range from 18 to 90, with a higher score indicating higher parenting stress. | baseline, week 15 |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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