Considering Racial and Acculturation Stress in Addressing Trauma

Study Overview
=================
Brief Summary
-----------------
Investigators plan to offer two evidence based interventions - Trauma Focused Cognitive Behavioral Therapy (CBT) (TF-CBT) and Trauma Systems therapy (TST) to traumatized children and their families. The investigators are looking to evaluate the effectiveness of these interventions in the context of additional stress related to racialized trauma and acculturation stress

Official Title
-----------------
Evaluating the Effectiveness of Evidence-based Trauma Interventions (Trauma Focused CBT - TF-CBT; and Trauma Systems Therapy - TST), Baseline Index Trauma, and PTSD Symptoms in the Context of Contributing Stress From Racialized Trauma and Acculturation Stress

Conditions
-----------------
Trauma-related PTSD

Intervention / Treatment
-----------------
* Behavioral: Trauma Focused CBT (TF-CBT)
* Behavioral: Trauma Systems therapy (TST)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child/adolescent aged 5-17 years of age who has experienced trauma with associated and related emotional dysregulation (i.e PTSD) and one of their parent/guardian Have capacity and willingness to provide consent or age-appropriate assent Exclusion Criteria: Individual with intellectual disability with an IQ<70 Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma Focused CBT (TF-CBT)<br>Patients and families randomized to engage in TF-CBT. | Behavioral: Trauma Focused CBT (TF-CBT)<br>* TF-CBT is an evidence-based treatment for children and adolescents impacted by trauma and their parents or caregivers. It is a components-based treatment model that incorporates trauma-sensitive interventions with cognitive behavioral, family, and humanistic principles and techniques.<br>|
| Experimental: Trauma Systems therapy (TST)<br>Patients and families randomized to engage in TST. | Behavioral: Trauma Systems therapy (TST)<br>* Trauma Systems Therapy (TST) is focused on the factors that contribute to children and adolescents who experience traumatic stress through the lens of the social context, vulnerabilities, and strengths of the person undergoing treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child and Adolescent Trauma Screen (CATS) Score at Baseline | CATS is a 15-item assessment of potentially traumatic events and of posttraumatic stress symptoms. The total score is the sum of responses and ranges from 0-60; higher scores indicates more symptoms. | Baseline (Day 1) | 
| CATS Score at Completion of Intervention | CATS is a 15-item assessment of potentially traumatic events and of posttraumatic stress symptoms. The total score is the sum of responses and ranges from 0-60; higher scores indicates more symptoms. | Completion of Intervention (Typically Month 3-4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acculturative Stress Scale (SAFE) Score at Baseline | SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress. | Baseline (Day 1) | 
| SAFE Score at Completion of Intervention | SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress. | Completion of Intervention (Typically Month 3-4) | 
| Bidimensional Acculturation Scale (BAS) Score at Baseline | BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation. | Baseline (Day 1) | 
| BAS Score at Completion of Intervention | BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation. | Completion of Intervention (Typically Month 3-4) | 
| Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline | 6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify. | Baseline (Day 1) | 
| Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention | 6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify. | Completion of Intervention (Typically Month 3-4) | 
| Trauma Symptoms of Discrimination Scale (TSDS) at Baseline | 21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms. | Baseline (Day 1) | 
| Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention | 21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms. | Completion of Intervention (Typically Month 3-4) |