Considering Racial and Acculturation Stress in Addressing Trauma

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

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

Study Overview

• Status: Recruiting
• Conditions: Trauma-related PTSD
• Intervention / Treatment: Behavioral: Trauma Focused CBT (TF-CBT); Behavioral: Trauma Systems therapy (TST)

• Study Type: Interventional
• Enrollment (Estimated): 475
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron Reliford; Phone Number: 646-594-8895; Email: Aaron.reliford@nyulangone.org
• Study Contact Backup: Name: Yessenia Mejia; Email: Yessenia.mejia@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trauma Focused CBT (TF-CBT); Patients and families randomized to engage in TF-CBT.	Behavioral: Trauma Focused CBT (TF-CBT); 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.
Experimental: Trauma Systems therapy (TST); Patients and families randomized to engage in TST.	Behavioral: Trauma Systems therapy (TST); 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.

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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA)
• Investigators: Principal Investigator: Aaron Reliford, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 23-00094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Shared only with study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No