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Recruiting NCT05974176

Considering Racial and Acculturation Stress in Addressing Trauma

No phase Interventional Trauma-related PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trauma Focused CBT (TF-CBT), Trauma Systems therapy (TST).
Who it may be relevant to
Registry conditions: Trauma-related PTSD. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Child and Adolescent Trauma Screen (CATS) Score at Baseline [Time frame: Baseline (Day 1)]
  • CATS Score at Completion of Intervention [Time frame: Completion of Intervention (Typically Month 3-4)]
Secondary outcome measures (8)
  • Acculturative Stress Scale (SAFE) Score at Baseline [Time frame: Baseline (Day 1)]
  • SAFE Score at Completion of Intervention [Time frame: Completion of Intervention (Typically Month 3-4)]
  • Bidimensional Acculturation Scale (BAS) Score at Baseline [Time frame: Baseline (Day 1)]
  • BAS Score at Completion of Intervention [Time frame: Completion of Intervention (Typically Month 3-4)]
  • Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline [Time frame: Baseline (Day 1)]
  • Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention [Time frame: Completion of Intervention (Typically Month 3-4)]
  • Trauma Symptoms of Discrimination Scale (TSDS) at Baseline [Time frame: Baseline (Day 1)]
  • Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention [Time frame: Completion of Intervention (Typically Month 3-4)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05974176 · 23-00094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗