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Clinical Trials/NCT05974176
NCT05974176
Recruiting
N/A

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

NYU Langone Health1 site in 1 country237 target enrollmentJuly 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Trauma-related PTSD
Sponsor
NYU Langone Health
Enrollment
237
Locations
1
Primary Endpoint
Child and Adolescent Trauma Screen (CATS) Score at Baseline
Status
Recruiting
Last Updated
9 months ago

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

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
August 1, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Child and Adolescent Trauma Screen (CATS) Score at Baseline

Time Frame: Baseline (Day 1)

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.

CATS Score at Completion of Intervention

Time Frame: Completion of Intervention (Typically Month 3-4)

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.

Secondary Outcomes

  • Acculturative Stress Scale (SAFE) Score at Baseline(Baseline (Day 1))
  • Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention(Completion of Intervention (Typically Month 3-4))
  • SAFE Score at Completion of Intervention(Completion of Intervention (Typically Month 3-4))
  • Trauma Symptoms of Discrimination Scale (TSDS) at Baseline(Baseline (Day 1))
  • Bidimensional Acculturation Scale (BAS) Score at Baseline(Baseline (Day 1))
  • Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline(Baseline (Day 1))
  • Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention(Completion of Intervention (Typically Month 3-4))
  • BAS Score at Completion of Intervention(Completion of Intervention (Typically Month 3-4))

Study Sites (1)

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