Considering Racial and Acculturation Stress in Addressing Trauma

NCT05974176 | Recruiting

• 1 other identifier: 23-00094
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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

Conditions

Trauma-related PTSD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Acculturative Stress Scale (SAFE) Score at Baseline

  Baseline (Day 1)

• SAFE Score at Completion of Intervention

  Completion of Intervention (Typically Month 3-4)

• Bidimensional Acculturation Scale (BAS) Score at Baseline

  Baseline (Day 1)

• BAS Score at Completion of Intervention

  Completion of Intervention (Typically Month 3-4)

• Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline

  Baseline (Day 1)

Study Arms (2)

Trauma Focused CBT (TF-CBT)

EXPERIMENTAL

Patients and families randomized to engage in TF-CBT.

Behavioral: Trauma Focused CBT (TF-CBT)

Trauma Systems therapy (TST)

EXPERIMENTAL

Patients and families randomized to engage in TST.

Behavioral: Trauma Systems therapy (TST)

Interventions

Trauma Focused CBT (TF-CBT) BEHAVIORAL

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.

Trauma Focused CBT (TF-CBT)

Trauma Systems therapy (TST) BEHAVIORAL

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.

Trauma Systems therapy (TST)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Individual with intellectual disability with an IQ\<70
• Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization

Sponsors & Collaborators

• NYU Langone Health: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Aaron Reliford

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Reliford

CONTACT

646-594-8895; Aaron.reliford@nyulangone.org

Yessenia Mejia

CONTACT

Yessenia.mejia@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)