Considering Racial and Acculturation Stress in Addressing Trauma

NCT ID: NCT05974176

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2027-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Trauma-related PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trauma Focused CBT (TF-CBT)

Patients and families randomized to engage in TF-CBT.

Group Type EXPERIMENTAL

Trauma Focused CBT (TF-CBT)

Intervention Type 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 Systems therapy (TST)

Patients and families randomized to engage in TST.

Group Type EXPERIMENTAL

Trauma Systems therapy (TST)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Reliford

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aaron Reliford

Role: CONTACT

646-594-8895

Yessenia Mejia

Role: CONTACT

Other Identifiers

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23-00094

Identifier Type: -

Identifier Source: org_study_id

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