Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT05974176

Conditions

Trauma-related PTSD

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Trauma Focused CBT (TF-CBT)

Trauma Systems therapy (TST)

Study Details

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

Study ID

NCT05974176

Start date

Jul 1, 2023

Status verified date

May, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

237 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trauma Focused CBT (TF-CBT)

Patients and families randomized to engage in TF-CBT.

experimental: Trauma Systems therapy (TST)

Patients and families randomized to engage in TST.

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Aaron Reliford

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

Yessenia Mejia

Yessenia.mejia@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-29.