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RecruitingNCT05974176Updated May 29, 2026

Considering Racial and Acculturation Stress in Addressing Trauma

An interventional study of Trauma Focused CBT (TF-CBT) and Trauma Systems therapy (TST) in Trauma-related PTSD, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
237
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
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Study 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

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Conditions studied

  • Trauma-related PTSD
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In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
237 participants (estimated)

Study arms

  • Experimental
    Trauma Focused CBT (TF-CBT)

    Patients and families randomized to engage in TF-CBT.

    Behavioral: Trauma Focused CBT (TF-CBT)

  • Experimental
    Trauma Systems therapy (TST)

    Patients and families randomized to engage in TST.

    Behavioral: Trauma Systems therapy (TST)

Interventions

  • BehavioralTrauma 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.

  • BehavioralTrauma 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (Day 1)

  2. 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.

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

Secondary outcomes

  1. Acculturative Stress Scale (SAFE) Score at Baseline

    SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress.

    Time frame: Baseline (Day 1)

  2. SAFE Score at Completion of Intervention

    SAFE is a 24-item assessment of acculturative stress. Items are rated on a scale from 1 (not at all true) to 4 (very true). The total score is the sum of responses and ranges from 24 to 96; higher scores indicate greater levels of acculturative stress.

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

  3. Bidimensional Acculturation Scale (BAS) Score at Baseline

    BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation.

    Time frame: Baseline (Day 1)

  4. BAS Score at Completion of Intervention

    BAS is a 24-item assessment of bidimensional acculturation. Items are rated on a 4-point scale. The total score is the sum of responses and ranges from 24 to 96; higher scores indicate higher levels of bidimensional acculturation.

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

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

    6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify.

    Time frame: Baseline (Day 1)

  6. Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention

    6-item questionnaire to assess the degree of ethnic identity among adolescents. Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The total score is the sum of responses and ranges from 6 to 30; higher scores indicate greater ethnic identify.

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

  7. Trauma Symptoms of Discrimination Scale (TSDS) at Baseline

    21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms.

    Time frame: Baseline (Day 1)

  8. Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention

    21-item questionnaire assessing trauma symptoms of discrimination. Each item is rated on a scale from 1 (never) to 4 (often). The total score is the sum of responses and ranges from 21 to 84; higher scores indicate greater symptoms.

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

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Study locations

1 of 1 sites recruiting
  • NYU Langone Health
    New York, New York 10016, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No — Shared only with study team.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05974176
Lead sponsor
NYU Langone Health
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
Responsible party
Sponsor
First posted
Aug 3, 2023
Start date
Jul 1, 2023
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
May 29, 2026

Study contacts

Aaron Reliford
Contact
Aaron.reliford@nyulangone.org
646-594-8895
Yessenia Mejia
Contact
Yessenia.mejia@nyulangone.org
Aaron Reliford
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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