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Considering Racial and Acculturation Stress in Addressing Trauma

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05974176
Enrollment
237
Registered
2023-08-03
Start date
2023-07-01
Completion date
2027-08-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma-related PTSD

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

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.

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER
Substance Abuse and Mental Health Services Administration (SAMHSA)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Child and Adolescent Trauma Screen (CATS) Score at BaselineBaseline (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 InterventionCompletion 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

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

Countries

United States

Contacts

CONTACTAaron Reliford
Aaron.reliford@nyulangone.org646-594-8895
CONTACTYessenia Mejia
Yessenia.mejia@nyulangone.org
PRINCIPAL_INVESTIGATORAaron Reliford

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026