Trauma-related PTSDNCT05974176
Considering Racial and Acculturation Stress in Addressing Trauma
A study testing Trauma Focused CBT (TF-CBT) and Trauma Systems therapy (TST) in people with Trauma-related PTSD, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Trauma-related PTSD
- What is being tested?
- Trauma Focused CBT (TF-CBT) and Trauma Systems therapy (TST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Individual with intellectual disability with an IQ<70
- Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yessenia Mejia contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: 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
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
- Being tested
- Trauma Focused CBT (TF-CBT), Trauma Systems therapy (TST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Focused CBT (TF-CBT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Trauma Focused CBT (TF-CBT) | Experimental | Patients and families randomized to engage in TF-CBT. Receives: Behavioral: Trauma Focused CBT (TF-CBT) |
| Trauma Systems therapy (TST) | Experimental | Patients and families randomized to engage in TST. Receives: Behavioral: Trauma Systems therapy (TST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Completion of Intervention (Typically Month 3-4)
Secondary outcomes (8)
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.
Measured: Baseline (Day 1)
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.
Measured: Completion of Intervention (Typically Month 3-4)
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.
Measured: Baseline (Day 1)
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.
Measured: Completion of Intervention (Typically Month 3-4)
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.
Measured: Baseline (Day 1)
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.
Measured: Completion of Intervention (Typically Month 3-4)
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.
Measured: Baseline (Day 1)
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.
Measured: Completion of Intervention (Typically Month 3-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma-related PTSDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Sponsor
- Investigators
- Aaron Reliford, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974176
- Sponsor's protocol ID
- 23-00094
- Status last verified
- May 2026
- First submitted
- 26 Jul 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Shared only with study team.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05974176
- Acronym / sponsor ID
- 23-00094
- Conditions
- Trauma-related PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma Focused CBT (TF-CBT) | Experimental | Behavioral: Trauma Focused CBT (TF-CBT)Patients and families randomized to engage in TF-CBT. |
| Trauma Systems therapy (TST) | Experimental | Behavioral: Trauma Systems therapy (TST)Patients and families randomized to engage in TST. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Individual with intellectual disability with an IQ<70
- Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Trauma Focused CBT (TF-CBT) |
| 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. | Behavioural | Trauma Systems therapy (TST) |
Primary outcome
Child and Adolescent Trauma Screen (CATS) Score at Baseline
Time frame: Baseline (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 Intervention
Time frame: Completion 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.
8 secondary outcomes
Acculturative Stress Scale (SAFE) Score at Baseline
Time frame: Baseline (Day 1)
SAFE Score at Completion of Intervention
Time frame: Completion of Intervention (Typically Month 3-4)
Bidimensional Acculturation Scale (BAS) Score at Baseline
Time frame: Baseline (Day 1)
BAS Score at Completion of Intervention
Time frame: Completion of Intervention (Typically Month 3-4)
Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline
Time frame: Baseline (Day 1)
Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention
Time frame: Completion of Intervention (Typically Month 3-4)
Trauma Symptoms of Discrimination Scale (TSDS) at Baseline
Time frame: Baseline (Day 1)
Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention
Time frame: Completion of Intervention (Typically Month 3-4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. Shared only with study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yessenia Mejia contact
Aaron Reliford principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Focused CBT (TF-CBT) and Trauma Systems therapy (TST) in people with Trauma-related PTSD, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Reliford (646-594-8895, Aaron.reliford@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Adolescent Trauma Screen (CATS) Score at Baseline (time frame: Baseline (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.