Back to resultsConsidering Racial and Acculturation Stress in Addressing Trauma
Primary Purpose
Trauma-related PTSD
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Focused CBT (TF-CBT)
Trauma Systems therapy (TST)
Sponsored by
About this trial
This is an interventional treatment trial for Trauma-related PTSD
Eligibility Criteria
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Trauma Focused CBT (TF-CBT)
Trauma Systems therapy (TST)
Arm Description
Patients and families randomized to engage in TF-CBT.
Patients and families randomized to engage in TST.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05974176
First Posted
July 26, 2023
Last Updated
September 27, 2023
Sponsor
NYU Langone Health
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
1. Study Identification
Unique Protocol Identification Number
NCT05974176
Brief Title
Considering Racial and Acculturation Stress in Addressing Trauma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
August 1, 2027 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Substance Abuse and Mental Health Services Administration (SAMHSA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma-related PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
475 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trauma Focused CBT (TF-CBT)
Arm Type
Experimental
Arm Description
Patients and families randomized to engage in TF-CBT.
Arm Title
Trauma Systems therapy (TST)
Arm Type
Experimental
Arm Description
Patients and families randomized to engage in TST.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Focused CBT (TF-CBT)
Intervention Description
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
Intervention Name(s)
Trauma Systems therapy (TST)
Intervention Description
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 Information:
Title
Child and Adolescent Trauma Screen (CATS) Score at Baseline
Description
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)
Title
CATS Score at Completion of Intervention
Description
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 Outcome Measure Information:
Title
Acculturative Stress Scale (SAFE) Score at Baseline
Description
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)
Title
SAFE Score at Completion of Intervention
Description
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)
Title
Bidimensional Acculturation Scale (BAS) Score at Baseline
Description
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)
Title
BAS Score at Completion of Intervention
Description
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)
Title
Multi-Group Ethnic Identity Measure (MEIM-6) Score at Baseline
Description
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)
Title
Multi-Group Ethnic Identity Measure (MEIM-6) Score at Completion of Intervention
Description
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)
Title
Trauma Symptoms of Discrimination Scale (TSDS) at Baseline
Description
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)
Title
Trauma Symptoms of Discrimination Scale (TSDS) at Completion of Intervention
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Reliford
Phone
646-594-8895
Email
Aaron.reliford@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Yessenia Mejia
Email
Yessenia.mejia@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Reliford
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Shared only with study team.
Learn more about this trial
Considering Racial and Acculturation Stress in Addressing Trauma
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