Considering Racial and Acculturation Stress in Addressing Trauma

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05974176
Collaborator
Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed)
475
1
2
49
9.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trauma Focused CBT (TF-CBT)
  • Behavioral: Trauma Systems therapy (TST)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
475 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trauma Focused CBT (TF-CBT)

Patients and families randomized to engage in TF-CBT.

Behavioral: 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.

Experimental: Trauma Systems therapy (TST)

Patients and families randomized to engage in TST.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Child and Adolescent Trauma Screen (CATS) Score at Baseline [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.

  2. CATS Score at Completion of Intervention [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.

Secondary Outcome Measures

  1. Acculturative Stress Scale (SAFE) Score at Baseline [Baseline (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.

  2. SAFE Score at Completion of Intervention [Completion 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.

  3. Bidimensional Acculturation Scale (BAS) Score at Baseline [Baseline (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.

  4. BAS Score at Completion of Intervention [Completion 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.

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
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:
  • Individual with intellectual disability with an IQ<70

  • Individual with active suicidality, homicidality, or other symptoms at the time of enrollment that warrants hospitalization

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Investigators

  • Principal Investigator: Aaron Reliford, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05974176
Other Study ID Numbers:
  • 23-00094
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023