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Helping Children With Trauma

Primary Purpose

Trauma, Post-Traumatic Stress Disorder

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Trauma Systems Therapy (TST)
Treatment as Usual (TAU)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Therapy, Trauma Systems Therapy

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between the ages of 7 and 17.
  • Have experienced a trauma and have symptoms of that trauma for more than 1 month
  • Have a legal guardian who is willing to give consent and a primary caregiver who will be available for assessments.

Exclusion Criteria:

  • Reside outside the study area
  • Currently participating in another study
  • Do not speak English
  • Receive psychotherapy elsewhere
  • Have a sibling already participating in the study
  • Are acutely suicidal or homicidal
  • Demonstrate they are in immediate danger
  • Legal guardian does not give consent
  • If the primary caregiver does not speak English, does not have consistent access to a telephone, does not have the capacity to answer questions, the child will be excluded.
  • If a potential subject has started, stopped, or changed a psychotropic medication within 2 weeks of their intake appointment. If the family is willing to wait for 2 weeks the participant may then be eligible.

Sites / Locations

  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TST

TAU Group

Arm Description

Outcomes

Primary Outcome Measures

UCLA-Post Traumatic Stress Disorder-Reaction Index-DSM-IV (UCLA-PTSD-RI-DSM-IV)
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Child Stress Disorder Checklist (CSDC)
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2016
Last Updated
March 30, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02737488
Brief Title
Helping Children With Trauma
Official Title
Helping Children With Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
February 1, 2016 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate if a trauma treatment called Trauma Systems Therapy (TST) decreases children's mental health symptoms (such as acting out, not controlling their emotions, etc.) as a result of a traumatic event (or events). A traumatic event or events can include experiencing or witnessing violence, excessive bullying, war, car accident, serious injury, getting mistreated or anything else that makes one feel scared or frightened. Children/teens who experience traumatic events have been shown to be at higher risk of poor mental and physical health. Trauma can impact family life, school life and interpersonal relationships well into adulthood. Unfortunately, most children who have experienced traumatic events do not undergo treatment. Although promising treatments do exist, most do not address the complexity of trauma, particularly related to ongoing stress and threats to safety in their environments. One hundred and twenty eligible youth will be randomized to receive either treatment with TST at NYU's Child Study Center or trauma treatment as usual (TAU) at a community mental health clinic. It is hypothesized that: Youth receiving TST will demonstrate a greater decrease in Post-Traumatic Stress Disorder (PTSD) symptoms at the 3, 6, and 9-month follow-up assessments compared to youth receiving treatment as usual (TAU) in the community. Youth receiving TST will demonstrate a greater decrease in symptoms of depression, anxiety and problem behaviors (aggression, violence, self-destructive behaviors, etc.) at the 3-, 6- and 9-month follow-up assessments compared to youth receiving TAU. Youth receiving TST will have fewer acute mental health service events, such as psychiatric hospitalizations and ED visits compared to youth receiving TAU. Greater fidelity to the TST model is associated with better treatment outcomes among youth receiving TST.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Post-Traumatic Stress Disorder
Keywords
Therapy, Trauma Systems Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TST
Arm Type
Experimental
Arm Title
TAU Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Trauma Systems Therapy (TST)
Intervention Description
Treatment will be delivered by clinicians and trainees working at the CSC who have been trained in delivering TST. Participants who begin treatment in the safety-focused phase will have their treatment sessions in their homes. Whenever a child enters a different phase of treatment, he or she will go to the site for office visits. At the beginning of treatment, TST clinicians will do a brief diagnostic assessment. All documentation that is completed by the clinician as part of TST treatment at the NYU Langone Medical Center will be documented using Epic, a standard of care integrated health information system for patient safety. Although we are not providing the CSC's standard of care in this study,we are replicating standard care as TST is standard care in other settings. Providing medication is part of standard TST treatment and conforms to good usual practice integrated with psychotherapy. Medication will not be prescribed for research purposes.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Youth in the control group will be referred to a mental health clinic in close proximity to their residence, in order to receive an evaluation and trauma treatment as usually provided. It cannot be specifically determined, in advance, the nature of this treatment. The clinics will be contacted after the family enrolls to determine if there was a specific protocol followed. An NYU CSC research coordinator will contact the clinic and assist in scheduling the subject's first visit. Families who do not enroll in any community treatment or dropout of treatment will be followed according to the research protocol for data collection. At the 3, 6, and 9 month assessments, the research coordinator will request the patient's records from the community treatment clinic they are attending in order to track and keep record of the youth's treatment modality, progress, and visit frequency.
Primary Outcome Measure Information:
Title
UCLA-Post Traumatic Stress Disorder-Reaction Index-DSM-IV (UCLA-PTSD-RI-DSM-IV)
Description
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Time Frame
9 Months
Title
Child Stress Disorder Checklist (CSDC)
Description
The primary outcome (PTSD symptom severity) will be collected at 3, 6 and 9 months post-randomization in addition to baseline. The effect of TST compared with TAU will be evaluated based on mixed effects model for longitudinal data.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the ages of 7 and 17. Have experienced a trauma and have symptoms of that trauma for more than 1 month Have a legal guardian who is willing to give consent and a primary caregiver who will be available for assessments. Exclusion Criteria: Reside outside the study area Currently participating in another study Do not speak English Receive psychotherapy elsewhere Have a sibling already participating in the study Are acutely suicidal or homicidal Demonstrate they are in immediate danger Legal guardian does not give consent If the primary caregiver does not speak English, does not have consistent access to a telephone, does not have the capacity to answer questions, the child will be excluded. If a potential subject has started, stopped, or changed a psychotropic medication within 2 weeks of their intake appointment. If the family is willing to wait for 2 weeks the participant may then be eligible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Saxe, MD
Organizational Affiliation
Glenn.Saxe@nyumc.org
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Helping Children With Trauma

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