Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02737488 · ClinicalTrials.gov registry record · Phase 3
Helping Children With Trauma
A Phase 3 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 3
- Development phase
- 14
- Enrollment target
NCT02737488 is a Phase 3 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 14 participants.
The verdict
NCT02737488, a Phase 3 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 14 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Treatment as Usual (TAU)
- BEHAVIORAL Trauma Systems Therapy (TST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02737488
The ClinicalTrials.gov registry entry for NCT02737488 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual (TAU) is the first listed.
NCT02737488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02737488 about?
NCT02737488 is a clinical study titled "Helping Children With Trauma". 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...
What is the current status of trial NCT02737488?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2016-02-01. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT02737488?
The interventions under investigation include: Treatment as Usual (TAU) (BEHAVIORAL), Trauma Systems Therapy (TST) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02737488?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.