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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: Clinical Trial Phase 3 study, sponsored by NYU Langone Health.
NCT02737488 is a Phase 3 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT02737488 stopped before completion
NCT02737488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual (TAU) is the first listed.
NCT02737488 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02737488's enrollment target sits among peer trials
14 1983rd of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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