Trauma Clinical Trial - Helping Children With Trauma

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02737488
Study type	Interventional
Source	New York University School of Medicine
Contact
Status	Terminated
Phase	Phase 3
Start date	February 1, 2016
Completion date	February 1, 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated	`NCT03781817` - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures	Phase 4
Completed	`NCT04342416` - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women	N/A
Recruiting	`NCT04856449` - DBT Skills Plus EMDR for BPD and Trauma	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT05669313` - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting	`NCT03622632` - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting	`NCT04725721` - Testing FIRST in Youth Outpatient Psychotherapy	N/A
Active, not recruiting	`NCT05530642` - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Not yet recruiting	`NCT03696563` - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS	N/A
Withdrawn	`NCT03249129` - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed	`NCT02240732` - Surgical Tourniquets and Cerebral Emboli	N/A
Completed	`NCT02227979` - Effects of PURPLE Cry Intervention	N/A
Withdrawn	`NCT01169025` - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients	N/A
Recruiting	`NCT01812941` - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients	N/A
Completed	`NCT01475344` - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)	Phase 1/Phase 2
Completed	`NCT03112304` - Child STEPS for Youth Mental Health in Maine Sustainability	N/A
Completed	`NCT01210417` - Trauma Heart to Arm Time	N/A
Completed	`NCT01201863` - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy	Phase 4