Stress Disorders, Posttraumatic Clinical Trial
Official title:
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
This study will evaluate the impact of a brief psychosocial intervention delivered to
children or adolescents who are hospitalized for an unintentional injury. The intervention
is designed to promote psychological recovery and enhance functional outcomes after injury.
The study will also provide preliminary data concerning cost-effectiveness of the
intervention.
The core study hypotheses are that children receiving the intervention will (1) have lower
severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2)
show greater adherence to discharge instructions and better health-related quality of life
at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments
and lower rates of emergency room utilization and re-hospitalization in the 6 months
post-injury, compared to those receiving usual care.
The purpose of this study is to examine the effectiveness of a stepped care model for
prevention of psychosocial distress (especially posttraumatic stress) after injury. The
model includes screening for risk, standard follow-up with those at risk, and additional
evidence-based interventions matched to individual need.
The study will evaluate the impact of the intervention on psychosocial outcomes (PTSD and
depression symptoms); as well as health outcomes (adherence to discharge instructions,
health-related quality of life), and will provide preliminary data to inform
cost-effectiveness analyses by describing the costs of providing the intervention and
examining its impact on subsequent health service utilization.
Study Design: 180 children at risk for persistent psychosocial distress post-injury, based
on a screening assessment, will be randomized to the Stepped Preventive Care intervention or
usual care. An additional comparison group of 90 low risk children will also receive usual
care and be followed for assessment.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00625131 -
Nicotine Patch Pretreatment for Smoking Cessation in PTSD
|
Phase 0 | |
| Completed |
NCT00373698 -
Re-Engineering Systems for the Primary Care Treatment for PTSD
|
Phase 3 | |
| Recruiting |
NCT04651296 -
Compassion Meditation vs. Health Education for Veterans
|
Phase 2 | |
| Completed |
NCT02226367 -
Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD
|
N/A | |
| Completed |
NCT01058031 -
Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans
|
N/A | |
| Completed |
NCT00674570 -
Veteran Stress and Learning Study
|
Phase 4 | |
| Recruiting |
NCT03642028 -
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
|
Phase 4 | |
| Completed |
NCT04002050 -
Creating Resilient Workplaces Study
|
N/A |