Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Recruitment status was Active, not recruiting
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.
Stress Disorders, Posttraumatic
Behavioral: stepped preventive care
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury|
- PTSD and depression symptoms in children and parents 6 weeks and 6 months post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Health-related quality of life 6 weeks and 6 months post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Adherence with medical discharge instructions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Health service utilization over the 6 months post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||August 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
receiving Stepped Preventive Care intervention
Behavioral: stepped preventive care
2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451282
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Nancy Kassam-Adams, PhD||Center for Injury Research and Prevention, Children's Hospital of Philadelphia|