Clinical trial NCT00451282: Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Official title: Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Disorders, Posttraumatic
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-03-23
Enrollment: 290
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 8 to 17
* Admitted to hospital for treatment of unintentional injury
* Sufficient English fluency to participate in an interview
* Family has access to a telephone (for telephone follow-up contacts)

Exclusion criteria:

* Child's medical status or cognitive functioning precludes participating in an interview
* Child has moderate to severe head injury, defined as Glasgow Coma Score (GCS) \<= 12
* Child's injury involved family violence or abuse (physical or sexual)
* No parent or guardian available to consent

Primary outcomes:
measure: PTSD Symptoms in Children 6 Weeks Post-injury
timeFrame: 6 weeks
measure: PTSD Symptoms in Children 6 Months Post-injury
timeFrame: 6 months
Secondary outcomes:
measure: Depression Symptoms in Children 6 Wks Post-injury
timeFrame: 6 weeks
measure: Depression Symptoms in Children 6 Mos Post-injury
timeFrame: 6 months
measure: Health-related Quality of Life 6 Weeks and 6 Months Post-injury
timeFrame: 6 months
measure: Adherence With Medical Discharge Instructions
timeFrame: 6 months
measure: Health Service Utilization Over the 6 Months Post-injury
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Center for Injury Research and Prevention, Children's Hospital of Philadelphia
name: Nancy Kassam-Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kassam-Adams N, Garcia-Espana JF, Marsac ML, Kohser KL, Baxt C, Nance M, Winston F. A pilot randomized controlled trial assessing secondary prevention of traumatic stress integrated into pediatric trauma care. J Trauma Stress. 2011 Jun;24(3):252-9. doi: 10.1002/jts.20640. Epub 2011 May 18.