Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 3

Conditions: Stress Disorders, Posttraumatic

Treatments: Behavioral: stepped preventive care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00451282

2006-9-4974

R49CE000987-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

Stepped Preventive Care

Experimental group

Description:

Receiving Stepped Preventive Care intervention - at least 2 brief assessments with nurse and/or social worker (1) during hospital admission , and (2) approximately 2 weeks post-discharge. Additional interventions provided as needed, based on manual.

Treatment:

Behavioral: stepped preventive care

Treatment as usual

No Intervention group

Description:

Medical and psychosocial care per usual hospital protocols, which may include social work support.