Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury - Full Text View

Sponsors and Collaborators:	Children's Hospital of Philadelphia Centers for Disease Control and Prevention
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00451282

Purpose

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 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.

Condition	Intervention	Phase
Stress Disorders, Posttraumatic	Behavioral: stepped preventive care	Phase III

MedlinePlus related topics: Depression Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	270
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)

Arms	Assigned Interventions
1: Experimental 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 CBT beginning at 4-6 weeks post-injury if needed.

Arms

Assigned Interventions

1: Experimental

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 CBT beginning at 4-6 weeks post-injury if needed.

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

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 GCS <= 12
child's injury involved family violence or abuse (physical or sexual)
no parent or guardian available to consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451282

Locations

United States, Pennsylvania
Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristen Kohser kohser@email.chop.edu
Principal Investigator: Nancy Kassam-Adams, PhD

Sponsors and Collaborators

Children's Hospital of Philadelphia

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Nancy Kassam-Adams, PhD

Center for Injury Research and Prevention, Children's Hospital of Philadelphia

More Information

Responsible Party:	Children's Hospital of Philadelphia ( Nancy Kassam-Adams / Principal Investigator )
Study ID Numbers:	2006-9-4974, R49-CE000987-01
Study First Received:	March 22, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00451282
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on January 14, 2009