Trial record 1 of 2 for:    "pediatric injury"
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Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00451282
First received: March 22, 2007
Last updated: April 2, 2015
Last verified: April 2015
  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 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.


Condition Intervention Phase
Stress Disorders, Posttraumatic
Behavioral: stepped preventive care
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • PTSD Symptoms in Children 6 Weeks Post-injury [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.

  • PTSD Symptoms in Children 6 Months Post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.


Secondary Outcome Measures:
  • Depression Symptoms in Children 6 Wks Post-injury [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

  • Depression Symptoms in Children 6 Mos Post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

  • Health-related Quality of Life 6 Weeks and 6 Months Post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.

  • Adherence With Medical Discharge Instructions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.

  • Health Service Utilization Over the 6 Months Post-injury [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.


Enrollment: 290
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stepped Preventive Care
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.
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.
No Intervention: Treatment as usual
Medical and psychosocial care per usual hospital protocols, which may include social work support.

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 Glasgow Coma Score (GCS) <= 12
  • Child's injury involved family violence or abuse (physical or sexual)
  • No parent or guardian available to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Nancy Kassam-Adams, PhD Center for Injury Research and Prevention, Children's Hospital of Philadelphia
  More Information

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00451282     History of Changes
Other Study ID Numbers: 2006-9-4974, R49-CE000987-01
Study First Received: March 22, 2007
Results First Received: December 23, 2010
Last Updated: April 2, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 01, 2015