Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Stress Disorders, Posttraumatic Clinical Trial

Official title:

Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451282
• Other study ID #: 2006-9-4974
• Secondary ID: R49CE000987-01
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2007
• Last updated: April 2, 2015
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: April 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Posttraumatic
• Stress Disorders, Traumatic

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kassam-Adams N, García-España 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptoms in Children 6 Weeks Post-injury	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.	6 weeks	No
Primary	PTSD Symptoms in Children 6 Months Post-injury	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.	6 months	No
Secondary	Depression Symptoms in Children 6 Wks Post-injury	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.	6 weeks	No
Secondary	Depression Symptoms in Children 6 Mos Post-injury	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.	6 months	No
Secondary	Health-related Quality of Life 6 Weeks and 6 Months Post-injury	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.	6 months	No
Secondary	Adherence With Medical Discharge Instructions	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.	6 months	No
Secondary	Health Service Utilization Over the 6 Months Post-injury	Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.	6 months	No