Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

NCT00451282 | Completed Phase 3 Results DMC

• 2 other identifiers: 2006-9-4974R49CE000987-01
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Posttraumatic

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Depression Symptoms in Children 6 Wks Post-injury

  6 weeks

• Depression Symptoms in Children 6 Mos Post-injury

  6 months

• Health-related Quality of Life 6 Weeks and 6 Months Post-injury

  6 months

• Adherence With Medical Discharge Instructions

  6 months

• Health Service Utilization Over the 6 Months Post-injury

  6 months

Study Arms (2)

Stepped Preventive Care

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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

Interventions

stepped preventive care BEHAVIORAL

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.

Stepped Preventive Care

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 21594900 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Nancy Kassam-Adams
• Organization: Children's Hospital of Philadelphia

nlkaphd@mail.med.upenn.edu

215-590-3118

Study Officials

• Nancy Kassam-Adams, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: April 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 20, 2015
• Results First Posted: April 20, 2015

Record last verified: 2015-04

Locations

US (1)