Phase 3
N=85
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Stress Disorders, Posttraumatic
Bottom Line
View on ClinicalTrials.gov: NCT00451282 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: PTSD Symptoms in Children 6 Weeks Post-injury — 12.6; 13.6 Units on a scale — p=.69
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- stepped preventive care (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Symptoms in Children 6 Weeks Post-injury |
12.6; 13.6 | .69 |
| PRIMARY PTSD Symptoms in Children 6 Months Post-injury |
12.6; 12.2 | .89 |
| SECONDARY Depression Symptoms in Children 6 Wks Post-injury |
15.0; 14.0 | .69 |
| SECONDARY Depression Symptoms in Children 6 Mos Post-injury |
15.6; 11.6 | .18 |
| SECONDARY Health-related Quality of Life 6 Weeks and 6 Months Post-injury |
— | — |
| SECONDARY Adherence With Medical Discharge Instructions |
— | — |
| SECONDARY Health Service Utilization Over the 6 Months Post-injury |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00451282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.