Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- PTSD Symptoms in Children 6 Months Post-injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: stepped preventive care (Behavioral)
Treatment as usual
Medical and psychosocial care per usual hospital protocols, which may include social work support.
结局指标
主要结局
PTSD Symptoms in Children 6 Months Post-injury
时间窗: 6 months
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.
PTSD Symptoms in Children 6 Weeks Post-injury
时间窗: 6 weeks
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.
次要结局
- Depression Symptoms in Children 6 Wks Post-injury(6 weeks)
- Health-related Quality of Life 6 Weeks and 6 Months Post-injury(6 months)
- Depression Symptoms in Children 6 Mos Post-injury(6 months)
- Adherence With Medical Discharge Instructions(6 months)
- Health Service Utilization Over the 6 Months Post-injury(6 months)