Pediatric Injury: Modules to Manage Medical Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 6
- 主要终点
- Child PTSD Symptom Scale (CPSS)
研究概览
简要总结
This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.
详细描述
As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Investigators will not be aware of study assignment.
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
- •8 years to 17 years at enrollment
- •Treated for an injury in the ED or hospitalized
- •Abbreviated Injury Scale (AIS) score 2 or greater
- •Parent and child English speaking
- •Broad band internet availability at home
- •Residing with parent or legal guardian
排除标准
- •Moderate or severe traumatic brain injury (GCS less than 13)
- •Diagnosed with moderate or severe intellectual disability
- •Pre-existing psychiatric disorder that required hospitalization
- •Abuse or interpersonal injury as mechanism of injury
- •Currently receiving psychotherapy
- •Hospitalized for injury over 30 ays
- •Death of a family member or friend at time of injury
结局指标
主要结局
Child PTSD Symptom Scale (CPSS)
时间窗: 10 weeks post-randomization
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. We used the combined child report and parent report. The highest item score from either parent or child was summed.
次要结局
- Screen for Anxiety Related Emotional Disorders (SCARED)(10 weeks post-randomization)
- Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms(10-weeks post-randomization)
- Pediatric Quality of Life Inventory (PedsQL)(10-weeks)