Care for Post-Concussive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in Depressive Symptoms
研究概览
简要总结
The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages 11 and 18
- •Have sustained a head impact during sports participation
- •Have incurred an onset or increase of at least three post-concussive symptoms following head impact
- •Have increased post-concussive symptoms following head impact have continued for at least 4 weeks
- •Live with their parents or legal guardians
- •Live within commuting distance of Seattle Children's Hospital
- •Willing to participate in assessment and treatment
- •Have at least one parent/caregiver willing to participate in assessment and treatment
排除标准
- •Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
- •Active suicidality
- •Substance dependence
研究组 & 干预措施
Experimental
Stepped Care
干预措施: Stepped Care (Behavioral)
Control
Usual Care
结局指标
主要结局
Change in Depressive Symptoms
时间窗: At enrollment, 1 month, 3 months, and 6 months
PHQ-9
Change in Concussion Symptoms
时间窗: At enrollment, 1 month, 3 months, and 6 months
Health Behavior Inventory Assessment
Change in Anxiety Symptoms
时间窗: At enrollment, 1 month, 3 months, and 6 months
PROMIS A-8
Change in Quality of Life
时间窗: At enrollment, 1 month, 3 months, and 6 months
PedsQL
次要结局
- Change in King-Devick Test(at enrollment and 6 months)
- Change in School Functioning(At enrollment, 1 month, 3 months, and 6 months)
- Change in Parent Depressive Symptoms(At enrollment, 1 month, 3 months, and 6 months)
- Change in Family Functioning(At enrollment, 1 month, 3 months, and 6 months)
- Change in Parent Anxiety Symptoms(At enrollment, 1 month, 3 months, and 6 months)
- Change in ImPACT Assessment(At enrollment and 6 months)
- NIH Toolbox - Dimensional Card Sort Test(At enrollment and 6 months)
- Change in NIH Toolbox - Picture Memory Sequence Test(At enrollment and 6 months)
研究者
Fred Rivara
Seattle Children's Guild Endowed Chair in Pediatrics
Seattle Children's Hospital