Readiness Outcomes Affecting Return to Sport 3.0
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Athletic Coping Skills Inventory (ACSI-28)
研究概览
简要总结
The primary aim is to determine if MST will improve coping skills in young athletes returning to sport after ACLR as measured by ACSI-28. Participants will undergo MST led by masters-level mental skills specialist pre-operatively, 3 months, 6 months, and 9 months post-operatively. Power analysis suggested at least 52 pairs are needed (α=0.05, β=0.80). There will be 65 patients enrolled in both the MST group and the control group (no MST) for a total of 130 patients. This will allow for a 4-point difference in ACSI and a 20% dropout rate.
The secondary aim is to determine if MST will improve psychological readiness and athletic identity as well as decrease psychological stress, anxiety, depression, and PTSD symptoms of young athletes returning to sport after ACLR as measured by ACL-RSI, AIMS, PROMIS-PSE, GAD-7, PHQ-9, and CRIES, respectively.
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
- None
入排标准
- 年龄范围
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a complete ACL tear
- •Undergoing ACL reconstruction at Boston Children's Hospital by a study-participating surgeon
- •Age at time of surgery between 8 and <=25
- •English-speaking patient
排除标准
- •Previous ACL tear
- •Torn MCL, LCL, or PCL that require reconstruction in addition to ACL
- •Non-English speaking patient/family
- •Lack of intention to return to sports/sporting activities
研究组 & 干预措施
Mental Skills Training (MST) Cohort
This group will receive MST. The enrollment will be randomized by the treating surgeon.
干预措施: Mental Skills Training (MST) (Behavioral)
Non-MST Cohort
This cohort will not receive mental skills training. The enrollment will be randomized by treating surgeon.
结局指标
主要结局
Athletic Coping Skills Inventory (ACSI-28)
时间窗: The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.
A questionnaire to assess the psychological skills and coping strategies employed by athletes. Scored on a 28-point scale, where higher scores indicate a greater ability to cope.
次要结局
- The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI)(The ACL-RSI will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.)
- The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS)(The Pedi-FABS will be assessed at baseline, 6 months, 9 months, 1 year, and 2 years)
- PROMIS Psychological Stress Experiences (PROMIS-PSE)(The PROMIS-PSE will be assessed at baseline, 3 months, 6 months, 9 months, 1 year, and 2 years.)
- Child Revised Impact of Events Scale (CRIES)(The CRIES will be administered preoperatively (baseline), 3 months, and 6 months.)
- General Anxiety Disorder-7 (GAD-7)(The GAD-7 will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.)
- Patient Health Questionnaire-9 (PHQ-9)(The PHQ-9 will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.)
- Athletic Identity Measurement Scale (AIMS)(The AIMS will be administered preoperatively (baseline) and at 1 year and 2 years postoperatively.)
- International Knee Documentation Committee (IKDC) or the Pedi-IKDC(The Pedi-IKDC will be administered preoperatively (baseline) and at 6 months, 9 months, 1 year, and 2 years postoperatively.)
研究者
Matthew Milewski
Orthopedic Surgeon
Boston Children's Hospital