An interventional study of Mental Skills Training (MST) in ACL Reconstruction, sponsored by Boston Children's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 8 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
This group will receive MST. The enrollment will be randomized by the treating surgeon.
Behavioral: Mental Skills Training (MST)
This cohort will not receive mental skills training. The enrollment will be randomized by treating surgeon.
Mental skills training aims to enhance coping strategies, motivation, and confidence. MST has been identified as a potential way to improve an athlete's psychological readiness both prior to injury a
Athletic Coping Skills Inventory (ACSI-28)
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.
Time frame: The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.
The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI)
A questionnaire to measure the psychological impact of returning to sport after ACL reconstruction surgery. Scored on a 100-point scale, where higher score indicates greater psychological readiness to return to sport.
Time frame: 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)
A questionnaire to quantify the activity of children between 10 and 18 years old. Scored on a 30-point scale, where higher scores indicate more physical activity.
Time frame: The Pedi-FABS will be assessed at baseline, 6 months, 9 months, 1 year, and 2 years
PROMIS Psychological Stress Experiences (PROMIS-PSE)
A questionnaire to assess the patient's psychological stress experiences. Scored on a 100-point scale, where 50 is a normative value and higher scores indicate worse psychological stress.
Time frame: 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)
A questionnaire to screen children for Post-Traumatic Stress Disorder (PTSD). Scored on a 65-point scale, where \>30 indicates PTSD symptoms.
Time frame: The CRIES will be administered preoperatively (baseline), 3 months, and 6 months.
General Anxiety Disorder-7 (GAD-7)
A questionnaire to measure anxiety severity. Scored on a 21-point scale, where higher scores indicate greater states of anxiety.
Time frame: 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)
A questionnaire to measure depression severity. Scored on a 27-point scale, where higher scores indicate greater states of depression.
Time frame: 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)
A questionnaire to measure the degree to which an individual's identity is tied to being an athlete. Scored on a 10-point scale, where higher scores indicate stronger identification.
Time frame: The AIMS will be administered preoperatively (baseline) and at 1 year and 2 years postoperatively.
International Knee Documentation Committee (IKDC) or the Pedi-IKDC
A questionnaire to assess the symptoms and function of the knee during daily activities in patients over the age of 18. The Pedi-IKDC is a modified version of the IKDC questionnaire for patients ages 10-18. Scored on a 100-point scale, where higher scores indicate less pain and higher functioning.
Time frame: The Pedi-IKDC will be administered preoperatively (baseline) and at 6 months, 9 months, 1 year, and 2 years postoperatively.
Plan to share: Yes — All IPD that will be shared will be de-identified and for manuscript and publishing purposes only. PHI data will not be accessible outside of the research team, and only de-identified data will be a part of the manuscript.
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