Readiness Outcomes Affecting Return to Sport 3.0

Overview

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.

Interventions

• Behavioral Mental Skills Training (MST)
  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

Primary outcome measures

• Athletic Coping Skills Inventory (ACSI-28) [Time frame: The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.]

Secondary outcome measures (8)

• The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI) [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) [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) [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) [Time frame: The CRIES will be administered preoperatively (baseline), 3 months, and 6 months.]
• General Anxiety Disorder-7 (GAD-7) [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) [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) [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 [Time frame: The Pedi-IKDC will be administered preoperatively (baseline) and at 6 months, 9 months, 1 year, and 2 years postoperatively.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Boston Children's Waltham — Waltham

Publications

• Griffith K, O'Brien K, McGurty S, Miller P, Christino MA. The Efficacy of a Mental Skills Training Course for Collegiate Athletes. J Athl Train. 2024 Jul 1;59(7):772-778. doi: 10.4085/1062-6050-0533.22. PMID 38014800
• Mercurio AM, Scott EJ, Sugimoto D, Christino MA, Coene RP, Gossman EC, Cook DL, Kocher MS, Kramer DE, Yen YM, Micheli LJ, Milewski MD. Assessing the Impact of Psychological Readiness on Performance and Symmetry in Functional Testing After ACL Reconstruction in Pediatric and Adolescent Patients. Orthop J Sports Med. 2024 Sep 27;12(9):23259671241274768. doi: 10.1177/23259671241274768. eCollection 20 PMID 39359482
• McPherson AL, Feller JA, Hewett TE, Webster KE. Psychological Readiness to Return to Sport Is Associated With Second Anterior Cruciate Ligament Injuries. Am J Sports Med. 2019 Mar;47(4):857-862. doi: 10.1177/0363546518825258. Epub 2019 Feb 12. PMID 30753794
• Milewski MD, Traver JL, Coene RP, Williams K, Sugimoto D, Kramer DE, Kocher MS, Micheli LJ, Yen YM, Christino MA. Effect of Age and Sex on Psychological Readiness and Patient-Reported Outcomes 6 Months After Primary ACL Reconstruction. Orthop J Sports Med. 2023 Jun 9;11(6):23259671231166012. doi: 10.1177/23259671231166012. eCollection 2023 Jun. PMID 37332533
• Linver MR, Roth JL, Brooks-Gunn J. Patterns of adolescents' participation in organized activities: are sports best when combined with other activities? Dev Psychol. 2009 Mar;45(2):354-67. doi: 10.1037/a0014133. PMID 19271824
• Hansen DML, R.W.; Dworkin, J.B.;. What Adolescents Learn in Organized Youth Activities: A Survey of Self-Reported Developmental Experiences. J of Research on Adolescence. 2003;13(1):25-55.
• Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98. PMID 23945179
• Christino MA, Coene RP, Williams KA, Daley M, Ackerman KE, Stracciolini A, Kramer DE. Athletic Identity Associations in Young Sports Medicine Patients. J Am Acad Orthop Surg Glob Res Rev. 2024 Sep 16;8(9):e24.00195. doi: 10.5435/JAAOSGlobal-D-24-00195. eCollection 2024 Sep 1. PMID 39284016

Identifiers

NCT: NCT07476430 · IRB-P00052897 · 1579291

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗