Readiness Outcomes Affecting Return to Sport 3.0

NCT07476430 | Not Yet Recruiting

• 2 other identifiers: IRB-P000528971579291
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Reconstruction

Keywords

psychological readiness; mental skills training; pediatric; adolescent

Outcome Measures

Primary Outcomes (1)

• 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.

  The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.

Secondary Outcomes (8)

• 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.

Study Arms (2)

Mental Skills Training (MST) Cohort

EXPERIMENTAL

This group will receive MST. The enrollment will be randomized by the treating surgeon.

Behavioral: Mental Skills Training (MST)

Non-MST Cohort

NO INTERVENTION

This cohort will not receive mental skills training. The enrollment will be randomized by treating surgeon.

Interventions

Mental Skills Training (MST) BEHAVIORAL

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

Mental Skills Training (MST) Cohort

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Waltham

Waltham, Massachusetts, 02453, United States

Location

Related Publications (22)

• 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 RESULT

• 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 2024 Sep.

  PMID: 39359482 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  RESULT

• 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 RESULT

• 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 RESULT

• Wright RW, Dunn WR, Amendola A, Andrish JT, Bergfeld J, Kaeding CC, Marx RG, McCarty EC, Parker RD, Wolcott M, Wolf BR, Spindler KP. Risk of tearing the intact anterior cruciate ligament in the contralateral knee and rupturing the anterior cruciate ligament graft during the first 2 years after anterior cruciate ligament reconstruction: a prospective MOON cohort study. Am J Sports Med. 2007 Jul;35(7):1131-4. doi: 10.1177/0363546507301318. Epub 2007 Apr 23.

  PMID: 17452511 RESULT

• Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.

  PMID: 24451111 RESULT

• Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15.

  PMID: 26772611 RESULT

• Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.

  PMID: 21098818 RESULT

• Ardern CL, Osterberg A, Tagesson S, Gauffin H, Webster KE, Kvist J. The impact of psychological readiness to return to sport and recreational activities after anterior cruciate ligament reconstruction. Br J Sports Med. 2014 Dec;48(22):1613-9. doi: 10.1136/bjsports-2014-093842. Epub 2014 Oct 7.

  PMID: 25293342 RESULT

• Birrer D, Morgan G. Psychological skills training as a way to enhance an athlete's performance in high-intensity sports. Scand J Med Sci Sports. 2010 Oct;20 Suppl 2:78-87. doi: 10.1111/j.1600-0838.2010.01188.x.

  PMID: 20840565 RESULT

• Weiss M, Buttner M, Richlan F. The Role of Sport Psychology in Injury Prevention and Rehabilitation in Junior Athletes. Behav Sci (Basel). 2024 Mar 20;14(3):254. doi: 10.3390/bs14030254.

  PMID: 38540557 RESULT

• Podlog LB, S.M.; Wadey, R; Hannon, J.C. Psychological Readiness to Return to Competitive Sport Following Injury: A Qualitative Study. Sport Psychol. 2015;29(1):1-14.

  RESULT

• Langford JL, Webster KE, Feller JA. A prospective longitudinal study to assess psychological changes following anterior cruciate ligament reconstruction surgery. Br J Sports Med. 2009 May;43(5):377-81. doi: 10.1136/bjsm.2007.044818. Epub 2008 Nov 19.

  PMID: 19019910 RESULT

• Johnson U. A Three-Year Follow-Up of Long-Term Injured Competitive Athletes: Influence of Psychological Risk Factors on Rehabilitation. J Sport Rehabil. 1997;6(3):256-271

  RESULT

• Ardern CL, Taylor NF, Feller JA, Whitehead TS, Webster KE. Psychological responses matter in returning to preinjury level of sport after anterior cruciate ligament reconstruction surgery. Am J Sports Med. 2013 Jul;41(7):1549-58. doi: 10.1177/0363546513489284. Epub 2013 Jun 3.

  PMID: 23733635 RESULT

• van Melick N, van Cingel RE, Brooijmans F, Neeter C, van Tienen T, Hullegie W, Nijhuis-van der Sanden MW. Evidence-based clinical practice update: practice guidelines for anterior cruciate ligament rehabilitation based on a systematic review and multidisciplinary consensus. Br J Sports Med. 2016 Dec;50(24):1506-1515. doi: 10.1136/bjsports-2015-095898. Epub 2016 Aug 18.

  PMID: 27539507 RESULT

• Barber-Westin S, Noyes FR. One in 5 Athletes Sustain Reinjury Upon Return to High-Risk Sports After ACL Reconstruction: A Systematic Review in 1239 Athletes Younger Than 20 Years. Sports Health. 2020 Nov/Dec;12(6):587-597. doi: 10.1177/1941738120912846. Epub 2020 May 6.

  PMID: 32374646 RESULT

• McCullough KA, Phelps KD, Spindler KP, Matava MJ, Dunn WR, Parker RD; MOON Group; Reinke EK. Return to high school- and college-level football after anterior cruciate ligament reconstruction: a Multicenter Orthopaedic Outcomes Network (MOON) cohort study. Am J Sports Med. 2012 Nov;40(11):2523-9. doi: 10.1177/0363546512456836. Epub 2012 Aug 24.

  PMID: 22922520 RESULT

Study Officials

• Matthew D Milewski, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelina M Sala, BS

CONTACT

720-340-6205; angie.sala@childrens.harvard.edu

Dai M Sugimoto, PhD

CONTACT

Dai.Sugimoto@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: One cohort will receive mental skills training. The other cohort will not receive mental skills training.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Access Criteria: IPD will be analyzed for the manuscript, and all will be de-identified. This is approximately from the end of the study collection June 2026 to September 2026 for analysis.

Locations

US (1)