Readiness Outcomes Affecting Return to Sport 3.0 (ROAR 3)

March 12, 2026 updated by: Matthew Milewski, Boston Children's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Boston Children's Waltham
        • Contact:
        • Principal Investigator:
          • Matthew D. Milewski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mental Skills Training (MST) Cohort
This group will receive MST. The enrollment will be randomized by the treating surgeon.
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
No Intervention: Non-MST Cohort
This cohort will not receive mental skills training. The enrollment will be randomized by treating surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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

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.
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.
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.
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.
A questionnaire to screen children for Post-Traumatic Stress Disorder (PTSD). Scored on a 65-point scale, where >30 indicates PTSD symptoms.
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.
A questionnaire to measure anxiety severity. Scored on a 21-point scale, where higher scores indicate greater states of anxiety.
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.
A questionnaire to measure depression severity. Scored on a 27-point scale, where higher scores indicate greater states of depression.
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.
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.
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.
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.
The Pedi-IKDC will be administered preoperatively (baseline) and at 6 months, 9 months, 1 year, and 2 years postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Matthew D Milewski, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-P00052897
  • 1579291 (Other Grant/Funding Number: Pediatric Orthopaedic Society of North America)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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