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Readiness Outcomes Affecting Return to Sport 3.0

NCT07476430 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-17

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Matthew D Milewski, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2028-06-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476430 on ClinicalTrials.gov