Readiness Outcomes Affecting Return to Sport 3.0

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07476430
Status
Not Yet Recruiting

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Conditions

  • ACL Reconstruction

Eligibility Criteria

Sex
ALL
Age
8 Years - 25 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Oct 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's WalthamWalthamMassachusetts02453
Angelina M Sala, BS
[email protected]
720-340-6205
Matthew D. Milewski, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Waltham· Waltham, MA

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