Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07476430

Readiness Outcomes Affecting Return to Sport 3.0

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ACL Reconstruction

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Waltham

Waltham, Massachusetts, 02453, United States

Location contact

Angelina M Sala, BS

CONTACT

[email protected]

720-340-6205

Matthew D. Milewski, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelina M Sala, BS

CONTACT

[email protected]

720-340-6205

Dai M Sugimoto, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Acronym: ROAR 3

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.