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Readiness Outcomes Affecting Return to Sport 3.0

Readiness Outcomes Affecting Return to Sport 3.0

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07476430
Acronym
ROAR 3
Enrollment
130
Registered
2026-03-17
Start date
2026-06-01
Completion date
2028-06-01
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL Reconstruction

Keywords

psychological readiness, mental skills training, pediatric, adolescent

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.

Interventions

BEHAVIORALMental 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

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

One cohort will receive mental skills training. The other cohort will not receive mental skills training.

Eligibility

Sex/Gender
ALL
Age
8 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Athletic Coping Skills Inventory (ACSI-28)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

MeasureTime frameDescription
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.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 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 yearsA 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.
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.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.
Child Revised Impact of Events Scale (CRIES)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.
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.A questionnaire to measure anxiety severity. Scored on a 21-point scale, where higher scores indicate greater states of anxiety.
Patient Health Questionnaire-9 (PHQ-9)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.
Athletic Identity Measurement Scale (AIMS)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.
International Knee Documentation Committee (IKDC) or the Pedi-IKDCThe 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.

Countries

United States

Contacts

CONTACTAngelina M Sala, BS
angie.sala@childrens.harvard.edu720-340-6205
CONTACTDai M Sugimoto, PhD
Dai.Sugimoto@childrens.harvard.edu
PRINCIPAL_INVESTIGATORMatthew D Milewski, MD

Boston Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026