Readiness Outcomes Affecting Return to Sport 3.0
ConditionACL Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-25
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mental Skills Training (MST)
BehavioralMental 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
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: Mental Skills Training (MST) CohortExperimental treatment 1 intervention
Group B: Non-MST CohortNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Athletic Coping Skills Inventory (ACSI-28)
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.
Time frame
The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.Secondary outcomes
1
The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI)
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.
Time frame
The ACL-RSI will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.2
The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS)
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.
Time frame
The Pedi-FABS will be assessed at baseline, 6 months, 9 months, 1 year, and 2 years3
PROMIS Psychological Stress Experiences (PROMIS-PSE)
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.
Time frame
The PROMIS-PSE will be assessed at baseline, 3 months, 6 months, 9 months, 1 year, and 2 years.4
Child Revised Impact of Events Scale (CRIES)
A questionnaire to screen children for Post-Traumatic Stress Disorder (PTSD). Scored on a 65-point scale, where \>30 indicates PTSD symptoms.
Time frame
The CRIES will be administered preoperatively (baseline), 3 months, and 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: