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Study setting {9}

This study will be conducted across three subsidiary hospitals, within a single major metropolitan Australian academic hospital (site details available on ANZ Trial Registry). All patients will be recruited from the adult orthopaedic outpatient clinic. A total of 66 participants will be recruited and randomised to a treatment arm. Owing to the nature of the randomisation model, greater than 66 patients may be recruited to reach the eventual target randomisation number. All data will be collected within Australia.

PMC10037835

Eligibility criteria {10}

ACL injury, rupture, re-rupture

INFLAMMATORY ARTHRITIS, PATHOLOGY

All inclusion criteria will be assessed by the treating surgeon and associate investigators.Participants can be included if they are:Waitlisted for ACLR with either of the associated investigators (S.T or L.B). Waitlisting is based on evidence of complete ACL rupture, based on clinical assessment and MRI imaging. Patients waitlisted will also have the appropriate lifestyle indications to warrant surgical reconstruction of the ligament.Able to give informed consent and to participate fully in the interventions and follow-up procedures.Aged 18 and over.Concomitant meniscal and/or osteochondral pathology can be included.Planned for surgery using an ipsilateral hamstring tendon autograftPatients will be excluded if they:Have had a previous ACL reconstruction on the ipsilateral knee.Have had a previous ACL injury to the non-operative knee.Are of a developmental age where the presence of open physes would otherwise alter the surgical technique utilised.Have grade 2 or 3 medial collateral ligament (MCL)/lateral collateral ligament (LCL) injury, associated posterior cruciate ligament (PCL)/ posterolateral corner (PLC) injury that requires surgical intervention.Have inflammatory arthritis.Are pregnant.Have an articular cartilage defect requiring treatment that would alter the post-operative rehabilitation protocol and timelines.Have a meniscal injury requiring treatment that would alter the post-operative rehabilitation protocol and timelines (i.e. meniscal root or bucket handle tear repair).Have an ACL re-rupture risk significant enough to warrant the addition of an osteotomy or deformity corrective procedure or lateral extraarticular tenodesis.

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Who will take informed consent? {26a}

EVENT

Participants will undergo assessment and provide written informed consent for ACLR surgery with their treating surgeon or one of the orthopaedic department’s trainee surgeons in consultation with the treating surgeon. Patients waitlisted for primary ACLR with either of the Associate Investigators (ST or LB) will be approached and offered participation in the study. Patients will either be approached in person or via phone after their appointment. All consent for trial involvement will be performed by an informed member of the research team. The patient will be advised that they have the right to privacy and any information obtained in connection with this project and that could identify them will remain strictly confidential. Information will only be disclosed with the patient’s permission, except as required by law. They will be informed that at the time that in the unlikely event that a patient is deceased, any original paper records kept will be treated according to standardised hospital policies. Given the intention-to-treat basis of this trial, data already collected will be included within the trial analysis. Information may be used in a deidentified manner within presentations and publications in peer-reviewed medical journals. In accordance with relevant Australian and/or Victorian privacy and other relevant laws, the patient will have the right to access the information collected and stored by the researchers. Patients will be informed that they are free to refuse participation, and if they decide or withdraw at any time, they will not compromise their future medical care. In either case, they will be given a physical or digital copy of the participant information and consent form (PICF) and offered the opportunity to ask questions of any member of the research team. They will be then sent (or given) a digital consent form via REDCAP to sign electronically, which will be then stored in our institution’s secure REDCap platform. A copy of the signed consent form will also be sent to the participant.

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Additional consent provisions for collection and use of participant data and biological specimens {26b}

Participants will undergo extended consent for use of study information in ancillary studies emanating from this trial. Participants will be advised that the results of this study may be utilised in a de-identified manner within publications or scientific research presentations.

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Interventions

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Explanation for the choice of comparators {6b}

This study will compare ACL reconstruction with hamstrings autograft with (ST-ACLR) and without (ACLR) suture tape augmentation. The suture tape will be looped through the proximal femoral button. Both procedures are standard care at our institution. The surgical technique has been decided at the discretion of the senior surgeons.

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Intervention description {11a}

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Graft fixation

Fixation will be performed with an adjustable suspensory ACL TightRope® 2 RT device (Arthrex, Naples, FL, USA) on the femoral side and a PEEK interference screw (Arthrex, Naples, FL, USA) on the tibial side with a diameter the same size as the tibial tunnel.

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Graft harvest and preparation

The semitendinosus and gracilis tendons will be harvested from the ipsilateral knee with a tendon harvester. Each tendon will be doubled over the ACL TightRope® 2 RT device (Arthrex, Naples, FL, USA) and the free ends sutured together with 2-Fibreloop suture (Arthrex, Naples, FL, USA) to create a 4-strand hamstring graft. If the graft diameter is less than 7mm in females or 7.5 mm in males, both tendons will be tripled to create a 6-strand construct. The length of the graft may be whipstitched with a 1 Vicryl suture to tubularise and compress the graft.

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Femoral tunnel preparation

An anatomic single-bundle reconstruction will be performed. The ACL femoral footprint will be identified and a point between the AM and PL bundles will be selected, erring towards the AM bundle. The position will be confirmed from the medial portal. A Spade Tip guide wire (Arthrex, Naples, FL, USA) will be passed via the anteromedial portal with the knee in maximum flexion and the tunnel length measured off the Spade Tip drill guide. A femoral reamer corresponding to the graft femoral diameter will be drilled via the anteromedial portal over the SpadeTip wire (Arthrex, Naples, FL, USA) to a depth of 25 to 30mm. A shuttling suture will be placed.

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Tibia tunnel preparation

The tibial footprint will be identified and any residual tibial stump will be preserved where possible. An Arthrex ACL aimer set to 55° will be passed via the medial portal to facilitate the passage of a guide wire through the mid-point of the tibial ACL attachment. The full tibial tunnel will be created with a cylindrical reamer corresponding with the graft tibial diameter [

PMC10037835

Graft passage, tensioning and fixation technique

knee

The femoral button sutures will be passed through the femoral tunnel using the shuttling suture. The cortical suspensory button will be passed and confirmed to have flipped with a toggle test and reference to a marking on the tightrope corresponding to the femoral tunnel length and a second mark 7 mm closer to the graft. The graft will then be docked into the femoral tunnel, 5 mm short of the tunnel depth by shortening the adjustable loop. Two markings on the graft corresponding to the tunnel depth and 5 mm short of the tunnel depth as measured from the femoral end of the graft will be used to assess the amount docked into the femoral tunnel. The tibial side of the graft is then cycled 15 times with maximal manual tension applied. Following this, a proprietary “fish scale” tensioning device (Arthrex Inc, Naples, FL) is used to apply tension to the graft at 80N and an interference screw (PEEK; Arthrex Inc.) is placed over a nitinol wire with the knee at 0° of flexion with a posterior force on the tibia. The knee is then cycled through range of motion to ensure full range. The graft re-tensioned from the femoral side at 30° of flexion.

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Suture tape augmentation technique

SwiveLock, knee

Patients randomised to the SA arm will use the Tightrope 2 femoral cortical button, which has a single strand of Fibertape looped through the proximal Tightrope to be run alongside the graft to serve as an augment. The femoral button and graft will then be docked into the femoral tunnel, 5 mm short of the tunnel depth by shortening the adjustable loop in a similar fashion to the standard ACL reconstruction group. The tibial side of the graft is then cycled 15 times with maximal manual tension applied. Secondary tibial fixation of the suture tape will be performed before the tibial graft, with a 4.75-mm SwiveLock anchor in full extension. A guide pin was drilled 1.5 cm distal to the tibial tunnel to a depth of 20mm and overrreamed with a 3.4-mm diameter reamer and 4.75-mm tap. Ensuring the free ends of the Fibertape are separate from the tibial-sided graft sutures, a haemostat is then placed underneath the FiberTape limbs to ensure it is not tighter than the graft. The suture tape is then fixed with a 4.75-mm SwiveLock anchor with the knee in maximal knee extension. The graft will be tensioned at 0° of knee flexion with a proprietary “fish scale” tensioning device used to apply tension to the graft at 80N, and a posterior force on the tibia. The tibial side of the graft will then be secured with an interference screw (PEEK; Arthrex Inc.), with the suture tape running alongside the graft through the tibial tunnel, with tension on the graft only. The knee is then cycled through a range of motion to ensure the full range is present. In order to ensure greater tension on the graft than the tape, the femoral side of the graft is then re-tensioned to ensure fully docked within the femoral tunnel at 30° of knee flexion.

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Closure

Closure is performed after irrigation and haemostasis in a layered fashion.

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Criteria for discontinuing or modifying allocated interventions {11b}

ACL knee rupture, rupture

ADVERSE EVENT

Owing to the nature of the intervention, being a surgical technique and use of specific implant, and the timing following randomisation, it is not anticipated that any participants will be discontinued from allocated intervention following randomisation. If a participant suffers graft failure or contralateral ACL knee rupture, then analysis via GNRB assessment may be changed. Participants may withdraw from the study without citing a reason, but reasons may include the participant has chosen to withdraw, postoperative graft rupture or failure or the participant has experienced an adverse event. If a patient indicates that they wish to withdraw, this will be recorded in the REDCap project, and they will not be asked to complete any further research-only assessments. They will be reassured that they will continue to receive care and any subsequent management at Western Health. If a patient withdraws from the study, data collected to this point will remain within the study for analysis unless the participant specifically requests otherwise.

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Strategies to improve adherence to interventions {11c}

All follow-up, short of one interaction, will be performed in conjunction with standard surgical care. All PROMs will be collected by easily accessible medium, including text message or email contact. This study will be co-ordinated by a dedicated research assistant in order to give participants the time to ask and have answered questions with regard to trial or concomitant care, as well as to ensure the workload of trial delivery is adequately met. The research team will remain in contact with all participants and encourage their attendance at standard care appointments where data collection will occur via SMS reminders and phone calls as required.

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Relevant concomitant care permitted or prohibited during the trial {11d}

lower extremity musculoskeletal dysfunction, sports-related, effusion, pain

EFFUSION

Post-operatively, all patients will undergo standardised medical and rehabilitative protocols according to the Fowler Kennedy Physiotherapy following ACL Reconstruction Protocol. All patients will receive day 1 physiotherapy and standard post-discharge management including wound review at 2 weeks, with clinical reviews at 6 weeks, 3 months and 12 months. Participants will be offered institutional physiotherapy or be free to pursue physiotherapy through an independent provider. Participants will not be asked to modify any of their medication or treatment relating to other medical conditions.Return to sport will not be permitted until criteria stipulated by the Fowler Kennedy protocol are met, as agreed by the senior investigators. As stipulated by the protocol, return to sport is initiated in a graduated format from the 6–9-month mark, provided the operative knee is without pain or effusion during, or after functional sports-related training drills. Lower extremity function scores (LEFS) should be 76 points or greater at this point in rehabilitation. The LEFS is a self-reported questionnaire used to evaluate the functional status of an individual with a lower extremity musculoskeletal dysfunction. The individual must also be able to demonstrate the appropriate strength and endurance needed for their specific sport.

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Provisions for post-trial care {30}

All participants will be offered routine medical and surgical post-trial care commensurate with their condition at the discretion of the treating surgeon. There will be no compensation offered to participants either for their involvement in the study. This is outlined in the participant information and consent form.

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Outcomes {12}

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Primary outcome

arthrometer, osteoarthritis

OSTEOARTHRITIS, SECONDARY

The primary outcome will be the side-to-side difference in anterior tibial translation as measured on the GNRB arthrometer at 2 years post-operatively, between groups. Maximum anteroposterior tibial translation at 134 N will be recorded on both the operative and non-operative knees pre-operatively and post-operatively at 3, 12 and 24 months. The goals of ACL reconstruction are to restore sagittal and rotatory stability to the knee and to prevent secondary injuries such as meniscal tears, and progression to osteoarthritis [

PMC10037835

Secondary outcomes

postoperative pain, Osteoarthritis, anxiety/depression, ACL, knee ACL rupture, Knee injury, pain, infection, knee injuries, knee effusion, arthrofibrosis, knee pain

OSTEOARTHRITIS, ADVERSE EVENTS, INFECTION, STERILE, EFFUSION, COMPLICATIONS, ARTHROFIBROSIS, COMPLICATIONS

Secondary outcomes are fourfold and will include (i) PROMs, (ii) return to sport rates, (iii) complications and (iv) examination findings.PROMs will be recorded preoperatively and post-operatively at 6 weeks, 3 months, 12 months and 24 months. PROMs collected will include the following:EQ5D-5L: The EuroQol EQ-5D-5L is a validated, generic, self-reported outcome measure covering five health domains that are used to facilitate the calculation of quality-adjusted life years (QALYs) in health economic evaluations. The original EQ-5D questionnaire contained three response options within each of five health domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) [The International Knee Documentation Committee (IKDC) score: The IKDC is a knee-specific patient outcome questionnaire often used after ACL reconstruction [Knee injury and Osteoarthritis Outcome Score Quality of Life sub-scale (KOOS-QOL): This subscale is a 4-item questionnaire designed to evaluate the knee-specific quality of life, has been utilised among ACL surgical trials [ACL return to sport index (ACL-RSI): Psychological readiness to return to sport will be evaluated with the ACL-RSI. It is a 12-point questionnaire validated to evaluate a patient’s confidence and readiness to return to sport [Self-reported pain: We will record postoperative pain levels and long-term knee pain scores utilising 10-point visual analogue scale pain scores (VAS) where 0 is no pain and 10 is the worst pain imaginable.Complications:We will record complications and adverse events including wound complications, infection rates, return to surgery, e.g. meniscal tears, graft failure, contralateral knee ACL rupture, residual effusion, rates of symptomatic arthrofibrosis of the knee and second look arthroscopy findings and the rates of sterile effusion. These will be recorded upon review of each patient’s medical record at 2 years.Return to sport and activity:Return to sport and activity will be assessed via a self-reported questionnaire delivered concomitantly with PROMs preoperatively and post-operatively at 6 weeks, 3 months, 12 months and 24 months. Return to activity will be evaluated through the Marx activity scale, a four-item activity rating scale which has been shown to have excellent retest reliability in patients with knee injuries [Examination findingsExamination findings will be taken preoperatively at examination under anaesthesia and post-operatively at 6 weeks, 3 months and 12 months. Examination findings including the range of motion (ROM), the presence of knee effusion, Lachmans, pivot shift and anterior drawer testing will be recorded. All assessments will be undertaken by lead surgeons S.T, L.B.

PMC10037835

Participant timeline {13}

arthrometer

COMPLICATION

Participants will be recruited from the orthopaedic outpatient clinic at our institution. Participants will be eligible for assessment if they are referred to either of the associated investigators’ clinic (L.B or S.T) and are consented for ACLR. Eligibility for trial participation based on inclusion and exclusion criteria will then be assessed. Patients who are eligible will be offered a discussion about the study and the opportunity to ask questions in line with best-practice informed consent. Data will be collected pre-operatively and post-operatively at four time points (6 weeks, 3 months, 1 year and 2 years) and will include arthrometric measure of anterior tibial translation on the GNRB arthrometer and PROM-based data, as well as return to sport data, complication rates and examination findings (Fig. SPIRIT figure summarising outcomes and assessment scheduleTrial flow pathwayPostoperatively, all GNRB measurements will be taken at the same standard time points to routine surgical follow-up by a member of the research team, or a member of the physiotherapy unit familiar with GNRB protocols. All PROMs and return to sport data will be recorded via online surveys directly into the REDCAP database. Follow-up surveys will be conducted via automated email service at the corresponding time point. All subsequent examinations will be conducted by lead surgeons S.T and L.B with data entered directly into a study data collection report form (paper version), and then manually entered into the REDCAP database. There will be only one time point (2 years) at which patients will be required to attend follow-up (for GNRB testing) without the need for a standard clinical follow-up as per standard practice; otherwise, patients will be within the hospital for their standard clinical follow-up at the time of testing.

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Sample size {14}

All statistical methods and power analysis were developed through consultation with an independent statistician. Power analysis was performed with G*power 3.1 Software. To achieve a minimum 80% statistical power with an alpha value of 0.05, power analysis based on a hypothesised mean residual side-to-side difference of 2 mm of anteroposterior tibial translation yielded a sample size of Secondary power analysis based on 2-year IKDC total scores yielded a total sample size of 48 (

PMC10037835

Recruitment {15}

RECRUITMENT, RECRUITMENT

Recruitment will be conducted continuously across patients eligible until the target randomised sample size is achieved. Based on institutional caseloads, it is anticipated this will take 1–2 years. A dedicated member of the research team will be tasked with recruitment on clinic days, such that all prospective participants are given appropriate opportunity to understand the study before and during involvement.

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Assignment of interventions: allocation

PMC10037835

Sequence generation {16a}

The randomisation design is a computer-generated permuted single-blind block randomisation. The randomisation sequence will be developed by an independent statistician, with all other research team members blinded to the randomisation sequence. Participants will be randomised using permuted block randomisation which allows for a better guarantee of equal-sized treatment groups [

PMC10037835

Concealment mechanism {16b}

The centrally managed, blinded randomisation model will ensure allocation concealment and prevent selection bias. The allocation sequence will be stored within the REDCap database and inaccessible to all but the statistician, ensuring concealment. Following randomisation, the allocation details will be displayed on the web-based system for each participant, and an automated email will be sent to members of the research team to ensure appropriate documentation in the medical record.

PMC10037835

Implementation {16c}

The allocation sequence will be developed by an independent statistician. It will be integrated into the REDCap automated randomisation platform and will be blinded to all other investigators. Enrolment of participants will be overseen by the lead surgeons, and associate investigators ST and LB, and will be carried out by associate investigators LH and EN. Randomisation and assignment to the intervention arm will be performed intraoperatively, following assessment and management of concomitant cartilage and meniscal injuries by the associate investigators LB and ST.

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Assignment of interventions: blinding

PMC10037835

Who will be blinded {17a}

SECONDARY

Trial participants will be blinded to the allocation arm for the duration of the study. GNRB arthrometric measurements are inherently low in bias, secondary to the computer-generated application of force to the posterior tibia; however, technicians taking the measures will be blinded to allocation arm. Owing to the nature of examination assessments, the best technician to carry these out is the same as the treating surgeon and thus blinding is not appropriate in this setting. The questionnaire-based outcomes are patient-reported and therefore also assessor-blinded.

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Procedure for unblinding if needed {17b}

As the surgeon and only outcome assessors are not blinded, unblinding will not be required.

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Data collection and management

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Plans for assessment and collection of outcomes {18a}

PROM

All data will be entered into a custom web-based REDCap database accessible by study research staff only. All GNRB data will be transposed from automated Genuroub software outputs to custom-designed data entry forms in the preoperative and postoperative setting by a member of the research team specifically trained in both software. PROMs and return to sport data will be collected by a single questionnaire and entered directly via online surveys by the participant. All validated PROM scores are cited above and can be found in the original citation; all non-validated questionnaires are included in the Additional file

PMC10037835

Plans to promote participant retention and complete follow-up {18b}

PROMs and return to sport data will be collected by online survey, deliverable by email or text message with the aims to increase follow-up rates among a technologically inclined patient cohort. All follow-up examinations and GNRB assessments will be performed concurrently with follow-up surgical appointments until the 12-month mark in order to reduce the study burden on the individual. If a participant withdraws from the study, or suffers graft failure, no further data will be collected; however, data collected up until this point will be included in the study and absent data will be analyzed according to intention to treat principles.

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Data management {19}

All data will be stored on a secure institutional REDCap server in a database custom-built for this study. Validation of data fields will be built into this platform where relevant, as well as the use of “required” fields to minimise missing data. Double data entry will not be possible.

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Confidentiality {27}

The research information will be re-identifiable. All participants will be assigned a study ID. A data re-identification key file will be stored as an encrypted file separate to the file containing the data. This will be a password-protected file stored on the hospital server. Only the research team can match the participant’s name to their code number, if it is necessary to do so. The Principal Investigator will be responsible for the secure storage of the data collected in this project. Any hard copy data will be identified by a study ID number only and kept secure in a locked filing cabinet within a locked office. Only named researchers will have access to all data collected in this project. Electronic datasets will be stored securely within the institutional server as a password-protected excel file/on the institutional REDCap platform.

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Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

No biological specimens will be collected as part of this study.

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Statistical methods

PMC10037835

Statistical methods for primary and secondary outcomes {20a}

Side-to-side difference in anterior tibial translation (the primary outcome), overall ACL-RSI, EQ5D-5L, Marx activity scales, IKDC and KOOS-QOL will be calculated as means, with measures of dispersion reported as standard deviation. Differences between groups will be reported as mean differences, with dispersion reported with confidence intervals. Data normality will be assessed with the Shapiro-Wilk test for continuous parametric assessment. Between-group comparisons, such as the primary outcome of mean difference in GNRB anteroposterior laxity at 2 years, will be assessed with independent samples

PMC10037835

Interim analyses {21b}

Interim analysis will be performed 1 year after the surgery of the final randomised participant. There will be no formal criteria for trial termination; however, if it is observed that the intervention is associated with significant harm to subsequently enrolled participants, then consideration of trial termination will be conducted.

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Methods for additional analyses (e.g. subgroup analyses) {20b}

arthrometer, knee laxity

Subgroup analysis will be explored to identify possible treatment effect modifying baseline factors such as age, sex, return to sport expectations and pre-operative ipsilateral knee laxity as measured on the GNRB arthrometer.

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Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

All principal analyses will be based on the intention-to-treat principle, analysing participants in the groups to which they are randomised. Missing data will be quantified and if possible multiple imputation will be used; otherwise, simple imputation will be used. Owing to the nature of enrolment and randomisation in this study, it is unlikely that a participant will be randomised and subsequently not receive the intervention, and thus adherence does not apply directly to the intervention arm.

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Plans to give access to the full protocol, participant-level data and statistical code {31c}

The protocol will be registered at the Australia New Zealand Clinical Trials Registry (ANZCTR), where specifics not present in the current publication may be reviewed.

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Oversight and monitoring

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Composition of the coordinating centre and trial steering committee {5d}

ADVERSE EVENTS

The Principal Investigator, the research assistant/co-ordinator and at least one other Investigator (Internal Trial Monitoring Committee) will meet at least monthly to monitor the progress of the trial to discuss study progress and procedures, adverse events and any other issues,

PMC10037835

Composition of the data monitoring committee, its role and reporting structure {21a}

The Principal Investigator will act as the data manager for the trial. The research team will meet as above in lieu of an official Data Monitoring Committee. Direct access to the data will be granted to authorised representatives from the sponsor, host institution or ethics board for monitoring and/or audit to ensure compliance with regulations.

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Adverse event reporting and harms {22}

death, bleeding, congenital anomaly, birth defect, disability or incapacity

BLEEDING, DELAYED WOUND HEALING, THROMBOEMBOLIC EVENT, ADVERSE EVENTS, WOUND INFECTION, COMPLICATIONS

Participant safety will be ensured via standard institutional protocols. The use of the GNRB is established to be safe in pre-operative [Serious adverse events (SAE) are defined as any untoward and unexpected medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing inpatients’ hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is any other important medical condition which, although not included in the above, may require medical or surgical intervention to prevent one of the outcomes listed. All SAEs will be reported to the approving ethics board within 72 h of the investigators becoming aware of them. SAEs that may be expected as part of the surgical interventions and that do not need to be reported to the HREC are complications of anaesthesia or surgery (wound infection, bleeding or damage to adjacent structures such as nerves, tendons and blood vessels, delayed wound healing, and thromboembolic events, femoral or tibial fracture).

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Frequency and plans for auditing trial conduct {23}

Auditing of trial conduct will be performed at a frequency and depth as determined by the local ethics board, independent of investigators and research team.

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Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}

All modifications to study protocols, following approval with the local ethics board, will be documented as amendments in the ANZ clinical trial registry. All participants having previously signed consent forms prior to change in protocol will be notified by email including the detail of the change and its impact on them and offered an opportunity to review a new written consent. If the change will not impact the participants’ involvement in the study, a change in the statistical methods, or a reduction in the frequency of recording of SAEs, or a change in study personnel, as an example, would not impact the participants’ involvement in the trial and thus they will not be notified of these changes.

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Dissemination plans {31a}

By signing the consent form, the participants give their permission to allow the de-identified data generated by this research to be shared/discussed with the local institutional orthopaedic unit and those working within it. Information may be used in publication in peer-reviewed medical journals. The results may also be presented at relevant national or international meetings and conferences. The information from this study will be disseminated within presentations or publications related to the present study, or within research related to this study.

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Discussion

ANTERIOR, COMPLICATION, COMPLICATIONS

This manuscript reports on the methodological design of the STACLR trial (Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction), the first randomised design prospective trial comparing suture tape-augmented ACL reconstruction to standard ACL reconstruction in adult patients. In this study, 2-year objective knee laxity, subjective patient-reported outcomes, complications and return to sport rates will be compared in patient treated with tape-augmented ACL reconstruction to those without. The hypothesis of the present study is that suture tape augmentation of ACL reconstruction will result in reduced side-to-side anterior tibial laxity at 2 years post-operative. Secondary hypotheses include an improvement in PROMs and equivalent complication profiles in tape-augmented grafts.There are several biomechanical studies comparing tape-augmented reconstruction to standard technique, whilst several animal studies and a scattering of retrospective nonrandomised clinical studies exist, all of which provide an established concept and lay the platform for future research. The most devastating complication of ACL reconstruction may be graft failure; however, owing to the sample size demanded, the present study will not feasibly investigate this, and it is important to note this when interpreting results. In a retrospective cohort study of tape augmentation in ACL reconstruction, Parkes et al. [Given the previous pitfalls of synthetic graft augmentation [

PMC10037835

Trial status

RECRUITMENT

The current protocol is Version 1.3, dated 30 August 2021. Recruitment commenced on 03 March 2022. Recruitment is anticipated to finish on 30 June 2024.

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Acknowledgements

The authors would like to acknowledge Dr Sara Vogrin, Statistician, The University of Melbourne, for her time and expertise in developing the statistical design of the present study. We would like to acknowledge the orthopaedic registrars at our institution who undertake substantial work in preparing patients for, delivering and monitoring post-operative recovery from surgery, without which, this trial would not be possible.

PMC10037835

Authors’ contributions {31b}

RP

ST conceived the idea of the study. PT is the chief investigator and will oversee the governance and delivery of the study. LH led the proposal and protocol development, in consultation with ST and LB, and led the submission for ethical approval. LB and ST are lead surgeons and will perform all surgical cases. LH, EN and AJ will lead day-to-day delivery of the study. OT provided statistical expertise in clinical trial design and will oversee data management. LS oversaw ethical submissions and will oversee trial compliance. RP will oversee the delivery of physiotherapy and GNRB arthrometric assessments in all patients. All authors contributed to the refinement of the study protocol and approved the submission of the final manuscript.

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Funding {4}

This study is funded both self-funded by the Western Health Orthopaedic Special Purpose Fund, administered by the Department of Surgery, Western Health. Secondary funding has been obtained via the Arthrex (Arthrex 2021 Inc) Investigator-Initiated Research Grant, and the Victorian Orthopaedic Foundation Grant.

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Availability of data and materials {29}

All study personnel will have access to the final trial dataset.

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Declarations

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Ethics approval and consent to participate {24}

This study was approved by the Melbourne Health Human Research Ethics Committee (HREC 2021.073), given governance approval by Western Health and was registered on the Australian New Zealand Clinical Trials Registry on 27/8/21 under Trial Number ACTRN12621001162808. Written informed consent will be obtained by the research staff from all study participants prior to enrolment. Patients are free to withdraw from the trial at any time without providing a reason. Details outlining participants’ rights to access their data, study results, how study data will be used, and the processes in place to ensure that individual confidentiality is protected are all specified in the participant information and consent form.

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Consent for publication {32}

Not applicable.Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.

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Competing interests {28}

This study has been allocated funding by Arthrex Inc via the Investigator-Initiated Research Grant. This funding was sought and approved only following final protocol approval and ethical and local governance approval. This funding will be utilised to supply the GNRB for use in the study and for the employment of a part-time research assistant. All external funding sources had no input into the design or outcome of this study.

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References

PMC10037835

Supplementary Information

Schools offer an advantageous setting for the prevention, early identification, and treatment of mental health problems for youth. However, school mental health (SMH) services are typically not based on evidence for effectiveness, nor are they efficiently delivered, with SMH practitioners (SMHPs) able to only treat a small number of students in need. The current study evaluated the feasibility, acceptability, efficiency, and outcomes of a four-session assessment, engagement, problem-solving, and triage strategy for SMHPs that aimed to improve efficiency while being based on elements of evidence-based care. The study, conducted in 15 US school districts in three states, used stratified random assignment to assign 49 high schools and their participating SMHP(s) to either the Brief Intervention for School Clinicians (BRISC; The online version contains supplementary material available at 10.1007/s11121-022-01463-4.

PMC10227122

Keywords

suicidality, depression, anxiety

Since 2010, rates of depression, anxiety, and suicidality in children and adolescents have risen to historic highs (Ivey-Stephenson et al.,

PMC10227122

Improving Efficiency and Effectiveness of School Mental Health Care

MH, MTSS, depressed

FRANKLIN

School-based services are characterized by large caseloads and clinician time constraints; they also tend to be crisis-driven (Langley et al., Education frameworks taking a broader public health approach, such as Multi-Tiered Systems of Supports (MTSS; National Center on Response to Intervention, While there is substantial support for the effectiveness of “Tier 1” universal strategies such as school-wide social-emotional learning programs (Durlak et al., Examples of efforts to tailor EBPs for use in school settings include adaptations of solution-focused brief therapy (SFBT). Early SFBT studies showed promise as a practical and efficient approach for students with internalizing and externalizing problems (Kim & Franklin, A second relevant example is provided by “modular” approaches to therapy that use “common elements” of EBP tailored to the needs of a specific student. “Show Me FIRST” is a brief (6 session) school-based modular approach for depressed and anxious youth that incorporates strategies such as relaxation training, cognitive restructuring, problem solving, and behavioral activation. A pilot trial found support for feasibility but no differences on mental health outcomes compared to school-based usual care. A review concluded that modular approaches are potentially useful to SMHPs, but that more research is needed to determine if school-based providers, given the demands of their settings, can deliver these approaches effectively (Kininger et al., In sum, whole-school frameworks such as applications of MTSS hold substantial promise for improving school-wide student MH outcomes. Such frameworks, however, also require targeted and intensive individual- and group-based SMH strategies for identified students that align with MTSS principles such as being research-based, data-informed, and provided within a tiered framework. Few models have been developed and rigorously tested for delivering SMH services that are both based on evidence for effectiveness as well as responsive to the vast and growing demands on SMHPs.

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Developing and Testing an Efficient SMH Model for “Real World” Schools

Working with local school districts, the current research team developed a SMH approach that incorporates problem-focused assessment, problem-solving, and flexibly applied evidence-based elements (Bruns et al., The current paper describes an initial efficacy test of this school-based triage and brief intervention approach. The Brief Intervention for School Clinicians (BRISC) provides a first-line, “Tier 2” intervention that aims to use consistent assessment to inform the level and type of ongoing services needed (including “Tier 3” services as needed) in a prevention-oriented, multi-tiered delivery model. BRISC incorporates modular elements of effective care (Weisz & Bearman, The BRISC theory of change posits two paths to positive outcomes. First, that SMHPs who use explicit engagement strategies, e.g., student’s identification of treatment target and ongoing data collection to guide decision-making will promote service outcomes such as greater alliance, treatment engagement and retention, and more appropriate and rapid referrals to other servies as needed. Second, that teaching effective problem solving and a targeted set of flexibly applied evidence-based strategies will promote better problem-solving, improved coping skills, and resolution of student top problems in the short term as well as connections to services if/as needed.The study sought to answer the following research questions:What were SMHPs’ perceptions of the Compared to SAU, what were the effects of BRISC on Compared to services as usual (SAU), what were the effects of BRISC on Compared to SAU, what were the effects of BRISC on Compared to SAU, what were the effects of BRISC on We hypothesized that BRISC would be feasible and acceptable to SMHPs, promote greater initial engagement in SMH services and more rapid completion of care, and be at least equally effective in improving symptoms and functioning as SAU.

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Methods

This study was pre-registered at ClinicalTrials.gov (protocol number 52229). Block randomization occurred at the level of the school, and participants completed assessments at baseline, 3, and 6-months follow-up for the primary outcome measures of interest. Academic outcomes were collected; however, the current paper focuses on mental health services and outcomes only.

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Participants

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Schools

The study was conducted in 15 school districts in 3 states: Maryland (13 schools, 2 districts), Minnesota (16 schools, 8 districts), and Washington (20 schools, 5 districts). School enrollment ranged from 67 to 2851 (

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School Mental Health Practitioners (SMHPs)

All SMHPs in participating schools were included. Licensed mental health clinicians (

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Youth Participants

All students seeking or referred to services from participating SMHPs in participating high schools were eligible. Students were referred to or requested SMH through standard procedures used by their school/district. Students were ineligible if they currently or in the past year received therapy or counseling. Students in an acute crisis situation were also excluded. Students had to speak English; however, consent forms were translated and administered in Spanish so that students with Spanish-only speaking parents/legal guardians could be included.

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Measures

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Mental Health Services Received

The Service Assessment for Children and Adolescents (SACA; Stiffman et al.,

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Service Processes and Satisfaction

The Multidimensional Adolescent Satisfaction Scale (MASS) is a 21-item measure of client satisfaction with mental health services. Response options are on a 4-point scale from 1 (“strongly disagree”) to 4 (“strongly agree”). The MASS has demonstrated acceptable to excellent overall internal and test–retest reliability (

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Therapeutic Alliance

It was collected using the Therapeutic Alliance Scale for Adolescents (TASA) and the Therapeutic Alliance Scale for Clinicians (TASC) at a 2-month follow-up (Faw et al.,

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Student-Identified Top Problems

At baseline, the Youth Top Problem Assessment (YTPA; Weisz et al.,

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Mental Health Symptoms and Functioning

anxiety

Mental health outcomes were measured using the Patient Health Questionnaire (PHQ-9; Richardson et al., The GAD-7 is a brief scale that queries about anxiety symptoms. Response options are on a 4-point scale from 0 (“not at all”) to 3 (“nearly every day"). Interrater reliability is good, with self-report scales correlated with clinician-administered versions (The CIS is a 13-item measure of adaptive functioning. Response options are on a 5-point scale from 0 (“no problem”) to 4 (“very big problem”). The CIS had good internal reliability (The Brief Problem Checklist (BPC) is a youth-reported, 12-item questionnaire adapted from items on the Youth Self-Report (YSR; Achenbach & Rescorla,

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Treatment Outcome

MH

At the end of the third year of the study, SMHPs in both groups reported on the treatment outcome and triage decision for the five students with whom treatment was most recently completed. SMHPs reported whether, after four sessions, treatment was concluded or continued. For students who completed service, SMHPs reported on the treatment outcome from a list of five options: no further services planned, developed a monitoring plan, referred to other school services, referred to more intensive MH services, and referred to both school services and more intensive MH services.

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BRISC Fidelity

BECT

The BRISC External Coding Tool (BECT) was developed for the study and includes 24 items derived from the 4 to 8 treatment components of each of the four BRISC sessions (e.g., “conducted stress rating”). Items are scored dichotomously (0 = criteria not met; 1 = met). For each BRISC clinician, the two BRISC trainer-consultants listened to audiotapes of all four sessions for at least the first two student clients each clinician enrolled and scored each session for fidelity criteria, overall quality, and student engagement on a 1–5 scale (i.e., 1 = low engagement/quality, 5 = high engagement/quality). Trainers double coded 22 recordings across all sessions (210 total items), achieving a single-measure absolute consistency of BRISC fidelity was also assessed by coding randomly selected sessions using the Therapy Process Observation Coding System (TPOCS; Garland et al.,

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BRISC Feasibility and Acceptability

Appropriateness

SMHPs were administered an exit interview after each school year that incorporated the Acceptability, Likely Effectiveness, Feasibility, and Appropriateness Questionnaire (ALFA-Q; Cook & Lyon,

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Procedures

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Randomization

To ensure condition comparability, we used stratified sampling. Within each state, a nearest neighbor matching algorithm matched schools based on characteristics of practitioners (e.g., degree, years’ experience, score on Evidence-Based Practices Attitudes Scale (Aarons,

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Recruitment and Enrollment

RECRUITMENT

Students were recruited and enrolled from October 2016 to November 2018. Figure CONSORT diagram for student recruitment and study participation by condition (BRISC and SAU) in the BRISC study

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Data Collection

Study procedures were approved by the Institutional Review Board at the University of Washington. Informed consent was obtained from students, caregivers, and SMHPs. Students completed measures at baseline, 2, and 6 months. Briefer surveys (YTPA only) were also conducted with students at 1 and 4 months. At the end of each treatment episode, all SMHPs completed the TASC; BRISC SMHPs also completed the feasibility self-report measures. All SMHPs completed implementation measures (including the ALFA-Q) and qualitative surveys at the end of each year.

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BRISC Intervention

The core BRISC strategy is implemented in four sessions. In session 1, the SMHP engages the student, assesses current functioning using brief standardized assessment measures, and identifies “top problems” (Weisz et al., BRISC-assigned SMHPs attended a 1.5-day in-person training by two Ph.D.-level clinical psychologists that incorporated strategies (e.g., modeling, role play) found to facilitate uptake of new skills (Rakovshik & McManus,

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Services as Usual

Students in SAU-assigned schools received individual counseling/therapy as usual from SMHPs. Based on previous research, the primary orientation of SMHPs in the SAU condition is supportive psychotherapy and crisis response (Holmes et al.,

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Data Analysis

Overall, attrition and differential attrition were calculated to examine potential selection bias. Mixed effects modeling with random effects at the clinician and client level were used for statistical testing of between-group differences. If models failed to converge, resulted in Hessian errors, or had no significant variance at these levels, these random effects were removed. Standard model building procedures were used (Raudenbush & Bryk,

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Results

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BRISC Fidelity

BECT

SESSION

Fidelity ratings via the BECT found excellent adherence for sessions 1, 2, and 4, at 94.2%, 90.8%, and 90.1% of items in each session, respectively. Adherence was acceptable but lower for session 3 with 77.4% of items meeting criteria. Session 3 focused on continued problem solving and skill-based elements of mental health care are taught to facilitate step completion. The lowest fidelity items for session 3 were “create a game plan for the coming week” (74.6% of sessions) and “obtained stress rating associated with identified problem” (89.8% of sessions). Items regarding fidelity for problem-solving tasks were high (98.3% of the sessions). Session quality ranged from 3.0 (session 3) to 3.7 (session 1) on the 5-point scale, and engagement ranged from 3.9 (session 3) to 4.2 (session 1) on the 5-point scale.Mixed-effect modeling of TPOCS scores confirmed treatment fidelity. Sessions from the BRISC condition featured more elements

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BRISC Feasibility and Acceptability

Results of anonymous exit surveys indicated that SMHPs perceived BRISC to be feasible and acceptable. Mean ratings across all items on the ALFA-Q were 3.05 (

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Service Processes

Therapeutic alliance as evaluated by total scores of the TASA and TASC and youth satisfaction as evaluated by the MASS total score and its four subscales found no significant differences, with one exception: Students in SAU rated their SMHP significantly higher than students in BRISC on the Counselor Qualities subscale of the MASS (

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Services Received

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Mental Health Symptoms and Functioning

Table

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Discussion

MTSS

This project evaluated the potential for improving the efficiency of SMH via a school-based assessment, brief intervention, and triage approach for students with socio-emotional concerns. BRISC provides a first-line intervention using consistent assessment to inform level and type of ongoing services needed in a prevention-oriented, multi-tiered delivery model. Research questions focused on feasibility, fidelity, student report of problems, and ability of BRISC to promote efficiency within SMH. We also measured a range of mental health outcomes over 6-month follow-up to evaluate whether this emphasis on efficiency compromised these outcomes compared to SMH “as usual.”SMHPs who participated in the study were predominantly outpatient clinic providers deployed to the school setting. Their training and established practice were geared to traditional, longer term supportive therapy. The structured, measurement-based, and goal-oriented BRISC approach represented a different way of practicing aligned with data-informed, multi-tiered frameworks used by schools. Despite the learning curve required and deviation from typical practice, SMHPs rated BRISC as feasible, acceptable, and appropriate. Importantly, the majority of SMHPs rated BRISC as easy to learn, “compatible with the school mission,” and “likely to improve students’ social, emotional, and academic success.” SMHPs delivered BRISC with fidelity; however, session 3 fidelity was lower than for other sessions. This was likely due to the complexity introduced by the option to use evidence-based treatment elements as needed.A second key finding was that SMHPs in the BRISC condition were significantly more likely (53% to 15%) to report that they had completed treatment after 4 sessions than SAU. BRISC-assigned SMHPs were also more likely to refer students to alternative and/or more intensive services. Students in the BRISC condition were also significantly more likely to report receipt of SMH at 2 months and less likely to report SMH services at 6 months. These results support the hypothesis that BRISC can promote SMH that is more efficient and better aligned with MTSS and public health frameworks.Finally, we asked whether SMHPs’ use of a brief strategy to achieve greater efficiency would compromise mental health outcomes. To the contrary, students served via BRISC showed significantly greater improvement on their self-rated top mental health problems at 2 and 6 months. Symptom and functioning measures showed significant improvement, but slopes did not differ by condition. Students served by BRISC SMHPs were less likely to receive outpatient care at 6 months. This finding could indicate that BRISC more effectively addressed students’ “top problems” to an extent that reduced their need for longer-term mental health services. Or, it could be that students in the BRISC condition felt more confident in their school-based provider to help them in the future, reducing the need for clinic-based services. Such questions will need to be examined in more in-depth research with longer follow-up.

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Limitations

Although the current study used rigorous methods, attrition from follow-up data collection was not trivial (15% at 2 months and 22% at 6 months) and significantly higher for students assigned to BRISC. Debriefs with interviewers suggested that SAU students were easier to schedule for follow-up interviews due to their continued mental health treatment, whereas more BRISC students had completed treatment by 3–6 months, making follow-up data collection more difficult. It is possible those lost to follow-up were actually more likely to have improved, reducing the effects found for BRISC.Second, SMHPs in the BRISC condition were explicitly trained to take stock of next steps after four sessions, meaning that the greater rate of treatment completion (53% to 15%) could be viewed as a demand characteristic in effect for just the BRISC condition. However, SMHPs in the BRISC condition were trained only to evaluate progress and triage as appropriate after four sessions, ending treatment only if progress data suggested it was warranted. As such, we do not believe this is an artifact of study design.Third, because treatment logs maintained by SMHPs were found to have been inconsistently maintained, the core outcome of treatment pathway after 4 sessions was only available via SMHP report after the third year of the study, limiting this outcome to only 22 of the 53 enrolled SMHPs. Finally, despite the multiplicity of analyses, we did not adjust for familywise error. Doing so over dozens of tests would have resulted in an unacceptable Type II error rate and presented an incomplete picture of results.

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Implications for School-Based Prevention and Treatment

MTSS

MITCHELL

Results indicate that BRISC holds promise as a method for equipping SMHPs with a structured approach to meeting the needs of a greater number of students with an array of problems. Developing such targeted strategies is important given that there are a limited number of such “Tier 2” SMH strategies available in schools (Mitchell, Stormont, & Gage, It is important to note that the components of BRISC—structured problem solving, standardized assessment, stepped care, and measurement-based care—are all “common elements” of evidence-based mental health treatment. Although BRISC was designed to help SMHPs incorporate these strategies over a sequence of four defined sessions, incorporating any one of these strategies into SMH may promote efficiency and effectiveness. Future research may shed light on how best to equip a range of school-employed helpers with one or more of these elements to help them respond more proactively to a greater number of students. Ideally, future research will also evaluate contextual factors such as fidelity to MTSS principles and procedures such as universal screening. Such data could uncover the degree to which fidelity and outcomes of a strategy such as BRISC are related to district- and school-level factors and how to better integrate SMH strategies.Finally, it is important to note that providing access to counseling is not, in and of itself, a solution to the rising rates of mental health concerns of youth. While treatment models such as BRISC may aim to serve as one element in a tiered continuum of data-driven, evidence-informed school strategies, they are also reactive and resource-intensive. They do not, as described by Herman et al. (

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Funding

The research reported here was supported by the Institute of Education Sciences, US Department of Education, through Grants R305A160111 and R305A120128 R305A16001 (PIs Bruns & McCauley). The opinions expressed are those of the authors and do not represent views of the Institute or the US Department of Education.

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Declarations

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Ethics Approval

All procedures in the present study were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This study was pre-registered at ClinicalTrials.gov (protocol number 52229). The study protocol was approved by the Institutional Review Board of the University of Washington (Study 00010952).

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Informed Consent

Informed consent to participate in the study was obtained from parents or legal guardians of all student participants; assent to participate was obtained from all students.

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Conflict of Interest

The authors declare no competing interests.

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