Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the implementation outcomes (i.e., feasibility, appropriateness, acceptability, and fidelity) of MBC in school-based mental health treatment services. The investigators plan to observe the effectiveness of MBC on student engagement and treatment outcomes as a secondary goal. This pilot implementation-effectiveness trial is designed to inform a future, large-scale trial with more participants.

Detailed Description
-----------------
A clustered, multiple-baseline design will be used to examine the impact of implementation support on clinicians' fidelity, use and ratings of MBC appropriateness, acceptability and fidelity. Approximately 50 school-based mental health (SMH) clinicians will be recruited to participate from up to three school districts. All clinicians will receive the same implementation supports; there is no random assignment to condition. Following an initial control period of at least 1 month, school districts will start receiving implementation supports. During the initial control period, baseline MBC use, attitudes, acceptability, feasibility and appropriateness (per clinician self-report) will be collected, as well as needs assessment data from clinician surveys to inform necessary adjustments to the implementation supports. Baseline engagement and student outcomes will be collected after initial clinician training session. MBC implementation outcomes (i.e., MBC use, attitudes, acceptability, appropriateness, and feasibility), engagement and student outcomes will be collected at 3-month and 6-month follow-up during intervention supports, plus a 9-month follow-up interval. This allows clinicians in the two school districts to be compared to each other and to their own baseline. The primary comparison is pre-post ratings of implementation outcomes for all N=50 clinicians. The secondary comparisons are pre-post ratings of engagement and student outcomes, and between-agency differences.

Official Title
-----------------
Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Conditions
-----------------
School-based Mental Health Treatment Services

Intervention / Treatment
-----------------
* Behavioral: Measurement-based care (MBC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible for inclusion in the study, a clinician must meet all of the following criteria: Female, male or other gender ≥18 years of age at the time of recruitment. Provide school-based individual and/or family mental health treatment in an elementary, middle or high school in a participating school district. Hold a professional license or certification in their state to provide mental health treatment OR be supervised by a licensed or certified mental health professional in their state. English-speaking. Ability to provide informed consent. Exclusion Criteria: - Clinicians who do not meet all inclusion criteria are excluded. There are no other exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Measurement-based care<br>Clinicians will receive a 3-hour interactive MBC training followed by six months of post-training consultation. Training and consultation will include how to collect, score, and use student- and parent-reported progress measures with students and families to inform collaborative progress monitoring and treatment decisions. | Behavioral: Measurement-based care (MBC)<br>* Clinicians will receive a 3-hour interactive MBC training followed by six months of post-training consultation. Training and consultation will include how to collect, score, and use student- and parent-reported progress measures with students and families to inform collaborative progress monitoring and treatment decisions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinician acceptability of MBC | Change in clinician-reported Acceptability of Intervention Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5) | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up | 
| Change in clinician appropriateness of MBC | Change in clinician-reported Intervention Appropriateness Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5) | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up | 
| Change in clinician feasibility of MBC | Change in clinician-reported Feasibility of Intervention Measure (e.g., a score of 5 = completely agree and is most favorable; possible scores range from 1-5) | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up | 
| Change in clinician fidelity to MBC components | Retrospective coding of progress notes in clinical records for evidence of scoring, interpretation and feedback provided on the PCOMS measures (ORS and SRS). A composite fidelity score will be calculated with higher fidelity scores being more favorable. The fidelity rubric is still under development as this is a pilot study. Possible scores range from 0-100%. | 3-month follow up, 9-month follow up | 
| Change in clinician use of MBC | Change in clinician-reported Current Assessment Practice Evaluation - Revised (e.g., a score of 100% across all items is most favorable). Possible scores range from 0-100%. | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up | 
| Change in clinician acceptability of the PCOMS ORS and SRS | Change in clinician-reported Usage Rating Profile - Assessment (e.g., a score of 6 = strongly agree and is most favorable; possible scores range from 1-6. ) | post training, 3-month follow up, 6-month follow up, 9-month follow up | 
| Change in clinician attitudes toward standardized assessment | Change in clinician-reported Attitudes toward Standardized Assessment-Monitoring and Feedback Scale (e.g., a score of 5 = strongly agree across is most favorable; possible scores range from 1-5) | Baseline, post training, 3-month follow up, 6-month follow up, 9-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child engagement | Change in the parent-reported Session Rating Scale (per chart review; where a score = 40 is most favorable and a score below 36 or less than 9 on any functioning domain should be discussed with the client). Possible scores range from 0 to 40. | 3-month follow up, 9-month follow up | 
| Change in child functioning | Change in the parent-reported Outcome Rating Scale (per chart review; where a score = 0 is most favorable and a score over 28 on a 0 to 40 scale is the clinical cutoff). Possible scores range from 0 to 40. | 3-month follow up, 9-month follow up | 
| Change in parent engagement | Change in parent-reported Therapeutic Alliance Scales for Caregivers and Parents (parent-reported to study staff over the phone, where 4 = very much true and is most favorable; possible scores range from 1-4) | Baseline, 3-month follow up, 6-month follow up, 9-month follow up | 
| Change in child emotional and behavioral symptoms | Change in the Pediatric Symptom Checklist, 35-item version (PSC-35; parent-reported to study staff over the phone where a score of 0 = no symptoms and is most favorable). Possible scores range from 0 to 70 and a score at or above 28 is the clinical cutoff for youth ages 6 to 16. | Baseline, 3-month follow up, 6-month follow up, 9-month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
measurement-based care (MBC)