Improving Student Mental Health: Adaptive School-based Implementation of CBT

Study Overview
=================
Brief Summary
-----------------
The overarching goal of this study is to improve the delivery of an established, evidence-based intervention (cognitive-behavioral therapy-CBT) in Michigan schools through different implementation strategies designed to better educate school professionals. Specifically, the study will assist the ongoing Transforming Research into Action to Improve the Lives of Students (TRAILS) Program by evaluating different ways to educate school professionals (SPs) to improve their delivery of CBT to high school students and ultimately improve student mental health outcomes in the state of Michigan. The three educational approaches are Replicating Effective Programs (REP), Coaching, and Facilitation.

Detailed Description
-----------------
This study seeks to develop an effective and efficient sequence of implementation strategies for encouraging delivery of Cognitive Behavioral Therapy (CBT) by school professionals in high schools across Michigan. In the run-in phase, all schools will receive support and training from REP for three months. After three months, schools will be randomized to either (1) continue with REP; or (1) augment REP with a minimum of 12 weeks of coaching. Eight weeks after this first randomization, schools will be evaluated to determine whether they might also benefit from an augmentation of their current strategy with Facilitation. Schools that could benefit from Facilitation (defined as delivering 3 or more CBT modules to less than 10 students or reporting 3 or more organizational barriers to delivering CBT) will be re-randomized to either (1) continue with their current strategy (REP or REP + Coaching); or (2) have their current strategy augmented with Facilitation. All implementation support will be discontinued 12 months after first randomization; outcomes will be assessed through 18 months after study start. This results in four sequences of implementation strategies: REP only; REP + Facilitation for those who did not adequately respond initially to REP alone; REP + Coaching; and REP + Coaching + Facilitation for those who did not adequately respond initially to REP + Coaching.

Official Title
-----------------
Improving Student Mental Health: Adaptive School-based Implementation of CBT

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Stage 1 Strategy: REP
* Behavioral: Stage 1 Strategy: REP + Coaching
* Behavioral: Stage 2 Strategy: Augment with Facilitation
* Behavioral: Stage 2 Strategy: No augmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
School Administrators Inclusion Criteria: Working at a school that is located within a 2-hour drive of a TRAILS coach Employed at a Michigan high school full or part time Able to read and understand English Exclusion Criteria: Unable to provide informed consent for participation in the study activities School Professional Inclusion Criteria: Working at a school that is located within a 2-hour drive of a TRAILS coach Employed at a Michigan high school full or part time Have a background in clinical school social work, counseling, psychology, or similar area Able to read and understand English Exclusion Criteria: Has previously received coaching in CBT through the TRAILS or similar programs Has a significant illness or condition that precludes their participation in the implementation strategies, including the REP training and student identification process, Coaching, or Facilitation Unable to provide informed consent for participation in the study activities Student Inclusion Criteria: Age 14-21 years Currently enrolled in the 9th, 10th, or 11th grade at time of first assessment at one of the participating schools Have at least one symptom of depression or anxiety that impacts their daily well-being or functioning, as determined by the SP Able to read and understand English and comprehend assessments Exclusion Criteria: Evidence of psychosis, as identified by any standardized measure; reported by the student, parent, or referral source; or noted by the SP during the recruitment and screening process Evidence of a severe pervasive developmental disability, mental retardation or other cognitive impairment that would interfere with the potential for benefit from skills groups, as identified by the student, parent, or referral source. Unable to attend CBT group sessions Students could withdraw from participation at any time by themselves, or by parent notification to the study team.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 99 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1: Optimal First Line Implementation Strategy<br>All schools enrolled will first be randomized to an optimal first line treatment in order to compare REP vs. REP + Coaching. Schools assigned to Stage 1 treatment REP will receive a daylong didactic training covering core elements of CBT and proper screening and identification of students; training to help SPs identify eligible students; a package that includes tools to deploy CBT; and ongoing technical assistance in CBT implementation. Schools assigned to Stage 1 treatment REP + Coaching will receive the REP components plus weekly visits from a CBT expert or Coach, for a minimum of 12 weeks. | Behavioral: Stage 1 Strategy: REP<br>* Schools will receive a daylong didactic training covering core elements of CBT and proper screening and identification of students; training to help SPs identify eligible students; a package that includes tools to deploy CBT; and ongoing technical assistance in CBT implementation.<br>Behavioral: Stage 1 Strategy: REP + Coaching<br>* Schools will receive a daylong didactic training covering core elements of CBT and proper screening and identification of students; training to help SPs identify eligible students; a package that includes tools to deploy CBT; ongoing technical assistance in CBT implementation; and weekly visits from a CBT expert or Coach, for a minimum of 12 weeks.<br>|
| Experimental: Stage 2: Added Value of Providing Facilitation<br>After 2 months, schools will be assessed to determine whether they could benefit from augmenting their current strategy with a step-up strategy called Facilitation. Schools identified as potentially benefiting will be re-randomized to compare the added value of augmenting their current strategy with Facilitation, compared to continuing with their same strategy. Stage 2 treatment strategy: step-up will include provision of an additional implementation strategy called Facilitation. A full-time Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools will support school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation will receive regular calls for up to a minimum of 10 weeks from the Facilitator. All schools will also continue to receive their first line treatment (i.e. REP or REP + Coaching). | Behavioral: Stage 2 Strategy: Augment with Facilitation<br>* In addition to first-line treatment (REP or REP + Coaching), schools will also receive support from a Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools will support SPs in strategic thinking and leadership skills to address organizational barriers.<br>Behavioral: Stage 2 Strategy: No augmentation<br>* Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CBT Sessions Delivered by School Professionals to Students After 18 Months | School professionals include counselors, social workers, and trained mental health providers working within the school. The primary aim is a comparison of schools offered the REP only intervention (the least intensive strategy) versus schools offered the adaptive implementation strategy involving REP, Coaching, and Facilitation (the most intensive strategy). | Baseline to 18-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Brief Individual CBT Sessions | The sum of the average number of brief individual CBT sessions (<15 min.) delivered to students by SPs over all four post-randomization phases occurring during Stages 1 and 2. | 18 months | 
| Number of Full Individual CBT Sessions | The sum of the average number of full individual CBT sessions (≥15 min.) delivered to students by SPs over all four post-randomization phases occurring during Stages 1 and 2. | 18 Months | 
| Number of Group CBT Sessions | The sum of the average number of group CBT sessions delivered to students by SPs over all four post-randomization phases occurring during Stages 1 and 2. | 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adaptive implementation, Coaching, Facilitation, School mental health, Implementation intervention