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

University of Michigan

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Stage 1 Strategy: REP; Behavioral: Stage 2 Strategy: Augment with Facilitation; Behavioral: Stage 2 Strategy: No augmentation; Behavioral: Stage 1 Strategy: REP + Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03541317

1R01MH11420301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,329 patients

Sex: All

Ages: 14 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,329 participants in 2 patient groups

Stage 1: Optimal First Line Implementation Strategy

Experimental group

Description:

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.

Treatment:

Behavioral: Stage 1 Strategy: REP

Behavioral: Stage 1 Strategy: REP + Coaching

Stage 2: Added Value of Providing Facilitation

Experimental group

Description:

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).

Treatment:

Behavioral: Stage 2 Strategy: Augment with Facilitation

Behavioral: Stage 2 Strategy: No augmentation