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

Not Applicable

Completed

• Conditions: Depression; Anxiety

• Registration Number: NCT03541317
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Study Start: 2018-07-19
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Results First Submitted: 2021-05-14
• Results First Submitted QC: 2021-07-01
• Results First Posted: 2021-07-26
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1329

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Number of CBT Sessions Delivered by School Professionals to Students After 18 Months	Baseline to 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).

Secondary Outcome Measures

Name	Time	Method
Number of Brief Individual CBT Sessions	18 months	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.
Number of Full Individual CBT Sessions	18 Months	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.
Number of Group CBT Sessions	18 Months	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States