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

NCT ID: NCT03541317

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2020-05-15

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Stage 1: Optimal First Line Implementation Strategy

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.

Group Type: EXPERIMENTAL

Stage 1 Strategy: REP

Intervention Type: BEHAVIORAL

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.

Stage 1 Strategy: REP + Coaching

Intervention Type: BEHAVIORAL

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.

Stage 2: Added Value of Providing Facilitation

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).

Group Type: EXPERIMENTAL

Stage 2 Strategy: Augment with Facilitation

Intervention Type: BEHAVIORAL

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.

Stage 2 Strategy: No augmentation

Intervention Type: BEHAVIORAL

Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered.

Interventions

Stage 1 Strategy: REP

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.

Intervention Type: BEHAVIORAL

Stage 1 Strategy: REP + Coaching

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.

Intervention Type: BEHAVIORAL

Stage 2 Strategy: Augment with Facilitation

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.

Intervention Type: BEHAVIORAL

Stage 2 Strategy: No augmentation

Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• 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

• Unable to provide informed consent for participation in the study activities

School Professional

• 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

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Amy M. Kilbourne

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy M Kilbourne, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Smith SN, Almirall D, Choi SY, Andrews C, Koschmann E, Rusch A, Bilek EL, Lane A, Abelson JL, Eisenberg D, Himle JA, Liebrecht C, Kilbourne AM. Student mental health outcomes of a clustered SMART for developing an adaptive implementation strategy to support school-based CBT delivery. J Affect Disord. 2024 Dec 15;367:399-407. doi: 10.1016/j.jad.2024.08.048. Epub 2024 Aug 14.

Reference Type: DERIVED

PMID: 39151756 (View on PubMed)

Smith SN, Almirall D, Choi SY, Koschmann E, Rusch A, Bilek E, Lane A, Abelson JL, Eisenberg D, Himle JA, Fitzgerald KD, Liebrecht C, Kilbourne AM. Primary aim results of a clustered SMART for developing a school-level, adaptive implementation strategy to support CBT delivery at high schools in Michigan. Implement Sci. 2022 Jul 8;17(1):42. doi: 10.1186/s13012-022-01211-w.

Reference Type: DERIVED

PMID: 35804370 (View on PubMed)

Kilbourne AM, Smith SN, Choi SY, Koschmann E, Liebrecht C, Rusch A, Abelson JL, Eisenberg D, Himle JA, Fitzgerald K, Almirall D. Adaptive School-based Implementation of CBT (ASIC): clustered-SMART for building an optimized adaptive implementation intervention to improve uptake of mental health interventions in schools. Implement Sci. 2018 Sep 5;13(1):119. doi: 10.1186/s13012-018-0808-8.

Reference Type: DERIVED

PMID: 30185192 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01MH11420301

Identifier Type: -

Identifier Source: org_study_id