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

NCT03541317 | Completed Results

• 1 other identifier: 1R01MH11420301
• Study Type: interventional
• Target: 1,329
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Adaptive implementation; Coaching; Facilitation; School mental health; Implementation intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Brief Individual CBT Sessions

  18 months

• Number of Full Individual CBT Sessions

  18 Months

• Number of Group CBT Sessions

  18 Months

Study Arms (2)

Stage 1: Optimal First Line Implementation Strategy

EXPERIMENTAL

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; Behavioral: Stage 1 Strategy: REP + Coaching

Stage 2: Added Value of Providing Facilitation

EXPERIMENTAL

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; Behavioral: Stage 2 Strategy: No augmentation

Interventions

Stage 1 Strategy: REP 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: Optimal First Line Implementation Strategy

Stage 1 Strategy: REP + Coaching 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 1: Optimal First Line Implementation Strategy

Stage 2 Strategy: Augment with Facilitation 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: Added Value of Providing Facilitation

Stage 2 Strategy: No augmentation BEHAVIORAL

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

Stage 2: Added Value of Providing Facilitation

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

• 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.

  PMID: 39151756 DERIVED

• 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.

  PMID: 35804370 DERIVED

• 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.

  PMID: 30185192 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Amy M Kilbourne
• Organization: University of Michigan

amykilbo@umich.edu

734-845-3452

Study Officials

• Amy M Kilbourne, PhD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: July 19, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: June 22, 2022
• Results First Posted: July 26, 2021

Record last verified: 2022-06

Locations

US (1)