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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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School Administrators
Inclusion Criteria:
Exclusion Criteria:
School Professional
Inclusion Criteria:
Exclusion Criteria:
Student
Inclusion Criteria:
Exclusion Criteria:
Students could withdraw from participation at any time by themselves, or by parent notification to the study team.
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| Name | Affiliation | Role |
|---|---|---|
| Amy M Kilbourne, PhD, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39151756 | Derived | 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. | |
| 35804370 |
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Pre-randomization, 21 schools and a total of 58 school professionals declined or did not meet eligibility and were dropped.
Stage 1 Randomization: 94 schools (employing 169 school professionals (SPs)) were enrolled in the sequentially-randomized trial.
Stage 2 Randomization: All 83 schools (employing 154 SPs) identified as potentially benefitting from augmentation with Facilitation (i.e., "schools that did not respond sufficiently following Stage 1 strategy") were re-randomized at Stage 2.
Of the 1329 consented, listed in registration: there were 103 School administrators (for 94 schools), 978 Students were enrolled into the study, 227 school professionals from 115 schools were enrolled/consented; 21 coaches were also consented.
Because primary and secondary outcome measures are all based on data collected from school professionals, only they are included in participant flow, baseline characteristics, outcome measures.
| ID | Title | Description |
|---|---|---|
| FG000 | REP Only, Responders, Continue | This group included schools who responded sufficiently to "REP only" in Stage 1, and then were assigned to Continue "REP only" in Stage 2. |
| FG001 | REP Only, Non-responders, Continue | This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to Continue "REP only" in Stage 2. |
| FG002 | REP Only, Non-responders, Facilitation | This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to Augment "REP" with "Facilitation" in Stage 2. |
| FG003 | REP + Coaching, Responders, Continue | This group included schools who responded sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Continue "REP + Coaching" in Stage 2. |
| FG004 | REP + Coaching, Non-responders, Continue | This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Continue "REP + Coaching" in Stage 2. |
| FG005 | REP + Coaching, Non-responders, Facilitation | This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Augment "REP + Coaching" with "Facilitation" in Stage 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 of the Implementation |
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| Stage 2 of the Implementation |
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Demographic data is presented for school professionals when human data is needed, because that is the group on which all primary and secondary outcome measures are based. Some baseline characteristics apply to school units rather than to school professionals.
| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 Strategy: REP: | Stage 1 Strategy: REP. This includes all three arms listed in Participant Flow as not receiving Coaching |
| BG001 | Stage 1 Strategy: REP + Coaching | Stage 1 Strategy: REP + Coaching This includes all three arms listed in Participant Flow as receiving Coaching. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age data was not collected from School Professionals, but all had to be adults to be in their roles. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The primary outcome measure pertains to delivery of CBT by school professionals only, and thus the number analyzed reflects data categorized by number of school professionals that had REP only vs. most intensive intervention: REP, Coaching and Facilitation | Posted | Mean | 95% Confidence Interval | number of CBT sessions | Baseline to 18-months | schools | schools |
|
18 months
AE Data was not collected for any group. While there was no request for school professionals to notify the study team about student adverse events, one professional spontaneously informed the team that one student had committed suicide from the REP Non-Responder, Facilitation group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REP Only, Responders, Continue | This group included schools who responded sufficiently to "REP only" in Stage 1, and then were assigned to continue "REP only" in Stage 2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy M Kilbourne | University of Michigan | 734-845-3452 | amykilbo@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2020 | Apr 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| 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 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 Strategy: No augmentation | Behavioral | Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered. |
|
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 |
| 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. |
| 30185192 | 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. |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| schools |
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| Count of Participants |
| Participants |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Rural schools (vs urban) (Binary proportion) | rural (1) or urban (0) | This baseline characteristic applies to school units rather than to school professionals. All participating schools are included in the analysis. | Mean | Standard Deviation | proportion | schools |
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| Schools with > 500 students (vs. ≤ 500 students), Binary Proportion | > 500 students (1) or ≤ 500 students (0) | As this baseline characteristic applies to schools, not to the school professionals who participated in the study, number of schools analyzed is shown. All schools are included. | Mean | Standard Deviation | proportion | schools |
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| Schools with ≥ 50% of students on free/reduced cost lunch | ≥ %50 (1) or < 50% (0), Binary proportion | Mean | Standard Deviation | proportion | schools |
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| School level average School Professional tenure | Mean | Standard Deviation | years | schools |
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| School level Proportion of School Professionals with graduate degree | Mean | Standard Deviation | Proportion | schools |
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| OG001 | Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation | This arm consists of those schools that received REP + Coaching in Stage 1, who were either Responders after Stage 1 or, as Non-Responders were randomized to additionally receive "Facilitation" in Stage 2. 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 supported school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation received regular calls for a minimum of 10 weeks from the Facilitator. Thus, this arm represents "REP + Coaching Responders, Continue" and "REP + Coaching, Non-Responders, Facilitation" from the Participant Flow. The 45 professionals represent 26 schools. |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Number of brief sessions | 18 months | schools | schools |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | full sessions | 18 Months | schools | schools |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | group sessions | 18 Months | schools | schools |
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| EG001 | REP Only, Non-Responders, Continue | This group included schools who did not respond sufficiently to "REP only" in Stage 1, and were assigned to continue "REP only" in Stage 2. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | REP Only, Non-Responders, Facilitation | This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to augment "REP" with "Facilitation" in Stage 2. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | REP + Coaching Responders, Continue | This group included schools who responded sufficiently to "REP + Coaching" in Stage 1 and were assigned to continue "REP + Coaching" in Stage 2. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | REP+ Coaching Non-Responders, Continue | This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1 and were assigned to continue "REP + Coaching" in Stage 2. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | REP + Coaching, Non-Responders, Facilitation | This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to augment "REP+ Coaching" with "Facilitation" in Stage 2. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Unknown |
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| Title | Measurements |
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| unknown |
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