Anxiety, Depression
Conditions
Keywords
Adaptive implementation, Coaching, Facilitation, School mental health, Implementation intervention
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.
Interventions
BEHAVIORALStage 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.
BEHAVIORALStage 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.
BEHAVIORALStage 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.
BEHAVIORALStage 2 Strategy: No augmentation
Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered.
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 99 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 Strategy: REP: Stage 1 Strategy: REP. This includes all three arms listed in Participant Flow as not receiving Coaching | 81 |
| Stage 1 Strategy: REP: Stage 1 Strategy: REP. This includes all three arms listed in Participant Flow as not receiving Coaching | 47 |
| Stage 1 Strategy: REP + Coaching Stage 1 Strategy: REP + Coaching This includes all three arms listed in Participant Flow as receiving Coaching. | 88 |
| Stage 1 Strategy: REP + Coaching Stage 1 Strategy: REP + Coaching This includes all three arms listed in Participant Flow as receiving Coaching. | 47 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Stage 2 of the Implementation | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Stage 1 Strategy: REP: | Stage 1 Strategy: REP + Coaching |
|---|---|---|---|
| Age, Customized > 18 years of age | 169 Participants | 81 Participants | 88 Participants |
| Race/Ethnicity, Customized non-white | 11 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized unknown | 7 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized white | 151 Participants | 71 Participants | 80 Participants |
| Rural schools (vs urban) (Binary proportion) | .56 proportion STANDARD_DEVIATION 0.5 | .55 proportion STANDARD_DEVIATION 0.5 | .57 proportion STANDARD_DEVIATION 0.5 |
| School level average School Professional tenure | 7.56 years STANDARD_DEVIATION 5.96 | 7.34 years STANDARD_DEVIATION 6.03 | 7.79 years STANDARD_DEVIATION 5.94 |
| School level Proportion of School Professionals with graduate degree | .90 Proportion STANDARD_DEVIATION 0.26 | .89 Proportion STANDARD_DEVIATION 0.28 | .91 Proportion STANDARD_DEVIATION 0.24 |
| Schools with > 500 students (vs. ≤ 500 students), Binary Proportion | 0.65 proportion STANDARD_DEVIATION 0.48 | 0.66 proportion STANDARD_DEVIATION 0.48 | 0.64 proportion STANDARD_DEVIATION 0.49 |
| Schools with ≥ 50% of students on free/reduced cost lunch | .36 proportion STANDARD_DEVIATION 0.48 | 0.36 proportion STANDARD_DEVIATION 0.49 | .36 proportion STANDARD_DEVIATION 0.49 |
| Sex/Gender, Customized Female | 143 Participants | 69 Participants | 74 Participants |
| Sex/Gender, Customized Male | 20 Participants | 8 Participants | 12 Participants |
| Sex/Gender, Customized Unknown | 6 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: Baseline to 18-months
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: REP Only | Number of CBT Sessions Delivered by School Professionals to Students After 18 Months | 121.1 number of CBT sessions |
| Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation | Number of CBT Sessions Delivered by School Professionals to Students After 18 Months | 111.4 number of CBT sessions |
p-value: 0.6395% CI: [-30.03, 49.4]weighted least squares regression
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.
Time frame: 18 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: REP Only | Number of Brief Individual CBT Sessions | 55.9 Number of brief sessions |
| Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation | Number of Brief Individual CBT Sessions | 52.1 Number of brief sessions |
p-value: 0.7295% CI: [-16.88, 24.44]weighted least squares regression
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.
Time frame: 18 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: REP Only | Number of Full Individual CBT Sessions | 49.5 full sessions |
| Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation | Number of Full Individual CBT Sessions | 41.7 full sessions |
p-value: 0.4695% CI: [-13.2, 28.91]Weighted Least Squares Regression
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.
Time frame: 18 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: REP Only | Number of Group CBT Sessions | 16.8 group sessions |
| Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation | Number of Group CBT Sessions | 17.5 group sessions |
Comparison: A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of group CBT sessions delivered to students by SPs over the four post-randomization phase occurring during Stages 1 and 2.p-value: 0.8795% CI: [-8.49, 7.16]Weighted Least Squares Regression