DepressionNCT03541317
Improving Student Mental Health: Adaptive School-based Implementation of CBT
A study testing Stage 1 Strategy: REP, Stage 1 Strategy: REP + Coaching and Stage 2 Strategy: Augment with Facilitation in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Stage 1 Strategy: REP, Stage 1 Strategy: REP + Coaching and Stage 2 Strategy: Augment with Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,329 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2018to 15 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Stage 1 Strategy: REP, Stage 1 Strategy: REP + Coaching, Stage 2 Strategy: Augment with Facilitation, Stage 2 Strategy: No augmentation
- Keywords
- Adaptive implementation, Coaching, Facilitation, School mental health, Implementation intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage 1 Strategy: REPBehavioural
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 + CoachingBehavioural
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 FacilitationBehavioural
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 augmentationBehavioural
Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Stage 2 Strategy: Augment with Facilitation; Behavioral: Stage 2 Strategy: No augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 18-months
Secondary outcomes (3)
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.
Measured: 18 months
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.
Measured: 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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start19 Jul 2018
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy M. Kilbourne, University of Michigan
- Investigators
- Amy M Kilbourne, PhD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541317
- Sponsor's protocol ID
- 1R01MH11420301
- Status last verified
- Jun 2022
- First submitted
- 17 May 2018
- Last updated
- 22 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39151756Smith 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.
PubMed 35804370Kilbourne 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.
PubMed 30185192
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Student Mental Health: Adaptive School-based Implementation of CBT
- ClinicalTrials.gov ID
- NCT03541317
- Acronym / sponsor ID
- 1R01MH11420301
- Conditions
- Depression, Anxiety
- Keywords
- Adaptive implementation, Coaching, Facilitation, School mental health, Implementation intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Posted 26 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Optimal First Line Implementation Strategy | Experimental | Behavioral: Stage 1 Strategy: REP, Behavioral: Stage 1 Strategy: REP + CoachingAll 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 | Behavioral: Stage 2 Strategy: Augment with Facilitation, Behavioral: Stage 2 Strategy: No augmentationAfter 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). |
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stage 1 Strategy: REPSchools 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. | Behavioural | Stage 1: Optimal First Line Implementation Strategy |
| Stage 1 Strategy: REP + CoachingSchools 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. | Behavioural | Stage 1: Optimal First Line Implementation Strategy |
| Stage 2 Strategy: Augment with FacilitationIn 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. | Behavioural | Stage 2: Added Value of Providing Facilitation |
| Stage 2 Strategy: No augmentationSchools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered. | Behavioural | Stage 2: Added Value of Providing Facilitation |
Primary outcome
Number of CBT Sessions Delivered by School Professionals to Students After 18 Months
Time frame: 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).
3 secondary outcomes
Number of Brief Individual CBT Sessions
Time frame: 18 months
Number of Full Individual CBT Sessions
Time frame: 18 Months
Number of Group CBT Sessions
Time frame: 18 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39151756Smith 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.
- Derived from this study: PubMed 35804370Smith 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.
- Derived from this study: PubMed 30185192Kilbourne 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy M Kilbourne, PhD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stage 1 Strategy: REP, Stage 1 Strategy: REP + Coaching and Stage 2 Strategy: Augment with Facilitation in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CBT Sessions Delivered by School Professionals to Students After 18 Months (time frame: Baseline to 18-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541317, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.