Clinical trial NCT03541317: Improving Student Mental Health: Adaptive School-based Implementation of CBT
Official title: Improving Student Mental Health: Adaptive School-based Implementation of CBT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Adaptive implementation
Coaching
Facilitation
School mental health
Implementation intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-05-30
Enrollment: 1329
Sex: ALL
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Exclusion Criteria:

* 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

Inclusion Criteria:

* 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:

* 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.

Primary outcomes:
measure: Number of CBT Sessions Delivered by School Professionals to Students After 18 Months
timeFrame: Baseline to 18-months
Secondary outcomes:
measure: Number of Brief Individual CBT Sessions
timeFrame: 18 months
measure: Number of Full Individual CBT Sessions
timeFrame: 18 Months
measure: Number of Group CBT Sessions
timeFrame: 18 Months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy M Kilbourne, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.