Depression Clinical Trial
Official title:
Improving Student Mental Health: Adaptive School-based Implementation of CBT
Verified date | June 2022 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1329 |
Est. completion date | May 15, 2020 |
Est. primary completion date | May 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | Baseline to 18-months | |
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. | 18 months | |
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. | 18 Months | |
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. | 18 Months |
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