Co-Principal Investigator: St. George, Sara M.

Purpose: The purpose of this mixed-methods evaluation project is to develop, refine, and pilot test a school-based, telehealth-delivered, indicated prevention program to address emotion regulation challenges faced by racially- and culturally-diverse adolescents with anxiety and depressive symptoms living in lower-income communities. The Unified Protocol for Preventing Emotional and Academic Challenges in Education (UP-PEACE) is based on a transdiagnostic form of cognitive behavioral therapy used in clinical settings.

Project Activities: The project involves developing and testing the feasibility of a modified version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A), an evidence-based intervention for anxiety and depression in adolescents via telehealth. The intervention will be an indicated prevention program targeting emotion regulation, which the researchers hypothesize will result in the reduction of clinical symptoms and improved academic achievement. The goal of this mixed methods evaluation project is to iteratively collect and integrate qualitative and quantitative data to develop UP-PEACE as a program that is easily implemented via telehealth, is scalable and sustainable in high schools with racially- and culturally-diverse youth being served in school-located healthcare settings. The project consists of three phases (Pre-Case Series Focus Groups; Case Series; Randomized Controlled Trial). Adolescent participants will be recruited from three public high schools in Miami-Dade County affiliated with the University of Miami's John T. MacDonald School Health Initiative. The team will recruit a total of 181 participants (92 adults and 89 adolescents) during the proposed study. Qualitative, quantitative and cost outcomes will be used to inform a fully-powered, randomized, effectiveness trial of the UP-PEACE program in school health settings.

Products: The research team will produce a fully developed version of the UP-PEACE indicated prevention program for anxiety and depression in racially- and culturally-diverse adolescents, including a clinician manual, participant workbook, clinician training and fidelity assessment materials suitable for use in both English and Spanish during future trials.

Structured Abstract

Setting: This study will take place in high schools in Miami-Dade County, Florida.

Sample: A diverse sample of students (ages 14–18) and school personnel will participate along with parents of students with higher or "indicated" risk for anxiety and depressive symptoms, and clinicians. Following a series of focus groups with key stakeholders that will give qualitative feedback on the development of UP-PEACE, an iterative case series with 12 adolescents will be conducted. Approximately 72 adolescents in three schools will then participate in the pilot randomized control trial (RCT).

Intervention: The research team will modify the UP-PEACE program for school settings from the existent Unified Protocol for Transdiagnostic Treatment for Emotional Disorders in Adolescents (UP-A), a transdiagnostic form of cognitive behavior therapy, using qualitative feedback from key stakeholders. The UP-A presents evidence-based practices for emotional disorders in a transdiagnostic context: cognitive strategies (e.g., reappraisal, problem-solving), mindfulness-based strategies (e.g., non-judgmental awareness), behavioral strategies (e.g., exposure, behavioral activation, opposite action). Likely modifications include an abbreviated, rolling group structure; telehealth delivery; in-school behavioral skill practice; and streamlined materials for school clinicians. In planned modifications to the UP-A, the researchers will also consider the context in which UP-PEACE is provided (school-located, integrated pediatric primary care), types of school mental health provider type delivering the program (determined via stakeholder feedback) and the lower-income, highly diverse communities from which the sample of adolescents for this study will be drawn.

Research Design and Methods: This mixed methods evaluation design involves multiple iterative phases, with the integration of qualitative and quantitative data occurring within and across phases. As a first step, the team will develop UP-PEACE as an acceptable indicated prevention program for use in schools with the input of focus groups with distinct stakeholders (school mental health providers, school administrators, adolescents, teachers and parents). Researchers will then conduct a case series consisting of two iterations will then be conducted with adolescents exhibiting elevated anxiety and/or depression symptoms, to evaluate preliminary feasibility and targets for further modification. Following each case series, the research team will conduct qualitative interviews and focus groups to obtain feedback on any factors influencing the implementation of the UP-PEACE within schools. The combination of quantitative and qualitative data collected concurrently during this phase will allow the researchers to better understand how individual treatment response may be related to perceived participation barriers and facilitators. Subsequently, they will conduct a pilot randomized controlled trial (RCT) in which adolescents will be randomly assigned to either UP-PEACE or services as usual in the in the school-located, integrated pediatric primary care clinic at their school (SAU). Following the RCT, they will conduct another round of qualitative data collection from purposefully sampled adolescents and parents as well as from school stakeholders who will provide their input on how to enhance the intervention, its implementation potential and scalability. Qualitative and quantitative data from all stages of the investigation, plus preliminary cost effectiveness data, will be used to prepare final procedures for a future, large-scale effectiveness trial.

Control Condition: Services as usual (SAU) in the school-located, integrated pediatric primary care clinics in which the study will take place will serve as the comparison condition for the RCT.

Key Measures: The research team will examine primary anxiety and depression symptom outcomes using brief, easily administered outcome measures, including the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item Scale. Changes in the target mechanism, emotion regulation, along with academic achievement and academic problems will also be assessed.

Data Analytic Strategy: Researchers will use qualitative thematic analysis to identify themes and subthemes in focus group and interview data. Quantitative analyses will use multilevel modeling (MLM), to account for nesting of repeated measures within clients and treatment groups; given the small number of schools and therapists, these variables will be included as control variables and probed for a future, fully-powered trial. Mixed methods analyses will involve developing joint displays following the case series and RCT to merge qualitative and quantitative data (e.g., compare illustrative quotes for adolescents who improve vs. worsen/remain unchanged following the intervention).

Cost Analysis: The project team will use calculate a preliminary estimate of costs associated with the intervention and its implementation as a tool for communication about UP-PEACE with stakeholders and to help prepare for future effectiveness research.