Feasibility, acceptability, and preliminary effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in clinical settings - PROJECT SUMMARY/ABSTRACT Autistic youth are far more likely to experience depression and suicidal thoughts and behaviors than their non- autistic peers, yet few autistic youth receive appropriate treatment. Untreated depression is associated with adverse short- (e.g., school refusal) and long-term outcomes (e.g., poor physical health) that impair quality of life. Families of autistic youth with depression encounter barriers to care including significant clinician shortages and high clinician uncertainty in treating this population. Clinicians frequently decline referrals due to limited autism training and few evidence-based treatments. Though Cognitive-Behavioral Therapy (CBT) is a leading intervention for depression in non-autistic youth, it has not been rigorously studied in autism. Given that autism- adapted CBT consistently outperforms standard CBT for anxiety and obsessive-compulsive disorder, it is likely that autism-adapted CBT for depression may be effective in treating symptoms; however, this remains largely underdeveloped and untested. To being to address this gap, we partnered with autistic stakeholders to develop Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) and tested the preliminary feasibility and acceptability of CBT-DAY in a pilot nonrandomized trial, with promising initial findings. CBT-DAY targets emotional reactivity, negative self-esteem, and autism self-knowledge in youth to improve depressive symptom severity. However, CBT-DAY has not been evaluated in a larger randomized controlled trial and when delivered by clinicians with limited autism training. Therefore, in this study, we seek to examine the feasibility, acceptability, and initial effectiveness of CBT-DAY and its associated clinician training model for verbally-fluent (Verbal IQ≥70) autistic youth with depression (11-17 years old) served in outpatient clinics. In the first phase of the study, we aim to develop a CBT-DAY clinician training model for clinicians with limited autism training based on feedback from 35 stakeholders including autistic youth with depression and their parents, clinicians, and clinic leaders. In the second phase, we will conduct a hybrid type 1 effectiveness-implementation trial with 60 autistic youth (11- 17 years old) with depression, 60 of their parents, and 20 clinicians with limited autism training in clinical settings, comparing CBT-DAY versus treatment-as-usual (TAU). We will test the initial feasibility, acceptability, and effectiveness of CBT-DAY in improving youth depressive symptom severity. In the final phase of the study, we will collect mixed methods data (i.e., interviews, surveys) on implementation outcomes (i.e., feasibility, acceptability, fidelity) and contextual factors influencing CBT-DAY implementation and sustainment from the recruited families, clinicians, and organizational leaders. Findings will inform future studies that scale up CBT- DAY and improve its implementation and sustainability in clinical settings. This R34 project has important clinical implications, as findings may support the testing and implementation of CBT-DAY and its associated clinician training model to improve outcomes for autistic youth with depression and increase the service workforce.