Jill Ehrenreich-May - US grants

[unreadable] DESCRIPTION (provided by applicant): This application is a request for a Mentored Patient-Oriented Research Career Development Award (K23) from the NIMH to foster the academic career development of the applicant, Jill T. Ehrenreich, Ph.D. The applicant will work with her primary mentor, Dr. David Barlow, her co-mentor, Dr. Wendy Silverman, and expert consultants, Dr. Laura Mufson, Dr. John Weisz, Dr. James Gross, Dr. Richard Lerner, and Dr. Timothy Brown, to develop expertise in conducting clinical research to establish innovative and efficacious interventions for adolescents with emotional disorders. In a career development plan spanning five years, the applicant has delineated short-term and long-term goals to prepare her for a patient-oriented research career. Short-term goals include obtaining didactic training and mentoring in several "core" areas that have been chosen to deepen her existing skills and to expand her skills into new areas. The applicant's long-term goals are to develop a programmatic line of research that is focused on developing innovative treatments for anxiety disorders in childhood and adolescence, and their most commonly comorbid conditions, as well as to launch a highly productive career as a clinical scientist. A formal research plan is proposed to investigate emotional disorders in adolescence, focusing specifically on anxiety disorders and unipolar mood disorders. Despite theory and research that suggests these disorders may share common biological and psychological vulnerabilities, demonstrate high comorbidity with one another, and evidence a potentially chronic impact on development, there have been few treatment studies investigating the efficacy of a single protocol with the applicability to treat this array of conditions in adolescence. The primary goal of the proposed research plan is to develop and apply a novel treatment for adolescents with emotional disorders, based on efficacious treatments for anxiety and depression in youth and an existent intervention for adults that unites fundamental treatment components appropriate for intervention with wide range of emotional disorders. The main goals of this project are: (1) to create a new treatment, entitled Adolescent Depression and Anxiety Protocol Treatment (ADAPT), for adolescents exhibiting a range of emotional disorders; (2) to conduct a small open trial using ADAPT with 15 adolescents evidencing anxiety and/or unipolar mood disorders; and, (3) to establish an initial effect size for the ADAPT program in a pilot study with 60 adolescents with anxiety and/or unipolar mood disorders and to assess maintenance of change at 3 and 6 months following treatment. The resulting treatment may have a far-reaching impact via dissemination to community providers treating adolescents with anxiety and depression by virtue of its relative consistency in format, combined with its breadth of application. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Autism spectrum disorders (ASD) affect approximately 1 out of 150 children and adolescents in the United States, making them one of the most common neurobiological conditions. Comorbid anxiety disorders affect as many as 80% of youth with ASD, causing substantial distress and impairment over and above that caused by an ASD diagnosis alone. While cognitive-behavioral therapy (CBT) has been established as the gold standard treatment for anxiety disorders among typically developing youth, and innovative work by the investigative team supports its utility in children with ASD and comorbid anxiety, a protocol does not exist for early adolescents with ASD and comorbid anxiety disorders. In fact, there are no empirically supported treatment options for early adolescents with ASD and comorbid anxiety disorders;and existing pharmacological interventions may have some disadvantages (e.g., limited efficacy in this population, side effects, and potential drug x drug interactions). Accordingly, we are proposing to develop a CBT protocol for anxiety and comorbid ASD in early adolescence, as well as a credible comparison protocol (Relaxation Training;RT) for use in a future multisite clinical trial to test the efficacy of CBT in this population. In response to the Recovery Act Limited Competition, each site will hire and train at least three new study staff to conduct this study. Initial protocol development efforts will focus on adapting relevant treatment elements from an efficacious CBT program for younger children with ASD and comorbid anxiety to the characteristics and clinical needs of early adolescents. Developmentally appropriate, novel treatment components will then be added. An extant RT treatment protocol will also be modified for use with early adolescents with ASD. In response to the NIH Roadmap Initiative, attention will be paid to protocol adaptability with varying presentations. Measures of treatment integrity and competence will be developed along with the protocols. Thereafter, protocol and measure development will be refined through our experiences treating 18 young adolescents (ages 11-14 years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and expert feedback. The feasibility of implementation of both protocols will then be examined in the context of a pilot study incorporating all the features of the planned future efficacy trial comparing CBT and RT, but with a limited sample size (N = 48). At the end of the project, refined treatment manuals will be completed, integrity and competence measures will be finalized and tested for reliability and validity, and the three recruitment sites will have developed protocols promoting and assessing the consistency of treatment delivery and assessment procedures across sites, and a linked R01 grant to test the efficacy of CBT will be written. The three recruitment sites for this study are the University of California, Los Angeles (UCLA);the University of South Florida;and the University of Miami. The UCLA Neuropsychiatric (Semel) Institute's Biostatistics Core will provide data management services. Considering the rising number of youth diagnosed with ASD, and the lack of empirically supported treatment options for those young adolescents with comorbid anxiety, our proposed work toward an efficacious CBT protocol will provide a timely contribution to public health efforts. PUBLIC HEALTH RELEVANCE: Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder but has yet to be adapted to meet the unique needs of adolescents with ASD and comorbid anxiety. With more youth being diagnosed with ASD after the early childhood period, a treatment protocol such as that proposed could contribute to public health efforts to address the mental health needs of early adolescents with ASD.

? DESCRIPTION (provided by applicant): Emotional disorders, encompassing a range of anxiety and depressive disorders, are the most prevalent and comorbid psychiatric disorders in adolescence. They are chronic, impairing, costly, and share overarching commonalities. Unfortunately, evidence-based therapies (EBTs) exist for only single disorders or domains (e.g., depression), are rarely adopted by community mental health center (CMHC) clinicians, and effect sizes are modest (40-50% of youth are treatment non-responders). Thus, methods for improving outcomes for these youth, particularly in CMHCs are needed. This study tests the effectiveness of two novel interventions to address this need. The first intervention is a transdiagnostic treatment (the Unified Protocol for the Treatment of Emotional Disorders in Adolescents, UP-A), a promising new approach that uses a small number of common strategies to treat a broad range of emotional disorders. Transdiagnostic models align with NIH's initiative to advance the understanding and treatment of psychopathology using the Research Domain Criteria (RDoC). Importantly, this treatment approach is expected to improve client outcomes and have quicker uptake by CMHC clinicians because: (1) comorbidity is the rule, rather than the exception making this intervention more relevant for the patients seen in CMHCs, and (2) protocols cutting across diagnostic boundaries reduce training burden. The second intervention is a standardized monitoring and feedback system (MFS; Youth Outcomes Questionnaires, YOQ). This intervention can be built into the existing electronic medical records infrastructure of CMHCs and thus has appeal for its acceptability, ease of transport into clinical practice, and sustainability. Emerging data suggests that MFS alone improves outcomes relative to TAU but has not been adequately tested in youth. As an added value, this study also addresses a common threat to the internal validity of previous RCTs evaluating an EBT by isolating the confounding effects of increased measurement and feedback to clinicians. Finally, addressing a central aim of this RFA and making a unique and critical contribution to the treatment literature, this study will examine theoretically linked mechanisms (both patient and provider level) of treatment outcomes of both the UP-A and the YOQ. This collaborative R01 application (in response to RFA-MH-15-325) was prepared by Drs. Ehrenreich-May and Jensen-Doss at the University of Miami (Miami) and Dr. Ginsburg at The University of Connecticut School of Medicine (UConn; applications are identical). To test study aims, 222 adolescents (ages 12-17) with anxiety and/or depressive disorders will be recruited in CMHCs in Miami and Hartford (111 adolescents and 9 clinicians at each site). Both adolescents and clinicians will be randomized to one of three conditions: (1) TAU alone; (2) TAU plus YOQ, and (3) UP-A plus YOQ. Research assessments will occur at baseline, 8 weeks and 16 weeks after treatment initiation and a 3-month follow-up. If effective, these interventions have the potential to change clinical practice i CMHCs by equipping clinicians with more effective interventions that can be applied to a broad range of patients.