The Specific Aims of this Midcareer Investigator Award renewal application are to 1) successfully implement an ongoing prospective longitudinal study to determine long term outcomes of pediatric patients with juvenile- onset fibromyalgia (JFM), 2) to refine and test a novel intervention, i.e., combined cognitive-behavioral therapy (CBT) and physical exercise to reduce pain and impairment, and increase coping and physical activity in adolescents with JFM, and 3) continue to use the candidate's ongoing and planned clinical studies in pediatric pain to train postdoctoral fellows and junior faculty. The Candidate s a nationally recognized pediatric pain researcher with a history of >10 years of independently funded patient-oriented research focused on clinical trials of behavioral treatment for JFM and other pain conditions, longitudinal studies, and mentorship of early career researchers. In the first 3.5 years of her current K24 funding, she completed the first rigorously controlled trial demonstrating that CBT is a safe and effective intervention for reduction of disability and depression in JFM and she published 22 papers (along with her mentees) based on her JFM and pediatric pain research. The proposed Research Plan for this renewal application includes two projects: 1) an ongoing NIAMS (R01) funded longitudinal study of long-term outcomes of adolescents with JFM, and 2) an ongoing pilot trial of a novel combined CBT and exercise - FIT Teens (Fibromyalgia Integrative Training for Teens) intervention. The innovation of this new program is that it builds on the candidate's established CBT program and seamlessly integrates an exercise component modified from sports-medicine/injury prevention to improve body mechanics and increase physical activity without fear of pain-flares and activity avoidance which is central to inactivity in JFM patients. Results will inform the next multi-site RCT in JFM. The Mentoring Plan is to train future clinical investigators in the field of clinical trials and outcoms research in pediatric chronic pain. The candidate's plan consists of 1) individualized mentoring of postdoctoral fellows/junior faculty supported by currently funded studies (longitudinal study in JFM (R01), PROMIS in pediatric pain and rheumatology (U01), a 40-site clinical trial of prevention medication for pediatric migraine (U01), and other ongoing studies, 2) mentoring of fellows/faculty to develop their own independent research and 3) participation of fellows in established didactic programs on manuscript/grant writing, research methodology and responsible conduct of human research. Cincinnati Children's provides an ideal setting for this award because of the strong institutional support for patient-oriented research and team-science, presence of an award winning chronic pain program, strong interdisciplinary research collaborations with pediatric rheumatology, pain medicine, sports medicine and neurology researchers interested in pediatric pain, a divisional data core and a commitment of the institution to """"""""change the outcomes"""""""" for pediatric patients.

Public Health Relevance

The candidate leads a nationally recognized research program in pediatric chronic pain, including poorly understood musculoskeletal conditions like juvenile fibromyalgia, in which she is doing pioneering work. Her contributions include rigorous clinical trials of behavioral interventions for pain management, innovative assessment methods using objective and patient-reported tools and longitudinal studies of long-term trajectories of pediatric pain into young adulthood. She is dedicated to the training and mentorship of the next generation of clinician-scientists in patient-oriented research in pediatric chronic pain, an under recognized but widely prevalent public health problem.

National Institute of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Midcareer Investigator Award in Patient-Oriented Research (K24)
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Arthritis and Musculoskeletal and Skin Diseases Special Grants Review Committee (AMS)
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Serrate-Sztein, Susana
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Jones, Jordan T; Cunningham, Natoshia; Kashikar-Zuck, SusmitA et al. (2016) Pain, Fatigue, and Psychological Impact on Health-Related Quality of Life in Childhood-Onset Lupus. Arthritis Care Res (Hoboken) 68:73-80
Kashikar-Zuck, Susmita; Tran, Susan T; Barnett, Kimberly et al. (2016) A Qualitative Examination of a New Combined Cognitive-Behavioral and Neuromuscular Training Intervention for Juvenile Fibromyalgia. Clin J Pain 32:70-81
Kashikar-Zuck, Susmita; King, Christopher; Ting, Tracy V et al. (2016) Juvenile Fibromyalgia: Different from the Adult Chronic Pain Syndrome? Curr Rheumatol Rep 18:19
Tran, Susan T; Guite, Jessica W; Pantaleao, Ashley et al. (2016) Preliminary outcomes of a cross-site cognitive-behavioral and neuromuscular integrative training intervention for juvenile fibromyalgia. Arthritis Care Res (Hoboken) :
Cunningham, Natoshia Raishevich; Jagpal, Anjana; Peugh, James et al. (2016) Risk Categorization Predicts Disability in Pain-associated Functional Gastrointestinal Disorders (FGIDs) After 6 Months. J Pediatr Gastroenterol Nutr :
Cunningham, Natoshia Raishevich; Jagpal, Anjana; Tran, Susan T et al. (2016) Anxiety Adversely Impacts Response to Cognitive Behavioral Therapy in Children with Chronic Pain. J Pediatr 171:227-33
Nelson, Sarah M; Cunningham, Natoshia Raishevich; Kashikar-Zuck, Susmita (2016) A Conceptual Framework for Understanding the Role of Adverse Childhood Experiences in Pediatric Chronic Pain. Clin J Pain :
Tran, Susan T; Thomas, Staci; DiCesare, Christopher et al. (2016) A pilot study of biomechanical assessment before and after an integrative training program for adolescents with juvenile fibromyalgia. Pediatr Rheumatol Online J 14:43
Cunningham, Natoshia Raishevich; Tran, Susan T; Lynch-Jordan, Anne M et al. (2015) Psychiatric Disorders in Young Adults Diagnosed with Juvenile Fibromyalgia in Adolescence. J Rheumatol 42:2427-33
Cunningham, Natoshia R; Cohen, Mitchell B; Farrell, Michael K et al. (2015) Concordant parent-child reports of anxiety predict impairment in youth with functional abdominal pain. J Pediatr Gastroenterol Nutr 60:312-7

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