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)
Project #
Application #
Study Section
Arthritis and Musculoskeletal and Skin Diseases Special Grants Review Committee (AMS)
Program Officer
Serrate-Sztein, Susana
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
United States
Zip Code
Kashikar-Zuck, Susmita; Cunningham, Natoshia; Peugh, James et al. (2018) Long-term outcomes of adolescents with juvenile-onset fibromyalgia into adulthood and impact of depressive symptoms on functioning over time. Pain :
Kashikar-Zuck, Susmita; Black, William R; Pfeiffer, Megan et al. (2018) Pilot Randomized Trial of Integrated Cognitive-Behavioral Therapy and Neuromuscular Training for Juvenile Fibromyalgia: The FIT Teens Program. J Pain 19:1049-1062
Lynch-Jordan, Anne M; Peugh, James; Cunningham, Natoshia R et al. (2018) Maternal Protective Parenting Accounts for the Relationship Between Pain Behaviors and Functional Disability in Adolescents. Clin J Pain 34:1089-1095
Cunningham, Natoshia R; Nelson, Sarah; Jagpal, Anjana et al. (2018) Development of the Aim to Decrease Anxiety and Pain Treatment for Pediatric Functional Abdominal Pain Disorders. J Pediatr Gastroenterol Nutr 66:16-20
Cunningham, Natoshia R; Jagpal, Anjana; Nelson, Sarah et al. (2018) Clinical Reference Points for the Screen for Child Anxiety Related Disorders in Two Investigations of Youth with Chronic Pain. Clin J Pain :
Donnelly, C; Cunningham, N; Jones, J T et al. (2018) Fatigue and depression predict reduced health-related quality of life in childhood-onset lupus. Lupus 27:124-133
Cunningham, Natoshia R; Kashikar-Zuck, Susmita; Mara, Constance et al. (2017) Development and validation of the self-reported PROMIS pediatric pain behavior item bank and short form scale. Pain 158:1323-1331
Nelson, Sarah M; Cunningham, Natoshia R; Kashikar-Zuck, Susmita (2017) A Conceptual Framework for Understanding the Role of Adverse Childhood Experiences in Pediatric Chronic Pain. Clin J Pain 33:264-270
Peugh, James L; Strotman, Daniel; McGrady, Meghan et al. (2017) Beyond intent to treat (ITT): A complier average causal effect (CACE) estimation primer. J Sch Psychol 60:7-24
Kroner, John W; Peugh, James; Kashikar-Zuck, Susmita M et al. (2017) Trajectory of Improvement in Children and Adolescents With Chronic Migraine: Results From the Cognitive-Behavioral Therapy and Amitriptyline Trial. J Pain 18:637-644

Showing the most recent 10 out of 61 publications