Study concept and design: Powers, Kashikar-Zuck, Kabbouche, Hershey.
Acquisition of data: Powers, Allen, LeCates, Slater, Zafar, Kabbouche, O’Brien, Shenk, Hershey.
Analysis and interpretation of data: Powers, Kashikar-Zuck, Allen, Shenk, Rausch, Hershey.
Drafting of the manuscript: Powers, Kashikar-Zuck, Allen, LeCates, Rausch.
Critical revision of the manuscript for important intellectual content: Kashikar-Zuck, Allen, Slater, Zafar, Kabbouche, O’Brien, Shenk, Rausch, Hershey.
Statistical analysis: Allen, Rausch.
Obtained funding: Powers, Hershey.
Administrative, technical, or material support: Powers, Allen, LeCates, Slater, O’Brien, Shenk, Hershey.
Study supervision: Powers, Kashikar-Zuck, Hershey.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: Funding was provided by grant R01NS05036 from the National Institute of Neurological Disorders and Stroke (Dr Powers), grant 8 UL1 TR000077 from the National Center for Research Resources and the National Center for Advancing Translational Sciences, and grant T32DK063929 from the National Institute of Diabetes and Digestive and Kidney Diseases for some of the postdoctoral fellows who contributed to the trial (Dr Powers, program director). Amitriptyline, which was provided without cost to participants, was purchased using National Institutes of Health grant funds and managed by the investigational pharmacy at Cincinnati Children’s Hospital Medical Center. If prevention drug was clinically prescribed during the 12-month follow-up period, families had financial responsibility for the medications as with typical clinical practice.
Role of the Sponsor: The National Institutes of Health had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Neurological Disorders and Stroke, the National Center for Advancing Translational Sciences, the National Institute of Diabetes and Digestive and Kidney Diseases, or the National Institutes of Health.
Additional Contributions: We thank all the children, adolescents, and families that participated in this clinical trial. Other members of the team that contributed to this project include Gloria Yeomans-Maldonado, BA, Ting Sa, BS, Christie Crosby, BS, Wendy Lopez, PsyD, Anne Lynch-Jordan, PhD, Lori Crosby, PsyD, Brandon Aylward, PhD, Lisa Clifford, PhD, Sandra Cortina, PhD, Stacy Flowers, PsyD, Elizabeth Kuhl, PhD, Irina Parkins, PhD, Megan Benoit Ratcliff, PhD, Stephanie Spear Filigno, PhD, Jessica Valenzuela, PhD, Laura Bimbo Smith, PhD, Ann Segers, BS, Paula Manning, BS, Judy Bush, BS, Polly Vaughan, BS, PNP, Shannon White, PhD, Joanne Kacperski, MD, Leigh Ann Chamberlin, MEd, Maxx Somers, MS, Megan Crawford Cohen, PhD, Stephanie Sullivan, BS, Samantha Morgan, BS, Kim Barnett, BS, Erin Brannon, MS, Jen Hembree, AS, John Kroner, BA, Kerry Simmons, BS, Leslie Korbee, BS, and Judy Bean, PhD (all from Cincinnati Children’s Hospital). Other than the grant funding from the National Institutes of Health that supported the work of Drs Aylward, Clifford, Kuhl, Ratcliff, Filigno, Valenzuela, Smith, Cohen, and Bean, Mss Chamberlin, Sullivan, Morgan, Barnett, Brannon, Hembree, Simmons, and Korbee, and Messrs Somers and Kroner, there was no other compensation for each person listed as contributors. We also thank the Cincinnati Children’s Headache Center, Divisions of Behavioral Medicine and Clinical Psychology and Neurology, and the Research Foundation Office for Clinical and Translational Research.
Additional Information: For more information regarding the cognitive behavioral therapy and headache education treatment manuals used in this trial, and to request copies of the manuals, please go to: http://www.cincinnatichildrens.org/research/divisions/b/psychology/labs/powers/default/.