Blank, Elizabeth
Gilbert, Donald L.
Wu, Steve W.
Larsh, Travis
Elmaghraby, Rana
Liu, Rui
Smith, Elizabeth
Westerkamp, Grace
Liu, Yanchen
Horn, Paul S.
Greenstein, Ethan
Sweeney, John A.
Erickson, Craig A.
Pedapati, Ernest V. http://orcid.org/0000-0002-7954-5104
Funding for this research was provided by:
Cincinnati Children’s Research Foundation (Development Award)
Article History
Accepted: 9 January 2024
First Online: 15 May 2024
Declarations
:
: The authors declare no competing interest (either financial or non-financial interest) with the present submitted manuscript described by the Journal of Autism and Developmental Disorders policy. The present study was federally funded by the Cincinnati Children’s Hospital Research Foundation. We have opted to provide full disclosures of all authors’ external commitments for the editor’s review for transparency. The basis of our disclosure was made after review of after review of these activities.The corresponding author, <b>Dr. Pedapati</b> reports no conflicts of interest and is supported by an NIH K23 Clinical Development Award (K23MH112936) and has received past research support from the American Academy of Child and Adolescent Psychiatry, and Cincinnati Children’s Hospital Research Foundation and textbook royalties from Springer. In the past he has consulted for Eccrine Systems, Forge Therapeutics, P&G, and Autism Speaks. The senior author <b>Dr. Erickson</b> is the principal investigator of the human portion of the NIH FXS Center. He has received compensation from Confluence Pharma, Novartis, F. Hoffmann-La Roche Ltd., Seaside Therapeutics, Riovant Sciences, Inc., Fulcrum Therapeutics, Forge Therapeutics, Neuren Pharmaceuticals Ltd., Alcobra Pharmaceuticals, Neurotrope, Zynerba Pharmaceuticals, Inc., and Ovid Therapeutics Inc. to consult on trial design or development strategies and/or conduct clinical trials in neurodevelopmental disorders. Dr. Erickson is additionally the inventor or co-inventor on several patents held by Cincinnati Children’s Hospital Medical Center and Indiana University School of Medicine describing methods of treatment of neurodevelopmental disorders. <b>Dr. Wu</b> receives research support from NIH, Quince Therapeutics, and Emalax Biosciences. <b>Dr. Sweeney</b> consults to VeraSci and has received support from NIH and Sichuan University. <b>Dr. Horn</b> has no conflicts of interest to disclose. <b>Dr. Gilbert</b> has received compensation for expert testimony for the U.S. National Vaccine Injury Compensation Program, through the Department of Health and Human Services. He has received payment for medical expert opinions through TeladocHealth International. He has served as a paid consultant for Emalex Biosciences. He has received research support from the United States National Institutes of Health (Tourette Syndrome, ADHD research) and the Department of Defense (Neurofibromatosis research). He has received salary compensation through Cincinnati Children’s for work as a clinical trial site investigator from Emalex (clinical trial, Tourette Syndrome), PTC Therapeutics (registry and clinical trial, Amino Acid Decarboxylase Deficiency). He has received book/publication royalties from Elsevier and Wolters Kluwer. <b>Dr. Larsh</b> has received research and travel support from the Tourette Association of America (TAA), as well as travel support and honoraria from the Child Neurology Society (CNS). <b>Dr. Elmaghraby</b>, <b>Dr. Liu</b>, and <b>Dr. Smith</b> have no disclosures of funding or external compensation.Finally, we acknowledge that Dr. Craig Erickson serves as an Associate Editor for the Journal of Autism and Developmental Disorders.
: This study was approved by the institutional review board at Cincinnati Children’s Hospital Medical Center (CCHMC) and registered with ClinicalTrials.gov (NCT01609374). Recruitment took place between November 2021 and November 2022 through clinician referrals, community flyers, emails, and clinics at a tertiary academic pediatric hospital. All participants provided written informed consent or assent for all study procedures.