Original Research/StudyImproving Developmental Abilities in Infants With Tuberous Sclerosis Complex A Pilot Behavioral Intervention StudyMcDonald, Nicole M. PhD; Hyde, Carly BS; Choi, April Boin EdM; Gulsrud, Amanda C. PhD; Kasari, Connie PhD; Nelson, Charles A. III PhD; Jeste, Shafali S. PhDAuthor Information UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California (Dr McDonald, Gulsrud, Kasari, and Jeste and Ms Hyde); Harvard Graduate School of Education, Boston, Massachusetts (Ms Choi); and Boston Children's Hospital, Harvard University, Boston, Massachusetts (Dr Nelson). Correspondence: Nicole M. McDonald, PhD, UCLA Semel Institute for Neuroscience and Human Behavior, 760 Westwood Plaza, Los Angeles, CA 90095 ([email protected]). The research reported in this article was supported by a Pilot Clinical Trial Award from the Department of Defense (DOD CDMRP TSCRP: W81XWH-15-1-0183). The authors acknowledge the contributions of Scott Huberty and the broader TSC study team in recruitment, assessment, intervention, and data management. The authors thank the families who participated in this research.S.S.J. serves as a consultant for Roche Pharmaceuticals and on the professional advisory board for the Tuberous Sclerosis Alliance. The remaining authors (N.M.M., C.H., A.B.C., A.G., C.K., and C.A.N.) do not have any conflicts of interest associated with this study. Infants & Young Children: April/June 2020 - Volume 33 - Issue 2 - p 108-118 doi: 10.1097/IYC.0000000000000160 Buy Metrics Abstract Tuberous sclerosis complex (TSC) is a rare genetic syndrome that confers risk for neurodevelopmental disorders, including autism spectrum disorder and intellectual disability. Delays in social communication and early cognitive abilities are observable as early as 9 months of age in children with TSC; however, there have been no studies of early behavioral intervention in TSC. We conducted a pilot study of an evidence-based, parent-mediated behavioral intervention focused on improving early social communication and play skills in 5 children with TSC (aged 1–3 years). Participants showed maintenance and sometimes gains in developmental abilities, relative to peers, following intervention. Parents generally found the intervention to be helpful and were able to administer the intervention with fidelity. Preliminary results demonstrate initial feasibility of an early play-based, parent-mediated intervention and support the need for a large-scale, randomized clinical trial in TSC. © 2020 Wolters Kluwer Health, Inc. All rights reserved.