Abstract
There is growing interest in measuring social disability as a core element of autism spectrum disorders in medication trials. We conducted a secondary analysis on the Aberrant Behavior Checklist Social Withdrawal subscale using data from two federally-funded, multi-site, randomized trials with risperidone. Study 1 included 52 subjects assigned to placebo and 49 subjects to risperidone under double-blind conditions. Study 2 included 49 subjects assigned to risperidone only and 75 subjects assigned to risperidone plus parent training. After 8 weeks of treatment, all active treatments were superior to placebo (effect sizes ranging from 0.42 to 0.65). The findings suggest that the Social Withdrawal subscale may be a useful measure of social disability in acute treatment trials.
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Acknowledgments
NIMH: Ann Wagner, Ph.D., William R. Harlan, M.D., Yale: Mary Ellen Pachler.MSN, Karol Katz, MS, Caitlin Tillberg, B.A. IU: Jon T. Diener, B·S.; Kelly A. Ernsperger, L.C.S.W.; Joy M. Fairbanks, M.S.; Jennifer E. Mullett, R.N.; Marianna R. Zaphiriou, B.A. OSU: Kristy Hall-Reel, M.A.; Amanda Wilkes, M.A.; Kristina Humphries, M.S.; Lorelai Ark, M.A.; Susan Thompson. For support as Scientific Advisors: Andrew C. Leon, Ph.D., Weill Medical College of Cornell University Jose Alvir, Dr.P.H., New York University Child Study Center; CT Gordon, M.D. (Private Practice, Rockville, Maryland); Sandra Harris, Ph.D., Rutgers University, State University of New Jersey; Henrietta Leonard, M.D., Brown University; Susan Swedo, M.D., NIMH Intramural Research Program; Richard Todd, Ph.D., M.D., Washington University School of Medicine. DSMB. This work was funded by National Institute of Mental Health by the following RUPP grants and contracts: Yale, N01MH70009, U10MH66764 (Dr Scahill); Ohio State University, N01MH80011, U10MH66768 (Dr Aman); Indiana University, N01MH70001, U10MH66766 (Dr McDougle); N01MH70010 (Dr McCracken); and. Johnson & Johnson Pharmaceutical Research & Development provided active risperidone and placebo for RUPP 1 and risperidone for RUPP 2. This publication was also supported by the Yale CTSA, UL1 RR024139, IU CTSA UL1 RR025761, OSU CTSA UL1 RR025755 from the National Center for Research Resources (NCRR); K24 MH001805 (Dr McCracken) from the National Institute of Mental Health, and by the Korczak Foundation, Amsterdam, the Netherlands (Dr Scahill).
Conflict of interest
Dr. Scahill: Roche, consultant; Pfizer, consultant; Bracket, consultatnt, BioMarin, consultant. Shire, research support; Roche, research support; Pfizer, research support. Dr. Aman: Roche, consultant; Bristol-Meyers Squibb, consultant, research grant; Forest, consultant; Pfizer, consultant; Supernus, consultant; Johnson & Johnson, research grant. Dr. McDougle: Bristol-Myers Squibb, consultant, research grant, speaker’s bureau; Forest Research Institute, consultant. Dr. McCracken: Hoffman-Roche, consultant; BioMarin, consultant; Shionogi, consultant; Novartis, consultant; Noven, consultant; PharmaNet consultant; Bristol Myers Squibb, consultant; Seaside Therapeutics, consultant, research support; Dr. Arnold: AstraZeneca, advisory board; Biomarin, advisory board; CureMark, research funding; Lilly, research funding; Noven, advisory board; Seaside therapeutics, advisory board; Shire, research funding. Dr. Tierney : BioMarin, consultant. Dr. Dziura and Dr. Vitiello report no financial relationships with commercial interests.
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Scahill, L., Hallett, V., Aman, M.G. et al. Brief Report: Social Disability in Autism Spectrum Disorder: Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials. J Autism Dev Disord 43, 739–746 (2013). https://doi.org/10.1007/s10803-012-1689-3
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DOI: https://doi.org/10.1007/s10803-012-1689-3